Chapter 400j

(1) “Administer” or “Administration” means the direct application of a drug or device to the body of a patient or research subject by injection, inhalation, ingestion or any other means;

(2) “Automated prescription dispensing machine” means a device and associated software operated by a pharmacy or a pharmacy that is registered as a nonresident pharmacy pursuant to section 20-627, in a nursing home or skilled nursing facility licensed pursuant to sections 19a-490 and 19a-491, that packages and labels patient-specific medication or multiple medications for the purposes of administration by a registered nurse or a licensed practical nurse based on a prescription that has completed final verification by a licensed pharmacist;

(3) “Care-giving institution” means an institution that provides medical services and is licensed, operated, certified or approved by the Commissioner of Public Health, the Commissioner of Developmental Services or the Commissioner of Mental Health and Addiction Services;

(4) “Commission” means the Commission of Pharmacy appointed under the provisions of section 20-572;

(5) “Commissioner” means the Commissioner of Consumer Protection;

(6) “Compound” means to combine, mix or put together two or more ingredients pursuant to a prescription and includes the preparation of drugs or devices in anticipation of prescriptions based on routine, regularly-observed prescribing patterns;

(7) “Correctional or juvenile training institution” means a facility for the detention or incarceration of persons convicted or accused of crimes or offenses or for training of delinquent juveniles, including those state facilities under the jurisdiction of the Commissioner of Correction, training schools for delinquent juveniles and any other facilities operated by the state or municipalities for such detention, incarceration or training;

(8) “Device” means instruments, apparatuses and contrivances, including their components, parts and accessories, intended (A) for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans or other animals, or (B) to affect the structure or any function of the body of humans or other animals, but does not mean contact lenses;

(9) “Department” means the Department of Consumer Protection;

(10) “Deprescribing” means the systematic process of identifying and discontinuing drugs in instances in which existing or potential harms outweigh existing or potential benefits within the context of an individual patient's care goals, current level of functioning, life expectancy, values and preferences;

(11) “Dispense” means those acts of processing a drug or device for delivery or for administration for a patient pursuant to a prescription consisting of: (A) Comparing the directions on the label with the directions on the prescription to determine accuracy; (B) the selection of the drug or device from stock to fill the prescription; (C) the counting, measuring, compounding or preparation of the drug or device; (D) the placing of the drug or device in the proper container; (E) the affixing of the label to the container; and (F) the addition to a written prescription of any required notations. “Dispense” does not include the acts of delivering a drug or device to a patient or of administering the drug or device to the patient;

(12) “Dispensing outpatient facility” means a facility operated by a corporation or municipality which provides medical services to patients on an outpatient basis and which maintains stocks of drugs for dispensing of drugs on a regular basis to patients for use off the premises;

(13) “Drug” means (A) an article recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States or official National Formulary, or any supplement to any of them, (B) an article intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans or other animals, (C) an article, other than food, intended to affect the structure or any function of the body of humans or any other animal, and (D) an article intended for use as a component of any article specified in this subdivision, but does not include a device;

(14) “Institutional pharmacy” means that area within a care-giving institution or within a correctional or juvenile training institution, commonly known as the pharmacy, that is under the direct charge of a pharmacist and in which drugs are stored and dispensed;

(15) “Legend device” means a device that is required by applicable federal or state law to be dispensed pursuant only to a prescription or is restricted to use by prescribing practitioners only or that, under federal law, is required to bear either of the following legends: (A) “RX ONLY” IN ACCORDANCE WITH GUIDELINES ESTABLISHED IN THE FEDERAL FOOD, DRUG AND COSMETIC ACT; or (B) “CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE FOR USE BY OR ON THE ORDER OF A LICENSED VETERINARIAN.”;

(16) “Legend drug” means a drug that is required by any applicable federal or state law to be dispensed pursuant only to a prescription or is restricted to use by prescribing practitioners only, or means a drug that, under federal law, is required to bear either of the following legends: (A) “RX ONLY” IN ACCORDANCE WITH GUIDELINES ESTABLISHED IN THE FEDERAL FOOD, DRUG AND COSMETIC ACT; or (B) “CAUTION: FEDERAL LAW RESTRICTS THIS DRUG FOR USE BY OR ON THE ORDER OF A LICENSED VETERINARIAN.”;

(17) “Medical device and oxygen provider” means a person who distributes devices or oxygen pursuant to a medical order or prescription, except if such person already maintains an active pharmacy license;

(18) “Medication reconciliation” means a process of comparing the medications a patient is taking and should be taking with newly ordered medications (A) for the purpose of addressing duplications, omissions and interactions and the need to continue current medications, and (B) by looking at information such as the medication name, dose, frequency, route of administration and purpose;

(19) “Nonlegend device” means a device that is not a legend device;

(20) “Nonlegend drug” means a drug that is not a legend drug;

(21) “Person” means an individual, corporation, business trust, estate trust, partnership, association, joint venture or any other legal or commercial entity;

(22) “Pharmacist” means an individual who is licensed to practice pharmacy under the provisions of section 20-590, 20-591, 20-592 or 20-593, and who is thereby recognized as a health care provider by the state of Connecticut;

(23) “Pharmacy” means a place of business where drugs and devices may be sold at retail and for which a pharmacy license has been issued to an applicant under the provisions of section 20-594;

(24) “Pharmacy intern” means an individual registered under the provisions of section 20-598;

(25) “Pharmacy technician” means an individual who is registered with the department and qualified in accordance with section 20-598a;

(26) “Polypharmacy” means the use of multiple drugs by a patient, including any medication that is inappropriate or not medically necessary, such as those not indicated, not effective or constituting a therapeutic duplication;

(27) “Practice of pharmacy” or “to practice pharmacy” means the sum total of knowledge, understanding, judgments, procedures, securities, controls and ethics used by a pharmacist to assure optimal safety and accuracy in the distributing, dispensing and use of drugs and devices;

(28) “Prescribing practitioner” means an individual licensed by the state of Connecticut, any other state of the United States, the District of Columbia, the Commonwealth of Puerto Rico or any territory or insular possession subject to the jurisdiction of the United States who is authorized to issue a prescription within the scope of the individual's practice;

(29) “Prescription” means a lawful order of a prescribing practitioner transmitted either orally, in writing or by electronic means for a drug or device for a specific patient;

(30) “Sale” includes barter, exchange or gift or offer and each such transaction made by a person whether as principal proprietor, agent, servant or employee;

(31) “Substitute” means to dispense without the prescribing practitioner's express authorization a different drug product than the drug product prescribed;

(32) “Third-party logistics provider” means a person who distributes drugs, devices or cosmetics while taking possession of the drugs, devices or cosmetics but who does not take title of the drugs, devices or cosmetics;

(33) “Virtual manufacturer” means a person who engages in the manufacture of drugs, devices or cosmetics for which such person: (A) Owns the new drug application or abbreviated new drug application number, if a prescription drug; (B) owns the unique device identification number, as available, for a prescription device; (C) contracts with a contract manufacturing organization for the physical manufacture of the drugs, devices or cosmetics; (D) is not involved in the physical manufacture of the drugs, devices or cosmetics; and (E) at no time takes physical possession of or stores the drugs, devices or cosmetics; and

(34) “Virtual wholesale distributor” means a person who facilitates or brokers the transfer of drugs, devices or cosmetics without taking physical possession of the drugs, devices or cosmetics.

(1969, P.A. 48, S. 1; P.A. 73-211; P.A. 78-310, S. 3; P.A. 85-241, S. 1; P.A. 86-403, S. 42, 132; P.A. 91-27, S. 2; P.A. 95-257, S. 11, 12, 21, 58; 95-264, S. 2; P.A. 98-31, S. 2; 98-120; P.A. 99-175, S. 6; P.A. 00-182, S. 5; June 30 Sp. Sess. P.A. 03-6, S. 146(c), (d); P.A. 04-169, S. 17; 04-189, S. 1; P.A. 07-73, S. 2 (b); P.A. 17-77, S. 7; July Sp. Sess. P.A. 20-4, S. 2; P.A. 21-192, S. 1.)

History: P.A. 73-211 defined “practice of pharmacy”; P.A. 78-310 included persons licensed by another state, the District of Columbia or the Commonwealth of Puerto Rico in definition of “licensed practitioner”; P.A. 85-241 deleted the definition of “administer”, redefined “legend drug” to add warning for drugs used by veterinarians and excluded agricultural food supplements from the definition of “medicine”; P.A. 86-403 made technical changes; P.A. 91-27 redefined “written prescription” to include orders described under Sec. 19a-509c; P.A. 95-257 replaced Commissioner and Department of Public Health and Addiction Services with Commissioner and Department of Public Health and replaced Commissioner and Department of Mental Health with Commissioner and Department of Mental Health and Addiction Services, effective July 1, 1995; P.A. 95-257 replaced Commissioner and Department of Public Health and Addiction Services with Commissioner and Department of Public Health and replaced Commissioner and Department of Mental Health with Commissioner and Department of Mental Health and Addiction Services, effective July 1, 1995; P.A. 95-264 replaced existing definitions with new definitions; Sec. 20-184a transferred to Sec. 20-571 in 1997; P.A. 98-31 amended Subdiv. (20) to redefine “pharmacy technician”; P.A. 98-120 amended Subdiv. (17) to redefine “pharmacist”; P.A. 99-175 made technical changes, replaced reference to Sec. 20-625 with reference to Sec. 20-630, amended Subdiv. (3) to add reference to Sec. 20-572 and amended Subdivs. (13) and (14) to change wording of required legends on legend devices and legend drugs; P.A. 00-182 amended Subdivs. (13) and (14) to make technical changes to “legend device” and “legend drug” definitions; June 30 Sp. Sess. P.A. 03-6 and P.A. 04-169 replaced Commissioner and Department of Consumer Protection with Commissioner and Department of Agriculture and Consumer Protection, effective July 1, 2004; P.A. 04-189 repealed Sec. 146 of June 30 Sp. Sess. P.A. 03-6, thereby reversing the merger of the Departments of Agriculture and Consumer Protection, effective June 1, 2004; pursuant to P.A. 07-73 “Commissioner of Mental Retardation” was changed editorially by the Revisors to “Commissioner of Developmental Services”, effective October 1, 2007; P.A. 17-77 added new Subdiv. (15) defining medical device and oxygen provider, redesignated existing Subdivs. (15) to (25) as Subdivs. (16) to (26), added Subdiv. (27) defining third-party logistics provider, added Subdiv. (28) defining virtual manufacturer and added Subdiv. (29) defining virtual wholesale distributor, and made technical changes, effective July 1, 2017; July Sp. Sess. P.A. 20-4 added new Subdiv. (16) defining nonlegend device and redesignated existing Subdivs. (16) to (29) as Subdivs. (17) to (30), effective January 1, 2021; P.A. 21-192 amended introductory language to change reference from Secs. 20-570 to 20-630 to “this chapter”, amended Subdiv. (1) by adding “or Administration”, added new Subdiv. (2) defining “automated prescription dispensing machine”, redesignated existing Subdivs. (2) to (8) as Subdivs. (3) to (9), added new Subdiv. (10) defining “deprescribing”, redesignated existing Subdivs. (9) to (15) as Subdivs. (11) to (17), added new Subdiv. (18) defining “medication reconciliation”, redesignated existing Subdivs. (16) to (22) as Subdivs. (19) to (25), added new Subdiv. (26) defining “polypharmacy” and redesignated existing Subdivs. (23) to (30) as Subdivs. (27) to (34), effective July 13, 2021.

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Sec. 20-572. (Formerly Sec. 20-163). Commission of Pharmacy. Appointment and term of members. There shall be in the department a Commission of Pharmacy that shall consist of seven persons appointed by the Governor, subject to the provisions of section 4-9a, five of whom shall be pharmacists each actively engaged in the practice of pharmacy on a full-time basis during the term of such person's appointment in this state and two of whom shall be public members. At least two of the pharmacist members shall be community retail pharmacists, one from an independent retail setting and one from a chain retail setting, and at least one of the pharmacist members shall be a pharmacist employed on a full-time basis as a pharmacist in a hospital in the state during the term of such pharmacist member's appointment. Members of the commission may be selected from lists of individuals nominated by the Connecticut Pharmacists Association or by other professional associations of pharmacists or pharmacies. Any vacancy on the commission shall be filled by the Governor.

(1949 Rev., S. 4463, 4480; 1969, P.A. 593, S. 14; P.A. 75-30, S. 1, 2; P.A. 77-79; 77-614, S. 196, 610; Nov. Sp. Sess. P.A. 81-11, S. 6, 19; P.A. 82-419, S. 40, 47; P.A. 95-264, S. 3; P.A. 99-175, S. 7; P.A. 13-86, S. 1.)

History: 1969 act increased membership from five to six, adding member who is hospital-employed licensed pharmacist, increased terms from 5 to 6 years and extended terms of members appointed before June 24, 1969, by 1 year; P.A. 75-30 specified that hospital-employed member be a “practicing” pharmacist on “full-time basis” in “licensed” hospital; P.A. 77-79 limited members to two full terms; P.A. 77-614 placed commission within the department of consumer protection, specified appointment of members by governor, reduced number of licensed pharmacist members from five to four and added two public members, revised appointment provision to delete June first appointment date and 6-year term and deleted reference to filling vacancies from nominees of Pharmaceutical Association, effective January 1, 1979; Nov. Sp. Sess. P.A. 81-11 replaced provision which allowed commission members $500 per annum and chairman an additional $1,000 per annum as compensation and allowed reimbursement for their traveling expenses with provision specifying that members receive no compensation but are to be reimbursed for necessary expenses incurred in performing their duties; P.A. 82-419 amended section to provide that appointments are subject to section 4-9a, to delete 10 years' experience requirement, to require that pharmacist members be actively engaged in full-time practice of pharmacy while serving and to require that two pharmacist members be community retail pharmacists; P.A. 95-264 increased number of commissioners from three to four, adding hospital pharmacist member, eliminated requirement for six-person nominee list, permitted members of the commission to be selected from lists of nominees offered by professional associations other than Connecticut Pharmacists Association and deleted redundant provisions re filling vacancies, term limitations and reimbursements; Sec. 20-163 transferred to Sec. 20-572 in 1997; P.A. 99-175 made technical and gender neutral changes; P.A. 13-86 increased commission membership from 6 to 7 members, required 5 rather than 4 members to be pharmacists and required 2 of the pharmacist members to be from an independent retail and chain retail setting, effective July 1, 2013.

See Sec. 4-9a for definition of “public member”.

See Sec. 4-10 re appointment of board and commission members from lists provided to Governor.

See Secs. 21a-6 to 21a-10, inclusive, re control, powers and duties of boards within the Department of Consumer Protection.

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Sec. 20-573. (Formerly Sec. 20-165). Meetings of commission. Records. (a) Meetings of the commission for the purpose of conducting business of the commission shall be held at the office of the commission at least six times per calendar year and at such other times and places in each year as the chairperson or a majority of the commission deems necessary.

(b) The commission shall keep a record of its proceedings. Such record shall be made available to the public upon request and shall contain the name and license number of any pharmacist or pharmacy that the commission has recommended formal disciplinary action against. A copy of any such record, certified by the commissioner, shall be admitted as evidence in any civil or criminal action in lieu of the record.

(1949 Rev., S. 4475; P.A. 82-419, S. 41, 47; P.A. 95-264, S. 4; P.A. 99-175, S. 8; P.A. 09-150, S. 2.)

History: P.A. 82-419 amended section to allow calling of meetings by chairperson; P.A. 95-264 required the commission to conduct business at its office at least six times a year and added Subsec. (b) requiring that record of proceedings be kept; Sec. 20-165 transferred to Sec. 20-573 in 1997; P.A. 99-175 made technical changes; P.A. 09-150 amended Subsec. (b) by adding provision re record being made available by request to public and containing certain information when commission has recommended formal disciplinary action.

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Sec. 20-574. (Formerly Sec. 20-164a). Supervision by Commissioner of Consumer Protection. The commissioner shall exercise supervision over the operations of the commission pursuant to sections 20-570 to 20-630, inclusive.

(1959, P.A. 412, S. 30; P.A. 77-614, S. 198, 610; P.A. 95-264, S. 5; P.A. 99-175, S. 9; P.A. 16-185, S. 43.)

History: P.A. 77-614 deleted statement placing commission within consumer protection department “for fiscal and budgetary purposes”, effective January 1, 1979; P.A. 95-264 made technical change; Sec. 20-164a transferred to Sec. 20-574 in 1997; P.A. 99-175 made technical changes and replaced reference to Sec. 20-625 with reference to Sec. 20-630; P.A. 16-185 deleted “general”, effective July 1, 2016.

Commissioner has the authority to review defendant pharmacy's billing records. 53 CA 129.

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Sec. 20-575. Powers and responsibilities. (a) The commission shall administer and enforce the provisions of sections 20-570 to 20-630, inclusive. The commission has all powers specifically granted in the general statutes, including the powers set forth in sections 21a-7 and 21a-9, and all further powers that are reasonable and necessary to enable the commission to protect the public interest in accordance with the duties imposed by sections 20-570 to 20-630, inclusive.

(b) The commission may compel attendance of witnesses and the production of documents by subpoena and may administer oaths. If any person refuses or fails to appear, testify or produce any document when so ordered, a judge of the Superior Court may, upon application of the commission, make such order as may be appropriate to enforce this subsection.

(c) The commission may apply to the Superior Court for and the court may, upon hearing and for cause shown, grant a temporary or permanent injunction enjoining any person from violating any provision of sections 20-570 to 20-630, inclusive, or any regulation adopted in accordance with chapter 54 by the commissioner, with the advice and assistance of the commission, pursuant to sections 20-570 to 20-630, inclusive, irrespective of whether an adequate remedy at law exists. The commission also may apply to the Superior Court for, and the court shall have jurisdiction to grant, a temporary restraining order pending a hearing.

(d) An application to the Superior Court under subsection (b) or (c) of this section shall be brought by the Attorney General.

(P.A. 95-264, S. 6; P.A. 99-175, S. 10.)

History: P.A. 99-175 made technical changes, replaced references to Sec. 20-625 with references to Sec. 20-630, amended Subsec. (c) to delete provision requiring department to adopt regulations and to instead require adoption of regulations by commissioner, with advice and assistance of commission and designated provisions re application to Superior Court by the Attorney General as Subsec. (d).

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Sec. 20-576. (Formerly Sec. 20-164). Regulations. (a) The commissioner may, with the advice and assistance of the commission, adopt regulations, in accordance with chapter 54, to govern the performance of the commission's duties, the practice of pharmacy and the business of retailing drugs and devices. Such regulations may include, but are not limited to, provisions (1) concerning the licensing of any pharmacist or pharmacy, disciplinary action that may be taken against a licensee, the conduct of a pharmacist and the operation of a pharmacy, (2) specifying various classes of pharmacy licenses issued under section 20-594, including, but not limited to, licenses for infusion therapy pharmacies and nuclear pharmacies and specifying requirements for operation of pharmacies under the classes of pharmacy licenses permitted under the regulations, (3) concerning creation and maintenance of prescription records, and (4) concerning registration and activities of pharmacy interns, registered pharmacy technicians and certified pharmacy technicians.

(b) The commissioner shall, with the advice and assistance of the commission, adopt regulations, in accordance with chapter 54, governing (1) the storage and retrieval of prescription information for noncontrolled substances, including refills, by pharmacists through the use of electronic data processing systems or other systems for the efficient storage and retrieval of information, (2) the operation of institutional pharmacies pursuant to chapters 368a and 418, and sections 17a-210 to 17a-273, inclusive, 19a-490 to 19a-520, inclusive, and 20-570 to 20-630, inclusive, and (3) the activities of pharmacy technicians in pharmacies and institutional pharmacies, including ratios of registered pharmacy technicians and certified pharmacy technicians to pharmacists in pharmacies and institutional pharmacies.

(1949 Rev., S. 4464; 1955, S. 2236d; September, 1957, P.A. 11, S. 13; P.A. 75-254, S. 1, 2; P.A. 77-614, S. 197, 610; P.A. 95-264, S. 7; P.A. 98-31, S. 3; P.A. 99-175, S. 11; P.A. 04-208, S. 1.)

History: P.A. 75-254 deleted authority for commission to publish and distribute regulations and to employ attorney to conduct prosecutions for violations of chapter, allowed commission to compel production of documents by subpoena, required annual report to commissioner of consumer protection rather than to governor and required certification of records “by executive secretary to the commission”, replacing less specific requirement for certification “by its secretary”; P.A. 77-614 transferred power to adopt regulations from commission to commissioner of consumer protection, retaining commission in advisory role and deleted provision re election of chairman, effective January 1, 1979; P.A. 95-264 added Subsec. (a)(1) to (4), inclusive, and Subsec. (b) re matters subject to regulation; Sec. 20-164 transferred to Sec. 20-576 in 1997; P.A. 98-31 amended Subsec. (a)(4) by adding reference to pharmacy technicians; P.A. 99-175 made technical changes and amended Subsec. (b) to require regulations to be adopted in accordance with chapter 54 and to replace reference to Sec. 20-625 with reference to Sec. 20-630; P.A. 04-208 added references to registered pharmacy technicians and certified pharmacy technicians, effective June 3, 2004.

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Sec. 20-576a. Acceptance and disposal of unused prescription drugs at pharmacies. Regulations. Not later than July 1, 2018, the Commissioner of Consumer Protection, with the advice and assistance of the Commission of Pharmacy, shall adopt regulations, in accordance with the provisions of chapter 54, to allow not more than fifty retail locations during the first year and not more than an additional fifty retail locations in each year thereafter, at pharmacies licensed pursuant to chapter 400j, to accept and dispose of unused prescription drugs. Such regulations shall: (1) Comply with federal law regarding the acceptance and disposal of unused prescription drugs at pharmacies, (2) establish a tracking and monitoring system and security requirements for such drugs, and (3) specify locations within pharmacies where such drugs may be accepted and stored. The commissioner, after consulting with the Commissioner of Energy and Environmental Protection, shall establish a process in such regulations to ensure the secure removal and destruction of such unused prescription drugs including, but not limited to, allowing for optional prescription drug disposal agreements with law enforcement authorities.

(P.A. 17-109, S. 1.)

History: P.A. 17-109 effective July 6, 2017.

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Sec. 20-577. (Formerly Sec. 20-179). Employment of inspectors by Commissioner of Consumer Protection; duties. Inspection of correctional, juvenile training and care-giving institutions, dispensing outpatient facilities, institutional and retail pharmacies by commissioner. (a) The commissioner shall employ inspectors whose duty it shall be to inspect all pharmacies and other places in which drugs and devices are or may be dispensed or retailed, and to report any violations of sections 20-570 to 20-630, inclusive, or other laws relating to drugs and devices and violations of laws regarding pharmacy licenses, nonlegend drug permits, licenses of pharmacists and supervision of pharmacy interns and pharmacy technicians.

(b) The commissioner shall inspect correctional or juvenile training institutions and care-giving institutions throughout the state with respect to the handling of drugs, shall report violations of law and make recommendations for improvements in procedures to the authority responsible for the operation of the institution and shall take such other steps as may be necessary to ensure proper and adequate storage, handling and administration of drugs in such institutions. The commissioner may also inspect dispensing outpatient facilities and institutional pharmacies and take such steps as the commissioner considers appropriate to correct deficiencies found in such facilities or institutional pharmacies with respect to their operation.

(c) The commissioner shall inspect each retail pharmacy not less than once every four years and shall develop a methodology to sample prescriptions dispensed by retail pharmacies for compliance with state laws concerning the dispensing of prescriptions. Such methodology shall be based on the number of prescriptions received by such retail pharmacies.

(1949 Rev., S. 4479; 1969, P.A. 593, S. 15; P.A. 77-614, S. 205, 610; P.A. 95-264, S. 8; P.A. 99-175, S. 12; P.A. 05-212, S. 3.)

History: 1969 act made employment of inspectors mandatory rather than optional, deleted requirement that inspections be made during usual business hours and included inspections of institutional pharmacies; P.A. 77-614 replaced commission of pharmacies with commissioner of consumer protection, effective January 1, 1979; P.A. 95-264 deleted obsolete reference to assistant pharmacist and added Subsec. (b) re commissioner's inspection of correctional, juvenile training and care-giving institutions, dispensing outpatient facilities and institutional pharmacies; Sec. 20-179 transferred to Sec. 20-577 in 1997; P.A. 99-175 made technical and gender neutral changes and amended Subsec. (a) to replace reference to Sec. 20-625 with reference to Sec. 20-630; P.A. 05-212 added Subsec. (c) re inspection of retail pharmacies, effective July 6, 2005.

See Sec. 21a-244 re regulations concerning storage and retrieval of prescription information for controlled substances.

Annotation to former section 20-179:

Cited. 207 C. 698.

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Sec. 20-578. (Formerly Sec. 21a-306). Information not to be disclosed. Exception. (a) Information received by the department, the commission or the Department of Public Health, through filed reports or inspection or as otherwise authorized under chapters 418, 420b, 420c and 420f and sections 20-570 to 20-630, inclusive, shall not be disclosed publicly in such a manner as to identify individuals or institutions, except: (1) In a proceeding involving the question of licensure or the right to practice; and (2) in a proceeding where the commission has voted in favor of formal disciplinary action against a pharmacist or pharmacy licensed pursuant to this chapter, when such disciplinary action is related to an error in the dispensing of medication. Nothing in this section shall be construed to prohibit the commissioner from disclosing information gained through the inspection of pharmacies and outlets holding permits for the sale of nonlegend drugs if the commissioner considers such disclosure to be in the interest of public health.

(b) Notwithstanding the provisions of subsection (a) of this section, section 21a-265 and chapter 55, the Commissioners of Consumer Protection and Public Health and the authorized agents of said commissioners, in carrying out their duties under subsection (a) of this section, may: (1) Exchange information relating to a license or registration issued by their respective agencies; or (2) exchange investigative information relating to violations of this chapter with each other, the Chief State's Attorney and any agencies charged with enforcing the pharmacy or drug laws of the United States, this state or other jurisdictions.

(1969, P.A. 593, S. 8; P.A. 77-614, S. 323, 610; P.A. 87-204; P.A. 93-381, S. 9, 39; P.A. 95-257, S. 12, 21, 58; 95-264, S. 9; P.A. 99-175, S. 13; P.A. 07-252, S. 73; P.A. 09-150, S. 1; P.A. 22-104, S. 30.)

History: P.A. 77-614 replaced department of health with department of health services, effective January 1, 1979; Sec. 19-504h transferred to Sec. 21a-306 in 1983; P.A. 87-204 added provision re disclosure of information deemed to be in the interest of public health; P.A. 93-381 authorized substitution of department of public health and addiction services for department of health services, effective July 1, 1993; P.A. 95-257 replaced Commissioner and Department of Public Health and Addiction Services with Commissioner and Department of Public Health, effective July 1, 1995; P.A. 95-264 made technical changes to conform language to similar provisions throughout statutes; Sec. 21a-306 transferred to Sec. 20-578 in 1997; P.A. 99-175 made technical changes and replaced reference to Sec. 20-625 with reference to Sec. 20-630; P.A. 07-252 designated existing provisions as Subsec. (a) and added Subsec. (b) authorizing exchange of information among Commissioners of Consumer Protection and Public Health, the Chief State's Attorney and other agencies charged with enforcing pharmacy or drug laws; P.A. 09-150 amended Subsec. (a) by adding Subdiv. (2) re exemption for information in proceeding where disciplinary action is related to an error in dispensing medication and by making a conforming change; P.A. 22-104 amended Subsec. (a) by adding references to Chs. 420c and 420f, and made technical and conforming changes, effective May 24, 2022.

Annotation to former section 21a-306:

For purposes of statute, compliance meetings are not “proceedings” and documents relating to such meetings were exempt from disclosure. 207 C. 698.

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Sec. 20-579. (Formerly Sec. 20-175). Causes for suspension, revocation, refusal to issue or renew or the placing of conditions on licenses, temporary permits and registrations and for assessment of civil penalty. (a) The commission may refuse to authorize the issuance of a temporary permit to practice pharmacy, may refuse to authorize the issuance or renewal of a license to practice pharmacy, a license to operate a pharmacy or a registration of a pharmacy intern or pharmacy technician, and may revoke, suspend or place conditions on a license or temporary permit to practice pharmacy, a license to operate a pharmacy, or a registration of a pharmacy intern or a pharmacy technician, and may assess a civil penalty of up to one thousand dollars per violation of any provision of this chapter or take other action permitted in subdivision (7) of section 21a-7 if the applicant or holder of the license, temporary permit or registration: (1) Has violated a statute or regulation relating to drugs, devices or the practice of pharmacy of this state, any state of the United States, the United States, the District of Columbia, the Commonwealth of Puerto Rico, any territory or insular possession subject to the jurisdiction of the United States or a foreign jurisdiction; (2) has been convicted of violating any criminal statute relating to drugs, devices or the practice of pharmacy of this state, any state of the United States, the United States, the District of Columbia, the Commonwealth of Puerto Rico, any territory or insular possession subject to the jurisdiction of the United States or a foreign jurisdiction; (3) has been disciplined by, or is the subject of pending disciplinary action or an unresolved complaint before, the duly authorized pharmacy disciplinary agency of any state of the United States, the United States, the District of Columbia, the Commonwealth of Puerto Rico, any territory or insular possession subject to the jurisdiction of the United States or a foreign jurisdiction; (4) has been refused a license or registration or renewal of a license or registration by any state of the United States, the United States, the District of Columbia, the Commonwealth of Puerto Rico, any territory or insular possession subject to the jurisdiction of the United States or a foreign jurisdiction based on grounds that are similar to grounds on which Connecticut could refuse to issue or renew such a license or registration; (5) has illegally possessed, diverted, sold or dispensed drugs or devices; (6) abuses or excessively uses drugs, including alcohol; (7) has made false, misleading or deceptive representations to the public or the commission; (8) has maintained exclusive telephone lines to, has maintained exclusive electronic communication with, or has exclusive access to computers located in offices of prescribing practitioners, nursing homes, clinics, hospitals or other health care facilities; (9) has substituted drugs or devices except as permitted in section 20-619; (10) has accepted, for return to regular stock, any drug already dispensed in good faith or delivered from a pharmacy, and exposed to possible and uncontrolled contamination or substitution; (11) has split fees for professional services, including a discount or rebate, with a prescribing practitioner or an administrator or owner of a nursing home, hospital or other health care facility; (12) has entered into an agreement with a prescribing practitioner or an administrator or owner of a nursing home, hospital or other health care facility for the compounding or dispensing of secret formula or coded prescriptions; (13) has performed or been a party to a fraudulent or deceitful practice or transaction; (14) has presented to the commission a diploma, license or certificate illegally or fraudulently obtained, or obtained from a college or school of pharmacy not approved by the commission; (15) has performed incompetent or negligent work; (16) has falsified a continuing education document submitted to the commission or department or a certificate retained in accordance with the provisions of subsection (d) of section 20-600; (17) has permitted a person not licensed to practice pharmacy in this state to practice pharmacy in violation of section 20-605, to use a pharmacist license or pharmacy display document in violation of section 20-608, or to use words, displays or symbols in violation of section 20-609; (18) has failed to maintain the entire pharmacy premises, its components and contents in a clean, orderly and sanitary condition; (19) has failed to demonstrate adherence to applicable provisions of United States Pharmacopeia, Chapter 797, Pharmaceutical Compounding - Sterile Preparations, as amended from time to time; or (20) has failed to demonstrate adherence to applicable provisions of United States Pharmacopeia, Chapter 795, Pharmaceutical Compounding – Nonsterile Preparations, as amended from time to time.

(b) The commission may refuse to authorize the issuance of a temporary permit to practice pharmacy, may refuse to authorize the issuance or renewal of a license to practice pharmacy, a license to operate a pharmacy or a registration of a pharmacy intern or pharmacy technician, and may revoke, suspend or place conditions on a license or temporary permit to practice pharmacy, a license to operate a pharmacy, or a registration of a pharmacy intern or a pharmacy technician, or take other action permitted in subdivision (7) of section 21a-7 if the commission determines that the applicant or holder of the license, temporary permit or registration has a condition including, but not limited to, physical illness or loss of skill or deterioration due to the aging process, emotional disorder or mental illness, abuse or excessive use of drugs or alcohol that would interfere with the practice of pharmacy, operation of a pharmacy or activities as a pharmacy intern or pharmacy technician, provided the commission may not, in taking action against a license, temporary permit or registration holder on the basis of such a condition, violate the provisions of section 46a-73 or 42 USC Section 12132 of the federal Americans with Disabilities Act.

(1949 Rev., S. 4472; 1961, P.A. 149; 1963, P.A. 243; February, 1965, P.A. 162; 304, S. 2; 1969, P.A. 74; P.A. 73-480, S. 3, 4; P.A. 75-95, S. 2, 3; P.A. 76-166, S. 5, 8; P.A. 77-126, S. 1, 2; 77-614, S. 203, 610; P.A. 82-419, S. 42, 47; P.A. 84-75; P.A. 87-401, S. 3, 4; P.A. 95-264, S. 10; P.A. 98-31, S. 4; P.A. 99-175, S. 14; P.A. 00-182, S. 7; P.A. 17-77, S. 9; P.A. 18-16, S. 1.)

History: 1961 act changed technical language, required conviction in Subdiv. (1), added refusal to comply in Subdiv. (3) and added Subdivs. (4) to (16); 1963 act added Subdiv. (17); 1965 acts added Subdiv. (18) and amended Subdiv. (3) by adding “chapter 343 or”; 1969 act added Subdiv. (19) allowing revocation or suspension of license for failure to maintain sanitary conditions; P.A. 73-480 revised Subdiv. (17) to ban advertising or promotion of legend drugs rather than of those bearing cautionary label and made ban more forceful by adding “directly or indirectly, by any means, in any form”; P.A. 75-95 deleted former Subdiv. (17) banning advertising and renumbered remaining Subdivs.; P.A. 76-166 revised Subdiv. (8) banning drug substitution except as provided in Secs. 20-185b and 20-185c rather than “except on the order of a practitioner legally licensed to prescribe such articles”; P.A. 77-126 deleted Subdiv. (17) banning use on words “discount” or “cut rate” etc. in promotion or advertisement of services, renumbering Subdiv. (18) accordingly; P.A. 77-614 transferred power to make regulations from commission to consumer protection commissioner, retaining commission as advisor, effective January 1, 1979; P.A. 82-419 amended section to eliminate crimes involving moral turpitude, lack of professional integrity, advertising professional superiority and unprofessional conduct as disciplinary grounds and to change grounds of unfitness, incompetence, unskillfulness or gross negligence to performance of grossly incompetent or negligent work; P.A. 84-75 added as a cause for the revocation or suspension of a license access to computers located in offices of practitioners, nursing homes or clinics; P.A. 87-401 made falsification of certificate of approved continuing education units grounds for suspension or revocation of license; P.A. 95-264 replaced existing section with new provisions permitting the suspension, revocation and refusal to issue or renew licenses and registrations; Sec. 20-175 transferred to Sec. 20-579 in 1997; P.A. 98-31 added provisions re pharmacy technicians and made technical changes; P.A. 99-175 made technical changes and amended Subsec. (a) to empower commission to assess $1,000 civil penalty against persons who violate pharmacy license or registration statutes, rules or regulations; P.A. 00-182 added provisions re temporary permit to practice pharmacy; P.A. 17-77 amended Subsec. (b) by adding Subdivs. (19) and (20) re adherence to United States Pharmacopeia, added provisions re placement of conditions on license, permit and registration, and made technical changes, effective July 1, 2017; P.A. 18-16 added “per violation of any provision of this chapter” re assessment of civil penalty, effective January 1, 2019.

See Sec. 19a-70 re violation of regulations governing distribution of biologic products during an emergency as grounds for suspension, revocation or annulment of license.

See Sec. 30-36 re druggist's permit to sell alcoholic beverages.

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Sec. 20-580. (Formerly Sec. 20-167). Revocation or suspension of nonlegend drug permit. A permit to sell nonlegend drugs issued under section 20-624 may be revoked or suspended by the commission for any violation of the provisions of chapter 419 or of sections 20-570 to 20-630, inclusive, or for any violation of any federal law concerning the sale or offer for sale of any nonlegend drug, or for the violation of any regulation concerning the sale or offer for sale of any nonlegend drugs.

(1949 Rev., S. 4466; 1959, P.A. 270; February, 1965, P.A. 304, S. 1; P.A. 77-614, S. 200, 610; P.A. 95-264, S. 11; P.A. 99-175, S. 15.)

History: 1959 act applied commission's authority to make regulations to sale or offer for sale of compounds, etc. rather than to the grant of a selling permit to an unlicensed pharmacy, specified above provision's application to proprietary or patent medicinal compounds be in the alternative and extended conditions under which permit may be revoked or suspended from violation of commission's regulations to those stated in second sentence; 1965 act added reference to chapter 343; P.A. 77-614 transferred power to make regulations from commission of pharmacy to commissioner of consumer protection, retaining commission as advisor and replaced permittee's right to appeal with right to judicial review, effective January 1, 1979; P.A. 95-264 deleted provisions concerning adoption of regulations re proprietary or patent medicines and substituted provisions re revocation or suspension of nonlegend drug permits; Sec. 20-167 transferred to Sec. 20-580 in 1997; P.A. 99-175 made a technical change and replaced reference to Sec. 20-625 with reference to Sec. 20-630.

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Sec. 20-581. (Formerly Sec. 20-185). Penalty for violation of Pharmacy Practice Act. Exception. Any person who violates any provision of sections 20-570 to 20-631, inclusive, and section 20-635 for the violation of which no other penalty has been provided shall be guilty of a class D felony. For the purposes of this section, each instance of patient contact or consultation that is in violation of any provision of sections 20-570 to 20-631, inclusive, and section 20-635 shall be a separate offense. Failure to renew in a timely manner any license issued under said sections is not a violation for purposes of this section.

(1949 Rev., S. 4486; P.A. 84-526, S. 12; P.A. 95-264, S. 12; P.A. 99-175, S. 16; P.A. 05-73, S. 1; P.A. 13-258, S. 87.)

History: P.A. 84-526 amended section by changing penalty for violation of any provision of Secs. 20-163 to 20-184c, inclusive, to a fine of not more than $500 or imprisonment of not more than five years, and added provisions that each instance of patient contact or consultation shall constitute a separate offense and failure to renew license in timely manner is not a violation for purposes of section; P.A. 95-264 increased maximum fine from $500 to $5,000 for violations of the Pharmacy Practice Act, excluding failure to renew license in a timely manner; Sec. 20-185 transferred to Sec. 20-581 in 1997; P.A. 99-175 made technical changes and replaced references to Sec. 20-625 with references to Sec. 20-630; P.A. 05-73 included references to Secs. 20-631 and 20-635, effective May 31, 2005; P.A. 13-258 changed penalty from fine of not more than $5,000 or imprisonment of not more than 5 years to a class D felony and made a technical change.

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Sec. 20-582. (Formerly Sec. 20-176). Appeals of decisions of Commission of Pharmacy. Any person (1) holding a license, permit or registration under sections 20-570 to 20-630, inclusive, who has been disciplined by the commission, or (2) who has been refused a license, permit or registration under said sections or refused a renewal of a license or permit under said sections, may appeal as provided in section 4-183.

(1949 Rev., S. 4473; 1971, P.A. 179, S. 13; 870, S. 61; P.A. 76-436, S. 425, 681; P.A. 77-603, S. 71, 125; 77-614, S. 204, 610; P.A. 78-280, S. 41, 42, 127; P.A. 95-264, S. 13; P.A. 99-175, S. 17.)

History: 1971 acts required that appeals be taken between 12 and 30 days after service rather than on next return day or the “next but one” and replaced superior court with court of common pleas, effective September 1, 1971, except that courts with cases pending retain jurisdiction unless pending matters deemed transferable; P.A. 76-436 replaced court of common pleas with superior court and added references to judicial districts, effective July 1, 1978; P.A. 77-603 replaced appeal provisions, except those concerning venue and privileged status with statement that appeals be in accordance with Sec. 4-183; P.A. 77-614 deleted provisions concerning venue and privileged status of appeals, effective January 1, 1979; P.A. 78-280 restored venue provision and provision granting appeals privileged status; P.A. 95-264 deleted provisions on where appeals are returnable; Sec. 20-176 transferred to Sec. 20-582 in 1997; P.A. 99-175 added Subdiv. indicators and added references to Secs. 20-570 to 20-630, inclusive.

Annotation to former section 20-176:

Cited. 179 C. 415.

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Sec. 20-583. Where appeals returnable. An appeal of a decision by the commission to discipline a person licensed to practice pharmacy or registered as a pharmacy intern or pharmacy technician, to refuse a person's application for a license to practice pharmacy or to refuse to register a person as a pharmacy intern or pharmacy technician shall be made returnable to the judicial district in which the person resides or, if the person does not reside in Connecticut, to the judicial district of New Britain. An appeal of a decision by the commission to discipline the holder of a pharmacy license or the holder of a permit to sell nonlegend drugs or to refuse a person's application for such a license or permit appeal shall be made returnable to the judicial district in which the building or store is located, for which the license or permit was sought or in which it was suspended or revoked. All appeals under the provisions of this section shall be treated as privileged and shall be assigned for trial and tried as soon as may be practicable.

(P.A. 88-230, S. 1, 12; P.A. 90-98, S. 1, 2; P.A. 93-142, S. 4, 7, 8; P.A. 95-220, S. 4–6; 95-264, S. 14; P.A. 98-31, S. 5; P.A. 99-215, S. 24, 29.)

History: (Revisor's note: P.A. 88-230, 90-98, 93-142 and 95-220 authorized substitution of “judicial district of Hartford” for “judicial district of Hartford-New Britain” in 1995 public and special acts, effective September 1, 1998); P.A. 98-31 added provisions re pharmacy technicians; P.A. 99-215 replaced “judicial district of Hartford” with “judicial district of New Britain”, effective June 29, 1999.

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Secs. 20-584 to 20-589. Reserved for future use.

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PART II

LICENSING OF PHARMACISTS AND PHARMACIES.
REGISTRATION OF PHARMACY INTERNS
AND PHARMACY TECHNICIANS

Sec. 20-590. (Formerly Sec. 20-170). Issuance of license or temporary permit to practice pharmacy; requirements. (a) The department shall, upon authorization of the commission, issue a license to practice pharmacy as a pharmacist to any individual provided the individual:

(1) Has submitted a written application on a form approved by the department;

(2) Has graduated from a college or school of pharmacy approved by the commission with a degree that was, at the time of graduation, an entry level professional pharmacy degree;

(3) Has the professional experience as a pharmacy intern required by regulations adopted by the commissioner, with the advice and assistance of the commission, in accordance with chapter 54;

(4) Has successfully passed any examinations required by the commissioner; and

(5) Is eighteen years of age or older at the time of application.

(b) The Department of Consumer Protection shall, upon authorization of the commission, issue a temporary permit to practice pharmacy to an individual who: (1) Practices under the direct supervision of a licensed pharmacist; (2) has an application for reciprocity on file with the commission; (3) is a licensed pharmacist in good standing in a state or jurisdiction from which such state's pharmacy board or commission of pharmacy grants similar reciprocal privileges to pharmacists licensed in this state; and (4) has no actions pending against such individual's license with any state's pharmacy board or commission of pharmacy.

(c) A temporary permit to practice pharmacy shall expire at the time the individual with the temporary permit is licensed as a pharmacist in this state, or not later than three months from the date of issuance of such temporary permit, whichever occurs first. The Department of Consumer Protection shall not issue more than one temporary permit to practice pharmacy to an individual, but the commission, at its discretion, may authorize one three-month extension of the temporary permit.

(1949 Rev., S. 4469; 1963, P.A. 197, S. 1; 1972, P.A. 127, S. 41; P.A. 76-113, S. 7; P.A. 77-614, S. 202, 610; P.A. 81-361, S. 3, 39; 81-471, S. 69, 71; P.A. 86-392, S. 2, 3; May Sp. Sess. P.A. 92-6, S. 25, 117; P.A. 93-79; P.A. 94-36, S. 7, 42; P.A. 95-264, S. 15; P.A. 99-175, S. 18; P.A. 00-182, S. 8; P.A. 02-82, S. 2; June 30 Sp. Sess. P.A. 03-6, S. 146(d); P.A. 04-169, S. 17; 04-189, S. 1; P.A. 11-121, S. 1.)

History: 1963 act established license year from April first to March thirty-first; 1972 act reduced minimum age of applicant from 21 to 18, reflecting changed age of majority; P.A. 76-113 deleted requirement that applicant be U.S. citizen; P.A. 77-614 required approval of exam by consumer protection commissioner and replaced regulation “prescribed by ... commission” with regulations “established under this chapter”, effective January 1, 1979; P.A. 81-361 amended section to allow the department rather than commission itself to issue licenses upon the authorization of the commission on and after July 1, 1981, and to require approval of application forms by the department instead of the commission; P.A. 81-471 amended section to establish procedure under which pharmacist licensed in another state and who was eligible for licensure in this state prior to October 22, 1976, by reason of his licensure in such other state may be licensed in this state by examination without regard to accreditation or nonaccreditation of the school of pharmacy which he attended; P.A. 86-392 changed the requirements for licensure for persons who are licensed pharmacists in another state to allow licensure for persons graduating after October 22, 1976, who have practiced for at least five years and to refer to alternative examination in addition to national boards; May Sp. Sess. P.A. 92-6 established an examination fee of $150; P.A. 93-79 required the commissioner of consumer protection to adopt regulations concerning the licensure of graduates of foreign schools of pharmacy (Revisor's note: In 1995 the term “pharmacy commission” was changed editorially by the Revisors to “commission of pharmacy”, where appearing, for consistency with Sec. 20-163); P.A. 94-36 deleted reference to “April first to March thirty-first” license year, effective January 1, 1995; P.A. 95-264 replaced existing provisions re qualifications for license with new provisions setting out the requirements which must be met; Sec. 20-170 transferred to Sec. 20-590 in 1997; P.A. 99-175 made technical changes and amended Subsec. (a)(3) to add provision requiring commissioner to seek advice and assistance of commission in adopting regulations re professional qualifications of pharmacy interns; P.A. 00-182 added Subsec. (c) re issuance of a temporary permit to practice pharmacy and Subsec. (d) re expiration and extension of a temporary permit to practice pharmacy; P.A. 02-82 amended Subsec. (a)(2) to require, as condition of issuance of license to practice pharmacy, a degree from an approved college or school of pharmacy and that the degree, at time of individual's graduation, was an “entry level professional pharmacy degree”; June 30 Sp. Sess. P.A. 03-6 and P.A. 04-169 replaced Department of Consumer Protection with Department of Agriculture and Consumer Protection, effective July 1, 2004; P.A. 04-189 repealed Sec. 146 of June 30 Sp. Sess. P.A. 03-6, thereby reversing the merger of the Departments of Agriculture and Consumer Protection, effective June 1, 2004; P.A. 11-121 amended Subsec. (a) by replacing “the examination described under subsection (b) of this section” with “any examinations required by the commissioner” in Subdiv. (4), substituting “application” for “the examination” in Subdiv. (5) and deleting former Subdiv. (6) re examination fee, deleted former Subsec. (b) re licensure examination, and redesignated existing Subsecs. (c) and (d) as Subsecs. (b) and (c), effective January 1, 2012.

See Sec. 21a-10(b) re staggered schedule for license renewals.

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Sec. 20-591. Graduates of foreign pharmacy schools. Regulations. (a) An individual who has graduated from a foreign school of pharmacy not approved by the commission may apply for a license to practice pharmacy under this section.

(b) The individual shall comply with the requirements of subdivisions (1), (2), (4) and (5) of subsection (a) of section 20-590 and with regulations adopted as provided in subsection (c) of this section.

(c) The commissioner shall, with the advice and assistance of the commission, adopt regulations in accordance with chapter 54 concerning licensure as a pharmacist of an individual who has graduated from and received an entry-level professional pharmacy degree from a foreign school of pharmacy. The regulations shall include a requirement that such a graduate pass a proficiency test for written and spoken English, a foreign pharmacy graduate equivalency examination and the examination described in subsection (b) of section 20-590.

(P.A. 95-264, S. 16; P.A. 99-175, S. 19; P.A. 11-121, S. 2.)

History: P.A. 99-175 made a technical change in Subsec. (a); P.A. 11-121 amended Subsec. (b) by deleting reference to Sec. 20-590(a)(6), effective January 1, 2012.

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Sec. 20-592. Licensure of individual who is a licensed pharmacist in another state or jurisdiction. Any individual who is a licensed pharmacist in any other state of the United States, the District of Columbia, the Commonwealth of Puerto Rico or any territory or insular possession subject to the jurisdiction of the United States, may be licensed to practice pharmacy in this state in accordance with regulations adopted under sections 20-570 to 20-630, inclusive, in accordance with chapter 54.

(P.A. 95-264, S. 17; P.A. 99-175, S. 20.)

History: P.A. 99-175 amended Subsec. (a) to delete subsection designation and reference to Subsec. (b) and replace reference to Sec. 20-625 with reference to Sec. 20-630 and deleted Subsec. (b).

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Sec. 20-593. (Formerly Sec. 20-172). Pharmacist license certificate; expiration; renewal; fee; display document. (a) A license to practice pharmacy issued under the provisions of section 20-590 or under the provisions of section 20-591 or 20-592 and a license to practice pharmacy renewed pursuant to subsections (b) and (c) of this section shall be evidenced by a certificate issued by the department upon authorization of the commission.

(b) A license to practice pharmacy shall expire annually and may be renewed upon completion of an application on a form approved by the department, payment of one hundred dollars and completion of continuing professional education, as required by sections 20-599 and 20-600.

(c) The commission shall not grant a renewal license to an applicant who has not held a license authorized by the commission within five years of the date of application unless the applicant has passed an examination satisfactory to the commission and has paid the fee required in subsection (b) of this section.

(d) In addition to the certificate of license to practice pharmacy issued under subsection (a) of this section, the department may issue a document suitable for display indicating that the individual has been issued a certificate of license to practice pharmacy.

(1949 Rev., S. 4471; 1959, P.A. 616, S. 55; June, 1971, P.A. 8, S. 62; 1972, P.A. 223, S. 9; P.A. 79-224, S. 3; P.A. 81-361, S. 5, 39; P.A. 89-251, S. 99, 203; May Sp. Sess. P.A. 92-16, S. 49, 89; P.A. 94-36, S. 8, 42; P.A. 95-264, S. 18; P.A. 99-175, S. 21; P.A. 11-121, S. 3; P.A. 22-118, S. 71.)

History: 1959 act increased license fees for pharmacists from $15 to $25 and renewal fees from $2 to $5 and doubled fees for pharmacists licensed in another state admitted to practice in this state; 1971 act increased fees for pharmacists and pharmacists licensed in another state from $25 and $50 respectively to $150 for both, for renewal from $5 to $100 and for renewal not within six months of expiration from $10 to $125; 1972 act reduced pharmacists' fees to $50 and annual renewal to $15; P.A. 79-224 required payment of fees to state treasurer rather than commission treasurer and introduced intermediate renewal penalty of $50 for failure to renew within 30 days of expiration; P.A. 81-361 amended section to provide that certificates of licensure are to be issued by the department instead of the commission and that application fees are nonrefundable; P.A. 89-251 increased fee for a pharmacist's license from $50 to $100, increased fee for renewal from $15 to $30 and increased fee for licensure from another jurisdiction from $50 to $100; May Sp. Sess. P.A. 92-16 replaced $30 renewal fee with professional service fee class established pursuant to Sec. 33-182l; (Revisor's note: In 1995 the term “pharmacy commission” was changed editorially by the Revisors to “commission of pharmacy” for consistency with Sec. 20-163); P.A. 94-36 deleted provision allowing license renewal late fees, effective January 1, 1995; P.A. 95-264 replaced existing provisions re licensure with new provisions concerning license certificates, their expiration, renewal and fee and the issuance of a display document by the department; Sec. 20-172 transferred to Sec. 20-593 in 1997; P.A. 99-175 made technical changes in Subsecs. (a) and (d); P.A. 11-121 amended Subsec. (b) by replacing annual license expiration with biennial license expiration and by replacing “the fee set forth in section 20-601” with “one hundred twenty dollars” and amended Subsec. (c) by replacing “fee required in section 20-601” with “fee required in subsection (b) of this section”, effective January 1, 2012; P.A. 22-118 amended Subsec. (b) by substituting “annually” for “biennially”, and “one hundred dollars” for “one hundred twenty dollars”, effective July 1, 2022.

See Sec. 21a-4(c) re fines for late license renewals.

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Sec. 20-594. (Formerly Sec. 20-168). Pharmacy license; application; information required; issuance or renewal of license; expiration. Transfer of pharmacy to new location. Report re administrative or legal action. (a) Except as limited by section 20-596, a pharmacist or any other person may apply to the commission for a pharmacy license or for renewal of a pharmacy license.

(b) The applicant shall disclose on the application the name and address of the applicant and the owner of the pharmacy, the name and street and mailing address of the pharmacy and the name, address and license number of the pharmacist who manages the pharmacy. The commissioner may, by regulation adopted with the advice and assistance of the commission, in accordance with chapter 54, require such other information on the application as is necessary for the department to carry out its duties under sections 20-570 to 20-630, inclusive.

(c) The department shall, after receipt of an application under this section, (1) issue, on authorization of the commission, a pharmacy license to an applicant for a new pharmacy on payment of the fee required in section 20-601 and on satisfactory evidence to the commission that the pharmacy will be managed by a pharmacist and will be operated in accordance with the general statutes and the regulations adopted by the commissioner in accordance with chapter 54, and (2) issue a renewal of a pharmacy license to an applicant on payment of the fee required in section 20-601.

(d) Pharmacy licenses shall expire annually. Pharmacy licenses may be renewed on application and payment of the fee required in section 20-601 for a period not to exceed one year.

(e) When a pharmacy is transferred to a new location the pharmacy license for such pharmacy shall terminate. A pharmacy license that has been terminated under this subsection may be renewed under the provisions of subsection (d) of this section and on satisfactory evidence to the commission that the pharmacy will be managed by a pharmacist and will be operated in accordance with the general statutes and the regulations adopted by the commissioner in accordance with chapter 54.

(f) Each pharmacy licensed pursuant to this section shall report to the department any administrative or legal action commenced against it by any state or federal regulatory agency or accreditation entity not later than ten business days after receiving notice of the commencement of such action.

(1949 Rev., S. 4467; 1959, P.A. 616, S. 54; 1967, P.A. 109, S. 4; June, 1971, P.A. 8, S. 61; 1972, P.A. 223, S. 8; P.A. 77-614, S. 201, 610; P.A. 81-361, S. 1, 39; P.A. 89-251, S. 96, 203; P.A. 94-36, S. 6, 42; P.A. 95-264, S. 19; P.A. 99-175, S. 22; P.A. 19-177, S. 29.)

History: 1959 act raised fee for renewal from $10 to $15; 1967 act added “or dentists” to first sentence; 1971 act raised fee for renewal license from $15 to $150; 1972 act reduced renewal fee to $50; P.A. 77-614 replaced regulations of commission with regulations established by consumer protection commissioner, effective January 1, 1979; P.A. 81-361 transferred licensing power from commission to department of consumer protection acting upon commission's authorization; P.A. 89-251 increased the licensing fee from $200 to $600 and increased the renewal fee from $50 to $150; P.A. 94-36 deleted reference to “September first” license expiration date, effective January 1, 1995; P.A. 95-264 replaced existing provisions re pharmacy licenses with new provisions concerning application for license or renewal of license, information required, issuance or renewal of license, expiration and transfer of pharmacy to new location; Sec. 20-168 transferred to Sec. 20-594 in 1997; P.A. 99-175 made technical changes and amended Subsecs. (c) and (e) to require that adoption of regulations be consistent with chapter 54; P.A. 19-177 added Subsec. (f) re report to department of administrative or legal action, effective July 9, 2019.

See Sec. 21a-10(b) re staggered schedule for license renewals.

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Sec. 20-595. (Formerly Sec. 20-168a). Pharmacy licenses held by corporations. Notice of change in officers or directors. Any corporation applying for a new or renewal pharmacy license under the provisions of section 20-594 shall state in the application the names of the officers and directors of the corporation. Notice of any change in such officers or directors shall be given by the corporation to the commission within ten days after the change. Such notice shall be accompanied by the filing fee set forth in section 20-601. Any such corporation that fails to give notice of a change in the officers or directors of the corporation within ten days of the change shall pay the late fee required in section 20-601.

(February, 1965, P.A. 421; P.A. 79-224, S. 1; P.A. 89-251, S. 97, 203; P.A. 95-264, S. 20; P.A. 99-175, S. 23.)

History: P.A. 79-224 imposed $25 fine for failure to give notice of change in officers or directors or to apply for renewal upon change in location or name; P.A. 89-251 increased fee for notice of change from $10 to $30; P.A. 95-264 replaced specific filing and late fees with references to fees set forth in Sec. 20-601; Sec. 20-168a transferred to Sec. 20-595 in 1997; P.A. 99-175 made technical changes.

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Sec. 20-596. (Formerly Sec. 20-168b). Ownership of pharmacies by prescribing practitioners. (a) No prescribing practitioner, spouse of a prescribing practitioner, except a spouse who is a pharmacist, or dependent child of a prescribing practitioner shall have an ownership or investment interest in a pharmacy.

(b) The provisions of this section do not apply to a prescribing practitioner or spouse or dependent child of a prescribing practitioner (1) having an ownership or investment interest in a pharmacy prior to July 1, 1993, (2) who inherits an ownership or investment interest in a pharmacy, or (3) who is not required to maintain professional liability insurance pursuant to section 20-11b, provided (A) if the prescribing practitioner reinstates any such professional liability insurance, the prescribing practitioner shall, within thirty days of doing so, notify the Commissioner of Public Health of such reinstatement and divest any interest the prescribing practitioner may have in any pharmacy, or (B) if the interest is owned by the prescribing practitioner's spouse or dependent child, the spouse or child shall divest such interest in any pharmacy. Failure of the prescribing practitioner or the prescribing practitioner's spouse or dependent child to divest any such interest in a pharmacy within thirty days shall result in the prescribing practitioner's license being suspended until such time as the prescribing practitioner or the prescribing practitioner's spouse or dependent child divests such interest in the pharmacy.

(c) As used in this section, “ownership of investment interest” does not include ownership of investment securities by a prescribing practitioner, or the prescribing practitioner's spouse or dependent children, in a publicly-held corporation that is traded on a national exchange or over-the-counter market, provided the investment securities held by the prescribing practitioner, the prescribing practitioner's spouse and the prescribing practitioner's dependent children, in the aggregate, do not exceed one-half of one per cent of the total number of shares issued by the corporation.

(P.A. 93-374, S. 1, 2; P.A. 95-257, S. 12, 21, 58; 95-264, S. 21; 95-271, S. 32; P.A. 99-175, S. 24.)

History: P.A. 93-374 effective July 1, 1993; P.A. 95-257 replaced Commissioner and Department of Public Health and Addiction Services with Commissioner and Department of Public Health, effective July 1, 1995; P.A. 95-264 substituted “prescribing practitioner” for “licensed practitioner”; P.A. 95-271 added Subsec. (b)(3) re exemption for certain individuals required to maintain professional liability insurance under Sec. 20-11b and that failure to divest within 30 days can result in suspension (Revisor's note: A reference to “licensed” practitioner was replaced editorially by the Revisors with “prescribing” practitioner to conform P.A. 95-271 with changes enacted in P.A. 95-264); Sec. 20-168b transferred to Sec. 20-596 in 1997; P.A. 99-175 made technical and gender neutral changes.

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Sec. 20-597. (Formerly Sec. 20-169). Pharmacy to be supervised and managed by pharmacist. Regulations re prescription department. Change in management, ownership or name of pharmacy. (a) No place of business may be operated as a pharmacy unless a pharmacy license has been issued for the place of business and unless it is under the direct supervision of a pharmacist on the premises, except that the commissioner, with the advice and assistance of the commission, shall adopt regulations, in accordance with chapter 54, that specify when a pharmacy may remain open for business during hours when a pharmacist is not present and directly supervising such pharmacy. Such regulations shall include, but not be limited to: (1) A provision requiring that the prescription department be closed and properly secured during times when a pharmacist is not present; (2) the minimum number of hours of operation applicable to the prescription department; (3) requirements for the physical security of the prescription department; (4) requirements for the physical security of legend drugs, controlled substances and legend devices stored in all areas of the pharmacy; and (5) a definition of the term “prescription department”.

(b) In addition to the on-premises supervision of a pharmacy required in subsection (a) of this section, a pharmacy shall be managed by a pharmacist practicing at the pharmacy on a full-time basis who is listed as manager in the application for a pharmacy license made under section 20-594 or enrolled with the commission under subsection (c) of this section. The managing pharmacist may also act as the supervising pharmacist. No pharmacist may manage more than one pharmacy at the same time.

(c) The person to whom a pharmacy license has been issued shall immediately notify the commission whenever the pharmacist who manages the pharmacy ceases such management and shall immediately enroll with the commission the name, address and license number of the pharmacist who assumes management of the pharmacy. The notice of change in management of a pharmacy required to be filed with the commission under this section shall be accompanied by the filing fee required in section 20-601. The pharmacist who ceases management of the pharmacy shall also immediately notify the commission of that fact.

(d) The person to whom a pharmacy license has been issued shall immediately notify the commission of a change in ownership of the pharmacy and of a change in name of the pharmacy. The notice shall be accompanied by the filing fee required in section 20-601. Any such person who fails to give the notice of a change in ownership or name of the pharmacy within ten days of the change shall pay the late fee required in section 20-601.

(1949 Rev., S. 4468; 1971, P.A. 385, S. 2; P.A. 79-224, S. 2; P.A. 89-251, S. 98, 203; P.A. 95-72, S. 3; 95-264, S. 22; P.A. 98-211, S. 1; P.A. 99-175, S. 25.)

History: 1971 act rephrased provision re operation of pharmacy by licensed pharmacist and added provisions requiring certain information to be reported to pharmacy commission by owner of pharmacy, pharmacist ceasing to be in charge of pharmacy, etc.; P.A. 79-224 imposed $25 fine for failure to give notice of change in officers or directors or failure to apply for renewal upon change in location or name; P.A. 89-251 established a $45 fee for notice of change; (Revisor's note: In 1995 the term “pharmacy commission” was changed editorially by the Revisors to “commission of pharmacy” for consistency with Sec. 20-163); P.A. 95-72 required commissioner to adopt regulations specifying when a pharmacy may remain open when the pharmacist is not present, deleting prior provision which had permitted assistant pharmacists to assume charge of pharmacy during pharmacist's temporary absence, but failed to take effect, P.A. 95-264 having taken precedence; P.A. 95-264 replaced existing provisions re supervision and management of pharmacy and change in ownership of pharmacy with new provisions concerning supervision and management of pharmacies, notification of Commission of Pharmacy when there is a change of management or change in ownership or name of pharmacy and payment of fees; Sec. 20-169 transferred to Sec. 20-597 in 1997; P.A. 98-211 amended Subsec. (a) by adding provisions re prescription department regulations; P.A. 99-175 amended Subsec. (c) to make technical changes.

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Sec. 20-598. (Formerly Sec. 20-177). Registration of pharmacy interns. (a) Each individual who is employed by or is serving under the supervision of a pharmacist in a pharmacy or institutional pharmacy for the purpose of obtaining the professional experience required under the provisions of section 20-590 shall register as a pharmacy intern with the commission at the time of commencing employment or service under such supervision. The applicant may not be registered as a pharmacy intern unless the applicant has successfully completed two years of college and is enrolled in a professional program at a school or college of pharmacy, accredited by the American Council on Pharmaceutical Education and approved by the commission, or has completed the requirements for graduation from such a school or college, or, if the applicant is a graduate from a foreign pharmacy school not approved by the commission, has passed a proficiency test for written and spoken English and a foreign pharmacy graduate equivalency examination. The application for registration shall be certified to, under oath, by the applicant.

(b) The fee required in section 20-601 shall accompany an application for registration and an identification number and card shall be issued by the commission to the applicant. The identification number and card shall become void and shall be returned to the commission if the pharmacy intern does not complete the requirements for graduation from, or terminates enrollment at, an accredited and approved school or college of pharmacy.

(1949 Rev., S. 4474; 1959, P.A. 616, S. 56; June, 1971, P.A. 8, S. 63; P.A. 82-70, S. 1, 2; P.A. 89-251, S. 100, 203; P.A. 95-264, S. 23; P.A. 99-175, S. 26.)

History: 1959 act increased fee from $0.50 to $5; 1971 act increased fee to $10; P.A. 82-70 required that pharmacy interns successfully complete two years of college and be enrolled in an accredited program or graduate from such college and be employed in a pharmacy before beginning the internship; and eliminated all references to an apprenticeship; P.A. 89-251 increased the registration fee from $10 to $30; P.A. 95-264 replaced provisions on registration of pharmacy interns with new provisions concerning the registration of pharmacy interns; Sec. 20-177 transferred to Sec. 20-598 in 1997; P.A. 99-175 made technical changes.

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Sec. 20-598a. Registration and certification of pharmacy technicians. (a) No person shall act as a pharmacy technician unless registered with, or certified with, the department.

(b) The department shall, upon authorization of the commission, register as a pharmacy technician any person who presents evidence satisfactory to the department that such person is qualified to perform, under the direct supervision of a pharmacist, routine functions in the dispensing of drugs that do not require the use of professional judgment. The qualifications for registration as a pharmacy technician under this section shall be in accordance with (1) the standards of an institutional pharmacy, a care-giving institution or a correctional or juvenile training institution, in the case of employment in any such pharmacy or institution, or (2) the standards established by regulation adopted by the commissioner in accordance with chapter 54, in the case of employment in a pharmacy. As used in this subsection, “direct supervision” means a supervising pharmacist (A) is physically present in the area or location where the pharmacy technician is performing routine drug dispensing functions, and (B) conducts in-process and final checks on the pharmacy technician's performance.

(c) The department shall, upon authorization of the commission, certify as a pharmacy technician any person who meets the requirements for registration as a pharmacy technician, pursuant to subsection (b) of this section, and who holds a certification from the Pharmacy Technician Certification Board or any other equivalent pharmacy technician certification program approved by the department.

(d) The fee required by section 20-601 shall accompany an application for registration under this section. A registration as a pharmacy technician shall be valid for one year and may be renewed upon application and payment of the fee required by section 20-601.

(P.A. 98-31, S. 1: P.A. 99-175, S. 27; P.A. 04-208, S. 2.)

History: P.A. 99-175 made technical changes in Subsecs. (a) and (b); P.A. 04-208 amended Subsec. (a) by adding “or certified with”, added new Subsec. (c) providing for the certification of pharmacy technicians, and relettered existing Subsec. (c) as Subsec. (d), effective June 3, 2004.

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Sec. 20-599. (Formerly Sec. 20-174a). Continuing education: Definitions. As used in this section and section 20-600:

(1) “Accredited continuing professional education” means any education of pharmacists which is designed to maintain professional competence in the practice of pharmacy and which is provided by an organization, institution or agency approved by the commission. Such education may include, but is not limited to, courses concerning: (A) The social, economic, behavioral, legal, administrative and managerial aspects of health care; (B) the properties and actions of drugs and dosage forms; (C) the etiology, characteristics, therapeutics and prevention of the disease states; (D) the pharmaceutical monitoring and management of patients; and (E) other areas of information unique to specialized types of professional pharmacy practice;

(2) “Certificate of continuing education units” means a document issued to a pharmacist by an organization, institution or agency approved by the commission which offers accredited continuing professional education, which (A) certifies that the pharmacist has satisfactorily completed a specified number of continuing education units, and (B) bears the name of such organization, institution or agency, the title of the program, the dates during which the program was conducted, the number of continuing education units satisfactorily completed and the signature of the director of such organization, institution or agency or the director's authorized agent;

(3) “Continuing education unit” means ten contact hours of participation in accredited continuing professional education;

(4) “Contact hours” means fifty to sixty minutes of participation in accredited continuing professional education;

(5) “Retired pharmacist” means a pharmacist who is at least sixty-two years of age and no longer actively engaged in the practice of pharmacy; and

(6) “Inactive license” means a license that is issued, in the same manner and for the same fee as specified in this chapter for a license to practice pharmacy, to a retired pharmacist which license does not authorize the retired pharmacist to practice pharmacy and on which the word “inactive” is printed or stamped.

(P.A. 87-401, S. 1, 4; P.A. 89-265, S. 1; P.A. 95-264, S. 24; P.A. 99-175, S. 28.)

History: P.A. 89-265 added definitions of “retired pharmacist” and “inactive license” as Subdivs. (6) and (7), renumbering former Subdiv. (6) as (8); P.A. 95-264 deleted definitions of “commission” and “department”, renumbering remaining Subdivs. as necessary; Sec. 20-174a transferred to Sec. 20-599 in 1997; P.A. 99-175 made technical and gender neutral changes and added Subpara. indicators in Subdivs. (1) and (2).

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Sec. 20-600. (Formerly Sec. 20-174b). Continuing education: Requirements; renewal of licenses; regulations. (a) Except as provided in subsections (b), (c), (f) and (g) of this section, the commission shall not authorize the department to renew a license to practice pharmacy as a pharmacist unless the pharmacist applying for the renewal submits a statement signed under the penalty of false statement that the pharmacist has satisfactorily completed not less than fifteen contact hours of accredited continuing professional education in the previous calendar year immediately preceding expiration of the license. Not less than five contact hours of the annual continuing education requirement shall be earned by attendance at a live presentation of an accredited continuing professional education program. At least one of the fifteen contact hours shall be on the subject matter of pharmacy law or drug law.

(b) The provisions of this section shall not apply to a pharmacist who applies for the first year of a license to practice pharmacy.

(c) A pharmacist submitting an application for renewal of a license to practice pharmacy, whose license has lapsed and who has not held a license authorized by the commission and issued by the department for more than two years, shall submit a statement signed under the penalty of false statement that the pharmacist has satisfactorily completed the requirements of this section in each of the years in the two-year period prior to the year of the application for renewal.

(d) A pharmacist who applies for renewal of a license to practice pharmacy shall retain all certificates of approved continuing education units for a period of not less than three years after the date on which such license is renewed. A pharmacist shall, upon the request of the department, and to satisfy the results of a random audit, make such certificates available to the department for purposes of verification.

(e) Continuing education units earned in one calendar year shall not be carried forward into the next calendar year for the purpose of fulfilling the subsequent year's accredited continuing professional education requirement for license renewal.

(f) A pharmacist who was unable to comply with the requirements of this section for reasons such as illness, incapacity or other extenuating circumstances may apply for a waiver of the requirements of this section or for an extension of time to fulfill the requirements of this section. A pharmacist who requests such a waiver or extension of time shall submit the request, in writing, to the department with the license renewal application. The department shall forward such a request to the commission for its consideration. If the commission waives the requirements of this section, the commission shall authorize the department to renew the license of such a pharmacist. If the commission extends the time for compliance with the requirements of this section, the commission shall authorize the department to renew the license, subject to the pharmacist's complying with the requirements of this section within the extended time period. If the pharmacist fails to comply with such requirements within the extended time period, the commission shall revoke or suspend the license.

(g) The commission may authorize the department to waive the requirements of this section and renew the license of a retired pharmacist provided the license is designated as an inactive license. A retired pharmacist holding an inactive license shall be required to obtain thirty hours of continuing education, not less than ten hours of which shall be earned by attendance at a live presentation, and apply for and receive a license to practice pharmacy issued pursuant to sections 20-570 to 20-630, inclusive, before the retired pharmacist reenters the active practice of pharmacy.

(h) The commissioner, with the advice and assistance of the commission, may adopt regulations, in accordance with chapter 54, to carry out the provisions of this section.

(P.A. 87-401, S. 2, 4; P.A. 89-265, S. 2; P.A. 95-264, S. 25; P.A. 99-175, S. 29; P.A. 02-48, S. 2; P.A. 05-41, S. 1; P.A. 16-117, S. 4.)

History: P.A. 89-265 made technical changes in Subsec. (f) and added Subsec. (g) re waiver of requirements for retired pharmacists obtaining inactive license and relettered the remaining Subsecs; P.A. 95-264 deleted reference to the requirement of 10 hours of continuing education per year before 1990, amended provisions relative to waiver of the requirement, permitted the extension of the time to complete continuing education credits and set the requirements for a retired pharmacist to renew his license; Sec. 20-174b transferred to Sec. 20-600 in 1997; P.A. 99-175 made technical and gender neutral changes and amended Subsec. (g) to replace reference to Sec. 20-625 with reference to Sec. 20-630; P.A. 02-48 amended Subsec. (a) by adding requirement that at least one of the five required contact hours of annual continuing education earned by attendance at a live presentation be on the subject matter of pharmacy law or drug law; P.A. 05-41 amended Subsec. (a) to replace “one of the five” with “one of the fifteen” re contact hours on pharmacy or drug law and delete requirement that such contact hours be earned by attendance at live presentation, effective May 17, 2005; P.A. 16-117 amended Subsec. (b) by replacing “first renewal” to “first year”, effective July 1, 2016.

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Sec. 20-601. Fees. The department shall collect the following nonrefundable fees:

(1) The fee for issuance of a pharmacist license is two hundred dollars, payable at the date of application for the license.

(2) The fee for renewal of a pharmacist license is the professional services fee for class A, as defined in section 33-182l. Before the commission grants a license to an applicant who has not held a license authorized by the commission within five years of the date of application, the applicant shall pay the fee required in subdivision (1) of this section.

(3) The fee for issuance of a pharmacy license is seven hundred fifty dollars.

(4) The fee for renewal of a pharmacy license is one hundred ninety dollars.

(5) The late fee for an application for renewal of a license to practice pharmacy, a pharmacy license or a permit to sell nonlegend drugs is the amount set forth in section 21a-4.

(6) The fee for notice of a change in officers or directors of a corporation holding a pharmacy license is sixty dollars for each pharmacy license held. A late fee for failing to give such notice within ten days of the change is fifty dollars in addition to the fee for notice.

(7) The fee for filing notice of a change in name, ownership or management of a pharmacy is ninety dollars. A late fee for failing to give such notice within ten days of the change is fifty dollars in addition to the fee for notice.

(8) The fee for application for registration as a pharmacy intern is sixty dollars.

(9) The fee for application for a permit to sell nonlegend drugs is one hundred forty dollars.

(10) The fee for renewal of a permit to sell nonlegend drugs is one hundred dollars.

(11) The late fee for failing to notify the commission of a change of ownership, name or location of the premises of a permit to sell nonlegend drugs within five days of the change is twenty dollars.

(12) The fee for issuance of a nonresident pharmacy certificate of registration is seven hundred fifty dollars.

(13) The fee for renewal of a nonresident pharmacy certificate of registration is one hundred ninety dollars.

(14) The fee for notice of a change in officers or directors of a corporation holding a nonresident pharmacy certificate of registration is sixty dollars for each pharmacy license held. A late fee for failing to give such notice within ten days of the change is fifty dollars, in addition to the fee for notice.

(15) The fee for filing notice of a change in name, ownership or management of a nonresident pharmacy is ninety dollars. A late fee for failing to give such notice within ten days of the change is fifty dollars, in addition to the fee for notice.

(16) The fee for application for registration as a pharmacy technician is one hundred dollars.

(17) The fee for renewal of a registration as a pharmacy technician is fifty dollars.

(18) The fee for issuance of a temporary permit to practice pharmacy is two hundred dollars.

(P.A. 95-264, S. 26; P.A. 98-31, S. 6; P.A. 99-175, S. 30; P.A. 00-182, S. 9; June Sp. Sess. P.A. 09-3, S. 273; P.A. 11-121, S. 4; P.A. 18-16, S. 2.)

History: P.A. 98-31 added new Subdivs. (13) and (14) re fees for pharmacy technician registrations; P.A. 99-175 made technical changes, added new Subdiv. (13) to include $600 fee for issuance of nonresident pharmacy certificate and added new Subdiv. (14) to include $150 fee for renewal of nonresident pharmacy certificate, renumbering remaining Subdivs. accordingly; P.A. 00-182 changed “shall be” to “is” throughout and added Subsec. (17) re fee for a temporary permit to practice pharmacy; June Sp. Sess. P.A. 09-3 increased fees; P.A. 11-121 deleted former Subdiv. (2) re fee for pharmacist license examination, redesignated existing Subdivs. (3) to (17) as Subdivs. (2) to (16) and amended redesignated Subdiv. (2) by making technical changes, effective January 1, 2012; P.A. 18-16 added new Subdiv. (14) re fee for notice of change in officers or directors of corporation holding nonresident pharmacy certificate of registration, added new Subdiv. (15) re fee for notice of change in name, ownership or management of nonresident pharmacy, redesignated existing Subdivs. (14) to (16) as Subdivs. (16) to (18), effective January 1, 2019.

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Secs. 20-602 to 20-604. Reserved for future use.

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PART III*

PRACTICE OF PHARMACY

*See Sec. 18-81q re return to vendor pharmacies of unused drug products by Department of Correction for repackaging and/or redispensing and reimbursement.

Sec. 20-605. Practice of pharmacy without license or temporary permit prohibited. No individual may engage in the practice of pharmacy unless the individual holds a current license or temporary permit to practice pharmacy issued by the department.

(P.A. 95-264, S. 27; P.A. 99-175, S. 31; P.A. 00-182, S. 10.)

History: P.A. 99-175 made a technical change; P.A. 00-182 added “or temporary permit”.

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Sec. 20-606. (Formerly Sec. 20-178). Use of the title “pharmacist”. A pharmacist who conforms to the regulations of the commissioner, adopted with the advice and assistance of the commission in accordance with chapter 54, may have, use and exhibit the title “pharmacist” in the practice of pharmacy.

(1949 Rev., S. 4476; P.A. 95-264, S. 28; P.A. 99-175, S. 32.)

History: P.A. 95-264 deleted references to licensed and assistant pharmacists and provisions which had prohibited pharmacist supervising more than one pharmacy and had allowed assistant pharmacist to work under supervision of pharmacist or during his temporary absence; Sec. 20-178 transferred to Sec. 20-606 in 1997; P.A. 99-175 replaced provision requiring adoption of regulations by commission with provision requiring adoption of regulations consistent with chapter 54 by commissioner with advice and assistance of commission.

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Sec. 20-607. (Formerly Sec. 20-173). Certificate of license, temporary permit or registration to be available for inspection. Each person practicing as a pharmacist, pharmacy intern or pharmacy technician shall at all times have available for inspection by an inspector of the department a current certificate of license or temporary permit to practice pharmacy or a current registration to act as a pharmacy intern or pharmacy technician.

(1949 Rev., S. 4477; P.A. 95-264, S. 29; P.A. 98-31, S. 7; P.A. 99-175, S. 33; P.A. 00-182, S. 11.)

History: P.A. 95-264 deleted reference to licensed or assistant pharmacist, deleted requirement that pharmacist must display certificate in the place he practices and required that a current certificate of license to practice must be available for inspection at all times; Sec. 20-173 transferred to Sec. 20-607 in 1997; P.A. 98-31 added provisions re pharmacy interns and pharmacy technicians; P.A. 99-175 made a technical change; P.A. 00-182 added “or temporary permit”.

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Sec. 20-608. (Formerly Sec. 20-174). Use of certificate of license, temporary permit or display document by unlicensed person prohibited. A pharmacist who permits such pharmacist's certificate of license, temporary permit or display document to be used by an unlicensed person for unlawful use shall be fined one hundred dollars and shall be subject to other disciplinary proceedings within the authority of the commission.

(1949 Rev., S. 4478; P.A. 95-264, S. 30; P.A. 99-175, S. 34; P.A. 00-182, S. 12.)

History: P.A. 95-264 deleted reference to licensed or assistant pharmacist, made prohibition applicable to a display document, eliminated forfeiture as a penalty and substituted disciplinary proceedings as a penalty; Sec. 20-174 transferred to Sec. 20-608 in 1997; P.A. 99-175 made technical and gender neutral changes; P.A. 00-182 added language re temporary permit.

See Sec. 19a-70 re violation of regulations governing distribution of biologic products during an emergency as grounds for suspension, revocation or annulment of a license or certificate.

See Sec. 30-101 re forfeiture of liquor permit and pharmacist's license for allowing on-premises consumption of alcohol.

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Sec. 20-609. (Formerly Sec. 20-184). Pharmacy license to be posted. Business which is not a pharmacy prohibited from using words, displays or symbols indicating it is a pharmacy; exemption. (a) A pharmacy license shall be conspicuously posted within the pharmacy.

(b) Any person owning, managing or conducting any store, shop or place of business not being a pharmacy who exhibits within or upon the outside of such store, shop or place of business, or includes in any advertisement the words “drug store”, “pharmacy”, “apothecary”, “drug”, “drugs” or “medicine shop” or any combination of such terms or any other words, displays or symbols indicating that such store, shop or place of business is a pharmacy shall be guilty of a class D misdemeanor. The provisions of this subsection shall not apply to any person that provides pharmacy-related services directly to pharmacies or practitioners and does not offer such services and drugs or medical services directly to the public.

(1949 Rev., S. 4485; P.A. 95-264, S. 31; P.A. 07-252, S. 74; P.A. 08-184, S. 29; P.A. 12-80, S. 71.)

History: P.A. 95-264 inserted provisions as Subsec. (a) requiring pharmacy license to be posted in pharmacy, designated previous provisions as Subsec. (b), clarified the prohibition on use of specified terms, displays or symbols and deleted obsolete provisions prohibiting the use of show bottles and globes; Sec. 20-184 transferred to Sec. 20-609 in 1997; P.A. 07-252 amended Subsec. (b) to exempt from provisions persons who provide pharmacy-related services directly to pharmacies or practitioners and who do not offer drugs or pharmacy or medical services directly to the public; P.A. 08-184 made a technical change in Subsec. (b); P.A. 12-80 amended Subsec. (b) to replace penalty of a fine of not more than $200 or imprisonment of not more than 30 days or both with a class D misdemeanor and make technical changes.

Annotation to former section 20-184:

Cited. 141 C. 288.

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Sec. 20-609a. Use of electronic technology or telepharmacy by hospital. Quality assurance evaluations. (a) As used in this section:

(1) “Electronic technology” or “telepharmacy” means the process: (A) By which each step involved in the dispensing of a sterile product is verified through use of a bar code tracking system and documented by means of digital photographs which are electronically recorded and preserved; and (B) which is monitored and verified through video and audio communication between a licensed supervising pharmacist and a pharmacy technician;

(2) “Sterile product” means any drug, as that term is defined in section 20-571, that is compounded, manipulated or otherwise prepared under sterile conditions during the dispensing process, is not intended for self-administration by a patient and is intended to be used in a hospital, or its satellite, remote or affiliated office-based locations;

(3) “Pharmacist” means an individual who is licensed to practice pharmacy under the provisions of section 20-590, 20-591, 20-592 or 20-593 and who is thereby recognized as a health care provider by the state of Connecticut; and

(4) “Pharmacy technician” means an individual who is registered with the department and qualified in accordance with section 20-598a.

(b) A hospital, licensed in accordance with the provisions of chapter 368v, which operates a hospital pharmacy, may use electronic technology or telepharmacy at the hospital and at the hospital's satellite or remote locations for purposes of allowing a pharmacist to supervise pharmacy technicians in the dispensing of sterile products. Notwithstanding the provisions of this chapter or regulations adopted pursuant to this chapter, a pharmacist shall be permitted to supervise a pharmacy technician through use of electronic technology, and under such supervision the pharmacist shall monitor and verify the activities of a pharmacy technician through audio and video communication. The pharmacist-to-technician ratio pursuant to section 20-576-33 of the regulations of Connecticut state agencies shall apply. In the event of a malfunction of the electronic technology, no sterile product prepared by a pharmacy technician during the time period of the malfunction may be distributed to patients, unless a licensed pharmacist is able to: (1) Personally review and verify the accuracy of all processes utilized in the dispensing of the sterile product; or (2) upon the restoration of the electronic technology, utilize the mechanisms of the electronic technology which recorded the actions of the pharmacy technician to confirm that all proper steps were followed in the dispensing of the sterile product. All orders for sterile products to be dispensed using telepharmacy shall be verified by a pharmacist prior to being delegated to a pharmacy technician for such dispensing. A hospital shall ensure that appropriately licensed personnel administer medications dispensed using telepharmacy. All of the processes involved in a hospital's use of telepharmacy shall be under the purview of the hospital's director of pharmacy.

(c) A hospital using telepharmacy shall undertake periodic quality assurance evaluations, not less than once per calendar quarter, which shall include, upon discovery, prompt review of any error in medication administration which occurs where telepharmacy is used to dispense such medication. A hospital shall make such quality assurance evaluations available for review and inspection by the Departments of Consumer Protection and Public Health.

(P.A. 11-242, S. 50; P.A. 12-28, S. 1.)

History: P.A. 11-242 effective July 13, 2011; P.A. 12-28 amended Subsec. (a) by redefining “electronic technology” or “telepharmacy” in Subdiv. (1) and replacing definition of “IV admixture” with definition of “sterile product” in Subdiv. (2), amended Subsec. (b) by deleting provisions re pilot program, adding provisions re use of telepharmacy, replacing provisions re IV admixture with provisions re sterile product and adding provision re pharmacist-to-technician ratio, amended Subsec. (c) by deleting provisions re pilot program, adding provisions re use of telepharmacy and adding provision requiring quality assurance evaluations not less than once per calendar quarter, and deleted former Subsec. (d) re commencement and termination of pilot program, effective July 1, 2012.

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Sec. 20-610. (Formerly Sec. 20-166). Dispensing or retail sale of legend drugs, legend devices and certain other drugs by other than pharmacies and hospitals, prohibited. (a) No legend drug, legend device or drugs listed in subsection (b) of this section may be dispensed or sold at retail except (1) in a pharmacy, (2) by a hospital licensed under sections 19a-490 to 19a-503, inclusive, to an employee of the hospital when prescribed by a prescribing practitioner for the employee or the employee's spouse or dependent children, or (3) by such hospital to a retiree of such hospital or the retiree's spouse in accordance with the retiree's retirement or pension plan.

(b) The following drugs may not be sold at retail except as permitted in subsection (a) of this section: (1) Injectable or ingestible antibiotics; (2) injectable biologicals; (3) sulfonamides and their compounds which are designed to be taken into the stomach for systemic action; (4) injectable or ingestible corticosteroids; or (5) camphorated tincture of opium.

(c) Any person who violates any provision of this section shall be fined not less than one hundred dollars nor more than five hundred dollars.

(1949 Rev., S. 4465; 1951, 1955, S. 2237d; 1959, P.A. 616, S. 53; 1963, P.A. 367; February, 1965, P.A. 319; 1967, P.A. 109, S. 3; 555, S. 77; 1971, P.A. 134; June, 1971, P.A. 8, S. 60; 1972, P.A. 223, S. 7; P.A. 73-670, S. 1, 2; P.A. 74-100, S. 1, 2; P.A. 76-286; P.A. 77-614, S. 199, 610; P.A. 79-16; P.A. 81-107; P.A. 85-241, S. 2; P.A. 86-403, S. 41, 132; P.A. 89-251, S. 95, 203; P.A. 94-36, S. 33, 42; P.A. 95-264, S. 32; P.A. 01-65, S. 1, 2.)

History: 1959 act increased permit fee for towns with population of less than 5,000 from $3 and doubled fee for towns with population of more than 5,000; 1963 act added corticosteroids and mild silver protein to, and deleted argyrol from, provision listing items prohibited from sale; 1965 act added penalty proviso for failure to renew in timely fashion and prohibited issuance of renewal permit until fee and penalty paid; 1967 acts added references to dentist's prescriptions and deleted descriptive references to opium, morphine and codeine content of preparations and compounds and substituted “any controlled drug as defined in section 19-443, except as permitted in sections 20-180 and part II of chapter 359” and added similar reference to “controlled drug” in list of items prohibited for sale by stores or shops not licensed as pharmacies; 1971 acts required permittee for sale of drugs, etc. to be at least 21, allowed imposition of penalty for failure to record change in permittee with commission of pharmacy and doubled permit fees; 1972 act established separate renewal fee of $10; P.A. 73-670 added exception to prohibition of retail sales except by pharmacist for methadone sold by hospitals; P.A. 74-100 expanded exception to include sales by hospitals to employees for themselves or their dependents; P.A. 76-286 deleted age, citizenship and moral character requirements for permit holders, deleted provision re sales by store not licensed as a pharmacy under special permit, replaced differential fees based on population with single fee of $35, raised renewal fee from ten to $25, made penalties $10 rather than 50% of permit fee, deleted provision allowing appeal by person who has been refused a permit and prohibited sales of “legend drugs” as defined in Sec. 20-184a; P.A. 77-614 replaced commission's regulations with regulations “established under this chapter”, effective January 1, 1979; P.A. 79-16 deleted exception re sales of methadone by hospitals; P.A. 81-107 qualified as “injectable” or “ingestible” the antibiotics and corticosteroids which may not be stored, kept, sold or offered for sale by stores or shops other than licensed pharmacies; P.A. 85-241 clarified that the sale of veterinary medicines, poisons or chemicals by permittees is not prohibited and substituted references to licensed practitioners for references to physicians and dentists; P.A. 86-403 made technical change; P.A. 89-251 increased the original fee from $35 to $70 and increased the renewal fee from $25 to $50; P.A. 94-36 deleted the provision allowing the collection of late license renewal fees, effective January 1, 1995; P.A. 95-264 divided sections into Subsecs., substituted reference to legend drugs for reference to substances used to compound medicine, deleted provisions re sale of patent medicines and specified certain types of drugs to be sold only as permitted in Subsec. (a) in new provision designated as Subsec. (b); Sec. 20-166 transferred to Sec. 20-610 in 1997; P.A. 01-65 amended Subsec. (a) by designating existing exceptions as Subdivs. (1) and (2) and adding new Subdiv. (3) re retirees of hospital, effective June 6, 2001.

See Sec. 21a-4(c) re fines for late license renewals.

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Sec. 20-611. (Formerly Sec. 20-175b). Advertising legend drug prices. A pharmacist or any person holding a pharmacy license (1) may advertise the price of any legend drug sold at retail based on the prescription of a prescribing practitioner, provided, each such advertisement shall clearly state the period during which the advertised price or prices shall remain in effect and shall not contain any statement indicating that the advertised price or prices are subject to change without notice; and (2) shall disclose, upon request, the price of any such legend drug to any prospective purchaser.

(P.A. 75-95, S. 1, 3; P.A. 95-264, S. 33.)

History: P.A. 95-264 made technical changes and changed references to “drug, medicine or chemical” to “legend drug”; Sec. 20-175b transferred to Sec. 20-611 in 1997.

See chapter 418 re Uniform Food, Drug and Cosmetic Act.

See chapter 419 re retail drug control.

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Sec. 20-612. Only pharmacy may accept prescription for dispensing. Subject to the provisions of subsection (f) of section 20-614, only a pharmacy shall accept a prescription for dispensing. No employee, personnel or owner of a place of business or establishment not licensed as a pharmacy may accept a prescription for transfer to or for collection for a pharmacy.

(P.A. 95-264, S. 35; P.A. 04-107, S. 2; P.A. 19-191, S. 2.)

History: P.A. 04-107 amended section so as to make it subject to the provisions of Sec. 20-614(d), which provides for electronic data intermediaries; P.A. 19-191 changed reference from Sec. 20-614(d) to Sec. 20-614(f).

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Sec. 20-612a. Confirmation of identification prior to release of controlled substance. Exceptions. A pharmacist licensed pursuant to this chapter or his or her agent shall require the presentation of valid photographic identification prior to releasing a controlled substance to any person not known to such pharmacist. The provisions of this section shall not apply in an institutional setting or to a long-term care facility, including, but not limited to, an assisted living facility or a hospital.

(P.A. 06-155, S. 3.)

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Sec. 20-613. (Formerly Sec. 21a-308). Dispensing of drug or legend device pursuant to prescription only; exceptions. Emergency dispensing of drug or device in care-giving, correctional or juvenile training institutions; regulations. Pharmacy technicians. Prescribing practitioner authorized to dispense own prescription, when. (a) Except as provided in subsections (b) and (d) of this section, a drug or a legend device may be dispensed pursuant to a prescription only in a pharmacy or institutional pharmacy by a pharmacist or by a pharmacy intern when acting under the direct supervision of a pharmacist, or by an individual holding a temporary permit.

(b) In care-giving institutions and correctional or juvenile training institutions in emergency situations when the pharmacist is not available for the dispensing of drugs or devices from the institutional pharmacy, the prescription shall be reviewed by the nursing supervisor or a physician before administration of the drug or device and recorded with the pharmacist in its original form or a copy thereof. After the required review in such emergency situations, the person authorized by the institution may dispense drugs and devices from the institutional pharmacy pursuant to regulations adopted by the commissioner, with the advice and assistance of the commission, in accordance with chapter 54.

(c) A pharmacy technician in a pharmacy or an institutional pharmacy may assist, under the direct supervision of a pharmacist, in the dispensing of drugs and devices. A person whose license to practice pharmacy is under suspension or revocation shall not act as a pharmacy technician.

(d) Nothing in sections 20-570 to 20-630, inclusive, shall prevent a prescribing practitioner from dispensing the prescribing practitioner's own prescriptions to the prescribing practitioner's own patients when authorized within the scope of the prescribing practitioner's own practice and when done in compliance with sections 20-14c to 20-14g, inclusive.

(1969, P.A. 593, S. 18; P.A. 81-200, S. 2; P.A. 91-47, S. 2; P.A. 95-264, S. 34; P.A. 99-175, S. 35; P.A. 00-182, S. 13.)

History: P.A. 81-200 added Subsecs. (f) and (g) specifying the functions which may be performed by supportive personnel and requiring the commissioner of consumer protection to adopt regulations governing the number and activities of such personnel in institutional pharmacies; Sec. 19-504j transferred to Sec. 21a-308 in 1983; P.A. 91-47 authorized supportive personnel in licensed pharmacies to compound and dispense medications and to perform other tasks and provided for the adoption of regulations by the commissioner of consumer protection for supportive personnel in licensed pharmacies; P.A. 95-264 deleted provisions governing refills, replaced provisions re permissible actions of support personnel with provision re pharmacy technicians, added provision re dispensing of prescriptions by prescribing practitioners, changed references to “drugs” in Subsec. (b) to “drugs and devices” and made technical changes; Sec. 21a-308 transferred to Sec. 20-613 in 1997; P.A. 99-175 made technical and gender neutral changes, amended Subsec. (b) to add provision requiring adoption of regulations to be consistent with chapter 54 and amended Subsec. (d) to replace reference to Sec. 20-625 with reference to Sec. 20-630; P.A. 00-182 amended Subsec. (a) by adding language re individual holding a temporary permit.

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Sec. 20-613a. Requests for controlled substance issued on results of answers to electronic questionnaire. Regulations. In the absence of a documented patient evaluation that includes a physical examination, any request for a controlled substance issued solely on the results of answers to an electronic questionnaire shall be considered to be issued outside the context of a valid practitioner-patient relationship and not be a valid prescription. The Commissioner of Consumer Protection may adopt regulations, in accordance with chapter 54, concerning such requests for controlled substances. For the purposes of this section, “electronic questionnaire” means any form in an electronic format that may require personal, financial or medical information from a consumer or patient.

(P.A. 05-73, S. 3.)

History: P.A. 05-73 effective May 31, 2005.

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Sec. 20-614. (Formerly Sec. 20-184b). Prescriptions: Form and content. Offer to consult with pharmacist. Electronic data intermediaries. (a) A prescription shall be transmitted in either an oral, written or electronic manner to a pharmacy.

(b) Whenever a pharmacy, or an institutional pharmacy in a hospital dispensing a drug or device for outpatient use or dispensing a drug or device that is prescribed for an employee of the hospital or for the employee's spouse or dependent children, receives an oral or electronically-transmitted prescription, except for a controlled drug, as defined in section 21a-240, a record of such prescription shall be maintained in writing or electronically. The pharmacist or pharmacy intern shall, not later than the end of the business day when the prescription was received, record the prescription on a prescription form or in an electronic record including: (1) The name and address of the prescribing practitioner; (2) the date of the prescription; (3) the name, dosage form, strength, where applicable, and the amount of the drug prescribed; (4) the name and address of the patient or, for veterinary prescriptions, the name and address of the owner and the species of the animal; (5) the directions for use; (6) any required cautionary statements; and (7) the number of times the prescription may be refilled, including the use of refill terms “PRN” and “ad lib” in lieu of a specific number of authorized refills.

(c) A written prescription shall bear: (1) The written signature of the prescribing practitioner or shall comply with the requirements of section 19a-509c; (2) the address of the practitioner; (3) the date of the prescription; (4) the name, dosage form, strength, where applicable, and amount of the drug prescribed; (5) the name and address of the patient or, for veterinary prescriptions, the name and address of the owner and the species of the animal; (6) the directions for use; (7) any required cautionary statements; and (8) the number of times the prescription may be refilled, including the use of refill terms “PRN” and “ad lib” in lieu of a specific number of authorized refills. No written prescription form for a schedule II substance may contain an order for any other legend drug or device.

(d) Prior to or simultaneous with the dispensing of a drug, from a pharmacy licensed pursuant to this chapter, a pharmacist or other employee of the pharmacy shall, whenever practicable, offer for the pharmacist to discuss the drug to be dispensed and to counsel the patient on the usage of the drug, except when the person obtaining the prescription is other than the person named on the prescription form or electronic record or the pharmacist determines it is appropriate to make such offer in writing. Any such written offer shall include an offer to communicate with the patient either in person at the pharmacy or by telephone.

(e) Nothing in this section shall be construed to require a pharmacist to provide counseling to a patient who refuses such counseling. The pharmacist shall keep a record of such counseling, any refusal by or inability of the patient to accept counseling or a refusal by the patient to provide information regarding such counseling. Records kept pursuant to this subsection shall be maintained for the same length of time as prescription records are maintained pursuant to section 20-615.

(f) (1) As used in this subsection, “electronic data intermediary” means an entity that provides the infrastructure that connects the computer systems or other electronic devices utilized by prescribing practitioners with those used by pharmacies in order to facilitate the secure transmission of electronic prescription orders, refill authorization requests, communications and other patient care information between such entities.

(2) An electronic data intermediary may transfer electronically transmitted data between a prescribing practitioner licensed and authorized to prescribe and a pharmacy of the patient's choice, licensed pursuant to this chapter or licensed under the laws of any other state or territory of the United States. Electronic data intermediaries shall not alter the transmitted data except as necessary for technical processing purposes. Electronic data intermediaries may archive copies of only that electronic data related to such transmissions necessary to provide for proper auditing and security of such transmissions. Such data shall only be maintained for the period necessary for auditing purposes. Electronic data intermediaries shall maintain patient privacy and confidentiality of all archived information as required by state and federal law.

(3) No electronic data intermediary shall operate without the approval of the Commissioner of Consumer Protection. An electronic data intermediary seeking approval shall apply to the Commission of Pharmacy in the manner prescribed by the commissioner. The commissioner, with the advice and assistance of the commission, shall adopt regulations, in accordance with the provisions of chapter 54, to establish criteria for the approval of electronic data intermediaries, to ensure that (A) procedures to be used for the transmission and retention of prescription data by an intermediary, and (B) mechanisms to be used by an intermediary to safeguard the confidentiality of such data, are consistent with the provisions and purposes of this section.

(1969, P.A. 48, S. 2; P.A. 75-20; P.A. 77-165, S. 2; P.A. 82-419, S. 43, 47; P.A. 87-589, S. 62, 87; P.A. 95-264, S. 36; P.A. 99-175, S. 36; P.A. 04-107, S. 1; P.A. 05-272, S. 41; P.A. 09-22, S. 1; P.A. 19-191, S. 1; P.A. 21-37, S. 47.)

History: P.A. 75-20 deleted requirement that prescriptions, whether oral and then recorded or written, contain narcotic registry number, if applicable, deleted exception for controlled drugs in requirements for written prescriptions and substituted “species” for “breed”; P.A. 77-165 limited to one the number of prescriptions allowed per blank; P.A. 82-419 amended section to allow more than one prescription on a blank except in case of schedule II substance where previously prohibition against multiple prescriptions on a blank was absolute; P.A. 87-589 added “including the use of refill terms “PRN” and “ad lib” in lieu of a specific number of authorized refills”; P.A. 95-264 divided section into Subsecs., adding new provision as Subsec. (a) permitting electronically transmitted prescriptions, made technical changes and required pharmacies to record electronically transmitted prescriptions; Sec. 20-184b transferred to Sec. 20-614 in 1997; P.A. 99-175 made technical changes and added Subdiv. indicators to Subsec. (b); P.A. 04-107 added Subsec. (d) providing for electronic data intermediaries; P.A. 05-272 amended Subsec. (d)(3) by requiring that regulations adopted by commissioner ensure that procedures and mechanisms are consistent with provisions and purposes of section and by making technical changes, effective July 13, 2005; P.A. 09-22 added requirement in Subsec. (b) re record of prescription being maintained in writing or electronically and made conforming changes, effective July 1, 2009; P.A. 19-191 added new Subsec. (d) re pharmacist or other pharmacy employee to offer to discuss drug being dispensed and counsel client on usage, added new Subsec. (e) re patient who refuses counseling and records of counseling, and redesignated existing Subsec. (d) as Subsec. (f); P.A. 21-37 amended Subsec. (d) by deleting reference to Subsec. (b) and adding reference to pharmacy licensed pursuant to this chapter, effective June 4, 2021.

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Sec. 20-615. (Formerly Sec. 20-184c). Prescriptions: Pharmacy to assign serial number and maintain records. Transfer of records to another pharmacy. (a) An institutional pharmacy dispensing a drug in circumstances described in subsection (g) of this section and a pharmacy shall assign and record a serial number to each prescription that it fills and shall keep all written prescriptions and the record of oral and electronically-transmitted prescriptions required in section 20-614 in numerical order in a suitable file, electronic file or ledger for a period of not less than three years. The records shall indicate the date of filling, the name and address of the prescribing practitioner, the name and address of the patient or the name and address of the owner of an animal for whom the prescription was written and the species of the animal and the name of the pharmacist who dispensed the drug.

(b) A refill of a prescription shall be recorded on the face or back of the original prescription or in an electronic system.

(c) Records maintained under this section shall be made available for inspection upon request of any authorized agent of the commissioner or other person authorized by law.

(d) When a pharmacy closes temporarily or permanently, the pharmacy shall, in the interest of public health, safety and convenience, make its complete prescription records immediately available to a nearby pharmacy and post a notice of this availability on the window or door of the closed pharmacy.

(e) Any violation of this section shall be punishable as provided in section 20-581.

(f) This section shall not apply to records maintained in accordance with regulations adopted pursuant to section 20-576, 21a-244 or 21a-244a.

(g) When an institutional pharmacy in a hospital dispenses a drug or device for outpatient use or dispenses a drug or device that is prescribed for an employee of the hospital or for the employee's spouse or dependent children, the provisions of subsections (a), (b), (c) and (e) of this section shall apply.

(1969, P.A. 29; 1971, P.A. 156; P.A. 77-277, S. 6; 77-614, S. 206, 610; P.A. 95-264, S. 37; P.A. 99-175, S. 37; P.A. 09-22, S. 2.)

History: 1971 act allowed recording of refill on back of original prescription; P.A. 77-277 added Subsec. (b) excepting certain records from provisions of section; P.A. 77-614 replaced agents of commission of pharmacy with agents of consumer protection commissioner as inspectors of records, effective January 1, 1979; P.A. 95-264 added provisions requiring a pharmacy to record a serial number for each prescription it fills, made technical changes and added a new Subsec. (g) re dispensing of drug or device by hospital pharmacy for outpatient use or for hospital employee or family member; Sec. 20-184c transferred to Sec. 20-615 in 1997; P.A. 99-175 amended Subsec. (c) to make technical changes; P.A. 09-22 added “electronic file” and made a technical change in Subsec. (a), added reference to electronic system in Subsec. (b) and replaced provision re inconsistent regulations with reference to Sec. 21a-244a in Subsec. (f), effective July 1, 2009.

Annotation to former section 20-184c:

Cited. 207 C. 698.

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(1) “Diabetes device” means a device, including, but not limited to, a blood glucose test strip, glucometer, continuous glucometer, lancet, lancing device or insulin syringe, that is (A) a legend device or nonlegend device, and (B) used to cure, diagnose, mitigate, prevent or treat diabetes or low blood sugar;

(2) “Diabetic ketoacidosis device” means a device that is (A) a legend or nonlegend device, and (B) used to screen for or prevent diabetic ketoacidosis;

(3) “Glucagon drug” means a drug that contains glucagon and is (A) a legend drug or nonlegend drug, (B) prescribed for self-administration on an outpatient basis, and (C) approved by the federal Food and Drug Administration to treat low blood sugar;

(4) “Insulin drug” means a drug, including, but not limited to, an insulin pen, that contains insulin and is (A) a legend drug or nonlegend drug, (B) prescribed for self-administration on an outpatient basis, and (C) approved by the federal Food and Drug Administration to treat diabetes; and

(5) “Usual customary charge to the public” means a charge for a particular prescription not covered by Medicaid, excluding charges made to third-party payors and special discounts offered to individuals, including, but not limited to, senior citizens.

(b) Except as provided in subsection (c) or (d) of this section, a prescription may be refilled only upon the written, oral or electronically-transmitted order of a prescribing practitioner.

(c) A pharmacist may exercise his professional judgment in refilling a prescription that is not for a controlled drug, as defined in section 21a-240, without the authorization of the prescribing practitioner, provided (1) the pharmacist is unable to contact such practitioner after reasonable effort, (2) failure to refill the prescription might result in an interruption of a therapeutic regimen or create patient suffering, and (3) the pharmacist informs the patient or representative of the patient at the time of dispensing that the refill is being provided without such authorization and informs the practitioner at the earliest reasonable time that authorization of the practitioner is required for future refills. Prescriptions may be refilled once pursuant to this subsection for a quantity of drug not to exceed a seventy-two hour supply.

(d) (1) (A) Notwithstanding subsection (c) of this section, a pharmacist may immediately prescribe and dispense to a patient not more than a thirty-day supply of a diabetic ketoacidosis device, insulin drug or glucagon drug, and any diabetes devices that are necessary to administer such supply of such insulin drug or glucagon drug, if:

(i) The patient informs the pharmacist that the patient has less than a seven-day supply of such insulin drug, glucagon drug, diabetes devices or diabetic ketoacidosis device;

(ii) The pharmacist determines, in the pharmacist's professional judgment, that the patient will likely suffer significant physical harm within seven days if the patient does not obtain an additional supply of such insulin drug, glucagon drug, diabetes devices or diabetic ketoacidosis device before the expiration of said seven days;

(iii) The pharmacist reviews the electronic prescription drug monitoring program established pursuant to section 21a-254 and determines that no pharmacist prescribed and dispensed a supply of such insulin drug, glucagon drug, diabetes devices or diabetic ketoacidosis device to the patient pursuant to this subsection during the twelve-month period immediately preceding, unless:

(I) The pharmacist determines, by contacting the pharmacy that filled the most recent prescription for such insulin drug, glucagon drug, diabetes devices or diabetic ketoacidosis device, by examining another prescription database or reviewing the most recent prescription for such insulin drug, glucagon drug, diabetes devices or diabetic ketoacidosis device or a prescription label containing the most recent prescription information for such insulin drug, glucagon drug, diabetes devices or diabetic ketoacidosis device, that no pharmacist dispensed a supply of such insulin drug, glucagon drug, diabetes devices or diabetic ketoacidosis device to the patient pursuant to this subsection during said twelve-month period; or

(II) The electronic prescription drug monitoring program established pursuant to section 21a-254 is unavailable; and

(iv) Not later than seventy-two hours after the pharmacist dispenses such insulin drug, glucagon drug, diabetes devices or diabetic ketoacidosis device the pharmacist, or the pharmacist's representative, provides notice to the practitioner who, other than the pharmacist, most recently prescribed such insulin drug, glucagon drug, diabetes devices or diabetic ketoacidosis device to the patient.

(B) A pharmacist shall immediately prescribe and dispense to a patient not more than a thirty-day supply of a diabetic ketoacidosis device, insulin drug or glucagon drug, and any diabetes devices that are necessary to administer such supply of the insulin drug or glucagon drug, if the criteria established in subparagraphs (A)(i) to (A)(iv), inclusive, of this subdivision have been satisfied and the patient pays, or has health insurance coverage, for such insulin drug, glucagon drug, diabetes devices or diabetic ketoacidosis device.

(2) No pharmacist who prescribes and dispenses a supply of a diabetic ketoacidosis device, insulin drug or glucagon drug, and any diabetes devices that are necessary to administer such supply of the insulin drug or glucagon drug, pursuant to subdivision (1) of this subsection shall require the patient to tender payment to the pharmacist for such supply in an amount that exceeds:

(A) The amount of the coinsurance, copayment, deductible or other out-of-pocket expense that the patient's health insurance coverage imposes for such supply of such insulin drug, glucagon drug, diabetes devices or diabetic ketoacidosis device; or

(B) The usual customary charge to the public for such supply of such insulin drug, glucagon drug, diabetes devices or diabetes ketoacidosis device if the patient does not have health insurance coverage for such supply of such insulin drug, glucagon drug, diabetes devices or diabetic ketoacidosis device.

(3) Nothing in subdivision (1) or (2) of this subsection shall be construed to prohibit a pharmacist from requiring a patient to submit to the pharmacist, before the pharmacist prescribes or dispenses a supply of a diabetic ketoacidosis device, insulin drug or glucagon drug, and any diabetes devices necessary to administer such insulin drug or glucagon drug, pursuant to said subdivisions, proof of health insurance coverage for the patient, personal identification for the patient, contact information for a health care provider providing treatment to the patient, information concerning previous prescriptions issued to the patient for the insulin drug, glucagon drug, diabetes devices or diabetic ketoacidosis device, a sworn statement by the patient stating that the patient is unable to timely obtain the insulin drug, glucagon drug, diabetes devices or diabetic ketoacidosis device that the patient is seeking pursuant to this subsection without suffering significant physical harm, and any amount required by the pharmacist under subdivision (2) of this subsection.

(4) Each pharmacist shall refer a patient who requests a supply of an insulin drug, glucagon drug, diabetes devices or diabetic ketoacidosis device pursuant to this subsection to a federally-qualified health center if:

(A) The pharmacist determines that the patient does not have health insurance coverage for such supply of such insulin drug, glucagon drug, diabetes devices or diabetic ketoacidosis device; or

(B) The patient informs the pharmacist that the patient is concerned that the net cost to the patient for such supply of such insulin drug, glucagon drug, diabetes devices or diabetic ketoacidosis device is unaffordable.

(e) Any prescription that is not for a controlled drug, as defined in section 21a-240, may be transferred orally or electronically between pharmacies, provided:

(1) The prescribing practitioner has authorized the original prescription to be refilled in accordance with subsection (b) of this section;

(2) The pharmacist transferring the prescription shall cancel the original prescription in such pharmacist's records and shall indicate in such records the name of the pharmacy to which the prescription is transferred and the date of the transfer, provided, such cancellation shall not be required in the case of any transfer between pharmacies which electronically access the same prescription records and utilize the same computer or other electronic prescription transfer system; and

(3) The pharmacist receiving the prescription shall indicate in such pharmacist's records, in addition to any other information required by law, (A) the fact that the prescription has been transferred and the names of the transferring pharmacy and pharmacist, (B) the date of issuance and the prescription number of the original prescription, (C) the date the original prescription was first dispensed, (D) the number of refills authorized by the original prescription and the complete refill record for the prescription as of the date of the transfer, and (E) the number of valid refills remaining as of the date of the transfer.

(P.A. 91-164, S. 1; P.A. 95-264, S. 38; P.A. 97-64, S. 1; July Sp. Sess. P.A. 20-4, S. 3.)

History: P.A. 95-264 added new Subsec. (a) re refills, designated existing provisions as Subsec. (b) and made technical changes; Sec. 20-184d transferred to Sec. 20-616 in 1997; P.A. 97-64 made technical changes in Subsec. (b) and added Subsec. (c) re transfer of prescriptions; July Sp. Sess. P.A. 20-4 added new Subsec. (a) defining “diabetes device”, “diabetic ketoacidosis device”, “glucagon drug”, “insulin drug” and “usual customary charge to the public”, redesignated existing Subsecs. (a) and (b) as Subsecs. (b) and (c), added Subsec. (d) re provision of thirty-day supply of diabetic ketoacidosis device, insulin drug, glucagon drug and diabetes device and referral to federally-qualified health center, redesignated existing Subsec. (c) as Subsec. (e) and made conforming changes, effective January 1, 2021.

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Sec. 20-616a. Prescription refills for quantity of drug greater than initial quantity prescribed. Conditions. A pharmacist may exercise his or her professional judgment in refilling a prescription for a quantity of a drug greater than the initial quantity of a drug prescribed by the prescribing practitioner, provided (1) such refill is made after the patient's initial prescription is dispensed, (2) such refill does not exceed a ninety-day supply of such drug and does not exceed the total quantity of such drug authorized by the prescribing practitioner, (3) the prescribing practitioner has not indicated that the initial quantity or refill quantity of the prescribed drug shall not be changed, (4) such drug is not a controlled drug, as defined in section 21a-240, (5) the pharmacist informs the prescribing practitioner of such refill at the earliest reasonable time, but not later than forty-eight hours after such refill is made, and (6) the patient's health insurance policy or health benefit plan, if any, will cover the refill quantity dispensed, without additional coinsurance, deductible or other out-of-pocket expense required from the patient.

(P.A. 15-116, S. 1.)

History: P.A. 15-116 effective July 1, 2015.

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Sec. 20-617. (Formerly Sec. 20-184e). Prescriptions: Notation of drug quantity, expiration date, generic name and drug manufacturer and MedWatch program information. Label information for generic drug substitutions. (a) Each pharmacist shall include on the label of each prescription container: (1) The quantity of prescribed drug placed in such container, in addition to any other information required by law, and (2) a prominently printed expiration date based on the manufacturer's recommended conditions of use and storage that can be read and understood by the ordinary individual. The expiration date required pursuant to subdivision (2) of this subsection shall be no later than the expiration date determined by the manufacturer.

(b) In addition to the information required to be included on the label of each prescription container pursuant to subsections (a) and (c) of this section, each pharmacist shall include on the label of each prescription container or on the receipt or other similar packaging in which the prescription is contained for a drug sold only by generic name, as defined in section 20-14a, and not by brand name, as defined in said section: (1) The name of the manufacturer of the generic drug placed in the container, and (2) the Internet web site address and toll-free telephone number for the United States Food and Drug Administration's safety information and adverse event reporting program (MedWatch).

(c) In addition to the information required to be included on the label of each prescription container pursuant to subsections (a) and (b) of this section, if a pharmacist substitutes a generic name drug for a brand name drug, such pharmacist shall include on the label of the prescription container: (1) The name of the generic drug placed in the container, and (2) the brand name of the drug that the generic drug was substituted for.

(P.A. 93-94; P.A. 99-49; 99-175, S. 38; P.A. 00-182, S. 3; P.A. 15-219, S. 1.)

History: Sec. 20-184e transferred to Sec. 20-617 in 1997; P.A. 99-49 made a technical change, added Subdiv. indicators and added provision requiring prescription drug container label to include drug's expiration date; P.A. 99-175 made technical changes and deleted reference to Sec. 20-590; P.A. 00-182 added language re manufacturer's recommended conditions of use and storage and deleted language re customary conditions of purchase, and use and storage and re absence of contrary data; P.A. 15-219 designated existing provisions as Subsec. (a), added Subsec. (b) re inclusion on label of name of manufacturer of generic drug and MedWatch program information, added Subsec. (c) re required label information for generic substitutes, and made technical changes, effective January 1, 2016.

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Sec. 20-617a. Flavoring agent added to prescription product. (a) For purposes of this section, “flavoring agent” means an additive used in food or drugs when such additive: (1) Is used in accordance with good manufacturing practice principles and in the minimum quantity required to produce its intended effect, (2) consists of one or more ingredients generally recognized as safe in food and drugs, has been previously sanctioned for use in food and drugs by the state or the federal government, meets United States Pharmacopeia standards or is an additive permitted for direct addition to food for human consumption pursuant to 21 CFR 172, (3) is inert and produces no effect other than the instillation or modification of flavor, and (4) is not greater than five per cent of the total weight of the product.

(b) A flavoring agent may be added to a prescription product by: (1) A pharmacist upon the request of the prescribing practitioner, patient for whom the prescription is ordered or such patient's agent, or (2) a pharmacist acting on behalf of a hospital, as defined in section 19a-490.

(P.A. 12-12, S. 1.)

History: P.A. 12-12 effective July 1, 2012.

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Sec. 20-618. (Formerly Sec. 21a-107). Repackaged drugs not considered misbranded, when. Notwithstanding the provisions of section 21a-106 concerning misbranding of drugs or devices, a drug shall not be considered misbranded when repackaged by a pharmacy or an institutional pharmacy into stock packages for use within the pharmacy or the institutional pharmacy, provided the stock packages contain a label indicating the drug's name, strength, lot number, manufacturer and expiration date, if any.

(P.A. 79-116, S. 2; P.A. 95-264, S. 39.)

History: Sec. 19-226a transferred to Sec. 21a-107 in 1983; P.A. 95-264 made technical changes; Sec. 21a-107 transferred to Sec. 20-618 in 1997.

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(1) “Biological product” has the same meaning as provided in 42 USC 262;

(2) “Brand name” means the proprietary or trade name selected by the manufacturer and placed upon a drug product, its container, label or wrapping at the time of packaging;

(3) “Generic name” means the established name designated in the official United States Pharmacopoeia-National Formulary, official Homeopathic Pharmacopoeia of the United States, or official United States Adopted Names or any supplement to any of said publications;

(4) “Interchangeable biological product” means a biological product that: (A) The federal Food and Drug Administration has licensed and determined to meet the standards for interchangeability pursuant to 42 USC 262(k)(4), or (B) is therapeutically equivalent to another biological product, as set forth in the latest edition of or supplement to the federal Food and Drug Administration's publication “Approved Drug Products with Therapeutic Equivalence Evaluations”;

(5) “Therapeutically equivalent” means drug products that are approved under the provisions of the federal Food, Drug and Cosmetic Act for interstate distribution and that will provide essentially the same efficacy and toxicity when administered to an individual in the same dosage regimen;

(6) “Dosage form” means the physical formulation or medium in which the product is intended, manufactured and made available for use, including, but not limited to, tablets, capsules, oral solutions, aerosol, inhalers, gels, lotions, creams, ointments, transdermals and suppositories, and the particular form of any physical formulation or medium that uses a specific technology or mechanism to control, enhance or direct the release, targeting, systemic absorption, or other delivery of a dosage regimen in the body;

(7) “Epilepsy” means a neurological condition characterized by recurrent seizures; and

(8) “Seizures” means a disturbance in the electrical activity of the brain.

(b) Except as limited by subsections (f), (h) and (l) of this section, unless the purchaser instructs otherwise, the pharmacist may substitute a generic drug product with the same strength, quantity, dose and dosage form as the prescribed drug product which is, in the pharmacist's professional opinion, therapeutically equivalent. When the prescribing practitioner is not reasonably available for consultation and the prescribed drug does not use a unique delivery system technology, the pharmacist may substitute an oral tablet, capsule or liquid form of the prescribed drug as long as the form dispensed has the same strength, dose and dose schedule and is therapeutically equivalent to the drug prescribed. The pharmacist shall inform the patient or a representative of the patient, and the practitioner of the substitution at the earliest reasonable time.

(c) Except as limited by subsections (f), (h) and (l) of this section, unless the purchaser instructs otherwise, the pharmacist may substitute a biological product for a prescribed biological product if: (1) It is an interchangeable biological product, and (2) the practitioner has not specified, in the manner described in subsection (f) of this section, that there shall be no substitution for the prescribed biological product.

(d) Upon the dispensing of an interchangeable biological product to a patient, the pharmacist or a duly authorized agent of the pharmacist shall inform the patient or a representative of the patient of a substitution of an interchangeable biological product for a prescribed biological product. Not later than seventy-two hours after the pharmacist has informed the patient or representative of the patient of the substitution, the pharmacist shall make an entry documenting the substitution in a manner authorized pursuant to subsection (m) of this section.

(e) Upon the dispensing of an interchangeable biological product, but not later than seventy-two hours following the dispensing of such product, the pharmacist shall inform the prescribing practitioner by facsimile, telephone or electronic transmission of the substitution of such interchangeable biological product for a prescribed biological product.

(f) A prescribing practitioner may specify in writing or by a telephonic or other electronic communication that there shall be no substitution for the specified brand name drug product or prescribed biological product specified on any prescription form, provided (1) for written prescriptions, the practitioner shall specify on the prescription form that the drug product or prescribed biological product is “brand medically necessary” or “no substitution”, (2) for prescriptions transmitted by telephonic means, the pharmacist shall specify “brand medically necessary” or “no substitution” on the prescription form in the pharmacist's handwriting or in the electronic prescription record and shall record on the prescription form the time the telephonic authorization was received and the name of the person who communicated the telephonic authorization to the pharmacist, and (3) for prescriptions transmitted by any other electronic communication, the practitioner shall select the dispense as written code on the certified electronic prescription form to indicate that a substitution is not allowed by the practitioner. No prescription form for written prescriptions, and no prescription form for prescriptions transmitted pursuant to subdivision (2) or (3) of this subsection, may default to “brand medically necessary” or “no substitution”.

(g) Each pharmacy shall post a sign in a location easily seen by patrons at the counter where prescriptions are dispensed stating that, “THIS PHARMACY MAY BE ABLE TO SUBSTITUTE A LESS EXPENSIVE DRUG PRODUCT OR INTERCHANGEABLE BIOLOGICAL PRODUCT WHICH IS THERAPEUTICALLY EQUIVALENT TO THE ONE PRESCRIBED BY YOUR DOCTOR UNLESS YOU DO NOT APPROVE.” The printing on the sign shall be in block letters not less than one inch in height.

(h) A pharmacist may substitute a drug product under subsection (b) or interchangeable biological product under subsection (c) of this section only when there will be a savings in cost passed on to the purchaser. The pharmacist shall disclose the amount of the savings at the request of the patient.

(i) Except as provided in subsection (j) of this section, when a pharmacist dispenses a substitute drug product as authorized by subsection (b) of this section or an interchangeable biological product as authorized by subsection (c) of this section, the pharmacist shall label the prescription container with the name of the dispensed drug product or interchangeable biological product. If the dispensed drug product or interchangeable biological product does not have a brand name, the prescription label shall indicate the generic name of the drug product or the nonproprietary name of the interchangeable biological product dispensed along with the name of the manufacturer of the drug product or interchangeable biological product.

(j) A prescription dispensed by a pharmacist shall bear upon the label the name of the drug or biological product in the container unless the prescribing practitioner writes “DO NOT LABEL”, or words of similar import, on the prescription or so designates in an oral or electronic transmission of the prescription.

(k) Neither the failure to instruct by the purchaser as provided in subsection (b) of this section nor the fact that a sign has been posted as provided in subsection (g) of this section shall be a defense on the part of a pharmacist against a suit brought by any such purchaser.

(l) Upon the initial filling or renewal of a prescription that contains a statistical information code based upon the most recent edition of the International Classification of Diseases indicating the prescribed drug is used for the treatment of epilepsy or to prevent seizures, a pharmacist shall not fill the prescription by using a different drug manufacturer or distributor of the prescribed drug or biological product, unless the pharmacist (1) provides prior notice of the use of a different drug or biological product manufacturer or distributor to the patient and the prescribing practitioner, and (2) obtains the written consent of the patient's prescribing practitioner. For purposes of obtaining the consent of the patient's prescribing practitioner required by this subsection, a pharmacist shall notify the prescribing practitioner via electronic mail or facsimile transmission. If the prescribing practitioner does not provide the necessary consent, the pharmacist shall fill the prescription without such substitution or use of a different drug or biological product manufacturer or distributor or return the prescription to the patient or to the patient's representative for filling at another pharmacy. If a pharmacist is unable to contact the patient's prescribing practitioner after making reasonable efforts to do so, such pharmacist may exercise professional judgment in refilling a prescription in accordance with the provisions of subsection (c) of section 20-616. For purposes of this subsection, “pharmacy” means a place of business where drugs and devices may be sold at retail and for which a pharmacy license was issued pursuant to section 20-594, including a hospital-based pharmacy when such pharmacy is filling prescriptions for employees and outpatient care, and a mail order pharmacy licensed by this state to distribute in this state. “Pharmacy” does not include a pharmacy serving patients in a long-term care facility, other institutional facility or a pharmacy that provides prescriptions for inpatient hospitals.

(m) Not later than forty-eight hours following the dispensing of an interchangeable biological product, the dispensing pharmacist or the pharmacist's designee shall make an entry of the specific product provided to the patient, including the name of the product and the manufacturer of the product. The entry shall be made in a manner that provides notice to the prescriber and may be made through one of the following means: (1) An interoperable electronic medical records system, (2) an electronic prescribing technology, (3) a pharmacy benefit management system, or (4) a pharmacy record. If the entry is not made by any of the means specified in subdivision (1), (2), (3) or (4) of this subsection, the pharmacist shall communicate the product dispensed to the prescriber using either facsimile, telephone or electronic transmission, provided such communication shall not be required when a refill prescription is not changed from the product dispensed on the prior filling of the prescription. The provisions of this subsection shall not apply to interchangeable biological products dispensed by a pharmacy operated by a hospital licensed in accordance with the provisions of chapter 368v.

(n) The commissioner, with the advice and assistance of the commission, shall adopt regulations, in accordance with chapter 54, to carry out the provisions of this section.

(P.A. 76-166, S. 1, 8; P.A. 94-32, S. 1; P.A. 95-264, S. 40; P.A. 99-175, S. 39; June Sp. Sess. P.A. 00-2, S. 42, 53; P.A. 04-76, S. 31; P.A. 11-44, S. 150; P.A. 13-234, S. 101; P.A. 14-224, S. 1; P.A. 18-74, S. 1; July Sp. Sess. P.A. 20-4, S. 12.)

History: P.A. 94-32 added definition of “dosage form” and made technical changes; P.A. 95-264 made technical changes in definitions, deleted definition of “substitute” and added Subsecs. (b) to (i) re substitutions; Sec. 20-185a transferred to Sec. 20-619 in 1997; P.A. 99-175 made technical changes and amended Subsec. (i) to add provision requiring adoption of regulations to be consistent with chapter 54; June Sp. Sess. P.A. 00-2 amended Subsec. (c) by adding provisions requiring practitioner to specify basis of medical necessity in prescriptions for assistance recipients, by deleting “NO SUBSTITUTION” phrase requirements and by making conforming and technical changes, effective July 1, 2000; P.A. 04-76 amended Subsec. (c) by deleting references to “general assistance”; P.A. 11-44 amended Subsec. (a) by making technical changes in Subdivs. (2) and (3) and adding Subdivs. (5) to (7) defining “epilepsy”, “seizures” and “antiepileptic drug”, amended Subsec. (b) by adding reference to new Subsec. (i), amended Subsec. (c) by deleting references to state-administered general assistance and making technical changes, added new Subsec. (i) re filling or renewal of prescriptions for drugs used to treat epilepsy, and redesignated existing Subsec. (i) as Subsec. (j); P.A. 13-234 amended Subsec. (c) to delete references to ConnPACE recipient, effective January 1, 2014; P.A. 14-224 amended Subsec. (c) by replacing former Subdivs. (1) and (2) with new Subdivs. (1) to (3) re written prescriptions, prescriptions transmitted by telephonic means and prescriptions transmitted by any other electronic communication, and by adding provision re “brand medically necessary” or “no substitution” default, effective July 1, 2014; P.A. 18-74 amended Subsec. (a) to add new Subdiv. (1) re definition of “biological product”, redesignate existing Subdivs. (1) and (2) as Subdivs. (2) and (3), add new Subdiv. (4) re definition of “interchangeable biological product”, redesignate existing Subdivs. (3) to (6) as Subdivs. (5) to (8), and delete former Subdiv. (7) re definition of “antiepileptic drug”, added new Subsec. (c) re pharmacist substitution of biological product, added new Subsec. (d) re pharmacist or agent to inform patient or patient representative of substitution of interchangeable biological product, added new Subsec. (e) re pharmacist to inform prescribing practitioner of substitution of interchangeable biological product, redesignated existing Subsecs. (c) to (i) as Subsecs. (f) to (l), amended redesignated Subsec. (i) to add provision re indication of nonproprietary name of interchangeable biological product and delete reference to drug distributor, added Subsec. (m) re pharmacist or designee to make entry of product, redesignated Subsec. (j) as Subsec. (n), and made technical and conforming changes; July Sp. Sess. P.A. 20-4 amended Subsec. (l) by substituting reference to Sec. 20-616(c) for reference to Sec. 20-616(b), effective January 1, 2021.

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Sec. 20-619a. Biological product prescribing. Prescribing practitioner discussion with patient or representative. Documentation. Patient request to sign for delivery. (a) Prior to prescribing a biological product, as defined in section 20-619, a prescribing practitioner shall discuss with the patient or a representative of the patient the treatment methods, alternatives to and risks associated with the use of such biological product. The prescribing practitioner shall inform the patient that he or she may opt to sign for delivery of the biological product. The prescribing practitioner shall document such discussion in the patient's medical record not later than twenty-four hours after such discussion has taken place. This section shall not apply to hospital inpatients, emergency care, F.D.A. approved vaccines, blood or blood components.

(b) The patient or a representative of the patient may make a request of the pharmacy that the patient or representative be present to sign for delivery of the interchangeable biological product. The patient or representative of the patient may rescind such request at any time by notifying the pharmacy of such rescission.

(P.A. 18-74, S. 2.)

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Sec. 20-620. (Formerly Sec. 20-185g). Pharmacist's duties towards Medicaid recipients: To obtain, record and maintain pertinent patient information about the recipient; to undertake a review of the drugs previously dispensed to the recipient and to offer to discuss the drugs to be dispensed and to counsel the recipient on their correct usage. Exception. (a) Prior to or simultaneously with dispensing a prescription in accordance with sections 17b-260 to 17b-262, inclusive, and 17b-264 to 17b-285, inclusive, a pharmacist or the designee of the pharmacist shall make a reasonable effort to obtain, record and maintain, in a manner deemed appropriate by the pharmacist, the following information regarding the individual receiving such prescription: (1) Name, address, telephone number, date of birth or age and gender; (2) individual history where significant, including disease states, known allergies and drug reactions; (3) a comprehensive list of drugs and relevant devices dispensed by the pharmacy within the last one hundred eighty days; and (4) the pharmacist's comments relevant to the individual's drug therapy.

(b) Prior to or simultaneously with dispensing a drug to an individual eligible for benefits in accordance with sections 17b-260 to 17b-262, inclusive, and 17b-264 to 17b-285, inclusive, a pharmacist shall undertake a review of drugs dispensed to the individual by the pharmacy during the previous one hundred eighty days. The review shall include screening for potential drug therapy problems due to therapeutic duplication, a contraindication between a drug and a disease, the interaction of one drug with another, incorrect drug dosage or duration of drug treatment, the interaction of a drug and an allergy, clinical abuse or misuse and any other significant clinical issues relating to the appropriate use of drugs. Such review shall be based upon current standards and information consistent with that provided in the following resources: The American Hospital Formulary Service Drug Information, the United States Pharmacopoeia Drug Information, the American Medical Association Drug Evaluations and the peer-reviewed medical literature.

(c) Prior to or simultaneously with dispensing drugs to individuals eligible for benefits in accordance with sections 17b-260 to 17b-262, inclusive, and 17b-264 to 17b-285, inclusive, a pharmacist shall, whenever practicable, offer in person to discuss the drugs to be dispensed and to counsel the client on their usage, except when the person obtaining the prescription is other than the person named on the prescription form or the pharmacist determines it is appropriate to make such offer in writing. Any such written offer shall include an offer to communicate with the client either in person at the pharmacy or by telephone.

(d) The discussion and counseling offered in accordance with subsection (c) of this section shall include information deemed significant by the pharmacist based upon the findings of the review conducted in accordance with subsection (b) of this section, including (1) the name and description of the drug; (2) dosage form, dosage, route of administration and duration of drug therapy; (3) special directions and precautions for preparation, administration and use by the patient; (4) common severe side or adverse effects or interactions and therapeutic contraindications or precautions which the pharmacist deems relevant; (5) techniques for self-monitoring drug therapy; (6) proper storage; (7) prescription refill information; and (8) action to be taken in the event of a missed dose or adverse reaction.

(e) Nothing in this section shall be construed as requiring a pharmacist to provide counseling or gather information when an individual receiving benefits refuses such counseling or refuses or is unable to provide the information requested. The pharmacist shall document the provision of counseling, a refusal by or the inability of the patient to accept counseling or a refusal by the patient to give information. Records kept pursuant to this subsection shall be maintained for the same length of time as prescription records are maintained pursuant to section 20-615.

(f) The provisions of subsections (c) and (d) of this section shall not apply to a drug dispensed to a patient of a nursing home that is in compliance with the requirements of 42 CFR 483.60.

(May Sp. Sess. P.A. 92-16, S. 41, 89; P.A. 95-264, S. 41.)

History: P.A. 95-264 moved provisions of Subsec. (d) to Subsec. (a), relettering Subsecs. as necessary and made technical changes; Sec. 20-185g transferred to Sec. 20-620 in 1997.

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Sec. 20-621. (Formerly Sec. 20-185h). Relabeling and dispensing of parenteral medication in hospital and nursing home pharmacies: When allowed. A pharmacist practicing in a hospital pharmacy or nursing home pharmacy may relabel and dispense to a registered inpatient, parenteral medication, except controlled substances, dispensed for another registered patient by a licensed pharmacy if the following requirements are met: (1) The original medication order for the drug is discontinued; (2) the medication is in an unopened tamper-evident package; (3) the medication is not expired; (4) the original patient is not charged for the medication; and (5) upon receipt of the medication by the facility from the licensed pharmacy, it is processed through the hospital's pharmacy or nursing home pharmacy.

(P.A. 93-173, S. 1.)

History: Sec. 20-185h transferred to Sec. 20-621 in 1997.

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Sec. 20-621a. Use of automated prescription dispensing machine in long-term care pharmacies authorized. Regulations. (a) As used in this section: (1) “Long-term care pharmacy” (A) means a pharmacy licensed under section 20-594, or registered as a nonresident pharmacy under section 20-627, that stores and dispenses legend drugs and legend devices to patients or residents of licensed nursing homes, rest homes, residential care homes or other supervised residential facilities and from which related pharmaceutical care services are provided, and (B) includes pharmacies located both inside and outside of such facilities but does not include those that are part of a licensed hospital; (2) “nursing home” has the same meaning as provided in section 19a-490; and (3) “automated prescription dispensing machine” has the same meaning as provided in section 20-571. A long-term care pharmacy may operate an automated prescription dispensing machine in a nursing home in accordance with a protocol approved in writing by the Department of Consumer Protection, until such time as regulations are adopted pursuant to subsection (b) of this section. The annual fee to operate an automated prescription dispensing machine shall be one hundred dollars per machine.

(b) The Commissioner of Consumer Protection shall adopt regulations, in accordance with the provisions of chapter 54, to implement the provisions of subsection (a) of this section. After the adoption of such regulations, the operation of an automated prescription dispensing machine, as described in subsection (a) of this section, shall be in accordance with such regulations.

(P.A. 21-192, S. 2; P.A. 22-104, S. 31.)

History: P.A. 21-192 effective July 13, 2021; P.A. 22-104 amended Subsec. (a)(1)(A) by adding provision re pharmacy registered as nonresident pharmacy under Sec. 20-627, and made technical and conforming changes in Subsec. (a), effective May 24, 2022.

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Sec. 20-622. (Formerly Sec. 20-180a). Licensed practitioners may authorize medication to be dispensed from a hospital emergency room. When the therapeutic needs of a patient require that medication be initiated immediately and the services of a licensed pharmacy are not available within a five-mile radius of a hospital emergency room, a person associated with such hospital authorized to dispense medication may dispense up to a twenty-four-hour supply of medication, excluding controlled substances, to such patient. Such dispensing shall be authorized by a verbal order of a licensed practitioner. For purposes of this section, “licensed practitioner” means a physician on the staff of such hospital or other prescribing practitioner associated with such hospital who has examined such patient and determined the patient's therapeutic needs.

(P.A. 93-173, S. 2; P.A. 99-175, S. 40.)

History: Sec. 20-180a transferred to Sec. 20-622 in 1997; P.A. 99-175 made technical and gender neutral changes and deleted reference to Sec. 20-184a.

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Sec. 20-623. Sale of nonlegend drugs. Labels, packaging and contents. Penalty. (a) No nonlegend drug may be sold at retail except at a pharmacy or at a store that has obtained from the commission a permit to sell nonlegend drugs. Nonlegend drugs shall be labeled and packaged in accordance with state and federal law.

(b) Any person who violates any provision of this section shall be fined not less than one hundred dollars nor more than five hundred dollars.

(P.A. 95-264, S. 42; P.A. 99-175, S. 41.)

History: P.A. 99-175 made a technical change in Subsec. (a).

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Sec. 20-624. Permit to sell nonlegend drugs. (a) Any person may apply to the commission for a permit to sell nonlegend drugs.

(b) The commission may, in accordance with regulations adopted under sections 20-570 to 20-630, inclusive, in accordance with chapter 54, and on payment of the fee required in section 20-601, issue to an applicant a permit to sell nonlegend drugs for one year.

(c) A permit that has expired under this section may be renewed, on application and payment of the renewal fee and any late fee required in section 20-601.

(d) The holder of a permit to sell nonlegend drugs shall notify the commission of a change of ownership, name or location of the permit premises. Any holder who fails to notify the commission of such change within five days of the change shall pay the late fee required in section 20-601.

(e) Any nonlegend drug permit issued by the commission pursuant to this section is nontransferable.

(P.A. 95-264, S. 43; P.A. 99-175, S. 42.)

History: P.A. 99-175 amended Subsec. (b) to replace reference to Sec. 20-625 with reference to Sec. 20-630 and add provision requiring adoption of regulations to be consistent with chapter 54 and added new Subsec. (e) to specify that nonlegend drug permits issued by commission are nontransferable.

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Sec. 20-625. Nonlegend veterinary drugs. Nothing in sections 20-570 to 20-630, inclusive, shall be construed to prohibit the sale of veterinary drugs that are nonlegend drugs by any person who holds a permit to sell nonlegend drugs.

(P.A. 95-264, S. 44; P.A. 99-175, S. 43.)

History: P.A. 99-175 replaced reference to Sec. 20-624 with reference to Sec. 20-630.

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Sec. 20-626. Confidentiality of pharmacy records. (a) No pharmacist or pharmacy shall reveal any records or information concerning the nature of pharmaceutical services rendered to a patient without the oral or written consent of the patient or the patient's agent. If a patient or a patient's agent gives oral consent to release records or information, the pharmacist shall promptly record, in writing or in electronic data base form, the oral consent by listing the patient's name, the name of the patient's agent, if applicable, the date and the nature of the records or information released.

(b) Notwithstanding subsection (a) of this section, a pharmacist or pharmacy may provide pharmacy records or information to the following: (1) The patient; (2) the prescribing practitioner or a pharmacist or another prescribing practitioner presently treating the patient when deemed medically appropriate; (3) a person registered or licensed pursuant to chapter 378 who is acting as an agent for a prescribing practitioner that is presently treating the patient or a person registered or licensed pursuant to chapter 378 providing care to the patient in a hospital; (4) third party payors who pay claims for pharmaceutical services rendered to a patient or who have a formal agreement or contract to audit any records or information in connection with such claims; (5) any governmental agency with statutory authority to review or obtain such information; (6) any individual, the state or federal government or any agency thereof or court pursuant to a subpoena; and (7) any individual, corporation, partnership or other legal entity which has a written agreement with a pharmacy to access the pharmacy's database provided the information accessed is limited to data which does not identify specific individuals.

(P.A. 95-85; P.A. 99-175, S. 44.)

History: P.A. 99-175 amended Subsec. (b) to make technical changes.

Subsec. (a):

Statute is intended to protect information concerning the nature of customer's treatment and not pharmacy's billing practices. 53 CA 129.

Subsec. (b):

Pharmacy required to comply with investigative demand of commissioner; civil investigative demand determined to be equivalent of subpoena. 53 CA 129.

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Sec. 20-627. Nonresident pharmacy. Definitions. Certificate of registration. Requirements. (a) As used in sections 20-627 to 20-630, inclusive, “nonresident pharmacy” means any pharmacy located outside this state that ships, mails or delivers, in any manner, legend devices or legend drugs into this state pursuant to a prescription order.

(b) A nonresident pharmacy shall be registered with the department, upon approval of the commission, and shall:

(1) Disclose annually in a report to the commission the location, names and titles of all principal corporate officers, if applicable, and all pharmacists who are dispensing drugs or devices to residents of this state;

(2) A nonresident pharmacy shall file a report within ten days after any change of name, ownership, management, officers or directors. Such report shall be accompanied by the filing fee set forth in section 20-601. Any nonresident pharmacy that fails to give notice as required pursuant to this subdivision within ten days after the change shall pay the late fee set forth in section 20-601;

(3) Comply with all lawful directions and requests for information from the regulatory or licensing agency of the state in which it is licensed as well as comply with all requests for information made by the commission or department pursuant to this section;

(4) Disclose to the department whether the nonresident pharmacy is dispensing sterile pharmaceuticals, as defined in section 20-633b, within this state. If any such dispensed sterile pharmaceutical is not patient-specific, the nonresident pharmacy shall submit a copy of the manufacturing license or registration issued by the regulatory or licensing agency of the state in which it is licensed, and a copy of any registration issued by the federal Food and Drug Administration to the department;

(5) Maintain at all times, a valid unexpired license, permit or registration to conduct such pharmacy in compliance with the laws of the state in which the nonresident pharmacy is located;

(6) Before receiving a certificate of registration from the department, submit a copy of the most recent inspection report resulting from an inspection conducted by the regulatory or licensing agency of the state in which the nonresident pharmacy is located. If the nonresident pharmacy is delivering sterile compounded products within this state, such inspection report shall include a section based on standards required in the most recent United States Pharmacopeia, Chapter 797, as amended from time to time. If the state in which the nonresident pharmacy is located does not conduct inspections based on standards required in the most recent United States Pharmacopeia, Chapter 797, as amended from time to time, such nonresident pharmacy shall provide proof to the department that it is in compliance with such standards;

(7) A nonresident pharmacy shall provide a toll-free telephone number to facilitate communication between patients in this state and a pharmacist at such nonresident pharmacy who has access to the patient's records at all times. Such toll-free telephone number shall be disclosed on a label affixed to each container of drugs dispensed to patients in this state;

(8) Notify the department if the nonresident pharmacy has had any disciplinary action or written advisement or warning by any federal or state regulatory agency or any accreditation body not later than ten business days after being notified of such action, advisement or warning; and

(9) Provide to the department the names and addresses of all residents of this state to whom legend devices or legend drugs have been delivered, not later than twenty-four hours after the nonresident pharmacy initiates a recall of any legend devices or legend drugs.

(P.A. 96-127, S. 1; P.A. 99-175, S. 45; P.A. 14-224, S. 3; P.A. 18-141, S. 11.)

History: P.A. 99-175 made technical changes, reordered Subsecs., amended Subsec. (a) to delete reference to Sec. 20-184a and deleted former Subsec. (c); P.A. 14-224 amended Subsec. (b) by adding new Subdiv. (3) re disclosure by nonresident pharmacy, redesignating existing Subdivs. (3) and (4) as Subdivs. (4) and (5), and adding provision re inspection report for nonresident pharmacy delivering sterile compounded products within this state in redesignated Subdiv. (5), redesignated existing Subsec. (c) as Subsec. (b)(6) and amended same to require toll-free telephone number for patients at all times, added Subsec. (b)(7) re notification of disciplinary action or warning, added Subsec. (b)(8) re provision of names and addresses of residents to whom legend devices or legend drugs have been delivered, and made technical changes, effective July 1, 2014; P.A. 18-141 amended Subsec. (b) by designating provision re nonresident pharmacy to file report as Subdiv. (2) and amending same by deleting reference to additional report, replacing “thirty days” with “ten days”, replacing “office, corporate officer or pharmacist” with “name, ownership, management, officers or directors”, adding provisions re filing fee and late fee, redesignating Subdivs. (2) to (8) as Subdivs. (3) to (9), and making technical changes, effective June 11, 2018.

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Sec. 20-628. Shipping, mailing or delivering legend devices or drugs. No nonresident pharmacy shall engage in the business of shipping, mailing or delivering legend devices or legend drugs in this state unless such nonresident pharmacy has been issued a certificate of registration by the commission and has paid the fee for issuance or renewal of such certificate of registration required in section 20-601. Applications for a certificate of registration as a nonresident pharmacy shall be made on a form furnished by the commission. The commission may require such information as it deems reasonably necessary to carry out the purpose of this section.

(P.A. 96-127, S. 2; P.A. 99-175, S. 46.)

History: P.A. 99-175 made technical changes, deleted reference to Sec. 20-184a and added provision requiring nonresident pharmacists to pay initial and renewal registration fees as a condition of shipping, mailing or delivering legend devices or drugs in this state.

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Sec. 20-629. Denial, revocation or suspension of nonresident pharmacy certificate of registration. Referral by commission. (a) The commission may deny, revoke or suspend any certificate of registration as a nonresident pharmacy for:

(1) Failure to comply with any requirement of this chapter or chapter 420b;

(2) Failure to comply with any federal or state statute or regulation concerning drugs or the practice of pharmacy;

(3) Delivering in any manner into this state legend drugs or legend devices that are adulterated or misbranded in violation of chapter 418; or

(4) Any disciplinary action taken against the nonresident pharmacy by any state or federal agency.

(b) The commission may, in addition to any action authorized under subsection (a) of this section, refer the matter to the regulatory or licensing agency in the state in which the nonresident pharmacy is located.

(P.A. 96-127, S. 3; P.A. 99-175, S. 47; P.A. 14-224, S. 4.)

History: P.A. 99-175 made technical changes; P.A. 14-224 amended Subsec. (a) by deleting reference to Secs. 20-627 to 20-630 and adding Subdivs. (1) to (4) re grounds for denial, revocation or suspension, and amended Subsec. (b) by deleting provision re nonresident pharmacy conduct, adding “in addition to any action authorized under subsection (a) of this section, refer” and deleting former Subdivs. (1) to (4) re regulatory or licensing agency action, effective July 1, 2014.

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Sec. 20-630. Advertising. It shall be unlawful for any nonresident pharmacy which has not been issued a certificate of registration pursuant to section 20-628 to advertise its services in this state, or for any person who is a resident of this state to advertise the pharmacy services of a nonresident pharmacy which has not received a certificate of registration from the commission, with the knowledge that the advertisement will or is likely to induce members of the public in this state to use the pharmacy to dispense prescription orders.

(P.A. 96-127, S. 4; P.A. 99-175, S. 48.)

History: P.A. 99-175 made a technical change.

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Sec. 20-631. Collaborative drug therapy care plans, management agreements and policies. Scope. Care-giving institutions, devices and qualified pharmacists. Regulations. (a) For the purposes of this section:

(1) “Care-giving institution” has the same meaning as provided in section 20-571;

(2) “Commissioner” means the Commissioner of Consumer Protection;

(3) “Collaborative drug therapy care plan” means a written document memorializing the outcome of the process through which one or more qualified pharmacists and one or more prescribing practitioners discuss, review and agree on an approach to achieve a patient's desired health outcome;

(4) “Collaborative drug therapy management agreement” means an agreement between one or more qualified pharmacists and one or more prescribing practitioners to manage the drug therapy of, and devices prescribed to, individual patients, or a patient population, based on a written protocol or a collaborative drug therapy care plan;

(5) “Collaborative drug therapy management policy” means a written policy adopted by a care-giving institution under which one or more qualified pharmacists manage the drug therapy of, and devices prescribed to, individual patients, or a patient population, based on a written protocol or a collaborative drug therapy care plan;

(6) “Device” has the same meaning as provided in section 20-571;

(7) “Pharmacist” has the same meaning as provided in section 20-571;

(8) “Prescribing practitioner” has the same meaning as provided in section 20-571;

(9) “Provider-patient relationship” means a relationship between a prescribing practitioner and a patient in which (A) the patient has made a medical complaint, (B) the patient has provided such patient's medical history, (C) the patient has received a physical examination, and (D) there exists a logical connection between such medical complaint, medical history and physical examination and any drug or device prescribed for such patient; and

(10) “Qualified pharmacist” means a pharmacist who (A) is deemed competent under regulations adopted by the commissioner pursuant to subsection (e) of this section, and (B) has reviewed the latest edition of the “Pharmacists' Patient Care Process” published by the Joint Commission of Pharmacy Practitioners.

(b) Except as provided in section 20-631b, one or more qualified pharmacists may enter into a collaborative drug therapy management agreement or manage the drug therapy of, and devices prescribed to, individual patients, or a patient population, under a collaborative drug therapy management policy. In order to enter into a collaborative drug therapy management agreement or collaborative drug therapy care plan, or operate under a collaborative drug therapy management policy, a prescribing practitioner shall first establish a provider-patient relationship with the patient or patients who will receive collaborative drug therapy or devices. Each patient's collaborative drug therapy or device management shall be based on a diagnosis made by such patient's prescribing practitioner or a specific test set forth in a collaborative drug therapy management agreement or collaborative drug therapy management policy.

(c) A collaborative drug therapy management agreement or collaborative drug therapy management policy may authorize a qualified pharmacist or qualified pharmacists to initiate, modify, continue, discontinue or deprescribe a drug therapy, or initiate, continue or discontinue use of, or deprescribe, a device, that has been prescribed for a patient, order associated laboratory tests and administer drugs, all in accordance with a patient-specific or patient population-specific written protocol or collaborative drug therapy care plan, but shall not authorize a qualified pharmacist or qualified pharmacists to establish a port to administer parenteral drugs. A collaborative drug therapy management agreement or collaborative drug therapy management policy may specifically address issues that may arise during a medication reconciliation and concerns related to polypharmacy that enable an authorized qualified pharmacist or qualified pharmacists to initiate, modify, continue, discontinue or deprescribe drug therapy. In instances where drug therapy is discontinued or deprescribed, the qualified pharmacist or qualified pharmacists shall notify the prescribing practitioner of such discontinuance or deprescribing not later than twenty-four hours after such drug therapy is discontinued or deprescribed. Each written protocol or collaborative drug therapy care plan developed, pursuant to a collaborative drug therapy management agreement or collaborative drug therapy management policy, shall contain detailed direction concerning the actions that the qualified pharmacist or qualified pharmacists may perform for the patient or patient population. Such written protocol or collaborative drug therapy care plan shall include, but need not be limited to, (1) the specific drug or drugs, therapeutic class of drug or classes of drugs, or devices to be managed by the qualified pharmacist or qualified pharmacists, (2) the terms and conditions under which drug therapy may be initiated, modified, continued, discontinued or deprescribed, or use of a device may be initiated, continued or discontinued, or a device may be deprescribed, (3) the conditions and events upon which the qualified pharmacist is, or qualified pharmacists are, required to notify the prescribing practitioner, (4) the laboratory tests that may be ordered, and (5) a definition of the patient population included in such written protocol or collaborative drug therapy care plan. All activities performed by the qualified pharmacist or qualified pharmacists in conjunction with the protocol or collaborative drug therapy care plan shall be documented in the patient's medical record in accordance with the prescribing practitioner's policies or, in the case of a care-giving institution, all applicable care-giving institution policies. Each collaborative drug therapy management agreement, collaborative drug therapy management policy, written protocol and collaborative drug therapy care plan shall be available for inspection by the Department of Consumer Protection and the Department of Public Health. A copy of the protocol shall be filed in the patient's medical record.

(d) A pharmacist shall be responsible for demonstrating, in accordance with regulations adopted pursuant to subsection (e) of this section, the competence necessary for the pharmacist to participate in each collaborative drug therapy management agreement, collaborative drug therapy management policy and collaborative drug therapy care plan in which such pharmacist seeks to participate by, among other things, demonstrating that such pharmacist has reviewed the latest edition of the “Pharmacists' Patient Care Process” published by the Joint Commission of Pharmacy Practitioners.

(e) The Commissioner of Consumer Protection, in consultation with the Commissioner of Public Health, shall (1) adopt regulations, in accordance with chapter 54, concerning competency requirements for participation in a collaborative drug therapy management agreement, the minimum content of the collaborative drug therapy management agreement and such other matters said commissioners deem necessary to carry out the purpose of this section, and (2) on or after July 1, 2022, amend such regulations to include competency requirements for participation in a collaborative drug therapy management policy or collaborative drug therapy care plan and the minimum content of collaborative drug therapy management policies, collaborative drug therapy care plans and written protocols governing collaborative drug therapy and device management.

(P.A. 02-41, S. 1; P.A. 03-164, S. 1; June 30 Sp. Sess. P.A. 03-6, S. 146; P.A. 04-169, S. 17; 04-189, S. 1; P.A. 05-217, S. 1; P.A. 10-117, S. 91; P.A. 19-98, S. 22; P.A. 21-192, S. 4; P.A. 22-118, S. 69.)

History: (Revisor's note: In codifying this section the Revisors editorially changed two references in Subsec. (b) from “pharmacists” to “pharmacist” for consistency); P.A. 03-164 amended Subsec. (a) by designating existing provisions as Subdiv. (1), making a technical change therein, and adding Subdiv. (2) allowing pharmacists employed by nursing home facilities to enter into collaborative drug therapy management agreement, and made conforming changes in Subsec. (c); June 30 Sp. Sess. P.A. 03-6 and P.A. 04-169 replaced Commissioner and Department of Consumer Protection with Commissioner and Department of Agriculture and Consumer Protection, effective July 1, 2004; P.A. 04-189 repealed Sec. 146 of June 30 Sp. Sess. P.A. 03-6, thereby reversing the merger of the Departments of Agriculture and Consumer Protection, effective June 1, 2004; P.A. 05-217 amended Subsec. (a) by adding Subdiv. (3) allowing hospital pharmacists to enter into collaborative drug therapy management agreements to manage drug therapy of patients receiving outpatient hospital care or services for diabetes, asthma, hypertension, hyperlipidemia, osteoporosis, congestive heart failure or smoking cessation; P.A. 10-117 amended Subsec. (a) by adding exception re Sec. 20-631b, replacing provision re pharmacist eligibility in accordance with Subsec. (c) with provision re pharmacist competency in accordance with regulations adopted pursuant to Subsec. (d), adding provisions requiring and defining physician-patient relationship for purposes of agreement, deleting former Subdiv. (1) designator and deleting provisions therein and former Subdivs. (1) and (2) re pharmacist employed by or under contract with a hospital or nursing home facility, amended Subsec. (c) by requiring demonstration of pharmacist competency in accordance with regulations adopted pursuant to Subsec. (d) and deleting former provisions re competency determination, and amended Subsec. (d) to require Commissioner of Consumer Protection, in consultation with Commissioner of Public Health, to adopt regulations re pharmacist competency requirements for participation in agreements (Revisor's note: In codifying P.A. 10-117, S. 91, a reference to “section 2 of this act” was deemed by the Revisors to be a reference to “section 92 of this act” and therefore cited as “section 20-631b” in Subsec. (a)); P.A. 19-98 amended Subsecs. (a) and (b) by adding references to advance practice registered nurse and further amended Subsec. (a) by replacing “physician-patient relationship” with “provider-patient relationship”; P.A. 21-192 amended Subsec. (a) by replacing “specific to the patient” with “which may include guideline-directed management”, amended Subsec. (b) by adding references to continuing and deprescribing drug therapy, adding provision re agreement addressing medication reconciliation and polypharmacy, changing provision re reporting every 30 days to encounters within scope of agreement and authorizing documenting information within shared medical record rather than reporting, effective July 13, 2021; P.A. 22-118 added new Subsec. (a) defining “care-giving institution”, “commissioner”, “collaborative drug therapy care plan”, “collaborative drug therapy management agreement”, “collaborative drug therapy management policy”, “device”, “pharmacist”, “prescribing practitioner”, “provider-patient relationship” and “qualified pharmacist”, redesignated existing Subsecs. (a) to (d) as Subsecs. (b) to (e), substantially amended redesignated Subsec. (b) re qualified pharmacists and redesignated Subsec. (c) re collaborative drug therapy management agreements including addition of provisions re collaborative drug therapy management policies, devices, patient populations, ports to administer parenteral drugs and Subdiv. (5) re definition of patient population included in written protocol or collaborative drug therapy care plan, amended redesignated Subsec. (d) by adding provisions re collaborative drug therapy management policies, collaborative drug therapy care plans and pharmacist review of latest edition of “Pharmacists' Patient Care Process” published by Joint Commission of Pharmacy Practitioners, amended redesignated Subsec. (e) by designating existing provisions re regulations as Subdiv. (1) and adding Subdiv. (2) re regulations re competency requirements and minimum content of collaborative drug therapy management policies, collaborative drug therapy care plans and written protocols governing collaborative drug therapy and device management, and made technical and conforming changes, effective July 1, 2022.

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Sec. 20-631a. Collaborative drug management agreements between pharmacists employed by community pharmacies and one or more physicians or advanced practice registered nurses. Pilot program. (a) Not later than January 1, 2006, the Commissioner of Consumer Protection, in consultation with the Commission of Pharmacy, shall establish and operate a two-year pilot program to allow not more than ten pharmacists licensed under this chapter who are determined eligible in accordance with subsection (c) of this section and employed by or under contract with a licensed community pharmacy, to enter into a written protocol-based collaborative drug therapy management agreement with one or more physicians licensed under chapter 370 or advanced practice registered nurses licensed under chapter 378, to manage the drug therapy of individual patients receiving drug therapy for diabetes, asthma, hypertension, hyperlipidemia, osteoporosis, congestive heart failure or smoking cessation, including patients who qualify as targeted beneficiaries under the provisions of Section 1860D-4(c)(2)(A)(ii) of the federal Social Security Act, in accordance with subsections (b) to (d), inclusive, of this section and subject to the approval of the licensed community pharmacy. Each patient's collaborative drug therapy management shall be governed by a written protocol specific to that patient established by the treating physician or advanced practice registered nurse in consultation with the pharmacist.

(b) A collaborative drug therapy management agreement may authorize a pharmacist to implement, modify or discontinue a drug therapy that has been prescribed for a patient, order associated laboratory tests and administer drugs, all in accordance with a patient-specific written protocol. Each protocol developed, pursuant to the collaborative drug therapy management agreement, shall contain detailed direction concerning the actions that the pharmacist may perform for that patient. The protocol shall include, but need not be limited to, (1) the specific drug or drugs to be managed by the pharmacist, (2) the terms and conditions under which drug therapy may be implemented, modified or discontinued, (3) the conditions and events upon which the pharmacist is required to notify the physician or advanced practice registered nurse, and (4) the laboratory tests that may be ordered. All activities performed by the pharmacist in conjunction with the protocol shall be documented in the patient's medical record. The pharmacist shall report to the physician or advanced practice registered nurse through oral, written or electronic manner regarding the implementation, administration, modification or discontinuation of a drug therapy that has been prescribed for a patient not later than twenty-four hours after such implementation, administration, modification or discontinuation. The collaborative drug therapy management agreement and protocols shall be available for inspection by the Departments of Public Health and Consumer Protection. A copy of the protocol shall be filed in the patient's medical record.

(c) In order to be selected for participation in the program, a pharmacist shall be responsible for demonstrating, in accordance with this subsection, the competence necessary for participation in each drug therapy management agreement into which such pharmacist may enter. The pharmacist's competency shall be determined by the Commission of Pharmacy using criteria based on the continuing education requirements of sections 20-599 and 20-600.

(d) The Commissioner of Consumer Protection and the Commission of Pharmacy shall evaluate the pilot program established under this section and shall submit a report of the commissioner's findings and recommendations to the joint standing committees of the General Assembly having cognizance of matters relating to public health, human services and general law, not later than December 31, 2008, in accordance with the provisions of section 11-4a. Such report shall include an evaluation of the data collected with respect to improved medication management and cost savings, based on patient outcomes.

(e) Records or information collected or maintained pursuant to this section shall not be disclosed pursuant to subsection (a) of section 1-210 for a period of six months from the date such records or information were created or collected and shall not be subject to subpoena or discovery or introduced into evidence in any judicial or administrative proceeding except as otherwise specifically provided by law.

(f) For purposes of this section, “community pharmacy” means a pharmacy licensed under section 20-594 that stores and dispenses legend drugs, as defined by section 20-571, and legend devices, as defined by said section 20-571, and from which related pharmaceutical care services are provided, primarily to noninstitutionalized patients living in a community setting.

(P.A. 05-217, S. 2; P.A. 19-98, S. 23.)

History: P.A. 05-217 effective July 6, 2005 (Revisor's note: The subsection designator “a” was inserted editorially by the Revisors at the beginning of the section); P.A. 19-98 amended Subsecs. (a) and (b) by adding references to advanced practice registered nurse.

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Sec. 20-631b. Collaborative drug therapy management agreements entered into prior to October 1, 2010. The provisions of section 20-631 in effect on September 30, 2010, shall apply to any written protocol-based collaborative drug therapy management agreement entered into prior to October 1, 2010.

(P.A. 10-117, S. 92.)

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Sec. 20-632. Regulatory action report re disciplinary action against persons with controlled substance registrations and sanctions against pharmacists or pharmacies. Not less than once every three months, the Department of Consumer Protection shall compile a regulatory action report that contains information regarding: (1) Any disciplinary action taken by the department against any person with a controlled substance registration, and (2) any sanction by the Commission of Pharmacy against a pharmacy or pharmacist. Such report shall contain the reasons for any such action or sanction and shall be posted on the web site of the department.

(P.A. 05-212, S. 5.)

History: P.A. 05-212 effective July 6, 2005.

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Sec. 20-633. Administration of vaccines by licensed pharmacists. Regulations. (a) Any person licensed as a pharmacist under part II of this chapter may (1) administer, to an adult, any vaccine, approved by the United States Food and Drug Administration that is listed on the National Centers for Disease Control and Prevention's Adult Immunization Schedule, and (2) on and after July 1, 2022, administer to any person between the ages of twelve and seventeen, with the consent of such person's parent or guardian, the influenza vaccine approved by the United States Food and Drug Administration, provided the administration of any vaccine under this subsection is conducted pursuant to the order of a licensed health care provider and in accordance with the regulations established pursuant to subsection (b) of this section.

(b) The Commissioner of Consumer Protection, in consultation with the Commissioner of Public Health and the Commission of Pharmacy, shall adopt regulations, in accordance with the provisions of chapter 54, to implement the provisions of this section. Such regulations shall (1) require any pharmacist who administers a vaccine pursuant to this section to successfully complete an immunization training program for pharmacists; (2) define the basic requirements of such training program, which shall include training and instruction in pre-administration education and screening, vaccine storage and handling, subcutaneous and intramuscular injections, recordkeeping, vaccine safety, cardiopulmonary resuscitation, basic cardiac life support and adverse event reporting; (3) identify qualifying training programs, which are accredited by the National Centers for Disease Control Prevention, the Accreditation Council for Pharmacy Education or other appropriate national accrediting body; and (4) establish a system of control and reporting.

(P.A. 05-212, S. 6; P.A. 10-82, S. 1; P.A. 12-207, S. 1; P.A. 22-92, S. 24.)

History: P.A. 05-212 effective July 6, 2005; P.A. 10-82 amended Subsec. (a) by deleting “On and after October 1, 2005”, replacing provision re administration of influenza vaccine with provision re administration of vaccine approved by U.S. Food and Drug Administration and adding Subdivs. (1) to (3) re types of vaccines that may be administered by licensed pharmacists and amended Subsec. (b) by deleting “Not later than September 1, 2005” and making technical changes; P.A. 12-207 amended Subsec. (a) by replacing provision re specified purposes for which a vaccine may be administered with provision re vaccine listed on the National Centers for Disease Control and Prevention's Adult Immunization Schedule and making a technical change; P.A. 22-92 amended Subsec. (a) by designating existing provisions re administration of a vaccine to an adult as Subdiv. (1) and adding Subdiv. (2) re administration of the influenza vaccine to any person between the ages of 12 and 17, Subsec. (b)(1) by deleting “to an adult” and Subsec. (c) by changing reference to “an individual” to “a person”, effective July 1, 2022.

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Sec. 20-633a. Pharmacy rewards program. Plain language summary. Violation. (a) For purposes of this section:

(1) “Pharmacy rewards program” means a promotional arrangement under which a retailer provides a consumer with store credits, discounts or other tangible benefits in exchange for the consumer filling drug prescriptions through such retailer or its affiliate;

(2) “HIPAA authorization” means an authorization to disclose medical records that meets the privacy requirements of the Health Insurance Portability and Accountability Act of 1996 (P.L. 104-191) (HIPAA), as amended from time to time, or regulations adopted thereunder;

(3) “Protected health information” has the meaning assigned to it in 45 CFR 160.103, as amended from time to time; and

(4) “Marketing” has the meaning assigned to it in 45 CFR 164.501, as amended from time to time.

(b) Prior to enrolling a consumer in a pharmacy rewards program, a retailer shall provide the consumer with a written plain language summary of the terms and conditions of such program. If the consumer is required to sign a HIPAA authorization form to participate in the program, the retailer shall include information on the form, adjacent to the point where the HIPAA authorization form is to be signed, that states: (1) The specific uses or disclosures of protected health information the HIPAA authorization allows, (2) whether protected health information obtained by the retailer will be disclosed to third parties and, if so disclosed, that such information will not be protected by federal or state privacy laws, (3) which, if any, third parties will have access to the consumer's protected health information, (4) how the consumer may revoke the HIPAA authorization, and (5) that the consumer is entitled to a copy of the HIPAA authorization form once signed.

(c) The terms “HIPAA”, “Health Insurance Portability and Accountability Act of 1996”, “HIPAA authorization”, “protected health information” and “marketing” shall be defined in promotional materials, in the plain language summary required pursuant to subsection (b) of this section, and on the HIPAA authorization form adjacent to the point where the HIPAA authorization form is to be signed, if such terms are used in such materials, summary or enrollment form.

(d) A violation of subsection (b) or (c) of this section shall be deemed an unfair or deceptive act or practice in the conduct of trade or commerce under subsection (a) of section 42-110b.

(P.A. 14-197, S. 1.)

History: P.A. 14-197 effective July 1, 2014.

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Sec. 20-633b. Sterile compounding pharmacies. Requirements. Regulations. (a) As used in this section:

(1) “Medical order” means a written, oral or electronic order by a prescribing practitioner, as defined in section 20-14c, for a drug to be dispensed by a pharmacy for administration to a patient;

(2) “Sterile compounding pharmacy” means a pharmacy, as defined in section 20-571, a nonresident pharmacy registered pursuant to section 20-627, that dispenses or compounds sterile pharmaceuticals;

(3) “Sterile pharmaceutical” means any dosage form of a drug, including, but not limited to, parenterals, injectables, surgical irrigants and ophthalmics devoid of viable microorganisms; and

(4) “USP chapters” means chapters 797, 800 and 825 of the United States Pharmacopeia that pertain to compounding sterile pharmaceuticals and their referenced companion documents, as amended from time to time.

(b) (1) If an applicant for a new pharmacy license pursuant to section 20-594 intends to compound sterile pharmaceuticals, the applicant shall file an addendum to its pharmacy license application to include sterile pharmaceutical compounding. The Department of Consumer Protection shall inspect the proposed pharmacy premises of the applicant and the applicant shall not compound sterile pharmaceuticals until it receives notice that the addendum application has been approved by the department and the Commission of Pharmacy.

(2) If an existing pharmacy licensed pursuant to section 20-594 intends to compound sterile pharmaceuticals for the first time on or after July 1, 2014, such pharmacy shall file an addendum application to its application on file with the department to include sterile pharmaceutical compounding. The Department of Consumer Protection shall inspect the pharmacy premises and the pharmacy shall not compound sterile pharmaceuticals until it receives notice that such addendum application has been approved by the department and the Commission of Pharmacy.

(3) If an applicant for a nonresident pharmacy registration intends to compound sterile pharmaceuticals for sale or delivery in this state, the applicant shall file an addendum to its application to include sterile pharmaceutical compounding. The applicant shall provide the department with written proof it has passed inspection by the appropriate state agency in the state where such nonresident pharmacy is located. Such pharmacy shall not compound sterile pharmaceuticals for sale or delivery in this state until it receives notice that the addendum application has been approved by the department and the Commission of Pharmacy.

(4) If a nonresident pharmacy registered pursuant to section 20-627 intends to compound sterile pharmaceuticals for sale or delivery in this state for the first time on or after July 1, 2014, the nonresident pharmacy shall file an addendum to its application to include sterile pharmaceutical compounding. The nonresident pharmacy shall provide the department with written proof it has passed inspection by the appropriate state agency in the state where such nonresident pharmacy is located. Such pharmacy shall not compound sterile pharmaceuticals until it receives notice that the addendum application has been approved by the department and the Commission of Pharmacy.

(c) A sterile compounding pharmacy shall comply with the USP chapters. A sterile compounding pharmacy shall also comply with all applicable federal and state statutes and regulations.

(d) An institutional pharmacy within a facility licensed pursuant to section 19a-490 that compounds sterile pharmaceuticals shall comply with the USP chapters, and shall also comply with all applicable federal and state statutes and regulations. Such institutional pharmacy may request from the Commissioner of Consumer Protection an extension of time, not to exceed six months, to comply, for state enforcement purposes, with any amendments to USP chapters, for good cause shown. The commissioner may grant an extension for a length of time not to exceed six months. Nothing in this section shall prevent such institutional pharmacy from requesting a subsequent extension of time or shall prevent the commissioner from granting such extension.

(e) (1) A sterile compounding pharmacy may only provide patient-specific sterile pharmaceuticals to patients, practitioners of medicine, osteopathy, podiatry, dentistry or veterinary medicine, or to an acute care or long-term care hospital or health care facility licensed by the Department of Public Health.

(2) If a sterile compounding pharmacy provides sterile pharmaceuticals without a patient-specific prescription or medical order, the sterile compounding pharmacy shall also obtain a certificate of registration from the Department of Consumer Protection pursuant to section 21a-70 and any required federal license or registration. A sterile compounding pharmacy may prepare and maintain on-site inventory of sterile pharmaceuticals no greater than a thirty-day supply, calculated from the completion of compounding, which thirty-day period shall include the period required for third-party analytical testing, to be performed in accordance with the USP chapters.

(f) (1) If a sterile compounding pharmacy plans to remodel any area utilized for the compounding of sterile pharmaceuticals or adjacent space, relocate any space utilized for the compounding of sterile pharmaceuticals or upgrade or conduct a nonemergency repair to the heating, ventilation, air conditioning or primary or secondary engineering controls for any space utilized for the compounding of sterile pharmaceuticals, the sterile compounding pharmacy shall notify the Department of Consumer Protection, in writing, not later than forty-five days prior to commencing such remodel, relocation, upgrade or repair. Such written notification shall include a plan for such remodel, relocation, upgrade or repair and such plan shall be subject to department review and approval. If a sterile compounding pharmacy makes an emergency repair, the sterile compounding pharmacy shall notify the department of such emergency repair, in writing, not later than twenty-four hours after such repair is commenced.

(2) If the USP chapters require sterile recertification after such remodel, relocation, upgrade or repair, the sterile compounding pharmacy shall provide a copy of its sterile recertification to the Department of Consumer Protection not later than five days after the sterile recertification approval. The recertification shall only be performed by an independent licensed environmental monitoring entity.

(g) A sterile compounding pharmacy shall report, in writing, to the Department of Consumer Protection any known violation or noncompliance with viable and nonviable environmental sampling testing, as defined in the USP chapters, not later than the end of the next business day after discovering such violation or noncompliance.

(h) (1) If a sterile compounding pharmacy initiates a recall of sterile pharmaceuticals that were dispensed pursuant to a patient-specific prescription or medical order, the sterile compounding pharmacy shall notify each patient or patient care giver, the prescribing practitioner and the Department of Consumer Protection of such recall not later than twenty-four hours after such recall was initiated.

(2) If a sterile compounding pharmacy initiates a recall of sterile pharmaceuticals that were not dispensed pursuant to a patient-specific prescription or a medical order, the sterile compounding pharmacy shall notify: (A) Each purchaser of such sterile pharmaceuticals, to the extent such sterile compounding pharmacy possesses contact information for each such purchaser, (B) the Department of Consumer Protection, and (C) the federal Food and Drug Administration of such recall not later than the end of the next business day after such recall was initiated.

(i) Each sterile compounding pharmacy and each institutional pharmacy within a facility licensed pursuant to section 19a-490 shall prepare and maintain a policy and procedure manual. The policy and procedure manual shall comply with the USP chapters.

(j) Each sterile compounding pharmacy shall report to the Department of Consumer Protection any administrative or legal action commenced against it by any state or federal regulatory agency or accreditation entity not later than five business days after receiving notice of the commencement of such action.

(k) Notwithstanding the provisions of subdivisions (3) and (4) of subsection (b) of this section, a sterile compounding pharmacy that is a nonresident pharmacy shall provide the Department of Consumer Protection proof that it has passed an inspection in such nonresident pharmacy's home state, based on the USP chapters. Such nonresident pharmacy shall submit to the Department of Consumer Protection a copy of the most recent inspection report with its initial nonresident pharmacy application and shall submit to the department a copy of its most recent inspection report every two years thereafter. If the state in which the nonresident pharmacy is located does not conduct inspections based on standards required in the USP chapters, such nonresident pharmacy shall provide satisfactory proof to the department that it is in compliance with the standards required in the USP chapters.

(l) A practitioner, as specified in subdivision (1) of subsection (e) of this section, a hospital or a health care facility that receives sterile pharmaceuticals shall report any errors related to such dispensing or any suspected adulterated sterile pharmaceuticals to the Department of Consumer Protection.

(m) (1) For purposes of this subsection, a “designated pharmacist” means a pharmacist responsible for overseeing the compounding of sterile pharmaceuticals and the application of the USP chapters, as said chapters pertain to sterile compounding.

(2) Any pharmacy licensed pursuant to section 20-594 or institutional pharmacy licensed pursuant to section 19a-490 that provides sterile pharmaceuticals shall notify the department of its designated pharmacist.

(3) The designated pharmacist shall be responsible for providing proof he or she has completed a program approved by the commissioner that demonstrates the competence necessary for the compounding of sterile pharmaceuticals, in compliance with all applicable federal and state statutes and regulations.

(4) The designated pharmacist shall immediately notify the department whenever he or she ceases such designation.

(5) Nothing in this section shall prevent a designated pharmacist from being the pharmacy manager.

(n) The Commissioner of Consumer Protection may adopt regulations, in accordance with chapter 54, to implement the provisions of this section.

(P.A. 14-224, S. 2; P.A. 17-77, S. 14; P.A. 18-16, S. 6; P.A. 19-177, S. 28; P.A. 21-37, S. 46.)

History: P.A. 14-224 effective July 1, 2014; P.A. 17-77 amended Subsec. (a)(2) by replacing “section 20-594, or” with “section 20-571,”, effective July 1, 2017; P.A. 18-16 amended Subsec. (c) by replacing “most recent United States Pharmacopeia, Chapter 797,” with “most recent version of the United States Pharmacopeia,”, effective January 1, 2019; P.A. 19-177 amended Subsec. (a) by adding Subdiv. (4) defining USP chapters, amended Subsec. (c) by replacing “most recent version of the United States Pharmacopeia, Pharmaceutical Compounding - Sterile Preparations, as amended from time to time” with “USP chapters”, replaced “Chapter 797” with “USP chapters” in Subsec. (d), amended Subsec. (f) by adding “, in writing,” re notice to Department of Consumer Protection and replacing “United States Pharmacopeia, Chapter 797, Pharmaceutical Compounding - Sterile Preparations, as amended from time to time” with “USP chapters”, replaced “most recent United States Pharmacopeia, Chapter 797, Pharmaceutical Compounding - Sterile Preparations, as amended from time to time” with “USP chapters” in Subsecs. (d),(e)(2), (g), (i) and (k), replaced “most recent United States Pharmacopeia, Chapter 797, Pharmaceutical Compounding - Sterile Preparations compliance standards, as amended from time to time” with “USP chapters” in Subsec. (k), added Subsec. (m) re designated pharmacist and redesignated existing Subsec. (m) as Subsec. (n), and made technical changes, effective January 1, 2020; P.A. 21-37 amended Subsec. (f) by changing references from pharmacy clean room within the facility to any area utilized for compounding of sterile pharmaceuticals, adding reference to secondary engineering controls, changing 10 to 45 days re notification timeframe, adding provision re plan for remodel, relocation, upgrade or repair, making technical changes and changing “as soon as possible” to not later than 24 hours, effective June 4, 2021.

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Sec. 20-633c. Prescribing of opioid antagonists by licensed pharmacists. Regulations. (a) A person who is licensed as a pharmacist under part II of this chapter and is certified in accordance with subsection (b) of this section may prescribe, in good faith, an opioid antagonist, as defined in section 17a-714a. Such pharmacist shall (1) provide appropriate training regarding the administration of such opioid antagonist to the person to whom the opioid antagonist is dispensed, and (2) maintain a record of such dispensing and the training required pursuant to this chapter.

(b) A pharmacist may only prescribe an opioid antagonist pursuant to this section if the pharmacist has been trained and certified by a program approved by the Commissioner of Consumer Protection.

(c) A pharmacist who prescribes an opioid antagonist in compliance with this section shall be deemed not to have violated any standard of care for a pharmacist.

(d) The provisions of this section shall apply only to a pharmacist certified in accordance with subsection (b) of this section. No pharmacist may delegate or direct any other person to prescribe an opioid antagonist or train any person in the administration of such opioid antagonist pursuant to the provisions of subsection (a) of this section.

(e) The Commissioner of Consumer Protection may adopt regulations, in accordance with chapter 54, to implement the provisions of this section.

(P.A. 15-198, S. 6.)

History: P.A. 15-198 effective June 30, 2015.

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Sec. 20-633d. Medical protocol standing order for dispensing of opioid antagonists by licensed pharmacists. Regulations. (a) A prescribing practitioner, as defined in section 20-14c, who is authorized to prescribe an opioid antagonist, as defined in section 17a-714a, and a pharmacy may enter into an agreement for a medical protocol standing order at such pharmacy allowing a pharmacist licensed under part II of this chapter to dispense an opioid antagonist that is (1) administered by an intranasal application delivery system or an auto-injection delivery system, (2) approved by the federal Food and Drug Administration, and (3) dispensed to any person at risk of experiencing an overdose of an opioid drug, as defined in 42 CFR 8.2, or to a family member, friend or other person in a position to assist a person at risk of experiencing an overdose of an opioid drug.

(b) Any such medical protocol standing order shall be deemed issued for a legitimate medical purpose in the usual course of the prescribing practitioner's professional practice. The pharmacy shall provide the Department of Consumer Protection with a copy of every medical protocol standing order agreement entered into with a prescribing practitioner under this section.

(c) A pharmacist may only dispense an opioid antagonist pursuant to a medical protocol standing order if the pharmacist has been trained and certified as part of a program approved by the Commissioner of Consumer Protection.

(d) A pharmacist who dispenses an opioid antagonist pursuant to a medical protocol standing order shall (1) provide appropriate training regarding the administration of such opioid antagonist to the person to whom the opioid antagonist is dispensed, (2) maintain a record of such dispensing and the training required pursuant to this chapter, and (3) send a copy of the record of such dispensing to the prescribing practitioner who entered into an agreement for a medical protocol standing order with the pharmacy.

(e) A pharmacist who dispenses an opioid antagonist in accordance with the provisions of this section shall be deemed not to have violated any standard of care for a pharmacist.

(f) The commissioner may adopt regulations, in accordance with chapter 54, to implement the provisions of this section.

(P.A. 17-131, S. 12.)

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Sec. 20-633e. Pharmacy and institutional pharmacy perpetual inventory of Schedule II controlled substances. Regulations. (a) As used in this section, “pharmacy” and “institutional pharmacy” have the same meanings as provided in section 20-571.

(b) Each pharmacy and institutional pharmacy shall maintain a perpetual inventory of each Schedule II controlled substance, designated as such in regulations adopted pursuant to section 21a-243.

(c) The perpetual inventory required pursuant to subsection (b) of this section shall be reconciled on a monthly basis. Any loss, theft or unauthorized destruction of a controlled substance discovered during the reconciliation shall be reported by a pharmacy or institutional pharmacy not later than seventy-two hours after discovery of any such occurrence to the Commissioner of Consumer Protection pursuant to section 21a-262 and section 21a-262-3 of the regulations of Connecticut state agencies.

(d) Schedule II controlled substance perpetual inventory records shall be (1) kept on the premises of the pharmacy or institutional pharmacy, (2) maintained in an orderly manner separate from all other records, (3) filed by date, and (4) retained for a period of not less than three years. Such records shall be made immediately available for inspection and copying by the Commissioner of Consumer Protection, the commissioner's authorized representative or other persons authorized to review such records pursuant to section 21a-265.

(e) The Commissioner of Consumer Protection may adopt regulations, in accordance with the provisions of chapter 54, to implement the provisions of this section.

(P.A. 18-16, S. 5.)

History: P.A. 18-16 effective January 1, 2019.

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Secs. 20-633f to 20-633h. Reserved for future use.

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Sec. 20-633i. Issuance of prescriptions for epinephrine auto injectors by pharmacists. (a) For purposes of this section, “epinephrine auto injector” means a prefilled auto injector or similar automatic injectable equipment used to deliver epinephrine in a standard dose for emergency first aid response to allergic reactions.

(b) A pharmacist, in his or her professional discretion, may issue a prescription for not more than two epinephrine auto injectors under the following conditions:

(1) The pharmacist identifies that the patient requesting such prescription has received an epinephrine auto injector by prescription from another pharmacy within the previous two years;

(2) The pharmacist identifies the patient's practitioner specified by the patient as his or her primary care provider at the time the request is made;

(3) The pharmacist informs the patient's primary care provider of the issuance of the prescription not later than seventy-two hours after such issuance, by either phone, facsimile or electronic transmission; and

(4) The prescription issued by the pharmacist does not have any refills and is not filled more than once per year.

(c) Nothing in this section shall prevent a pharmacist from verifying a previous prescription at any pharmacy in any part of the United States, including any state, district, commonwealth, territory or insular possession thereof, or any area subject to the legal authority of the United States of America.

(P.A. 21-37, S. 45.)

History: P.A. 21-37 effective June 4, 2021.

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Sec. 20-634. Reserved for future use.

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PART IV

PRESCRIPTION ERROR REPORTING

Sec. 20-635. Prescription error reporting. Definitions. Informational signs and statements. Regulations. Nondisclosure of records. (a) As used in this section:

(1) “Dispensing” means those acts of processing a drug for delivery or for administration for a patient pursuant to a prescription consisting of: (A) Comparing the directions on the label with the directions on the prescription to determine accuracy; (B) the selection of the drug from stock to fill the prescription; (C) the counting, measuring, compounding or preparation of the drug; (D) the placing of the drug in the proper container; (E) the affixing of the label to the container; and (F) the addition to a written prescription of any required notations;

(2) “Drug” means (A) an article recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States or official National Formulary, or any supplement to any of them, (B) an article intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans, (C) an article, other than food, intended to affect the structure or any function of the body of humans;

(3) “Pharmacy” means a place of business where drugs may be sold at retail and for which a pharmacy license has been issued to an applicant under the provisions of section 20-594. For the purposes of this section, “pharmacy” shall include any areas of an institutional pharmacy where prescription drugs are dispensed to outpatients, employees and retirees;

(4) “Prescribing practitioner” means an individual licensed by the state of Connecticut, any other state of the United States, the District of Columbia, the Commonwealth of Puerto Rico or any territory or insular possession subject to the jurisdiction of the United States who is authorized to issue a prescription within the scope of the individual's practice;

(5) “Prescription” means a lawful order of a prescribing practitioner transmitted either orally, in writing or by electronic means for a drug for a specific patient; and

(6) “Prescription error” means an act or omission of clinical significance relating to the dispensing of a drug that results in or may reasonably be expected to result in injury to or death of a patient.

(b) Each pharmacy shall display a sign concerning the reporting of prescription errors in a conspicuous location visible to consumers of prescription drugs. The sign shall measure a minimum of eight inches in height and ten inches in length and the lettering shall be in a size and style that allows such sign to be read without difficulty by consumers standing at the pharmacy prescription department distribution counter. The sign shall bear the following statement: “If you have a concern that an error may have occurred in the dispensing of your prescription you may contact the Department of Consumer Protection, Drug Control Division, by calling (Department of Consumer Protection telephone number authorized pursuant to section 21a-2 of the general statutes)”.

(c) Each pharmacy that dispenses a prescription to a consumer shall include the following printed statement on the receipt or in the bag or other similar packaging in which the prescription is contained: “If you have a concern that an error may have occurred in the dispensing of your prescription you may contact the Department of Consumer Protection, Drug Control Division, by calling (Department of Consumer Protection telephone number authorized pursuant to section 21a-2 of the general statutes)”. The statement shall be printed in a size and style that allows such statement to be read without difficulty by consumers.

(d) The Commissioner of Consumer Protection shall adopt regulations, with the advice and assistance of the Commission of Pharmacy, in accordance with chapter 54, concerning the implementation of a quality assurance program designed to detect, identify and prevent prescription errors in pharmacies. Such regulations shall require that each pharmacy implement a quality assurance program that describes in writing policies and procedures to be maintained in such pharmacy. Such policies and procedures shall include directions for communicating the details of a prescription error to the prescribing practitioner and to the patient, the patient's caregiver or appropriate family member if the patient is deceased or is unable to fully comprehend the communication. Such communication shall describe methods of correcting the prescription error or reducing the negative impact of the error on the patient. Such regulations shall require that records of all reported prescription errors shall be maintained in a manner ready for inspection for a minimum period of three years and that such records shall be made available for inspection by the Commissioner of Consumer Protection within forty-eight hours in any case where the commissioner is investigating a report of a prescription error.

(e) Records collected or maintained pursuant to this section shall not be required to be disclosed pursuant to subsection (a) of section 1-210 for a period of six months from the date such records were created pursuant to subsections (c) and (d) of this section and shall not be subject to subpoena or discovery or introduced into evidence in any judicial proceeding except as otherwise specifically provided by law.

(P.A. 02-48, S. 1; P.A. 03-164, S. 2; June 30 Sp. Sess. P.A. 03-6, S. 146(c), (d); P.A. 04-169, S. 17; 04-189, S. 1.)

History: P.A. 03-164 added Subsec. (e) re disclosure of records; June 30 Sp. Sess. P.A. 03-6 and P.A. 04-169 replaced Commissioner and Department of Consumer Protection with Commissioner and Department of Agriculture and Consumer Protection, effective July 1, 2004; P.A. 04-189 repealed Sec. 146 of June 30 Sp. Sess. P.A. 03-6, thereby reversing the merger of the Departments of Agriculture and Consumer Protection, effective June 1, 2004.

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Sec. 20-636. Sign re storage and disposal of prescription drugs. Not later than January 1, 2023, each pharmacy, as defined in section 20-635, shall post a sign in a conspicuous place on the premises of such pharmacy, notifying consumers that they may visit the Internet web site of the Department of Consumer Protection for information concerning the safe storage of prescription drugs and disposal of unused and expired prescription drugs.

(P.A. 22-81, S. 19.)

History: P.A. 22-81 effective July 1, 2022.

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Secs. 20-637 to 20-639. Reserved for future use.

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