Sec. 20-612. Only pharmacy may accept prescription for dispensing.
Sec. 20-633b. Sterile compounding pharmacies. Requirements. Regulations.
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.
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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. 20-614. (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 pursuant to subsection (b) of this section, 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.)
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).
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Sec. 20-631. Collaborative drug therapy management agreements between pharmacists and physicians or advanced practice registered nurses. Scope. Pharmacist competency requirements. Regulations. (a) Except as provided in section 20-631b, one or more pharmacists licensed under this chapter who are determined competent in accordance with regulations adopted pursuant to subsection (d) of this section may 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. In order to enter into a written protocol-based collaborative drug therapy management agreement, such physician or advanced practice registered nurse shall have established a provider-patient relationship with the patient who will receive collaborative drug therapy. 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. For purposes of this subsection, a “provider-patient relationship” is a relationship based on (1) the patient making a medical complaint, (2) the patient providing a medical history, (3) the patient receiving a physical examination, and (4) a logical connection existing between the medical complaint, the medical history, the physical examination and any drug prescribed for the patient.
(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. In instances where drug therapy is discontinued, the pharmacist shall notify the treating physician or advanced practice registered nurse of such discontinuance no later than twenty-four hours from the time of such discontinuance. 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 at least every thirty days to the physician or advanced practice registered nurse regarding the patient's drug therapy management. 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) A pharmacist shall be responsible for demonstrating, in accordance with regulations adopted pursuant to subsection (d) of this section, the competence necessary for participation in each drug therapy management agreement into which such pharmacist enters.
(d) The Commissioner of Consumer Protection, in consultation with the Commissioner of Public Health, shall adopt regulations, in accordance with chapter 54, concerning competency requirements for participation in a written protocol-based collaborative drug therapy management agreement described in subsection (a) of this section, the minimum content of the collaborative drug therapy management agreement and the written protocol and such other matters said commissioners deem necessary to carry out the purpose of this section.
(P.A. 02-41, S. 1; P.A. 03-164, S. 1; June 30 Sp. Sess. P.A. 03-6, S. 146(c), (d); 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.)
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”.
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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. 20-633b. 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 a pharmacy clean room within the sterile compounding facility, relocate a pharmacy clean room within the facility or upgrade or conduct a nonemergency repair to the heating, ventilation, air conditioning or primary engineering controls for a pharmacy clean room within the facility, the sterile compounding pharmacy shall notify the Department of Consumer Protection, in writing, not later than ten days prior to commencing such remodel, relocation, upgrade or repair. If a sterile compounding pharmacy makes an emergency repair, the sterile compounding pharmacy shall notify the department of such repair, in writing, as soon as possible 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.)
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.
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