Substitute House Bill No. 6301
AN ACT CONCERNING THE PRACTICE OF PHARMACY AND ELECTRONIC PRESCRIPTIONS.
Be it enacted by the Senate and House of Representatives in General Assembly convened:
Section 1. Section 20-614 of the general statutes is repealed and the following is substituted in lieu thereof (Effective July 1, 2009):
(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, as amended by this act, [the] 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 [computerized printed] 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) (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.
Sec. 2. Section 20-615 of the general statutes is repealed and the following is substituted in lieu thereof (Effective July 1, 2009):
(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 [initials] 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, [or] 21a-244 [, to the extent such regulations are inconsistent with this section] or 21a-244a, as amended by this act.
(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.
Sec. 3. Subdivision (45) of section 21a-240 of the general statutes is repealed and the following is substituted in lieu thereof (Effective July 1, 2009):
(45) "Prescription" means a written, [or] oral or electronic order for any controlled substance or preparation from a licensed practitioner to a pharmacist for a patient.
Sec. 4. Section 21a-244a of the general statutes is repealed and the following is substituted in lieu thereof (Effective July 1, 2009):
(a) The following terms shall have the following meanings when used in this section:
(1) "Drug" means (A) articles 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) articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals; (C) articles, other than food, intended to affect the structure or any function of the body of man or any other animal; and (D) articles intended for use as a component of any articles specified in this subdivision; but shall not include devices or their components, parts or accessories;
(2) "Licensed practitioner" means a person licensed by the state of Connecticut, any other state, the District of Columbia or the Commonwealth of Puerto Rico and authorized to prescribe medication within the scope of his practice; and
(3) "Drug record" means a record maintained pursuant to chapter 400j, 417, 418, 420b or 420c of drug ordering, drug distribution, receipt of drugs, storage of drugs, disposition of drugs, and orders of drugs issued by a licensed practitioner for a patient.
(b) In lieu of maintaining written drug records required by state or federal law to be kept in the state, such records may be created and maintained on electronic data processing systems or other electronic media systems. If a conflict exists between maintaining a written drug record and maintaining an electronic drug record, the written drug record shall be maintained.
(c) Electronic identifiers, including, but not limited to, electronic codes or signatures, voice prints, retinal prints or handprints may be substituted in lieu of required written signatures or initials.
(d) The Commissioner of Consumer Protection may adopt regulations, in accordance with the provisions of chapter 54, establishing the use of electronic data processing systems or other electronic media systems for maintaining drug records. No such electronic data processing system shall be implemented prior to the adoption of these regulations.
Sec. 5. Section 21a-249 of the general statutes is repealed and the following is substituted in lieu thereof (Effective July 1, 2009):
(a) All prescriptions for controlled drugs shall include (1) the name and address of the patient, or the name and address of the owner of an animal and the species of the animal, (2) whether the patient is an adult or a child, or his specific age, (3) the compound or preparation prescribed and the amount thereof, (4) directions for use of the medication, (5) the name and address of the prescribing practitioner, (6) the date of issuance, and (7) the Federal Registry number of the practitioner. No prescription blank containing a prescription for a schedule II substance shall contain more than one prescription.
(b) [Prescriptions when written] Written prescriptions shall be written in ink or in indelible pencil or by typewriter. No duplicate, carbon or photographic copies and no printed or rubber-stamped orders shall be considered valid prescriptions within the meaning of this chapter. No prescription or order for any controlled substance issued by a practitioner to an inanimate object or thing shall be considered a valid prescription within the meaning of this chapter.
(c) Prescriptions for schedule II substances, if in writing, shall be signed by the prescribing practitioner at the time of issuance and previously signed orders for such schedule II substances shall not be considered valid prescriptions within the meaning of this chapter. No practitioner shall prescribe, dispense or administer schedule II sympathomimetic amines as anorectics, except as may be authorized by regulations adopted by the Departments of Public Health and Consumer Protection acting jointly. The Department of Public Health and the Department of Consumer Protection, acting jointly, may adopt regulations, in accordance with chapter 54, allowing practitioners to prescribe, dispense or administer schedule II sympathomimetic amines as anorectics under certain specific circumstances. Nothing in this subsection shall be construed to require a licensed pharmacist to determine the diagnosis of a patient prior to dispensing a prescription for such substances to a patient.
(d) To the extent permitted by the federal Controlled Substances Act, 21 USC 801, as from time to time amended, a prescribing practitioner may issue an oral order or an electronically transmitted prescription order and, except as otherwise provided by regulations adopted pursuant to sections 21a-243, [and] 21a-244 and 21a-244a, as amended by this act, such oral order or electronically transmitted prescription order shall be promptly reduced to writing on a prescription blank or a hardcopy printout [shall be produced] or created as an electronic record and filed by the pharmacist filling it. For the purposes of subsections (d) and (h) of this section the term "electronically transmitted" means transmitted by facsimile machine, computer modem or other similar electronic device.
(e) To the extent permitted by the federal Controlled Substances Act, in an emergency the dispensing of schedule II substances may be made upon the oral order of a prescribing registrant known to or confirmed by the filling pharmacist who shall promptly reduce the oral order to writing on a prescription blank, provided, in such cases such oral order shall be confirmed by the proper completion and mailing or delivery of a prescription prepared by the prescribing registrant to the pharmacist filling such oral order within seventy-two hours after the oral order has been given. Such prescription of the registrant shall be affixed to the temporary prescription prepared by the pharmacist and both prescriptions shall be maintained on file as required in this chapter.
(f) All prescriptions for controlled substances shall comply fully with any additional requirements of the federal food and drug laws, [federal laws and regulations Part 306, U. S. Department of Justice, Bureau of Narcotics and Dangerous Drugs-Federal Register Volume 36 No. 80 et seq. ] the federal Controlled Substances Act, and state laws and regulations adopted under this chapter.
(g) Repealed by P. A. 82-419, S. 46, 47.
(h) Except when dispensed directly by a practitioner, other than a pharmacy, to an ultimate user, a controlled substance included in schedule III or IV, which is a prescription drug as determined under federal food and drug laws, shall not be dispensed without a written, electronically transmitted or oral prescription of a practitioner. The prescription shall not be filled or refilled more than six months after the date thereof or be refilled more than five times, unless renewed by the practitioner.
(i) A controlled substance included in schedule V shall not be distributed or dispensed other than for a medical purpose.
(j) A pharmacy may sell and dispense controlled substances upon the prescription of a prescribing practitioner, as defined in subdivision (22) of section 20-571.
(k) Pharmacies shall file filled prescriptions for controlled substances separately from other prescriptions. All schedule II prescriptions shall be filed in a separate file or in an electronic file. All schedule III, IV and V prescriptions shall be filed in another separate file or in an electronic file, except as otherwise provided for in regulations adopted pursuant to section 21a-243, 21a-244 or 21a-244a, as amended by this act. [Such] All written controlled substance prescriptions shall, immediately upon filling, be filed chronologically and consecutively.
(l) Any pharmacy may transfer prescriptions for controlled substances included in schedules III, IV and V to any other pharmacy in accordance with the requirements set forth in the federal Controlled Substances Act 21 USC 801 et seq. and the regulations promulgated thereunder, as from time to time amended.
(m) A practitioner authorized to prescribe controlled substances shall not prescribe anabolic steroids for the sole purpose of enhancing a patient's athletic ability or performance.
Approved May 8, 2009