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) “Health care institution” means institution, as defined in section 19a-490;

(15) “Health care institutional pharmacy” means an institutional pharmacy located within a health care institution;

(16) “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;

(17) “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.”;

(18) “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.”;

(19) “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;

(20) “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;

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

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

(23) “Nonresident pharmacy” has the same meaning as provided in section 20-627;

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

(25) “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;

(26) “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;

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

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

(29) “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;

(30) “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;

(31) “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;

(32) “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;

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

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

(35) “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;

(36) “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

(37) “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; P.A. 23-19, 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; P.A. 23-19 added new Subdiv. (14) defining “health care institution” and new Subdiv. (15) defining “health care institutional pharmacy”, redesignated existing Subdivs. (14) to (20) as Subdivs. (16) to (22), added new Subdiv. (23) defining “nonresident pharmacy”, redesignated existing Subdivs. (21) to (34) as Subdivs. (24) to (37), and made technical and conforming changes in Subdivs. (1), (8), (13) and redesignated Subdiv. (20), effective July 1, 2023.

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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, nuclear pharmacies and health care institutional 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; P.A. 23-19, S. 6.)

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; P.A. 23-19 amended Subsec. (a)(2) by adding reference to health care institutional pharmacies, effective July 1, 2023.

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Sec. 20-579a. Adverse license, permit or registration eligibility action based on provision of reproductive health care services prohibited. (a) As used in this section, “reproductive health care services” has the same meaning as provided in section 52-571m.

(b) Notwithstanding any provision of this chapter, the Commissioner of Consumer Protection and the Commission of Pharmacy shall not deny the eligibility of an applicant for a license, permit or registration under this chapter based on pending disciplinary action, an unresolved complaint or the imposition of disciplinary action against the applicant by a duly authorized professional disciplinary agency of another state, the District of Columbia or a commonwealth, territory or possession of the United States that is based solely on the alleged provision of, receipt of, assistance in provision or receipt of, material support for, or any theory of vicarious, joint, several or conspiracy liability derived therefrom, reproductive health care services that are permitted under the laws of this state and were provided in accordance with the standard of care applicable to such services, regardless of whether the patient receiving such services was a resident of this state. The provisions of this subsection shall not apply where the underlying conduct of the applicant would constitute the basis of disciplinary action against the applicant under the laws of this state if the applicant had been licensed, permitted or registered in this state and the conduct had occurred in this state.

(c) Notwithstanding any provision of this chapter, the Commissioner of Consumer Protection and the Commission of Pharmacy shall not impose disciplinary action against any person licensed, permitted or registered pursuant to the provisions of this chapter based on pending disciplinary action, an unresolved complaint or the imposition of disciplinary action against the applicant by a duly authorized professional disciplinary agency of another state, the District of Columbia, or a commonwealth, territory or possession of the United States that is based solely on the alleged provision of, receipt of, assistance in provision or receipt of, material support for, or any theory of vicarious, joint, several or conspiracy liability derived therefrom, reproductive health care services that are permitted under the laws of this state and were provided in accordance with the standard of care applicable to such services, regardless of whether the patient receiving such services was a resident of this state. The provisions of this subsection shall not apply where the underlying conduct of the person licensed, permitted or registered would constitute the basis of disciplinary action against such person under the laws of this state if such person had been licensed, permitted or registered in this state and the conduct had occurred in this state.

(P.A. 23-128, S. 2.)

History: P.A. 23-128 effective June 27, 2023.

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PART II

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

Sec. 20-593. (Formerly Sec. 20-172). *(See end of section for amended versions of subsections (b) and (c) and effective date.) 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.)

*Note: On and after July 1, 2025, subsections (b) and (c) of this section, as amended by section 258 of public act 23-204, are to read as follows:

“(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 the fee required in section 20-601 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 section 20-601.”

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; P.A. 23-204 amended Subsec. (b) by substituting “the fee required in section 20-601” for “one hundred dollars” and amended Subsec. (c) by substituting reference to Sec. 20-601 for reference to Subsec. (b), effective July 1, 2025.

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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, health care institution 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 the department's 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 such pharmacy 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; P.A. 23-19, S. 7.)

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; P.A. 23-19 amended Subsec. (a) by adding reference to health care institutions, and made technical changes in Subsecs. (b) and (f), effective July 1, 2023.

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Sec. 20-601. *(See end of section for amended version and effective date.) 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.)

*Note: On and after July 1, 2025, this section, as amended by section 259 of public act 23-204, is to read as follows:

“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 one hundred five dollars. 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. On or before the last day of January, April, July and October in each year, the commissioner shall transfer five dollars of each renewal fee collected pursuant to this subdivision to the pharmacy professional assistance program account established in section 20-638c.

(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.

(8) The fee for application for registration as a pharmacy intern is sixty-five dollars. On or before the last day of January, April, July and October in each year, the commissioner shall transfer five dollars of each fee collected pursuant to this subdivision to the pharmacy professional assistance program account established in section 20-638c.

(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.

(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; P.A. 23-204, S. 259.)

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; P.A. 23-204 amended Subdiv. (2) by substituting “one hundred five dollars” for “the professional services fee for class A, as defined in section 33-182l”, amended Subdiv. (8) by substituting “sixty-five dollars” for “sixty dollars”, and added provisions in Subdivs. (2) and (8) re transfers to pharmacy professional assistance program account, effective July 1, 2025.

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PART III

PRACTICE OF PHARMACY

Sec. 20-617a. Flavoring agent added to prescription product. Exemptions. (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.

(c) The addition of a flavoring agent in accordance with subsections (a) and (b) of this section shall be exempt from the requirements established in subsections (a) to (m), inclusive, of section 20-633b, any regulations adopted pursuant to subsection (o) of section 20-633b and United States Pharmacopeia, Chapter 795, Pharmaceutical Compounding – Nonsterile Preparations, and Chapter 800, Hazardous Drugs, as both may be amended from time to time.

(P.A. 12-12, S. 1; P.A. 23-52, S. 5.)

History: P.A. 12-12 effective July 1, 2012; P.A. 23-52 added Subsec. (c) re exemption from requirements established in Sec. 20-633b(a) to (m), regulations adopted pursuant to Sec. 20-633b(o) and United States Pharmacopeia, Chs. 795 and 800, and made technical changes in Subsecs. (a) and (b), effective June 13, 2023.

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Sec. 20-623. Sale of nonlegend drugs, nonlegend devices and test strips. Labels, packaging, contents and vending machines. Penalty. (a) No nonlegend drug may be sold at retail except at a pharmacy, at a store or in a vending machine that is owned and operated by a business that has obtained from the commission or the department a permit to sell nonlegend drugs pursuant to section 20-624. Nonlegend drugs may be sold in a vending machine, which vending machine shall be owned and operated by a business that has obtained from the department a permit for each vending machine in which such business offers nonlegend drugs for sale. If an applicant seeks to locate two or more vending machines selling nonlegend drugs at a single premises, only one permit to sell nonlegend drugs shall be required. Any person who is not licensed as a pharmacy and wishes to sell nonlegend drugs in a vending machine shall apply to the department, in a form and manner prescribed by the commissioner, in order to obtain a permit to sell nonlegend drugs. Nonlegend drugs shall be labeled and packaged in accordance with state and federal law.

(b) (1) A vending machine offering nonlegend drugs may also offer nonlegend devices or test strips intended for use by an individual to test for a particular substance prior to injection, inhalation or ingestion of the substance to prevent accidental overdose by injection, inhalation or ingestion of such substance. Each vending machine offering nonlegend drugs or nonlegend devices shall be individually registered with the department, and each application to register a vending machine offering nonlegend drugs or nonlegend devices shall designate an individual who shall be responsible for properly maintaining such vending machine.

(2) Each person who registers a vending machine pursuant to subdivision (1) of this subsection, and the individual designated as the individual responsible for properly maintaining the registered vending machine, shall ensure that such vending machine (A) maintains the proper temperature and humidity for each nonlegend drug offered in such vending machine as required by the original manufacturer of such nonlegend drug, (B) only contains nonlegend drugs and nonlegend devices that remain in the original containers provided by the manufacturers of such nonlegend drugs or nonlegend devices, (C) only offers nonlegend drugs and nonlegend devices that are unexpired and unadulterated, (D) only offers nonlegend drugs and nonlegend devices that are not subject to a recall, provided any nonlegend drug or nonlegend device that is the subject of a recall shall be promptly removed from such vending machine, (E) only contains nonlegend drugs and nonlegend devices, sundries and other nonperishable items, (F) has a clear and conspicuous written statement attached to such vending machine disclosing the name, address and toll-free telephone number of the owner and operator of such vending machine, (G) has a clear and conspicuous written statement attached to such vending machine advising a consumer to check the expiration date of a nonlegend drug or nonlegend device contained in such vending machine before the consumer uses such nonlegend drug or nonlegend device, (H) has attached to such vending machine, in a size and prominent location visible to consumers, a written notice stating “Drug tampering or expired product? Notify the Department of Consumer Protection, Drug Control Division, by calling (telephone number of the toll-free telephone line established by the department pursuant to section 21a-2)”, (I) does not offer any nonlegend drug or nonlegend device that requires age verification, is subject to any quantity limit or is subject to any sales restriction under state or federal law, and (J) does not contain any package of a nonlegend drug that contains more than a five-day supply of the nonlegend drug as determined according to the usage directions provided by the manufacturer of such nonlegend drug.

(c) Any person who violates any provision of this section shall be fined not more than one thousand dollars per violation.

(P.A. 95-264, S. 42; P.A. 99-175, S. 41; P.A. 23-52, S. 6.)

History: P.A. 99-175 made a technical change in Subsec. (a); P.A. 23-52 amended Subsec. (a) by adding provisions re sale of nonlegend drugs in vending machines and made technical and conforming changes, added new Subsec. (b) re sale of nonlegend devices and test strips in vending machines, registration of vending machines and designation of individual responsible for maintaining vending machine, redesignated Subsec. (b) as Subsec. (c) and amended same by substituting “not more than one thousand dollars per violation” for “not less than one hundred dollars nor more than five hundred dollars”, effective June 13, 2023.

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Sec. 20-633. Administration of vaccines and epinephrine cartridge injectors by pharmacists and pharmacy technicians. Disclosures. Training. Recordkeeping. Regulations. (a)(1) Any person licensed as a pharmacist under part II of this chapter may administer:

(A) Any vaccine, approved or authorized by the United States Food and Drug Administration that is listed on the National Centers for Disease Control and Prevention's Adult Immunization Schedule, to any patient who is: (i) Eighteen years of age or older; or (ii) at least twelve years of age but younger than eighteen years of age with (I) the consent of such patient's parent, legal guardian or other person having legal custody of such patient, or (II) proof that such patient is an emancipated minor.

(B) Any vaccine not included on the National Centers for Disease Control and Prevention's Adult Immunization Schedule, provided the vaccine administration instructions for such vaccine are available on the National Centers for Disease Control and Prevention's Internet web site; and

(2) A pharmacist shall make a reasonable effort to review a patient's vaccination history to prevent any inappropriate use of a requested vaccine.

(3) All vaccines administered pursuant to this section shall be administered in accordance with the: (A) Vaccine manufacturer's package insert or the orders of a prescribing practitioner; and (B) regulations adopted pursuant to subsection (d) of this section.

(b) A pharmacist who has completed the training required in regulations adopted pursuant to subsection (d) of this section may administer an epinephrine cartridge injector, as defined in section 19a-909, to a patient whom the pharmacist reasonably believes, based on such pharmacist's knowledge and training, is experiencing anaphylaxis, regardless of whether such patient has a prescription for an epinephrine cartridge injector. Such pharmacist, or such pharmacist's designee, shall call the 9-1-1 emergency telephone number either before or immediately after such pharmacist administers the epinephrine cartridge injector to such patient. Such pharmacist shall document the date, time and circumstances in which such pharmacist administered such epinephrine cartridge injector, and maintain such documentation for at least three years.

(c) (1) A certified and registered pharmacy technician may administer a vaccine to a patient at a pharmacy if: (A) The managing pharmacist of such pharmacy is authorized to administer vaccines under this section; and (B) such pharmacy technician (i) has successfully completed a course of hands-on training, certified by the American Council for Pharmacy Education, concerning the administration of vaccines, (ii) has been trained at such pharmacy regarding the process for administering vaccines to patients at such pharmacy, (iii) successfully completes at least one hour of annual continuing education concerning immunization, (iv) has been evaluated by the managing pharmacist of such pharmacy, and (v) administers such vaccine at the direction of the pharmacist on duty at such pharmacy.

(2) During the period beginning on September first and ending on March thirty-first of the succeeding calendar year, a certified and registered pharmacy technician shall not count toward the pharmacist-to-technician ratio set forth in section 20-576-33 of the regulations of Connecticut state agencies if such pharmacy technician: (A) Is authorized to administer vaccines under this section; and (B) exclusively performs duties related to the administration of vaccines during such period.

(d) 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 another 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; P.A. 23-19, S. 5.)

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; P.A. 23-19 substantially amended Subsec. (a) re vaccine administration, added new Subsec. (b) re administration of epinephrine cartridge injectors by pharmacists, added new Subsec. (c) re administration of vaccines by pharmacy technicians, redesignated Subsec. (b) re adoption of regulations as Subsec. (d) and made technical changes, and deleted former Subsec. (c) defining “adult”, effective July 1, 2023.

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

(1) “Medical order” means a written, oral or electronic order by a prescribing practitioner for a drug to be dispensed by a pharmacy for administration to a patient;

(2) “Prescribing practitioner” has the same meaning as provided in section 20-14c;

(3) “Sterile compounding pharmacy” means a pharmacy or nonresident pharmacy that dispenses or compounds sterile pharmaceuticals;

(4) “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

(5) “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) (A) If an applicant for a new pharmacy license under section 20-594 intends to compound sterile pharmaceuticals, the applicant shall file an addendum to the pharmacy license application such applicant files pursuant to section 20-594 to include sterile pharmaceutical compounding. The department shall inspect the proposed pharmacy premises of such applicant and such applicant shall not compound sterile pharmaceuticals until such applicant receives notice that the addendum to such applicant's application has been approved by the department and the commission. Nothing in this section shall be construed to affect a licensed hospital's ability to compound sterile pharmaceuticals for such hospital's patients consistent with federal law.

(B) 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 apply for an addendum to such pharmacy's application on file with the department to include sterile pharmaceutical compounding. The department shall inspect the pharmacy premises of such pharmacy and such pharmacy shall not compound sterile pharmaceuticals until such pharmacy receives written notice that such addendum application has been approved by the department and the commission.

(C) If an existing health care institutional pharmacy licensed pursuant to section 20-594 intends to compound sterile pharmaceuticals for the first time on or after July 1, 2023, such health care institutional pharmacy shall apply for an addendum to such health care institutional pharmacy's application on file with the department to include sterile pharmaceutical compounding. The department shall inspect the pharmacy premises of such health care institutional pharmacy, and such health care institutional pharmacy shall not compound sterile pharmaceuticals until such health care institutional pharmacy receives written notice that such health care institutional pharmacy's addendum application has been approved by the department and the commission.

(2) (A) If an applicant for a new nonresident pharmacy registration intends to compound sterile pharmaceuticals for sale or delivery in this state, the applicant shall file an addendum to the registration application such applicant files pursuant to section 20-627 to include sterile pharmaceutical compounding. Such applicant shall provide to the department written proof that such applicant has passed inspection by the appropriate state agency in the state where such applicant is located. Such applicant shall not compound sterile pharmaceuticals for sale or delivery in this state until such applicant receives written notice that such addendum has been approved by the department and the commission.

(B) If an existing nonresident pharmacy intends to compound sterile pharmaceuticals for sale or delivery in this state for the first time on or after July 1, 2014, such nonresident pharmacy shall apply for an addendum to such nonresident pharmacy's application on file with the department to include sterile pharmaceutical compounding. Such nonresident pharmacy shall provide to the department written proof that such nonresident pharmacy has passed inspection by the appropriate state agency in the state where such nonresident pharmacy is located. Such nonresident pharmacy shall not compound sterile pharmaceuticals until such nonresident pharmacy receives written notice that such addendum application has been approved by the department and the commission.

(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) (1) A sterile compounding pharmacy may only provide patient-specific sterile pharmaceuticals to patients, to 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.

(e) (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 such sterile compounding pharmacy's 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.

(f) 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.

(g) (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.

(h) Each sterile compounding pharmacy shall prepare and maintain a policy and procedure manual. The policy and procedure manual shall comply with the USP chapters.

(i) Each sterile compounding pharmacy shall report to the Department of Consumer Protection any administrative or legal action commenced against such sterile compounding pharmacy 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.

(j) Notwithstanding the provisions of subdivision (2) of subsection (b) of this section, a sterile compounding pharmacy that is a nonresident pharmacy shall provide to the Department of Consumer Protection proof that such nonresident pharmacy 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 such nonresident pharmacy's initial nonresident pharmacy application and shall submit to the department a copy of such nonresident pharmacy's most recent inspection report every two years thereafter. If the state in which such 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 such nonresident pharmacy is in compliance with the standards required in the USP chapters.

(k) A practitioner, as specified in subdivision (1) of subsection (d) 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.

(l) (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 that provides sterile pharmaceuticals shall notify the department of such pharmacy's designated pharmacist.

(3) The designated pharmacist shall be responsible for providing proof such designated pharmacist 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 such designated pharmacist ceases such designation.

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

(m) Notwithstanding the provisions of this section, the addition of a flavoring agent in accordance with subsections (a) and (b) of section 20-617a shall be exempt from the requirements of United States Pharmacopeia, Chapter 795, Pharmaceutical Compounding – Nonsterile Preparations, and Chapter 800, Hazardous Drugs, as both may be amended from time to time.

(n) The Commissioner of Consumer Protection may adopt regulations, in accordance with chapter 54, to implement the provisions of subsections (a) to (m), inclusive, 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; P.A. 23-19, S. 8; 23-52, S. 7.)

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; P.A. 23-19 amended Subsec. (a) by adding new Subdiv. (2) defining “prescribing practitioner” and redesignating existing Subdivs. (2) to (4) as Subdivs. (3) to (5), amended Subsec. (b)(1) by designating existing provisions as Subpara. (A) and adding provision re compounding by licensed hospital for hospital's patients, redesignated Subsec. (b)(2) as Subsec. (b)(1)(B), added Subsec. (b)(1)(C) re addendum to health care institutional pharmacy's application, redesignated Subsec. (b)(3) as Subsec. (b)(2)(A) and Subsec. (b)(4) as Subsec. (b)(2)(B), deleted former Subsec. (d) re institutional pharmacy within facility licensed pursuant to Sec. 19a-490, redesignated Subsecs. (e) to (n) as Subsecs. (d) to (m), and made technical and conforming changes throughout, effective July 1, 2023; P.A. 23-52 added new Subsec. (n), codified by the Revisors as new Subsec. (m), re exemption for addition of flavoring agent in accordance with Sec. 20-617a(a) and (b), redesignated existing Subsec. (n) as Subsec. (o), and made technical and conforming changes in Subsecs. (h)(2) and (o), effective June 13, 2023.

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(1) “COVID-19” means the respiratory disease designated by the World Health Organization on February 11, 2020, as coronavirus 2019, and any related mutation thereof recognized by said organization;

(2) “COVID-19-related test” means any laboratory test, or series of laboratory tests, for any virus, antibody, antigen or etiologic agent thought to cause, or indicate the presence of, COVID-19;

(3) “HIV-related prophylaxis” means any drug approved by the federal Food and Drug Administration or any successor agency as a pre-exposure or post-exposure prophylaxis for the human immunodeficiency virus;

(4) “HIV-related test” has the same meaning as provided in section 19a-7o; and

(5) “Influenza-related test” means any laboratory test, or series of laboratory tests, for any virus, antibody, antigen or etiologic agent thought to cause, or indicate the presence of, influenza disease.

(b) (1) Any pharmacist licensed under this chapter may order, and administer to a patient, a COVID-19-related test or influenza-related test if: (A) Such pharmacist (i) is employed by a pharmacy that has submitted to the Department of Public Health a complete clinical laboratory improvement amendment application for certification for the COVID-19-related test or influenza-related test and the Department of Public Health has approved such application, and (ii) has completed any training required by the Department of Consumer Protection; and (B) the patient is (i) eighteen years of age or older, or (ii) at least twelve years of age but younger than eighteen years of age with (I) the consent of such patient's parent, legal guardian or other person having legal custody of such patient, or (II) proof that such patient is an emancipated minor.

(2) Any pharmacist licensed under this chapter may order, and administer to a patient, a COVID-19-related test or influenza-related test if: (A) Such pharmacist is employed by a hospital; and (B) the patient is (i) eighteen years of age or older, or (ii) at least twelve years of age but younger than eighteen years of age with (I) the consent of such patient's parent, legal guardian or other person having legal custody of such patient, or (II) proof that such patient is an emancipated minor.

(c) (1) On or after the adoption of regulations pursuant to subsection (g) of this section, any pharmacist licensed under this chapter may order, and administer to a patient, an HIV-related test if: (A) Such pharmacist (i) is employed by a pharmacy that has submitted to the Department of Public Health a complete clinical laboratory improvement amendment application for certification for the HIV-related test and the Department of Public Health has approved such application, and (ii) has completed the training required under regulations adopted pursuant to subsection (g) of this section; and (B) the patient is (i) eighteen years of age or older, or (ii) at least twelve years of age but younger than eighteen years of age with (I) the consent of such patient's parent, legal guardian or other person having legal custody of such patient, or (II) proof that such patient is an emancipated minor.

(2) On or after the adoption of regulations pursuant to subsection (g) of this section, any pharmacist licensed under this chapter may order, and administer to a patient, an HIV-related test if: (A) Such pharmacist is employed by a hospital; and (B) the patient is (i) eighteen years of age or older, or (ii) at least twelve years of age but younger than eighteen years of age and such pharmacist has obtained (I) the consent of such patient's parent, legal guardian or other person having legal custody of such patient, or (II) proof that such patient is an emancipated minor.

(d) If a pharmacist orders and administers a COVID-19-related test or influenza-related test under subsection (b) of this section, or an HIV-related test under subsection (c) of this section, the pharmacist shall: (1) Provide the results of such test to (A) the patient, in writing, (B) the patient's primary care provider, if the patient identifies any such primary care provider, and (C) the Commissioner of Consumer Protection or said commissioner's designee, upon request by said commissioner or such designee; (2) report the results of such test to the director of health of the town, city or borough in which such case resides and to the Department of Public Health in the manner set forth in section 19a-215 and applicable regulations; and (3) maintain a record of the results of such test for three years.

(e) (1) If a pharmacist orders and administers an HIV-related test under subsection (c) of this section and the result of such test is negative, the pharmacist may prescribe and dispense to the patient any HIV-related prophylaxis according to the manufacturer's package insert, provided: (A) Such pharmacist has completed the training required under the regulations adopted pursuant to subsection (g) of this section; (B) such patient satisfies the criteria established in such package insert; and (C) such HIV-related prophylaxis is prescribed and dispensed in accordance with all applicable requirements established in (i) this section, (ii) this chapter, or (iii) any regulations adopted pursuant to subsection (g) of this section or this chapter.

(2) If a pharmacist prescribes any HIV-related prophylaxis under subdivision (1) of this subsection, the pharmacist shall provide to the Commissioner of Consumer Protection or the commissioner's designee, upon request by said commissioner or such designee: (A) A copy of the results of the HIV-related test described in subdivision (1) of this subsection; (B) prescription information maintained pursuant to this chapter; and (C) any other documentation the commissioner may require in regulations adopted pursuant to subsection (g) of this section.

(f) Notwithstanding the provisions of section 1-210, all information a pharmacist submits to the Department of Consumer Protection pursuant to this section, or any regulation adopted pursuant to subsection (g) of this section, shall be confidential. The department shall use such information to perform the department's duties concerning pharmacy, to ensure compliance with and enforce provisions of the general statutes and regulations of Connecticut state agencies concerning pharmacy and for no other purpose. If the department brings an enforcement action and uses any such information as part of such action, the department may disclose such information to the parties to such action only if such disclosure is required by applicable law. No such party shall further disclose such information except to a tribunal, the Commission of Pharmacy, an administrative agency or a court with jurisdiction over such action. Such tribunal, commission, agency or court shall ensure that such information is subject to a qualified protective order, as defined in 45 CFR 164.512(e), as amended from time to time.

(g) The Commissioner of Consumer Protection, in consultation with the Commissioner of Public Health, the Commission of Pharmacy, a state-wide professional society representing the interests of physicians practicing medicine in this state and a state-wide organization representing the interests of health care professionals and scientists specializing in the control and prevention of infectious diseases, shall adopt regulations, in accordance with chapter 54, to implement the provisions of this section. Such regulations shall, at a minimum: (1) Ensure compliance with all applicable guidance issued by the federal Centers for Disease Control and Prevention; (2) ensure that each HIV-related prophylaxis prescribed and dispensed under subsection (e) of this section is prescribed and dispensed in accordance with the approval the federal Food and Drug Administration has granted for such HIV-related prophylaxis; (3) establish permissible routes of administration; (4) establish prescription duration limits not to exceed (A) sixty days for any pre-exposure HIV-related prophylaxis, or (B) thirty days for any post-exposure HIV-related prophylaxis; (5) specify (A) how frequently a pharmacist shall provide treatment to a patient under this section, (B) when a pharmacist providing treatment to a patient under this section shall refer such patient to such patient's primary care provider or any other health care provider identified by such patient, and (C) the circumstances in which a pharmacist shall recommend that a patient undergo screenings for sexually transmitted infections other than the human immunodeficiency virus; (6) establish requirements concerning private areas for consultations between pharmacists and patients; (7) establish training requirements concerning (A) methods to obtain a patient's complete sexual history, (B) delivering a positive HIV-related test result to a patient, (C) referring a patient who has tested positive for the human immunodeficiency virus to the services that are available to such patient, and (D) using HIV-related prophylaxes for patients who have tested negative for the human immunodeficiency virus; (8) identify qualifying training programs, which are accredited by the National Centers for Disease Control and Prevention, the Accreditation Council for Pharmacy Education or another appropriate national accrediting body; and (9) establish a system of control and reporting.

(P.A. 23-19, S. 2.)

History: P.A. 23-19 effective July 1, 2023.

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Sec. 20-633g. Operation of mobile pharmacies by licensed pharmacies. Application. Recordkeeping. Operations. Regulations. (a)(1) A pharmacy may apply to the department, in a form and manner prescribed by the commissioner, to operate a mobile pharmacy in a temporary location for the purpose of: (A) Conducting (i) a temporary pharmacy operation, (ii) a vaccination event, or (iii) an opioid antagonist training and prescribing event; or (B) serving a community that may not have adequate access to pharmacy services.

(2) No pharmacy may operate a mobile pharmacy without prior written approval from the department. Each mobile pharmacy shall be supervised by a pharmacist. The department may inspect a mobile pharmacy before pharmacy services are provided in the mobile pharmacy, and at any time during usual business hours or while such mobile pharmacy is in operation. The department may issue an order closing a mobile pharmacy if the department determines that: (A) The mobile pharmacy has failed to comply with (i) any provision of this section or this chapter, (ii) any regulation adopted pursuant to subsection (d) of this section or this chapter, or (iii) any applicable law or regulation of any jurisdiction concerning drugs, devices or the practice of pharmacy; (B) conditions are unsafe to store or dispense drugs; or (C) there is insufficient security at such mobile pharmacy.

(b) A pharmacy that operates a mobile pharmacy under this section shall: (1) Maintain a record of all drugs that are removed from the pharmacy premises for the purpose of operating such mobile pharmacy; (2) maintain a record of each drug that is dispensed at such mobile pharmacy and include such record in such pharmacy's records not later than twenty-four hours after such drug is dispensed; (3) except as provided in subsection (c) of this section, inventory and return all unused drugs to the pharmacy premises by the close of business each day; (4) while operating such mobile pharmacy, store all drugs in such mobile pharmacy in a manner that (A) prevents any drug diversion, and (B) is consistent with the storage conditions specified by the manufacturers of such drugs; (5) establish and maintain a patient communication plan to ensure that patients can obtain prescription refills if such mobile pharmacy is unavailable; and (6) if permitted by the federal Drug Enforcement Administration or a successor agency, store controlled substances in the mobile pharmacy in accordance with regulations adopted by the commissioner pursuant to section 21a-262.

(c) No pharmacy shall, without prior approval from the department: (1) Operate a mobile pharmacy for more than (A) seven consecutive days in a single location, or (B) fourteen days within a five-mile radius of the prior mobile pharmacy location; or (2) store drugs overnight in a mobile pharmacy or outside of the pharmacy premises.

(d) The commissioner may, with the advice and consent of the commission, adopt regulations in accordance with chapter 54 to implement the provisions of this section.

(P.A. 23-19, S. 3.)

History: P.A. 23-19 effective July 1, 2023.

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Sec. 20-633h. Unscheduled closings by licensed pharmacies. Plan. Disclosures. Prescription transfers. Regulations. (a) For the purposes of this section, “pharmacy district manager” means an individual who (1) supervises at least three pharmacies within this state, and (2) is responsible for the activities within such pharmacies, including, but not limited to, staffing, payroll and hiring.

(b) Each pharmacy shall maintain a plan to manage unscheduled closings. Such plan shall be reviewed and updated, if necessary, on an annual basis, and be provided to, and reviewed with, all pharmacy personnel on an annual basis. Such plan shall include:

(1) The name of the individual who is responsible for notifying the Commission of Pharmacy of an unscheduled closing;

(2) The name of the individual who is responsible for updating the hours of operation in the pharmacy's electronic record system to prevent acceptance of electronically transmitted prescriptions during an unscheduled closing;

(3) The name of the individual who is responsible for updating the pharmacy's telephone system during an unscheduled closing to (A) prevent the acceptance of orally transmitted prescriptions during the unscheduled closing, and (B) provide a message that alerts patients that such pharmacy will be closed and their prescriptions may be obtained from a nearby pharmacy;

(4) A list of all pharmacies that are located within a two-mile radius of the pharmacy that is experiencing an unscheduled closing, or the next closest pharmacy if there is no pharmacy within such two-mile radius; and

(5) The name of the individual who is responsible for posting, at the entrance to such pharmacy and at each entrance of the structure if such pharmacy is located within another structure, signage stating the duration of an unscheduled closing.

(c) If a pharmacy experiences an unscheduled closing, the pharmacist manager of the pharmacy or, if the pharmacy operates more than five pharmacy locations in this state, the pharmacy district manager shall:

(1) Modify such pharmacy's hours of operation in such pharmacy's electronic record system to prevent the acceptance of electronically transmitted prescriptions during the unscheduled closing;

(2) Adjust such pharmacy's telephone system to prevent the acceptance of orally transmitted prescriptions during the unscheduled closing;

(3) Provide a telephone system message alert to patients notifying patients that (A) such pharmacy is not open, and (B) patients may obtain medications from a nearby pharmacy;

(4) Post signage at the entrance to such pharmacy, and at each entrance of the structure if such pharmacy is located within another structure, (A) stating that such pharmacy is closed, (B) disclosing the duration of the unscheduled closing, and (C) providing (i) a list of all pharmacies that are located within a two-mile radius of such pharmacy, or (ii) the next closest pharmacy if there is no pharmacy within such two-mile radius; and

(5) Upon request by another pharmacy to transfer a prescription to such other pharmacy, transfer any prescription dispensed by the pharmacy experiencing the unscheduled closing and reverse any third-party payor claims associated with such prescription.

(d) Any pharmacy that verifies that another pharmacy is experiencing an unscheduled closing may, upon a patient's request, dispense a prescription that is dispensed and waiting at the pharmacy experiencing the unscheduled closing by using information obtained from the closed pharmacy, the electronic prescription drug monitoring program or another source that the pharmacist dispensing such prescription believes provides a reasonable assurance of accurate information necessary to dispense such prescription. In the event that a pharmacy dispenses a prescription during an unscheduled closing of another pharmacy:

(1) The pharmacy dispensing such prescription shall contact the pharmacy experiencing the unscheduled closing not later than twenty-four hours after such closed pharmacy reopens to transfer such prescription, in accordance with section 20-616;

(2) The pharmacy that experienced the unscheduled closing shall provide to the pharmacy that dispensed such prescription during such unscheduled closing all information necessary for the transfer of such prescription; and

(3) The pharmacy that experienced the unscheduled closing shall reverse any third-party payor claims associated with such transferred prescription not later than twenty-four hours after such pharmacy reopens.

(e) The Department of Consumer Protection shall adopt regulations, in accordance with chapter 54, to implement the provisions of this section. Such regulations shall include, but need not be limited to, provisions for the placement of a secured container at a pharmacy that allows patients to, during the hours in which the pharmacy may be open or closed, obtain prescriptions that were dispensed by such pharmacy. Prior to the effective date of such regulations, the department may temporarily permit the use and placement of a secured container at a pharmacy, provided the pharmacy submits to the department, for the department's approval, written protocols prior to placing, providing access to or using the secured container and such pharmacy receives written approval from the department for such placement, access or use. To obtain temporary approval under this subsection, a secure container shall:

(1) Weigh more than seven hundred fifty pounds or be affixed to the physical structure of the building where the pharmacy is located, and be located immediately adjacent to the portion of such building where such pharmacy is located;

(2) Only permit access to authorized pharmacy personnel or individuals retrieving the prescriptions with a unique identification system;

(3) Be under video surveillance at all times;

(4) Be capable of maintaining a record of all products that are placed inside of the secure container, and the date and time each individual prescription is accessed; and

(5) Comply with any other protocol required by the department to ensure patient confidentiality, ensure public health and safety and prevent diversion.

(P.A. 23-19, S. 4.)

History: P.A. 23-19 effective July 1, 2023.

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Sec. 20-633j. Authorization, refilling and dispensing of legend devices by licensed pharmacists. Notice to prescribing practitioner. (a) For the purposes of this section, “drug”, “legend device”, “pharmacist” and “prescribing practitioner” have the same meanings as provided in section 20-571.

(b) A pharmacist may authorize or refill a prescription for a legend device if such legend device is approved by the federal Food and Drug Administration for use in combination with a drug prescribed by a prescribing practitioner.

(c) A pharmacist who dispenses a legend device as described in subsection (b) of this section shall identify the prescribing practitioner who prescribed the drug that is associated with such legend device, and shall send written notice to such prescribing practitioner, not later than seventy-two hours after the pharmacist dispenses such legend device to the patient, disclosing that such pharmacist dispensed such legend device to such patient.

(P.A. 23-52, S. 2.)

History: P.A. 23-52 effective June 13, 2023.

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

(2) “Emergency contraceptive” means a drug, or a combination of drugs, approved by the federal Food and Drug Administration to prevent pregnancy as soon as possible following (A) unprotected sexual intercourse, or (B) a known or suspected contraceptive failure;

(3) “Hormonal contraceptive” means a drug, including, but not limited to, a hormonal contraceptive patch, an intravaginal hormonal contraceptive or an oral hormonal contraceptive, composed of a hormone, or a combination of hormones, approved by the federal Food and Drug Administration to prevent pregnancy;

(4) “Legend drug” has the same meaning as provided in section 20-571;

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

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

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

(8) “Prescribe” means to order, or designate a remedy or any preparation of, a legend drug for a specific patient.

(b) A pharmacist who satisfies the requirements established in this section, and any regulations adopted pursuant to subsection (e) of this section, may prescribe, in good faith, an emergency contraceptive or hormonal contraceptive to a patient subject to the following conditions:

(1) The pharmacist has completed an educational training program that (A) concerns prescribing emergency contraceptives and hormonal contraceptives by a pharmacist, (B) addresses appropriate medical screening of patients, contraindications, drug interactions, treatment strategies and modifications and when to refer patients to medical providers, and (C) is accredited by the Accreditation Council for Pharmacy Education;

(2) The pharmacist has reviewed the most current version of the United States Medical Eligibility Criteria for Contraceptive Use published by the Centers for Disease Control and Prevention, or any successor document thereto, prior to prescribing any emergency contraceptive or hormonal contraceptive and, if the pharmacist deviates from the guidance provided in such document, documents the pharmacist's rationale in deviating from such guidance in writing;

(3) Prior to dispensing an emergency contraceptive or hormonal contraceptive and at least once per calendar year thereafter for any returning patient, the pharmacist completes a screening document, which the department shall make available on the department's Internet web site, and the pharmacist, or the pharmacy that employs such pharmacist, retains such document for at least three years, except nothing in this subdivision shall be construed to prevent a pharmacist, in the pharmacist's professional discretion, from issuing a prescription for a hormonal contraceptive for a period not to exceed twelve months or from requiring more frequent screenings;

(4) If the pharmacist determines that prescribing an emergency contraceptive or hormonal contraceptive to a patient is clinically appropriate, the pharmacist shall (A) counsel the patient about what the patient should monitor and when the patient should seek additional medical attention, and (B) send notice to any health care provider that the patient identifies as the patient's primary care provider or, if the patient does not disclose the identity of the patient's primary care provider, provide to the patient any relevant documentation; and

(5) The pharmacist provides to the patient a document outlining age-appropriate health screenings that are consistent with recommendations made by the Centers for Disease Control and Prevention.

(c) A pharmacy technician may, at a pharmacist's request, assist the pharmacist in prescribing an emergency contraceptive or hormonal contraceptive to a patient by providing screening documentation to the patient, taking and recording the patient's blood pressure and documenting the patient's medical history, provided the pharmacy technician has completed an educational training program that satisfies the requirements established in subdivision (1) of subsection (b) of this section.

(d) Each pharmacy shall maintain copies of all documents concerning any screening performed under this section for at least three years, and each pharmacy shall, upon request by the department, make such screening documents available to the department for inspection.

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

(P.A. 23-52, S. 3.)

History: P.A. 23-52 effective June 13, 2023.

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Sec. 20-633l. Disclosure of information by licensed pharmacists regarding drugs used for termination of pregnancy. Prohibition concerning automatic reciprocal jurisdiction. (a) For the purposes of this section, “drug”, “pharmacist” and “pharmacy” have the same meanings as provided in section 20-571.

(b) A pharmacist who is employed by a pharmacy that has been approved to dispense drugs for the termination of a pregnancy shall provide to any patient who is seeking any such drug a list of the pharmacies nearest to such patient that dispense such drug if the pharmacy does not have a supply of such drug.

(c) A pharmacist who is, or has been, licensed in another state or jurisdiction shall not be subject to automatic reciprocal discipline in this state for any disciplinary action taken in such other state or jurisdiction, provided such disciplinary action was based solely on the termination of a pregnancy under conditions which would not violate the laws of this state.

(P.A. 23-52, S. 4.)

History: P.A. 23-52 effective June 13, 2023.

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Sec. 20-634. Dispensing group practices and dispensing assistants. Registration. Fees. Exemptions. Prohibitions. Penalties. (a) For the purposes of this section:

(1) “Centralized dispensing practitioner” means a prescribing practitioner (A) who is employed by, or affiliated with, a dispensing group practice, and (B) whom the dispensing group practice designates as the prescribing practitioner who is authorized to dispense legend drugs and legend devices on behalf of other prescribing practitioners who are employed by, or affiliated with, such dispensing group practice;

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

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

(4) “Dispensing assistant” means an individual who is (A) registered with the department under subdivision (1) of subsection (d) of this section, (B) employed by a dispensing group practice, and (C) supervised by (i) the centralized dispensing practitioner, or (ii) a pharmacist employed by the dispensing group practice;

(5) “Dispensing group practice” means a group practice that (A) centralizes the dispensing of legend drugs or legend devices prescribed by prescribing practitioners who are employed by, or affiliated with, the group practice through (i) a centralized dispensing practitioner, or (ii) a pharmacist employed by the dispensing group practice, and (B) is registered with the department pursuant to subsection (b) of this section;

(6) “Group practice” has the same meaning as provided in section 19a-486i;

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

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

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

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

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

(12) “Prescription” has the same meaning as provided in section 20-635;

(13) “Professional samples” has the same meaning as provided in section 20-14c; and

(14) “Seventy-two-hour supply” means a quantity of a legend drug or legend device that does not exceed the dosage amount necessary for seventy-two hours according to the directions for use of the legend drug or legend device.

(b) (1) No group practice may dispense legend drugs or legend devices as a dispensing group practice unless such group practice submits an application to, and receives a registration from, the department under this subdivision. Each application submitted to the department under this subdivision shall be submitted on a form, and in a manner, prescribed by the department and designate a centralized dispensing practitioner or a pharmacist who is employed by the group practice and shall serve as the primary contact for the department, and shall be accompanied by a registration fee in the amount of two hundred dollars. Each registration issued pursuant to this subdivision shall be valid for a period of two years, and the department may renew such registration for additional two-year periods upon its receipt of a complete renewal application submitted on a form, and in a manner, prescribed by the department and a renewal fee of two hundred dollars.

(2) Except as provided in subdivision (3) of this subsection, each dispensing group practice that dispenses, or proposes to dispense, in this state more than a seventy-two-hour supply of any legend drug or legend device shall (A) register for access to the electronic prescription drug monitoring program established pursuant to subsection (j) of section 21a-254, and (B) comply with all reporting and usage requirements for the electronic prescription drug monitoring program as set forth in subsection (j) of section 21a-254.

(3) No dispensing group practice that dispenses, or proposes to dispense, less than a seventy-two-hour supply of legend drugs or legend devices shall be subject to the provisions of subdivision (2) of this subsection if such dispensing group practice exclusively dispenses such supply of legend drugs or legend devices as professional samples.

(c) A dispensing group practice that employs a pharmacist for the purpose of dispensing legend drugs or legend devices shall not be required to obtain a pharmacy license for the dispensing group practice's premises under section 20-594. The pharmacist shall report directly to a prescribing practitioner who is employed by, or affiliated with, the dispensing group practice, and may supervise dispensing assistants employed by such dispensing group practice, perform in-process and final checks without obtaining any additional verification from the prescribing practitioner to whom such pharmacist reports and perform any component of the practice of pharmacy.

(d) (1) No individual may act as a dispensing assistant unless such individual submits an application to, and receives a registration from, the department under this subdivision. Each application submitted to the department under this subdivision shall be submitted on a form, and in a manner, prescribed by the department, and shall be accompanied by a registration fee in the amount of one hundred dollars. Each registration issued pursuant to this subdivision shall be valid for a period of two years, and the department may renew such registration for additional two-year periods upon its receipt of a complete renewal application submitted on a form, and in a manner, prescribed by the department and a renewal fee of one hundred dollars.

(2) A dispensing assistant who is registered with the department under subdivision (1) of this subsection may perform the duties of a pharmacy technician, provided the dispensing assistant performs such duties under the supervision of a prescribing practitioner who is employed by or affiliated with, or a pharmacist who is employed by, the dispensing group practice that employs such dispensing assistant. Each dispensing assistant shall be subject to the same responsibilities and liabilities set forth in this chapter, and any regulations adopted pursuant to this chapter, concerning pharmacy technicians.

(e) A prescribing practitioner who is employed by, or affiliated with, a dispensing group practice may dispense legend drugs or legend devices to the prescribing practitioner's patients without engaging the services of the centralized dispensing practitioner or a pharmacist who is employed by the dispensing group practice.

(f) (1) No centralized dispensing practitioner or pharmacist employed by a dispensing group practice shall dispense a legend drug, legend device or controlled substance for, or order that a legend drug, legend device or controlled substance be dispensed to, any individual who is not being treated by a prescribing practitioner who is employed by, or affiliated with, the dispensing group practice.

(2) No dispensing group practice shall accept or dispense any prescription from a prescribing practitioner who is not employed by, or affiliated with, the dispensing group practice.

(3) No dispensing group practice shall exhibit within or upon the outside of the premises occupied by such dispensing group practice, or include in any advertisement for such dispensing group practice, (A) the words “drug store”, “pharmacy”, “apothecary” or “medicine shop” or any combination thereof, or (B) any other display, symbol or word indicating that such dispensing group practice or premises is a pharmacy.

(g) The department may refuse to issue or renew a dispensing group practice registration under subsection (b) of this section or a dispensing assistant registration under subsection (d) of this section, revoke, suspend or place conditions on a dispensing group practice's registration issued under subsection (b) of this section or a dispensing assistant's registration under subsection (d) of this section, and assess a civil penalty not to exceed one thousand dollars per violation if the dispensing group practice or a centralized dispensing practitioner, dispensing assistant or pharmacist employed by, or acting as an agent on behalf of, such dispensing group practice violates any provision of (1) subsections (a) to (f), inclusive, of this section, or (2) this chapter, or any regulations adopted pursuant to this chapter, concerning dispensing legend drugs or legend devices.

(P.A. 23-52, S. 1.)

History: P.A. 23-52 effective January 1, 2024.

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PART IV

PRESCRIPTION ERROR REPORTING

Sec. 20-636. Sign re storage and disposal of prescription drugs. Sticker or label on container or packaging. (a) 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.

(b) On and after January 1, 2024, each pharmacy shall affix a fluorescent orange sticker or label to each container or packaging in which an opioid drug, as defined in section 20-14o, or controlled substance in schedule II, III, IV or V, is sold or dispensed, containing the following statement in black ink:

“DANGER TO CHILDREN

KEEP OUT OF REACH”.

(c) Not later than July 1, 2024, the Commissioner of Consumer Protection shall adopt regulations, in accordance with chapter 54, to provide guidance for pharmacies concerning the optimal size of and font size used on the stickers or labels required pursuant to subsection (b) of this section. Not later than September 1, 2023, the commissioner shall implement policies and procedures necessary to implement such guidance while in the process of adopting such policies and procedures as regulations. Policies and procedures implemented pursuant to this section shall be valid until the time final regulations are adopted.

(P.A. 22-81, S. 19; P.A. 23-100, S. 1.)

History: P.A. 22-81 effective July 1, 2022; P.A. 23-100 designated existing provision re posting of signage as Subsec. (a), deleted reference to January 1, 2023, and added Subsec. (b) provision re pharmacies to affix sticker or label to certain containers or packaging and Subsec. (c) provision re adoption of regulations to provide guidance re size of stickers or labels and size of font used on stickers or labels, effective June 27, 2023.

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PART V

ASSISTANCE PROGRAM AND PETITIONS CONCERNING SAFE AND
SKILLFUL PRACTICE

Sec. 20-638. Definitions. As used in this section and sections 20-638a to 20-638c, inclusive:

(1) “Assistance program” has the same meaning as provided in subsection (a) of section 19a-12a;

(2) “Chemical dependency” has the same meaning as provided in subsection (a) of section 19a-12a;

(3) “Health care professionals” has the same meaning as provided in subsection (a) of section 19a-12a;

(4) “Hospital” has the same meaning as provided in section 19a-490;

(5) “Medical review committee” has the same meaning as provided in subsection (a) of section 19a-12a;

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

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

(8) “Pharmacy intern” has the same meaning as provided in section 20-571.

(P.A. 23-204, S. 251.)

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Sec. 20-638a. Admission of pharmacists and pharmacy interns. Referral to department. Notification of disciplinary action against program participants. Recordkeeping and confidentiality. Annual reports and audit. (a) Any pharmacist or pharmacy intern may access the assistance program, provided the assistance program: (1) Satisfies the requirements established in this section; and (2) includes at least one medical review committee that satisfies the requirements established in subsections (b) to (h), inclusive, of this section.

(b) (1) Prior to admitting any pharmacist or pharmacy intern into the assistance program, a medical review committee shall: (A) Determine whether such pharmacist or pharmacy intern is an appropriate candidate for rehabilitation and participation in such program; and (B) establish the terms and conditions for such pharmacist's or pharmacy intern's participation in such program.

(2) No action taken by a medical review committee pursuant to subdivision (1) of this subsection shall be construed as the practice of medicine or mental health care.

(c) (1) Except as provided in subsection (f) of this section, a medical review committee shall not admit into the assistance program any pharmacist or pharmacy intern who: (A) Has any pending disciplinary charges, prior history of disciplinary action or consent order issued by any professional licensing, registering or disciplinary body; (B) has been charged with, or convicted of, (i) any felony under the laws of this state, or (ii) any offense committed outside of this state that, if committed within this state, would constitute a felony under the laws of this state; or (C) is alleged to have harmed a patient.

(2) A medical review committee shall refer any pharmacist or pharmacy intern who satisfies the criteria established in subdivision (1) of this subsection to the Department of Consumer Protection, and shall submit to the department all records and files maintained by such committee concerning such pharmacist or pharmacy intern. Such referral may include the medical review committee's recommendations concerning which intervention, referral assistance, rehabilitation or support services are appropriate for such pharmacist or pharmacy intern.

(d) (1) The assistance program shall regularly review the sources of information available to such program to determine whether, and a pharmacist or pharmacy intern participating in such program shall immediately send notice to such program if: (A) Any disciplinary charges are filed against such pharmacist or pharmacy intern; (B) any professional licensing, registering or disciplinary body takes any disciplinary action against such pharmacist or pharmacy intern; or (C) such pharmacist or pharmacy intern is charged with, or convicted of, (i) any felony under the laws of this state, or (ii) any offense committed outside of this state that, if committed within this state, would constitute a felony under the laws of this state.

(2) Upon determining that a pharmacist or pharmacy intern satisfies the criteria established in, or receiving any notice sent by a pharmacist or pharmacy intern pursuant to, subdivision (1) of this subsection, the assistance program shall refer the pharmacist or pharmacy intern to the Department of Consumer Protection and submit to the department all records and files maintained by the assistance program concerning such pharmacist or pharmacy intern.

(e) The assistance program shall refer a pharmacist or pharmacy intern to the Department of Consumer Protection, and shall submit to the department all records and files maintained by such program concerning the pharmacist or pharmacy intern, if: (1) The assistance program determines that such pharmacist or pharmacy intern (A) is unable to practice such pharmacist's or pharmacy intern's profession with skill and safety or poses a threat to the health and safety of any person or patient in the health care or pharmacy setting, and (B) does not refrain from practicing such pharmacist's or pharmacy intern's profession or fails to participate in a recommended program of rehabilitation; or (2) such pharmacist or pharmacy intern fails to comply with the terms or conditions of, or refuses to participate in, the assistance program.

(f) Upon receiving a referral under subdivision (2) of subsection (c) of this section, subdivision (2) of subsection (d) of this section, subsection (e) of this section or subparagraph (A) of subdivision (3) of subsection (e) of section 19a-12b, the Department of Consumer Protection shall determine if the pharmacist or pharmacy intern is eligible to participate in, or continue participating in, the assistance program and whether such participation shall be treated as confidential as set forth in subsection (h) of this section. The Department of Consumer Protection may seek the advice of the assistance program and professional health care societies or organizations in determining which intervention, referral assistance, rehabilitation or support services are appropriate for the pharmacist or pharmacy intern. If the Department of Consumer Protection determines that the pharmacist or pharmacy intern is an appropriate candidate for confidential participation in the assistance program, and such pharmacist or pharmacy intern participates in such program in accordance with the terms agreed upon by such program, the department and such pharmacist or pharmacy intern, the entire record of the referral and investigation of such pharmacist or pharmacy intern shall be confidential and shall not be disclosed, except at the request of such pharmacist or pharmacy intern, for the duration of such pharmacist's or pharmacy intern's participation in, and following successful completion of, such assistance program.

(g) Upon written notice to the Department of Consumer Protection by the oversight committee that the assistance program is in compliance with a corrective action plan developed pursuant to subdivision (2) of subsection (e) of section 19a-12b, the department may refer pharmacists and pharmacy interns to the assistance program for continued intervention, rehabilitation, referral assistance or support services and shall submit to the assistance program all records and files concerning such pharmacists and pharmacy interns.

(h) (1) All information given or received in connection with any intervention, rehabilitation, referral assistance or support services provided by the assistance program pursuant to this section, including, but not limited to, the identity of any pharmacist or pharmacy intern seeking or receiving such intervention, rehabilitation, referral assistance or support services, shall be confidential and shall not be disclosed: (A) To any third person or entity, unless such disclosure is reasonably necessary for the purposes of (i) such intervention, rehabilitation, referral assistance or support services, or (ii) an audit conducted in accordance with subsection (j) of this section; or (B) in any civil or criminal case or proceeding or in any administrative or other legal proceeding unless (i) the pharmacist or pharmacy intern seeking or obtaining such intervention, rehabilitation, referral assistance or support services waives such confidentiality, or (ii) such disclosure is otherwise required by law.

(2) Except as provided in subdivision (1) of this subsection, no person shall request or require in any civil or criminal case or proceeding, or in any administrative or other legal proceeding, disclosure of any information given or received in connection with the intervention, rehabilitation, referral assistance or support services provided pursuant to this section.

(3) The proceedings of a medical review committee shall not be subject to discovery or introduced into evidence in any civil action for or against a pharmacist or pharmacy intern arising out of matters that are subject to evaluation and review by such committee, and no person who was in attendance at such proceedings shall be permitted or required to testify in any such civil action as to the content of such proceedings. Nothing in this subdivision shall be construed to preclude in any civil action: (A) The use of any writing recorded independently of such proceedings; (B) the testimony of any person concerning such person's knowledge, acquired independently of such proceedings, about the facts that form the basis for instituting such civil action; (C) arising out of allegations of patient harm caused by health care or pharmacy services rendered by a pharmacist or pharmacy intern who, at the time such services were rendered, had been requested to refrain from practicing such pharmacist's or pharmacy intern's profession or whose practice of such profession was restricted, the disclosure of such request to refrain from practicing or such restriction; or (D) against a pharmacist or pharmacy intern, disclosure of the fact that the pharmacist or pharmacy intern participated in the assistance program, the dates of participation, the reason for participation and confirmation of successful completion of the assistance program, provided a court of competent jurisdiction has determined that good cause exists for such disclosure after (i) notification to such pharmacist or pharmacy intern of the request for such disclosure, and (ii) a hearing concerning such disclosure at the request of any party, and provided further, the court imposes appropriate safeguards against unauthorized disclosure or publication of such information.

(4) Nothing in this subsection shall be construed to prevent the assistance program from disclosing any information in connection with any administrative proceeding related to the imposition of any disciplinary action against any pharmacist or pharmacy intern whom the assistance program refers to the Department of Consumer Protection pursuant to subdivision (2) of subsection (c) of this section, subdivision (2) of subsection (d) of this section, subsection (e) of this section or subparagraph (A) of subdivision (3) of subsection (e) of section 19a-12b.

(i) (1) The assistance program shall report annually to the appropriate professional licensing or registering board or commission or, in the absence of such board or commission, to the Department of Consumer Protection: (A) On the number of pharmacists and pharmacy interns participating in the assistance program who are under the jurisdiction of such board or commission or, in the absence of such board or commission, the Department of Consumer Protection; (B) the purposes for participating in the assistance program; and (C) whether participants are practicing their profession with skill and safety, and without posing a threat to the health and safety of any person or patient, in the health care or pharmacy setting.

(2) On or before December thirty-first, annually, the assistance program shall report the information described in subdivision (1) of this subsection to the joint standing committee of the General Assembly having cognizance of matters relating to general law, in accordance with the provisions of section 11-4a.

(j) (1) If the Department of Public Health notifies the Department of Consumer Protection that the Department of Public Health has waived the annual audit requirement established in subsection (l) of section 19a-12a, the Department of Consumer Protection may require an audit of the assistance program for the year that is the subject of such waiver for the purposes of examining the quality control of such program and ensuring compliance with the requirements established in this section. Each audit conducted pursuant to this subsection shall: (A) Be conducted on the premises of the assistance program by an auditor (i) who has been selected by the assistance program, and (ii) whom the assistance program and the Department of Consumer Protection have jointly determined is qualified to conduct such audit; and (B) consist of a random sampling of at least twenty per cent of the assistance program's files for pharmacists and pharmacy interns or ten such files, whichever is greater.

(2) Prior to conducting an audit pursuant to this subsection, the auditor shall agree, in writing: (A) Not to copy any of the assistance program's files or records; (B) not to remove any of the assistance program's files or records from the premises of such program; (C) to destroy all personally identifying information about pharmacists and pharmacy interns participating in the assistance program upon completion of the audit; (D) not to disclose any personally identifying information about any pharmacist or pharmacy intern participating in the assistance program to any person or entity other than a person employed by the assistance program who is authorized by such program to receive such disclosure; and (E) not to disclose in any audit report any personally identifying information about any pharmacist or pharmacy intern participating in the assistance program.

(3) Upon completion of an audit conducted pursuant to this subsection, the auditor shall submit a written audit report to the assistance program, the Department of Consumer Protection, the Professional Assistance Oversight Committee established under section 19a-12b, and the joint standing committee of the General Assembly having cognizance of matters relating to general law, in accordance with the provisions of section 11-4a.

(P.A. 23-204, S. 252.)

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Sec. 20-638b. Petition re inability of pharmacist or pharmacy intern to practice with reasonable skill or safety. Report re arrest or disciplinary action. Investigation. Disclosure. Procedure. (a)(1) Any health care professional, hospital, pharmacy, pharmacist or pharmacy intern shall, and any other person may, file a petition with the Department of Consumer Protection when such health care professional, hospital, pharmacy, pharmacist, pharmacy intern or other person has any information that appears to show that a pharmacist or pharmacy intern is, or may be, unable to practice such pharmacist's or pharmacy intern's profession with reasonable skill or safety for any of the following reasons: (A) Physical illness or loss of motor skill, including, but not limited to, deterioration through the aging process; (B) emotional disorder or mental illness; (C) abuse or excessive use of drugs, including, but not limited to, alcohol, narcotics or other chemicals; (D) illegal, incompetent or negligent conduct in the practice of such pharmacist's or pharmacy intern's profession; (E) possession, use, prescription for use or distribution of controlled substances or legend drugs, except for therapeutic or other medically proper purposes; (F) misrepresentation or concealment of a material fact in obtaining or reinstating a license or registration to practice such pharmacist's or pharmacy intern's profession; or (G) violation of any provision of this chapter or any regulation adopted under this chapter.

(2) A health care professional, hospital, pharmacy, pharmacist or pharmacy intern shall, and any other person may, file a petition described in subdivision (1) of this subsection not later than thirty days after obtaining the information to support such petition. Each petition shall be filed with the Department of Consumer Protection in a form and manner prescribed by the Commissioner of Consumer Protection.

(b) Any health care professional, hospital, pharmacy, pharmacist or pharmacy intern that refers a pharmacist or pharmacy intern to the assistance program for intervention shall be deemed to have satisfied the obligations imposed on such health care professional, hospital, pharmacy, pharmacist or pharmacy intern under subsection (a) of this section with respect to the pharmacist's or pharmacy intern's inability to practice such pharmacist's or pharmacy intern's profession with reasonable skill or safety due to chemical dependency, emotional or behavioral disorder or physical or mental illness.

(c) Any pharmacist or pharmacy intern who has been the subject of an arrest arising out of an allegation of the possession, use, prescription for use or distribution of alcohol, a controlled substance or a legend drug shall, not later than thirty days after such arrest, send notice to the Department of Consumer Protection, in a form and manner prescribed by the Commissioner of Consumer Protection, disclosing such arrest. Such pharmacist or pharmacy intern shall be deemed to have satisfied such notice requirement if such pharmacist or pharmacy intern seeks intervention with the assistance program during such thirty-day period.

(d) If a duly authorized professional disciplinary agency of any state, the District of Columbia, a United States possession or territory or a foreign jurisdiction takes any disciplinary action against a pharmacist or pharmacy intern that is similar in nature to any action specified in section 20-579, the pharmacist or pharmacy intern shall report such disciplinary action to the Department of Consumer Protection not later than thirty days after such agency takes such action. Any failure to report in accordance with the provisions of this subsection may constitute grounds for disciplinary action under this chapter.

(e) No health care professional, hospital, pharmacy, pharmacist, pharmacy intern or other person who files a petition pursuant to subsection (a) of this section, or provides any information to the Department of Consumer Protection or the assistance program, shall, without a showing of malice, be liable for damage or injury to the pharmacist or pharmacy intern for filing such petition or providing such information. The assistance program shall not be liable for damage or injury to the pharmacist or pharmacy intern without a showing of malice.

(f) The Department of Consumer Protection shall investigate each petition filed pursuant to subsection (a) of this section, in accordance with the provisions of section 21a-11, to determine if probable cause exists to issue a statement of charges and institute proceedings against the pharmacist or pharmacy intern under subsection (i) of this section.

(g) As part of an investigation of a petition filed pursuant to subsection (a) of this section, the Department of Consumer Protection may order the pharmacist or pharmacy intern to submit to a physical or mental examination to be performed by a physician or an advanced practice registered nurse chosen from a list approved by the department. The Department of Consumer Protection may seek the advice of established medical organizations or health care professionals in determining the nature and scope of any diagnostic examinations to be used as part of any such physical or mental examination. The chosen physician or advanced practice registered nurse shall make a written statement of such physician's or advanced practice registered nurse's findings.

(h) If the pharmacist or pharmacy intern fails to obey the Department of Consumer Protection's order to submit to an examination or attend a hearing, the department may petition the superior court for the judicial district of Hartford to order such examination or attendance and said court, or any judge assigned to said court, shall have jurisdiction to issue such order.

(i) Subject to the provisions of section 4-182, the Department of Consumer Protection shall not restrict, suspend or revoke any license or registration, or limit a pharmacist's or pharmacy intern's right to practice the pharmacist's or pharmacy intern's profession, until the pharmacist or pharmacy intern has been given notice and opportunity for hearing in accordance with said section.

(P.A. 23-204, S. 253.)

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Sec. 20-638c. Pharmacy professional assistance program account. There is established an account to be known as the “pharmacy professional assistance program account” which shall be a separate, nonlapsing account within the General Fund. The account shall contain any moneys required by law to be deposited in the account. Moneys in the account shall be paid by the Commissioner of Consumer Protection to the assistance program for the provision of education, prevention, intervention, referral assistance, rehabilitation and support services to pharmacists and pharmacy interns who have a chemical dependency, an emotional or behavioral disorder or a physical or mental illness.

(P.A. 23-204, S. 254.)

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