Sec. 20-624. Permit to sell nonlegend drugs.
Sec. 20-627. Nonresident pharmacy. Definitions. Certificate of registration. Requirements.
Sec. 20-638c. Pharmacy professional assistance program account.
Sec. 20-579a. Adverse license, permit or registration eligibility action based on provision of reproductive health care services or gender-affirming health care services prohibited. (a) As used in this section, “reproductive health care services” and “gender-affirming health care services” have the same meanings 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 or gender-affirming 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 or gender-affirming 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; P.A. 25-168, S. 281.)
History: P.A. 23-128 effective June 27, 2023; P.A. 25-168 added references to gender-affirming health care services throughout and made technical changes, effective July 1, 2025.
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Sec. 20-623. Sale of nonlegend drugs, nonlegend devices and test strips. Labels, packaging, contents and vending machines. Exception re nonlegend naloxone distributed through secure box. 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 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) Notwithstanding the provisions of this section, no person who solely distributes nonlegend naloxone to the public through a secure box, without compensation or consideration, shall be required to obtain a permit to sell nonlegend drugs pursuant to section 20-624, provided the secure box satisfies the requirements established in section 21a-286. As used in this subsection, “secure box” has the same meaning as provided in section 21a-286.
(d) 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; P.A. 25-171, S. 3.)
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; P.A. 25-171 amended Subsec. (a) by deleting reference to commission, added new Subsec. (c) re persons who solely distribute nonlegend naloxone to public through secure box and redesignated existing Subsec. (c) as Subsec. (d), effective July 8, 2025.
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Sec. 20-624. Permit to sell nonlegend drugs. (a) Any person may apply to the department, in a form and manner prescribed by the commissioner, for a permit to sell nonlegend drugs.
(b) (1) The department may, in accordance with regulations adopted under sections 20-570 to 20-630, inclusive, in accordance with chapter 54, and on payment of the fee required in section 20-601, issue to an applicant a permit to sell nonlegend drugs for one year.
(2) Notwithstanding subdivision (1) of this subsection, an applicant for a permit to sell nonlegend drugs shall not be required to pay any permit application or renewal fee required in section 20-601 if, as part of the applicant's application, the applicant attests that the applicant shall utilize such permit solely to distribute nonlegend drugs without compensation or consideration.
(c) A permit that has expired under this section may be renewed, on application and payment of the renewal fee and any late fee required in section 20-601 or 21a-4.
(d) The holder of a permit to sell nonlegend drugs shall electronically submit to the department, in a form and manner prescribed by the commissioner, notification of a change of ownership, name or location of the permanent physical location. Any holder who fails to notify the department of such change within five days of the change shall pay the late fee required in section 20-601.
(P.A. 95-264, S. 43; P.A. 99-175, S. 42; P.A. 25-171, S. 4.)
History: P.A. 99-175 amended Subsec. (b) to replace reference to Sec. 20-625 with reference to Sec. 20-630 and add provision requiring adoption of regulations to be consistent with chapter 54 and added new Subsec. (e) to specify that nonlegend drug permits issued by commission are nontransferable; P.A. 25-171 amended Subsec. (a) by adding provision re application be in form and manner prescribed by commissioner, amended Subsec. (b) by designating existing provisions as Subdiv. (1) and adding Subdiv. (2) re fee exception for distribution of nonlegend drugs without compensation or consideration, amended Subsec. (c) by adding reference to Sec. 21a-4, amended Subsec. (d) by providing for electronic submission of notification, replacing “permit premises” with “permanent physical location”, deleted former Subsec. (e) re nontransferability of permit, and replaced “commission” with “department” throughout, effective July 8, 2025.
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Sec. 20-627. Nonresident pharmacy. Definitions. Certificate of registration. Requirements. (a) As used in sections 20-627 to 20-630, inclusive, “nonresident pharmacy” means any pharmacy located outside this state that ships, mails or delivers, in any manner, legend devices or legend drugs into this state pursuant to a prescription order.
(b) A nonresident pharmacy shall be registered with the department, upon approval of the commission, and shall:
(1) Disclose annually in a report to the commission the location, names and titles of all principal corporate officers, if applicable, and all pharmacists who are dispensing drugs or devices to residents of this state;
(2) File a report within ten days after any change of name, ownership, management, officers or directors. Such report shall be accompanied by the filing fee set forth in section 20-601. Any nonresident pharmacy that fails to give notice as required pursuant to this subdivision within ten days after the change shall pay the late fee set forth in section 20-601;
(3) Comply with all lawful directions and requests for information from the regulatory or licensing agency of the state in which it is licensed as well as comply with all requests for information made by the commission or department pursuant to this section;
(4) Disclose to the department whether the nonresident pharmacy is dispensing sterile pharmaceuticals, as defined in section 20-633b, within this state. If any such dispensed sterile pharmaceutical is not patient-specific, the nonresident pharmacy shall submit a copy of the manufacturing license or registration issued by the regulatory or licensing agency of the state in which it is licensed, and a copy of any registration issued by the federal Food and Drug Administration to the department;
(5) Maintain at all times, a valid unexpired license, permit or registration to conduct such pharmacy in compliance with the laws of the state in which the nonresident pharmacy is located;
(6) Before receiving a certificate of registration from the department, submit a copy of the most recent inspection report resulting from an inspection conducted by the regulatory or licensing agency of the state in which the nonresident pharmacy is located. If the nonresident pharmacy is delivering sterile compounded products within this state, such inspection report shall include a section based on standards required in the most recent United States Pharmacopeia, Chapter 797, as amended from time to time. If the state in which the nonresident pharmacy is located does not conduct inspections based on standards required in the most recent United States Pharmacopeia, Chapter 797, as amended from time to time, such nonresident pharmacy shall provide proof to the department that it is in compliance with such standards;
(7) Provide a toll-free telephone number to facilitate communication between patients in this state and a pharmacist at such nonresident pharmacy who has access to the patient's records at all times. Such toll-free telephone number shall be disclosed on a label affixed to each container of drugs dispensed to patients in this state;
(8) Notify the department if the nonresident pharmacy has had any disciplinary action or written advisement or warning by any federal or state regulatory agency or any accreditation body not later than ten business days after being notified of such action, advisement or warning; and
(9) Provide to the department the names and addresses of all residents of this state to whom legend devices or legend drugs have been delivered, not later than twenty-four hours after the nonresident pharmacy initiates a recall of any legend devices or legend drugs.
(c) If a nonresident pharmacy that is registered with the department under this section sells, delivers or offers sterile compounded products in this state, such nonresident pharmacy shall submit to the department inspection reports, as provided in section 20-633b, from a government agency or third-party entity with expertise in sterile compounding evidencing that such nonresident pharmacy's program, processes and facilities comply with the standards required in the most recent United States Pharmacopeia, Chapter 797, as amended from time to time.
(P.A. 96-127, S. 1; P.A. 99-175, S. 45; P.A. 14-224, S. 3; P.A. 18-141, S. 11; P.A. 25-101, S. 2.)
History: P.A. 99-175 made technical changes, reordered Subsecs., amended Subsec. (a) to delete reference to Sec. 20-184a and deleted former Subsec. (c); P.A. 14-224 amended Subsec. (b) by adding new Subdiv. (3) re disclosure by nonresident pharmacy, redesignating existing Subdivs. (3) and (4) as Subdivs. (4) and (5), and adding provision re inspection report for nonresident pharmacy delivering sterile compounded products within this state in redesignated Subdiv. (5), redesignated existing Subsec. (c) as Subsec. (b)(6) and amended same to require toll-free telephone number for patients at all times, added Subsec. (b)(7) re notification of disciplinary action or warning, added Subsec. (b)(8) re provision of names and addresses of residents to whom legend devices or legend drugs have been delivered, and made technical changes, effective July 1, 2014; P.A. 18-141 amended Subsec. (b) by designating provision re nonresident pharmacy to file report as Subdiv. (2) and amending same by deleting reference to additional report, replacing “thirty days” with “ten days”, replacing “office, corporate officer or pharmacist” with “name, ownership, management, officers or directors”, adding provisions re filing fee and late fee, redesignating Subdivs. (2) to (8) as Subdivs. (3) to (9), and making technical changes, effective June 11, 2018; P.A. 25-101 added Subsec. (c) re inspection reports for registered nonresident pharmacy that sells, delivers or offers sterile compounded products in state, and made conforming changes in Subsec. (b)(2) and (7), effective January 1, 2026.
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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 submit to the Department of Consumer Protection an inspection report from a government agency with regulatory oversight over such nonresident pharmacy or from a third-party entity with expertise in sterile compounding. Such report shall demonstrate that such nonresident pharmacy is in compliance with the standards required in the most recent United States Pharmacopeia, Chapter 797, as amended from time to time. Such nonresident pharmacy shall submit to the department a copy of the most recent inspection report with such nonresident pharmacy's initial nonresident pharmacy application, which inspection report shall be dated by the inspector and evidence that the inspection was performed during the six-month period immediately preceding the submission date of such initial application. Not later than June thirtieth of each even-numbered calendar year following such initial application, such nonresident pharmacy shall submit to the department a new inspection report demonstrating that such nonresident pharmacy remains in compliance with the standards required in the most recent United States Pharmacopeia, Chapter 797, as amended from time to time, which inspection report shall be dated by the inspector and indicate that the inspection was performed not earlier than January first of such even-numbered calendar year. Notwithstanding the provisions of this subsection, a sterile compounding pharmacy that is a nonresident pharmacy shall not be required to submit more than one inspection report during the calendar year after the nonresident pharmacy is issued an initial registration.
(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; P.A. 25-101, S. 3.)
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; P.A. 25-101 substantially amended Subsec. (j) including by requiring submission of inspection report from government agency or third party with expertise in sterile compounding, effective January 1, 2026.
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Sec. 20-633d. Medical protocol standing order for dispensing of opioid antagonists by licensed pharmacists. Regulations. (a) A prescribing practitioner, as defined in section 20-14c, who is authorized to prescribe an opioid antagonist, as defined in section 17a-714a, and a pharmacy may enter into an agreement for a medical protocol standing order at such pharmacy allowing a pharmacist licensed under part II of this chapter to dispense an opioid antagonist that is (1) administered by an intranasal application delivery system or an auto-injection delivery system, (2) approved by the federal Food and Drug Administration, and (3) dispensed to any person at risk of experiencing an overdose of an opioid drug, as defined in section 20-14o, or to a family member, friend or other person in a position to assist a person at risk of experiencing an overdose of an opioid drug.
(b) Any such medical protocol standing order shall be deemed issued for a legitimate medical purpose in the usual course of the prescribing practitioner's professional practice. The pharmacy shall provide the Department of Consumer Protection with a copy of every medical protocol standing order agreement entered into with a prescribing practitioner under this section.
(c) A pharmacist may only dispense an opioid antagonist pursuant to a medical protocol standing order if the pharmacist has been trained and certified as part of a program approved by the Commissioner of Consumer Protection.
(d) A pharmacist who dispenses an opioid antagonist pursuant to a medical protocol standing order shall (1) provide appropriate training regarding the administration of such opioid antagonist to the person to whom the opioid antagonist is dispensed, (2) maintain a record of such dispensing and the training required pursuant to this chapter, and (3) send a copy of the record of such dispensing to the prescribing practitioner who entered into an agreement for a medical protocol standing order with the pharmacy.
(e) A pharmacist who dispenses an opioid antagonist in accordance with the provisions of this section shall be deemed not to have violated any standard of care for a pharmacist.
(f) The commissioner may adopt regulations, in accordance with chapter 54, to implement the provisions of this section.
(P.A. 17-131, S. 12; P.A. 25-101, S. 26; 25-168, S. 120.)
History: P.A. 25-101 replaced reference to 42 CFR 8.2 with reference to Sec. 20-14o, effective June 24, 2025; P.A. 25-168 made an identical change as P.A. 25-101, effective June 30, 2025.
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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. 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; P.A. 25-110, S. 74.)
History: P.A. 25-110 deleted reference to General Fund and made a technical change, effective July 1, 2025.
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