2023 Connecticut General Statutes › Title 20 - Professional and Occupational Licensing, Certification, Title Protection and Registration. Examining Boards › Chapter 400j - Pharmacy › Section 20-633b. - Sterile compounding pharmacies. Requirements. Regulations.

(a) As used in this section:
(1) “Medical order” means a written, oral or electronic order by a prescribing practitioner, as defined in section 20-14c, for a drug to be dispensed by a pharmacy for administration to a patient;
(2) “Sterile compounding pharmacy” means a pharmacy, as defined in section 20-571, a nonresident pharmacy registered pursuant to section 20-627, that dispenses or compounds sterile pharmaceuticals;
(3) “Sterile pharmaceutical” means any dosage form of a drug, including, but not limited to, parenterals, injectables, surgical irrigants and ophthalmics devoid of viable microorganisms; and
(4) “USP chapters” means chapters 797, 800 and 825 of the United States Pharmacopeia that pertain to compounding sterile pharmaceuticals and their referenced companion documents, as amended from time to time.
(b) (1) If an applicant for a new pharmacy license pursuant to section 20-594 intends to compound sterile pharmaceuticals, the applicant shall file an addendum to its pharmacy license application to include sterile pharmaceutical compounding. The Department of Consumer Protection shall inspect the proposed pharmacy premises of the applicant and the applicant shall not compound sterile pharmaceuticals until it receives notice that the addendum application has been approved by the department and the Commission of Pharmacy.
(2) If an existing pharmacy licensed pursuant to section 20-594 intends to compound sterile pharmaceuticals for the first time on or after July 1, 2014, such pharmacy shall file an addendum application to its application on file with the department to include sterile pharmaceutical compounding. The Department of Consumer Protection shall inspect the pharmacy premises and the pharmacy shall not compound sterile pharmaceuticals until it receives notice that such addendum application has been approved by the department and the Commission of Pharmacy.
(3) If an applicant for a nonresident pharmacy registration intends to compound sterile pharmaceuticals for sale or delivery in this state, the applicant shall file an addendum to its application to include sterile pharmaceutical compounding. The applicant shall provide the department with written proof it has passed inspection by the appropriate state agency in the state where such nonresident pharmacy is located. Such pharmacy shall not compound sterile pharmaceuticals for sale or delivery in this state until it receives notice that the addendum application has been approved by the department and the Commission of Pharmacy.
(4) If a nonresident pharmacy registered pursuant to section 20-627 intends to compound sterile pharmaceuticals for sale or delivery in this state for the first time on or after July 1, 2014, the nonresident pharmacy shall file an addendum to its application to include sterile pharmaceutical compounding. The nonresident pharmacy shall provide the department with written proof it has passed inspection by the appropriate state agency in the state where such nonresident pharmacy is located. Such pharmacy shall not compound sterile pharmaceuticals until it receives notice that the addendum application has been approved by the department and the Commission of Pharmacy.
(c) A sterile compounding pharmacy shall comply with the USP chapters. A sterile compounding pharmacy shall also comply with all applicable federal and state statutes and regulations.
(d) An institutional pharmacy within a facility licensed pursuant to section 19a-490 that compounds sterile pharmaceuticals shall comply with the USP chapters, and shall also comply with all applicable federal and state statutes and regulations. Such institutional pharmacy may request from the Commissioner of Consumer Protection an extension of time, not to exceed six months, to comply, for state enforcement purposes, with any amendments to USP chapters, for good cause shown. The commissioner may grant an extension for a length of time not to exceed six months. Nothing in this section shall prevent such institutional pharmacy from requesting a subsequent extension of time or shall prevent the commissioner from granting such extension.
(e) (1) A sterile compounding pharmacy may only provide patient-specific sterile pharmaceuticals to patients, practitioners of medicine, osteopathy, podiatry, dentistry or veterinary medicine, or to an acute care or long-term care hospital or health care facility licensed by the Department of Public Health.
(2) If a sterile compounding pharmacy provides sterile pharmaceuticals without a patient-specific prescription or medical order, the sterile compounding pharmacy shall also obtain a certificate of registration from the Department of Consumer Protection pursuant to section 21a-70 and any required federal license or registration. A sterile compounding pharmacy may prepare and maintain on-site inventory of sterile pharmaceuticals no greater than a thirty-day supply, calculated from the completion of compounding, which thirty-day period shall include the period required for third-party analytical testing, to be performed in accordance with the USP chapters.
(f) (1) If a sterile compounding pharmacy plans to remodel any area utilized for the compounding of sterile pharmaceuticals or adjacent space, relocate any space utilized for the compounding of sterile pharmaceuticals or upgrade or conduct a nonemergency repair to the heating, ventilation, air conditioning or primary or secondary engineering controls for any space utilized for the compounding of sterile pharmaceuticals, the sterile compounding pharmacy shall notify the Department of Consumer Protection, in writing, not later than forty-five days prior to commencing such remodel, relocation, upgrade or repair. Such written notification shall include a plan for such remodel, relocation, upgrade or repair and such plan shall be subject to department review and approval. If a sterile compounding pharmacy makes an emergency repair, the sterile compounding pharmacy shall notify the department of such emergency repair, in writing, not later than twenty-four hours after such repair is commenced.
(2) If the USP chapters require sterile recertification after such remodel, relocation, upgrade or repair, the sterile compounding pharmacy shall provide a copy of its sterile recertification to the Department of Consumer Protection not later than five days after the sterile recertification approval. The recertification shall only be performed by an independent licensed environmental monitoring entity.
(g) A sterile compounding pharmacy shall report, in writing, to the Department of Consumer Protection any known violation or noncompliance with viable and nonviable environmental sampling testing, as defined in the USP chapters, not later than the end of the next business day after discovering such violation or noncompliance.
(h) (1) If a sterile compounding pharmacy initiates a recall of sterile pharmaceuticals that were dispensed pursuant to a patient-specific prescription or medical order, the sterile compounding pharmacy shall notify each patient or patient care giver, the prescribing practitioner and the Department of Consumer Protection of such recall not later than twenty-four hours after such recall was initiated.
(2) If a sterile compounding pharmacy initiates a recall of sterile pharmaceuticals that were not dispensed pursuant to a patient-specific prescription or a medical order, the sterile compounding pharmacy shall notify: (A) Each purchaser of such sterile pharmaceuticals, to the extent such sterile compounding pharmacy possesses contact information for each such purchaser, (B) the Department of Consumer Protection, and (C) the federal Food and Drug Administration of such recall not later than the end of the next business day after such recall was initiated.
(i) Each sterile compounding pharmacy and each institutional pharmacy within a facility licensed pursuant to section 19a-490 shall prepare and maintain a policy and procedure manual. The policy and procedure manual shall comply with the USP chapters.
(j) Each sterile compounding pharmacy shall report to the Department of Consumer Protection any administrative or legal action commenced against it by any state or federal regulatory agency or accreditation entity not later than five business days after receiving notice of the commencement of such action.
(k) Notwithstanding the provisions of subdivisions (3) and (4) of subsection (b) of this section, a sterile compounding pharmacy that is a nonresident pharmacy shall provide the Department of Consumer Protection proof that it has passed an inspection in such nonresident pharmacy's home state, based on the USP chapters. Such nonresident pharmacy shall submit to the Department of Consumer Protection a copy of the most recent inspection report with its initial nonresident pharmacy application and shall submit to the department a copy of its most recent inspection report every two years thereafter. If the state in which the nonresident pharmacy is located does not conduct inspections based on standards required in the USP chapters, such nonresident pharmacy shall provide satisfactory proof to the department that it is in compliance with the standards required in the USP chapters.
(l) A practitioner, as specified in subdivision (1) of subsection (e) of this section, a hospital or a health care facility that receives sterile pharmaceuticals shall report any errors related to such dispensing or any suspected adulterated sterile pharmaceuticals to the Department of Consumer Protection.
(m) (1) For purposes of this subsection, a “designated pharmacist” means a pharmacist responsible for overseeing the compounding of sterile pharmaceuticals and the application of the USP chapters, as said chapters pertain to sterile compounding.
(2) Any pharmacy licensed pursuant to section 20-594 or institutional pharmacy licensed pursuant to section 19a-490 that provides sterile pharmaceuticals shall notify the department of its designated pharmacist.
(3) The designated pharmacist shall be responsible for providing proof he or she has completed a program approved by the commissioner that demonstrates the competence necessary for the compounding of sterile pharmaceuticals, in compliance with all applicable federal and state statutes and regulations.
(4) The designated pharmacist shall immediately notify the department whenever he or she ceases such designation.
(5) Nothing in this section shall prevent a designated pharmacist from being the pharmacy manager.
(n) The Commissioner of Consumer Protection may adopt regulations, in accordance with chapter 54, to implement the provisions of this section.
(P.A. 14-224, S. 2; P.A. 17-77, S. 14; P.A. 18-16, S. 6; P.A. 19-177, S. 28; P.A. 21-37, S. 46.)
History: P.A. 14-224 effective July 1, 2014; P.A. 17-77 amended Subsec. (a)(2) by replacing “section 20-594, or” with “section 20-571,”, effective July 1, 2017; P.A. 18-16 amended Subsec. (c) by replacing “most recent United States Pharmacopeia, Chapter 797,” with “most recent version of the United States Pharmacopeia,”, effective January 1, 2019; P.A. 19-177 amended Subsec. (a) by adding Subdiv. (4) defining USP chapters, amended Subsec. (c) by replacing “most recent version of the United States Pharmacopeia, Pharmaceutical Compounding - Sterile Preparations, as amended from time to time” with “USP chapters”, replaced “Chapter 797” with “USP chapters” in Subsec. (d), amended Subsec. (f) by adding “, in writing,” re notice to Department of Consumer Protection and replacing “United States Pharmacopeia, Chapter 797, Pharmaceutical Compounding - Sterile Preparations, as amended from time to time” with “USP chapters”, replaced “most recent United States Pharmacopeia, Chapter 797, Pharmaceutical Compounding - Sterile Preparations, as amended from time to time” with “USP chapters” in Subsecs. (d),(e)(2), (g), (i) and (k), replaced “most recent United States Pharmacopeia, Chapter 797, Pharmaceutical Compounding - Sterile Preparations compliance standards, as amended from time to time” with “USP chapters” in Subsec. (k), added Subsec. (m) re designated pharmacist and redesignated existing Subsec. (m) as Subsec. (n), and made technical changes, effective January 1, 2020; P.A. 21-37 amended Subsec. (f) by changing references from pharmacy clean room within the facility to any area utilized for compounding of sterile pharmaceuticals, adding reference to secondary engineering controls, changing 10 to 45 days re notification timeframe, adding provision re plan for remodel, relocation, upgrade or repair, making technical changes and changing “as soon as possible” to not later than 24 hours, effective June 4, 2021.