2015 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 20-594, or a nonresident pharmacy registered pursuant to section 20-627, that dispenses or compounds sterile pharmaceuticals; and

(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.

(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 most recent United States Pharmacopeia, Chapter 797, Pharmaceutical Compounding - Sterile Preparations, as amended from time to time. 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 most recent United States Pharmacopeia, Chapter 797, Pharmaceutical Compounding - Sterile Preparations, as amended from time to time, 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 Chapter 797, for good cause shown. The commissioner may grant an extension for a length of time not to exceed six months. Nothing herein 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 most recent United States Pharmacopeia, Chapter 797, Pharmaceutical Compounding - Sterile Preparations, as amended from time to time.

(f) (1) If a sterile compounding pharmacy plans to remodel a pharmacy clean room within the sterile compounding facility, relocate a pharmacy clean room within the facility or upgrade or conduct a nonemergency repair to the heating, ventilation, air conditioning or primary engineering controls for a pharmacy clean room within the facility, the sterile compounding pharmacy shall notify the Department of Consumer Protection not later than ten days prior to commencing such remodel, relocation, upgrade or repair. If a sterile compounding pharmacy makes an emergency repair, the sterile compounding pharmacy shall notify the department of such repair, in writing, as soon as possible after such repair is commenced.

(2) If the United States Pharmacopeia, Chapter 797, Pharmaceutical Compounding - Sterile Preparations, as amended from time to time, requires 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 most recent United States Pharmacopeia, Chapter 797, Pharmaceutical Compounding - Sterile Preparations, as amended from time to time, 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 most recent United States Pharmacopeia, Chapter 797, Pharmaceutical Compounding - Sterile Preparations, as amended from time to time.

(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 most recent United States Pharmacopeia, Chapter 797, Pharmaceutical Compounding - Sterile Preparations compliance standards, as amended from time to time. 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 most recent United States Pharmacopeia, Chapter 797, Pharmaceutical Compounding, as amended from time to time, such nonresident pharmacy shall provide satisfactory proof to the department that it is in compliance with the standards required in the most recent United States Pharmacopeia, Chapter 797, Pharmaceutical Compounding as amended from time to time.

(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) 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.)

History: P.A. 14-224 effective July 1, 2014.