1. (a) A pharmacy may operate a collection receptacle if the pharmacy:

   1. (1) meets the requirements specified in 21 CFR 1307 and 21 CFR 1317;
   2. (2) meets the requirements set forth in sections 20-576a-1 to 20-576a-7, inclusive, of the Regulations of Connecticut State Agencies; and (3) registers with the department as an authorized collector.
2. (b) An authorized collector applicant shall submit an application and all other required documentation on forms prescribed by the commissioner. No certificate of registration shall be issued under this section until the applicant has furnished proof satisfactory to the commissioner that the applicant has adequate facilities to properly carry on the business described in the application and that the applicant conforms to and is in compliance with all applicable federal and state requirements. Registrations shall be renewed annually on or before January 31.
3. (c) Prior to the issuance of a certificate of registration, the commissioner shall perform an initial inspection of the applicant’s premises, collection receptacle and written operating procedures prior to the commencement of collection activities from ultimate users.
4. (d) The commissioner shall have the right to deny an authorized collector a certificate of registration if the commissioner determines that the issuance of such registration is inconsistent with the public interest, or may have a negative impact on public health and safety.
5. (e) An authorized collector shall not participate in a take back event, as defined in 21 CFR 1317.65, within the interior of the same building in which the authorized collector’s collection receptacle is located.
6. (f) An authorized collector shall not participate in a mail back program as outlined in 21 CFR 1317.70, whereby the authorized collector receives drugs returned to it via mail.
7. (g) An authorized collector shall not dispose of its inventory or stock of drugs in the collection receptacle.
8. (h) An authorized collector shall maintain the confidentiality of ultimate users that utilize the collection receptacle.
9. (i) No employees, including authorized employees, of an authorized collector shall handle, count, sort, or inventory any drugs brought by ultimate users for deposit in the collection receptacle.
10. (j) Authorized collectors shall permit the commissioner to enter and inspect their premises and collection receptacles, and to audit their records and written operating procedures, at reasonable times and in a reasonable manner.

11. (k) All records required by sections 20-576a-1 to 20-576a-7, inclusive, of the Regulations of Connecticut State Agencies shall be kept on the premises of the registrant and maintained current and separate from other business records in such form as to be readily available for inspection and copying by the commissioner at reasonable times. The records shall be maintained by the authorized collector for a period of three years.

    (l) Any authorized collector that intends to discontinue its use of a collection receptacle shall notify the director of the Drug Control Division in writing 30 days prior to discontinuing collection activities. Upon the termination of operation, the authorized collector shall dispose of the inner liner and rigid container by following the procedure for disposal of inner liners and rigid containers outlined in section 20-576a-5 of the Regulations of Connecticut State Agencies, and remove the collection receptacle from the prescription department area.

(Effective July 8, 2019)