Conn. Agencies Regs. § 20-576a-5

Current through October 16, 2024
Section 20-576a-5 - Disposal
(a) To dispose of inner liners and rigid containers:
(1) the reverse distributor shall be present and ready to receive the inner liner;
(2) two authorized employees shall be present and performing the removal and replacement of the rigid container and inner liner, and one such authorized employee shall be a Connecticut licensed pharmacist;
(3) the rigid container, including the inner liner, shall be removed from the collection receptacle together and the inner liner shall be immediately sealed and replaced with a new rigid container and inner liner;
(4) the rigid container shall then be sealed at all openings with tamper evident tape and display the unique identification number of the inner liner contained therein;
(5) the rigid container shall not have any outer markings that would indicate the nature of its contents;
(6) the authorized employees present during the disposal shall record all required information and perform all actions necessary to record log entries pursuant to this section;
(7) the authorized employees shall provide the sealed rigid container that contains the sealed inner liner to a registered reverse distributor for destruction, who shall sign the authorized collector's log book; and
(8) the entire process shall be monitored and recorded by video camera, pursuant to section 20-576a-3 of the Regulations of Connecticut State Agencies.
(b) An authorized employee shall record the following information for each transaction in record logs:
(1) the date that the new inner liner and rigid container were placed in the collection receptacle;
(2) the inner liner unique identification number;
(3) the date that the numbered inner liner and rigid container was taken and sealed from the collection receptacle and provided to the reverse distributor;
(4) the names and signatures of the two authorized employees who witnessed and performed both the removal and replacement of the inner liner and rigid container; and (5) the name, registration number, and address of the reverse distributor. Inner liner and rigid container record logs shall be maintained by the authorized collector for three years and shall be made available for inspection upon request by the department.
(c) No materials deposited in the collection receptacle and captured in the inner liner shall be removed, counted, sorted or otherwise handled.
(d) Upon placing a new inner liner and rigid container into a collection receptacle, the inner liner is presumed to contain prescription medications, including controlled substances and legend and non-legend drugs and shall be disposed of in accordance with 21 CFR 1317 and sections 20-576a-1 to 20-576a-7, inclusive, of the Regulations of Connecticut State Agencies. Inner liners and rigid containers shall not be reused in a collection receptacle.
(e) No on-site destruction of any rigid container, inner liner or its contents shall be permitted by the authorized collector or at such collector's premises.
(f) The reverse distributor may designate a third-party logistics provider to serve as an authorized representative of the reverse distributor.
(g) Law enforcement authorities may, pursuant to an agreement with an authorized collector, accept delivery of the sealed rigid container that contains the sealed inner liner in the same manner as a reverse distributor as set forth in sections 20-576a-1 to 20-576a-7, inclusive, of the Regulations of Connecticut State Agencies, provided law enforcement authorities shall not be required to register with the department as a reverse distributor. Law enforcement authorities may destroy the sealed inner liner and rigid container pursuant to their department procedures and policies. Law enforcement authorities shall not be required by this section to participate in the collection and disposal of returned drugs to pharmacies.

Conn. Agencies Regs. § 20-576a-5

Adopted 7/8/2019