21 CFR 1317.15 – Reverse distributor registration requirements and authorized activities
(a) Any person that reverse distributes a controlled substance shall be registered with the Administration as a reverse distributor, unless exempted by law or otherwise authorized pursuant to this chapter.
Terms Used In 21 CFR 1317.15
- Contract: A legal written agreement that becomes binding when signed.
(b) A reverse distributor shall acquire controlled substances from a registrant pursuant to §§ 1317.05 and 1317.55(a) and (c) in the following manner:
(1) Pick-up controlled substances from a registrant at the registrant’s registered location or authorized collection site; or
(2) Receive controlled substances delivered by common or contract carrier or delivered directly by a non-practitioner registrant.
(i) Delivery to the reverse distributor by an authorized registrant directly or by common or contract carrier may only be made to the reverse distributor at the reverse distributor’s registered location. Once en route, such deliveries may not be re-routed to any other location or person, regardless of registration status.
(ii) All controlled substance deliveries to a reverse distributor shall be personally received by an employee of the reverse distributor at the registered location.
(c) Upon acquisition of a controlled substance by delivery or pick-up, a reverse distributor shall:
(1) Immediately store the controlled substance, in accordance with the security controls in parts 1301 and 1317 of this chapter, at the reverse distributor’s registered location or immediately transfer the controlled substance to the reverse distributor’s registered location for secure storage, in accordance with the security controls in parts 1301 and 1317 of this chapter, until timely destruction or prompt return of the controlled substance to the registered manufacturer or other registrant authorized by the manufacturer to accept returns or recalls on the manufacturer’s behalf;
(2) Promptly deliver the controlled substance to the manufacturer or another registrant authorized by the manufacturer to accept returns or recalls on the manufacturer’s behalf; or
(3) Timely destroy the controlled substance in a manner authorized in subpart C of this part.
(d) A reverse distributor shall destroy or cause the destruction of any controlled substance received for the purpose of destruction no later than 30 calendar days after receipt.