subpart_subject: "Disposal of Controlled Substances Collected From Ultimate Users and Other Non-Registrants"
section_number: "1317.40"
section_subject: "Registrants authorized to collect and authorized collection activities."
cfr_reference: "21 CFR 1317.40"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Part 1300 to End"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(a)Manufacturers, distributors, reverse distributors, narcotic treatment programs, hospitals/clinics with an on-site pharmacy, and retail pharmacies that desire to be collectors shall modify their registration to obtain authorization to be a collector in accordance with § 1301.51 of this chapter. Authorization to be a collector is subject to renewal. If a registrant that is authorized to collect ceases activities as a collector, such registrant shall notify the Administration in accordance with § 1301.52(f) of this chapter.
(b)Collection by registrants shall occur only at the following locations:
(1)Those registered locations of manufacturers, distributors, reverse distributors, narcotic treatment programs, hospitals/clinics with an on-site pharmacy, and retail pharmacies that are authorized for collection; and
(2)Long-term care facilities at which registered hospitals/clinics or retail pharmacies are authorized to maintain collection receptacles.
(c)Collectors may conduct the following activities:
(1)Receive and destroy mail-back packages pursuant to § 1317.70 at an authorized registered location that has an on-site method of destruction;
(2)Install, manage, and maintain collection receptacles located at their authorized collection location(s) pursuant to §§ 1317.75 and 1317.80; and
(3)Promptly dispose of sealed inner liners and their contents as provided for in § 1317.05(c)(2).