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§1317.40. Registrants authorized to collect and authorized collection activities.

21 C.F.R. § 1317.40

(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).
Notes, amendments, and revision history

Authority

Authority: 21 U.S.C. 821, 822, 823, 827, 828, 871(b), and 958.

Source

Source: 79 FR 53565, Sept. 9, 2014, unless otherwise noted.