21 C.F.R. § 1305.03

Current through November 30, 2024
Section 1305.03 - Distributions requiring a Form 222 or a digitally signed electronic order

Either a DEA Form 222 or its electronic equivalent as set forth in subpart C of this part and Part 1311 of this chapter is required for each distribution of a Schedule I or II controlled substance except for the following:

(a) Distributions to persons exempted from registration under Part 1301 of this chapter.
(b) Exports from the United States that conform with the requirements of the Act.
(c) Deliveries to a registered analytical laboratory or its agent approved by DEA.
(d) Delivery from a central fill pharmacy, as defined in § 1300.01 of this chapter, to a retail pharmacy.
(e) Deliveries to an authorized DEA registrant by an ultimate user, a long-term care facility on behalf of an ultimate user who resides or has resided at that facility, or a person authorized to dispose of the ultimate user decedent's property.
(f) Distributions to reverse distributors and distributors by collectors and law enforcement pursuant to § 1317.55 of this chapter.
(g) Deliveries of controlled substances from ultimate users for the purpose of recalls pursuant to § 1317.85 of this chapter.

21 C.F.R. §1305.03

70 FR 16911 , Apr. 1, 2005, as amended at 77 FR 4235 , Jan. 27, 2012; 79 FR 53564 , Sept. 9, 2014