21 CFR 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:
Terms Used In 21 CFR 1305.03
- Decedent: A deceased person.
(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.