21 CFR § 1305.03 - Distributions requiring a Form 222 or a digitally signed electronic order.

---
identifier: "/us/cfr/t21/s1305.03"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 1305.03 - Distributions requiring a Form 222 or a digitally signed electronic order."
title_number: 21
title_name: "Food and Drugs"
section_number: "1305.03"
section_name: "Distributions requiring a Form 222 or a digitally signed electronic order."
chapter_name: "DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE"
part_number: "1305"
part_name: "ORDERS FOR SCHEDULE I AND II CONTROLLED SUBSTANCES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 821, 828, 871(b), unless otherwise noted."
regulatory_source: "70 FR 16911, Apr. 1, 2005, unless otherwise noted."
cfr_part: "1305"
---


# 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.

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