21 C.F.R. § 1305.03

Distributions requiring a Form 222 or a digitally signed electronic order

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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.

(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]

Notes of Decisions

Cited in 3 cases, 1980–2019 · leading case: Williamson v. Dist. of Columbia Bd. of Dentistry, 647 A.2d 389 (D.C. 1994).

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Williamson v. Dist. of Columbia Bd. of Dentistry, 647 A.2d 389 (D.C. 1994). · cites it 2× “14(a)(25), 21 C.F.R. §§ 1305.03 , 1305.13 (1993). 9 After a two day hearing on this matter, the Board, on December 12, 1992, sustained all four charges, revoked petitioner’s license and imposed several conditions on reinstatement including a five year minimum period of…”

State v. Udin, 419 A.2d 251 (R.I. 1980). “§ 828 ; 21 C.F.R. §§ 1305.03 . A purchaser must submit copy 1 and copy 2 of the order form to the supplier and retain copy 3 in his own files.”

United States v. Greene (N.D. Ga. 2019). · cites it 4× “§ 827 (a)(3); 21 C.F.R. §§ 1305.03 , 1305.13. For the forms he did have that covered the relevant timeframe, Dr.”

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