21 C.F.R. § 1301.44

Burden of proof

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(a) At any hearing on an application to manufacture any controlled substance listed in Schedule I or II, the applicant shall have the burden of proving that the requirements for such registration pursuant to section 303(a) of the Act (21 U.S.C. 823(a)) are satisfied. Any other person participating in the hearing pursuant to § 1301.35(b) shall have the burden of proving any propositions of fact or law asserted by such person in the hearing.

(b) At any hearing on the granting or denial of an applicant to be registered to conduct a narcotic treatment program or as a compounder, the applicant shall have the burden of proving that the requirements for each registration pursuant to section 303(g) of the Act (21 U.S.C. 823(g)) are satisfied.

(c) At any hearing on the granting or denial of an application to be registered to import or export any controlled substance listed in Schedule I or II, the applicant shall have the burden of proving that the requirements for such registration pursuant to sections 1008(a) and (d) of the Act (21 U.S.C. 958 (a) and (d)) are satisfied. Any other person participating in the hearing pursuant to § 1301.34 shall have the burden of proving any propositions of fact or law asserted by him/her in the hearings.

(d) At any other hearing for the denial of a registration, the Administration shall have the burden of proving that the requirements for such registration pursuant to section 303 or section 1008(c) and (d) of the Act (21 U.S.C. 823 or 958(c) and (d)) are not satisfied.

(e) At any hearing for the revocation or suspension of a registration, the Administration shall have the burden of proving that the requirements for such revocation or suspension pursuant to section 304(a) or section 1008(d) of the Act (21 U.S.C. 824(a) or 958(d)) are satisfied.

[62 FR 13956, Mar. 24, 1997]

Notes of Decisions

Cited in 8 cases (1 in the last 5 years), 1987–2023 · leading case: Jones Total Health Care Pharmacy, LLC v. Drug Enf't Admin., 881 F.3d 823 (11th Cir. 2018).

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Jones Total Health Care Pharmacy, LLC v. Drug Enf't Admin., 881 F.3d 823 (11th Cir. 2018). “21 C.F.R. § 1301.44 (d), (e). If the government proves its prima fade case, the burden of proof shifts to the registrant to show why it can be trusted with a registration.”

Craker v. Drug Enf't Admin., 714 F.3d 17 (1st Cir. 2013). “21 C.F.R. § 1301.44 (a). Since 1968, the National Center for Natural Products Research (“NCNPR”) at the University of Mississippi has held the necessary registration and a government contract to grow marijuana for research purposes.”

MacKay v. Drug Enf't Admin., 664 F.3d 808 (10th Cir. 2011). “21 C.F.R. § 1301.44 (e). Cognizant of this, the Deputy Administrator has consistently held that once the government establishes a prima facie case showing a practitioner has committed acts which render his registration inconsistent with the public interest, the burden shifts to…”

Commonwealth v. Chatfield-Taylor, 502 N.E.2d 512 (Mass. 1987). “21 C.F.R. § 1301.44 . The DEA issues order forms to registered physicians, which contain the name, address and Federal registration number of the applicant, to facilitate the purchase of controlled substances for use in the physician’s practice.”

Penick Corp. v. Drug Enf't Admin., 491 F.3d 483 (D.C. Cir. 2007). · cites it 2× “” 21 C.F.R. § 1301.44 (c). Yet 21 C.F.R. § 1301.”

Pharmacy Doctors Enter., Inc. v. Drug Enf't Admin. (11th Cir. 2019). “3d at 830 (citing 21 C.F.R. § 1301.44 (d)-(e)). “If the government proves its prima facie case, the burden of proof shifts to the registrant to show why it can be trusted with a registration.”

Samson Kanla Orusa v. DEA (6th Cir. 2023). “21 C.F.R. § 1301.44 (e). The Administrator’s decision to revoke a registration will be set aside if it is “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.”

Becker v. Drug Enf't Admin., 541 F. App'x 587 (6th Cir. 2013). “21 C.F.R. § 1301.44 (e). In evaluating the government’s showing under the five factors delineated at 21 U.”

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