21 C.F.R. § 1301.37

Order to show cause

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(a) If, upon examination of the application for registration from any applicant and other information gathered by the Administration regarding the applicant, the Administrator is unable to make the determinations required by the applicable provisions of section 303 and/or section 1008 of the Act (21 U.S.C. 823 and 958) to register the applicant, the Administrator shall serve upon the applicant an order to show cause why the registration should not be denied.

(b) If, upon information gathered by the Administration regarding any registrant, the Administrator determines that the registration of such registrant is subject to suspension or revocation pursuant to section 304 or section 1008 of the Act (21 U.S.C. 824 and 958), the Administrator shall serve upon the registrant an order to show cause why the registration should not be revoked or suspended.

(c) The order to show cause shall call upon the applicant or registrant to appear before the Administrator at a time and place stated in the order, which shall not be less than 30 days after the date of receipt of the order. The order to show cause shall also contain a statement of the legal basis for such hearing and for the denial, revocation, or suspension of registration and a summary of the matters of fact and law asserted.

(d)(1) When to File: Hearing Request. A party that wishes to request a hearing in response to an order to show cause must file with the Office of the Administrative Law Judges and serve on DEA such request no later than 30 days following the date of receipt of the order to show cause. Service of the request on DEA shall be accomplished by sending it to the address, or email address, provided in the order to show cause.

(2) When to File: Answer. A party requesting a hearing shall also file with the Office of the Administrative Law Judges and serve on DEA an answer to the order to show cause no later than 30 days following the date of receipt of the order to show cause. A party shall also serve its answer on DEA at the address, or the email address, provided in the order to show cause. The presiding officer may, upon a showing of good cause by the party, consider an answer that has been filed out of time.

(3) Contents of Answer; Effect of Failure to Deny. For each factual allegation in the order to show cause, the answer shall specifically admit, deny, or state that the party does not have and is unable to obtain sufficient information to admit or deny the allegation. When a party intends in good faith to deny only a part of an allegation, the party shall specify so much of it as is true and shall deny only the remainder. A statement of a lack of information shall have the effect of a denial. Any factual allegation not denied shall be deemed admitted.

(4) Amendments. Prior to the issuance of the prehearing ruling, a party may as a matter of right amend its answer one time. Subsequent to the issuance of the prehearing ruling, a party may amend its answer only with leave of the presiding officer. Leave shall be freely granted when justice so requires.

(e) When authorized by the Administrator, any agent of the Administration may serve the order to show cause.

[62 FR 13955, Mar. 24, 1997; 87 FR 68044, Nov. 14, 2022]

Notes of Decisions

Cited in 11 cases (1 in the last 5 years), 1998–2026 · leading case: MD Pharm., Inc. v. Drug Enf't Admin., 133 F.3d 8 (D.C. Cir. 1998).

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MD Pharm., Inc. v. Drug Enf't Admin., 133 F.3d 8 (D.C. Cir. 1998). · cites it 4× “21 C.F.R. § 1301.37 (a) (1994). Because the new regulations eliminated the opportunity for third parties to obtain a hearing, the new rules stated that an application could be withdrawn without the permission of the Administrator at any time before the applicant receives an…”

Cardinal Health, Inc. v. Holder, 846 F. Supp. 2d 203 (D.D.C. 2012). · cites it 3× “” 21 C.F.R. § 1301.37 (c). However, in cases where the DEA has reason to believe that a registrant’s continued operation would pose “an imminent danger to the public health or safety,” it can suspend that party’s registration immediately, prior to an administrative hearing, by…”

Craker v. Drug Enf't Admin., 714 F.3d 17 (1st Cir. 2013). · cites it 2× “§ 824 (c); 21 C.F.R. § 1301.37 (a), (c). The order first concluded that Dr.”

Holiday Cvs, L.L.C. v. Holder, 839 F. Supp. 2d 145 (D.D.C. 2012). “” 21 C.F.R. § 1301.37 (c). In cases where the DEA has reason to believe that a registrant’s continued operation would pose “an imminent danger to the public health or safety,” it can suspend that party’s registration immediately, prior to an administrative hearing, by issuing an…”

Volkman v. United States Drug Enf't Admin., 567 F.3d 215 (6th Cir. 2009). “” 21 C.F.R. § 1301.37 (c). Volkman’s procedural attack focuses on his notice of the charges against him.”

Morris & Dickson Co. v. Whitaker, 360 F. Supp. 3d 434 (W.D. La. 2018). “§ 824(c) ; 21 C.F.R. § 1301.37 (c). Following the hearing, the presiding ALJ issues a report recommending findings of fact and conclusions of law; the ALJ forwards this report and the administrative record to the DEA Administrator.”

Easy Returns Worldwide, Inc. v. United States, 266 F. Supp. 2d 1014 (E.D. Mo. 2003). “§ 824 (c); 21 C.F.R. 1301.37(c). The revocation becomes effective after an administrative hearing, if one is requested, and upon final order of the Administrator.”

Pharmacy Doctors Enter., Inc. v. Drug Enf't Admin. (11th Cir. 2019). · cites it 2× “§ 824(c)(1); 21 C.F.R. § 1301.37 , alleging that Pharmacy Doctors was dispensing controlled substances in violation of federal and state law and proposing to revoke its registration, 21 U.”

Stanford Anthony Williamson v. U.S. Dep't of Just., al. (E.D. Va. 2026). · cites it 2× “21 C.F.R. § 1301.37 (b). That order to show cause (“OSC”) commences an administrative proceeding before a DEA Administrative Law Judge (“ALJ”) and must “contain a statement of the basis for the .”

Oak Hill Hometown Pharmacy v. Dhillon (S.D.W. Va 2019). “§ 824(c); 21 C.F.R. § 1301.37 (c). Following the hearing, the presiding administrative law judge (“ALJ”) makes a recommendation to the DEA administrator, who issues a final ruling on that recommendation.”

Paul Volkman v. U.S. Drug Enf't Admin (6th Cir. 2009). “” 21 C.F.R. § 1301.37 (c). Volkman’s procedural attack focuses on his notice of the charges against him.”

— 21 C.F.R. § 1301.37(c) — 1 case

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