C.F.R. » Title 21 » CHAPTER II—DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE › PART 1316—ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES › Subpart D—Administrative Hearings

21 C.F.R. § 1316.65

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(a) As soon as practicable after the time for the parties to file proposed findings of fact and conclusions of law has expired, the presiding officer shall prepare a report containing the following:

(1) His recommended rulings on the proposed findings of fact and conclusions of law;

(2) His recommended findings of fact and conclusions of law, with the reasons therefore; and

(3) His recommended decision.

(b) The presiding officer shall serve a copy of his report upon each party in the hearing. The report shall be considered to have been served when it is mailed to such party or its attorney of record.

(c) Not less than twenty-five days after the date on which he caused copies of his report to be served upon the parties, the presiding officer shall certify to the Administrator the record, which shall contain the transcript of testimony, exhibits, the findings of fact and conclusions of law proposed by the parties, the presiding officer's report, and any exceptions thereto which may have been filed by the parties.

[36 FR 7778, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973 and amended at 44 FR 55332, Sept. 26, 1979]
Notes of Decisions
Cited in 4 cases (3 in the last 5 years), 2018–2025 · leading case: Fares Rabadi v. Usdea, 122 F.4th 371 (9th Cir. 2024).
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Fares Rabadi v. Usdea, 122 F.4th 371 (9th Cir. 2024). · cites it 2× “21 C.F.R. §§ 1316.65 , 1316.67. The President appoints the Administrator and presumably may remove her at will, as no statute limits her removal.”
Morris & Dickson Co. v. Whitaker, 360 F. Supp. 3d 434 (W.D. La. 2018). “§ 824 (c) ; 21 C.F.R. § 1316.65 (a), (c). 7 If the Administrator finds against Morris & Dickson, the company may then appeal to the D.”
Suntree Pharmacy & Suntree Med. Equip., LLC v. Drug Enf't Agency (11th Cir. 2022). “See 21 C.F.R. §§ 1316.65 , .67. The final order must be published “[a]s soon as practicable after the [administrative law judge] has certified the record to the Administrator.”
Sualeh Ashraf v. United States Drug Enf't Admin. (11th Cir. 2025). “21 C.F.R. §§ 1316.65 . If the registrant does not request a hearing within 30 days of the publication of the order to show cause, he waives his right to a hearing.”
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