21 C.F.R. § 1316.46

Inspection of record

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(a) The record bearing on any proceeding, except for material described in subsection (b) of this section, shall be available for inspection and copying by any person entitled to participate in such proceeding, during office hours in the office of the Hearing Clerk, Drug Enforcement Administration. See the Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing address.

(b) The following material shall not be available for inspection as part of the record:

(1) A research protocol filed with an application for registration to conduct research with controlled substances listed in Schedule I, pursuant to § 1301.32 (a)(6) of this chapter, if the applicant requests that the protocol be kept confidential;

(2) An outline of a production or manufacturing process filed with an application for registration to manufacture a new narcotic controlled substance, pursuant to § 1301.33 of this chapter, if the applicant requests that the outline be kept confidential;

(3) Any confidential or trade secret information disclosed in conjunction with an application for registration, or in reports filed while registered, or acquired in the course of an investigation, entitled to protection under subsection 402(a) (8) of the Act (21 U.S.C. 842(a) (8)) or any other law restricting public disclosure of information; and

(4) Any material contained in any investigatory report, memorandum, or file, or case report compiled by the Administration.

[36 FR 7820, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR 13970, Mar. 24, 1997; 75 FR 10645, Mar. 9, 2010]

Notes of Decisions

Cited in 2 cases (1 in the last 5 years), 1998–2025 · 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). “Indeed, even in those instances in which a hearing is required, participants are not entitled to inspect “[a]ny confidential or trade secret information disclosed in conjunction with an application,” nor “[a]ny material contained in any investigatory report, memorandum, or file,…”

Sualeh Ashraf v. United States Drug Enf't Admin. (11th Cir. 2025). “Further, under 21 C.F.R. § 1316.46 , had Dr. Ash- raf requested a hearing, he would have had the right to inspect and copy the record bearing on the hearing.”

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