21 C.F.R. § 1301.42
Purpose of hearing
If requested by a person entitled to a hearing, the Administrator shall hold a hearing for the purpose of receiving factual evidence regarding the issues involved in the denial, revocation, or suspension of any registration, and the granting of any application for registration to import or to manufacture in bulk a basic class of controlled substance listed in Schedule I or II. Extensive argument should not be offered into evidence but rather presented in opening or closing statements of counsel or in memoranda or proposed findings of fact and conclusions of law.
Notes of Decisions
Cited in 4
cases (2 in the last 5 years), 1987–2025 · leading case: Lester Grinspoon, M.D. v. Drug Enf't Admin., 828 F.2d 881 (1st Cir. 1987).
Lester Grinspoon, M.D. v. Drug Enf't Admin., 828 F.2d 881 (1st Cir. 1987). “42; mandatory reporting and security procedures beyond those required for drugs placed in Schedules II through V; unavoidable bureaucratic delays; and other adverse impacts due to the grave concern caused by a substance’s placement in Schedule I, such as difficulty in obtaining…”
Pharmacy Doctors Enter., Inc. v. Drug Enf't Admin. (11th Cir. 2019). “” 21 C.F.R. § 1301.42 . The government bears the burden to show that registration violates or would violate the CSA.”
Virtus Pharm., LLC v. Garland (D.D.C. 2025). “and Opp’n at 19; see also 21 C.F.R. § 1301.42 . The seizure of Virtus’s property from Woodfield Distribution’s facility was not a “forfeiture proceeding” triggering CAFRA’s notice requirement, either.”
Sualeh Ashraf v. United States Drug Enf't Admin. (11th Cir. 2025). “” 21 C.F.R. § 1301.42 . In other words, the hearing is the proper place for Dr.”
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