(a) In the case of an application for registration or reregistration to manufacture in bulk a basic class of controlled substance listed in Schedule I or II, the Administrator shall, upon the filing of such application, publish in the Federal Register a notice naming the applicant and stating that such applicant has applied to be registered as a bulk manufacturer of a basic class of narcotic or nonnarcotic controlled substance, which class shall be identified. A copy of said notice shall be mailed simultaneously to each person registered as a bulk manufacturer of that basic class and to any other applicant therefor. Any such person may, within 60 days from the date of publication of the notice in the Federal Register, file with the Administrator written comments on or objections to the issuance of the proposed registration.
(b) In order to provide adequate competition, the Administrator shall not be required to limit the number of manufacturers in any basic class to a number less than that consistent with maintenance of effective controls against diversion solely because a smaller number is capable of producing an adequate and uninterrupted supply.
(c) Except as provided in paragraph (d) of this section, this section shall not apply to the manufacture of basic classes of controlled substances listed in Schedule I or II as an incident to research or chemical analysis as authorized in § 1301.13(e)(1).
(d) An application for registration to manufacture marihuana that involves the planting, cultivating, growing, or harvesting of marihuana shall be subject to the requirements of this section and the additional requirements set forth in part 1318 of this chapter.
[62 FR 13953, Mar. 24, 1997, as amended at 85 FR 82352, Dec. 18, 2020]
Notes of Decisions
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…”
Noramco of Delaware, Inc. v. Drug Enf't Admin., 375 F.3d 1148 (D.C. Cir. 2004).
“38 (noting that “[t]he current regulation concerning the registration of a manufacturer of Schedule I and II substances states: '(b) In order to provide adequate competition, the Administrator shall not be required to limit the number of manufacturers in any basic class to a…”
VoteHemp, Inc. v. Drug Enf't Admin., 567 F. Supp. 2d 1 (D.D.C. 2004).
“However, based on the information provided by the DEA, this court is unable to determine whether the registrations actually pertain to applications for registration or reregistration to manufacture in bulk controlled substances listed in Schedule I or II. Accordingly, this Court…”
Thomas Taylor v. United States, 550 F.2d 983 (4th Cir. 1977).
“32 (a)(7) & (8) (1975); 21 C.F.R. § 1301.33 (1975). And applications may be taken for bulk manufacture of schedule I substances.”
All. for Cannabis Therapeutics v. Drug Enf't Admin., 15 F.3d 1131 (D.C. Cir. 1994).
“See 21 C.F.R. §§ 1301.33 , 1301.42. The CSA allows the Attorney General to reschedule a drug if he finds that it does not meet the criteria for the schedule to which it has been assigned.”
Annotations are extracted automatically from the opinions in the
Syfert caselaw corpus and ranked by authority, recency, and
treatment. Dots show Syfertize treatment of the citing case itself.