C.F.R. » Title 21 » CHAPTER II—DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE › PART 1301—REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES

21 C.F.R. § 1301.46

Final order

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As soon as practicable after the presiding officer has certified the record to the Administrator, the Administrator shall issue his/her order on the granting, denial, revocation, or suspension of registration. In the event that an application for registration to import or to manufacture in bulk a basic class of any controlled substance listed in Schedule I or II is granted, or any application for registration is denied, or any registration is revoked or suspended, the order shall include the findings of fact and conclusions of law upon which the order is based. The order shall specify the date on which it shall take effect. The Administrator shall serve one copy of his/her order upon each party in the hearing.

[62 FR 13956, Mar. 24, 1997]
Notes of Decisions
Cited in 5 cases (2 in the last 5 years), 1988–2026 · leading case: Cardinal Health, Inc. v. Holder, 846 F. Supp. 2d 203 (D.D.C. 2012).
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Cardinal Health, Inc. v. Holder, 846 F. Supp. 2d 203 (D.D.C. 2012). “See 21 C.F.R. § 1301.46 . This regulation is, however, plainly not comparable to § 1301.”
Matter of Burka, 684 F. Supp. 1300 (E.D. Pa. 1988). · cites it 3× “See 21 C.F.R. § 1301.46 . Pursuant to 21 C.F.”
Easy Returns Worldwide, Inc. v. United States, 266 F. Supp. 2d 1014 (E.D. Mo. 2003). “See 21 C.F.R. § 1301.46 . The Attorney General can, in his discretion, suspend any registration simultaneously with the institution of proceedings under Section 824 where he finds that there is an imminent danger to the public health or safety.”
Evergreen Pharmacy, Inc. v. Garland (N.D. Ill. 2022). “§§ 556 (c)(10), 557; 21 C.F.R. § 1301.46 . However, if a registrant poses an “imminent danger to the public health or safety,” the CSA authorizes the immediate suspension of the entity’s registration.”
Adya LLC v. Cole (D.D.C. 2026). “§§ 556 (c)(10), 557; 21 C.F.R. § 1301.46 . Any judicial review of that decision occurs in a circuit court.”
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