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§1301.12. Separate registrations for separate locations. — Inbound Citations

21 C.F.R. § 1301.12

Cited by 3 regulations in release Current.

Citations to 21 C.F.R. § 1301.12 as a whole

  • (b) If a practitioner holds multiple DEA registrations, the practitioner or his agent must select the appropriate registration number for the prescription being issued in accordance with the requirements of § 1301.12 of this chapter.

Citations to §1301.12(a)

Citations to §1301.12(b)(4)

  • (i) Subject to paragraph (2)(ii) of this definition, a drug or hormonal substance (other than estrogens, progestins, corticosteroids, and dehydroepiandrosterone) that is not listed in § 1308.13(f) of this chapter and is derived from, or has a chemical structure substantially similar to, one or more anabolic steroids listed in § 1308.13(f) of this chapter shall be considered to be an anabolic steroid for purposes of this chapter if—
    (A) The drug or substance has been created or manufactured with the intent of producing a drug or other substance that either—
    (1) Promotes muscle growth; or
    (2) Otherwise causes a pharmacological effect similar to that of testosterone; or
    (B) The drug or substance has been, or is intended to be, marketed or otherwise promoted in any manner suggesting that consuming it will promote muscle growth or any other pharmacological effect similar to that of testosterone.
    (ii) A substance shall not be considered to be a drug or hormonal substance for purposes of this definition if it—
    (A) (1) An herb or other botanical;
    (2) A concentrate, metabolite, or extract of, or a constituent isolated directly from, an herb or other botanical; or
    (3) A combination of 2 or more substances described in paragraph (2)(ii)(A)(1) or (2) of this definition;
    (B) Is a dietary ingredient for purposes of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.); and
    (iii) In accordance with 21 U.S.C. 885(a), any person claiming the benefit of an exemption or exception under paragraph (2)(ii) of this definition shall bear the burden of going forward with the evidence with respect to such exemption or exception.
    Automated dispensing system means a mechanical system that performs operations or activities, other than compounding or administration, relative to the storage, packaging, counting, labeling, and dispensing of medications, and which collects, controls, and maintains all transaction information.
    Basic class means, as to controlled substances listed in Schedules I and II: