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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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[Code of Federal Regulations]
[Title 21, Volume 9]
[CITE: 21CFR1308.50]



TITLE 21--FOOD AND DRUGS
CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION
DEPARTMENT OF JUSTICE

PART 1308 -- SCHEDULES OF CONTROLLED SUBSTANCES

Hearings

Sec. 1308.50 Temporary and permanent scheduling of recently emerged anabolic steroids.

(a) The Administrator may issue a temporary order adding a drug or other substance to the definition of anabolic steroids if the Administrator finds that -

(1) The drug or other substance satisfies the criteria for being considered an anabolic steroid under 21 U.S.C. 802(41) but is not listed in that section or by regulation of the Attorney General as being an anabolic steroid; and

(2) Adding such drug or other substance to the definition of anabolic steroids will assist in preventing abuse or misuse of the drug or other substance.

(b) An order issued under paragraph (a) of this section shall not take effect until 30 days after the date of the publication by the Administrator of a notice in the Federal Register of the intention to issue such order and the grounds upon which such order is to be issued. The order shall expire not later than 24 months after the date it becomes effective, except that the Administrator may, during the pendency of proceedings under paragraph (f) of this section, extend the temporary scheduling order for up to 6 months.

(c) The Administrator shall transmit notice of an order proposed to be issued under paragraph (a) of this section to the Secretary of Health and Human Services. In issuing an order under paragraph (a), the Administrator shall take into consideration any comments submitted by the Secretary in response to a notice transmitted pursuant to this paragraph (c).

(d) A temporary scheduling order issued under paragraph (a) of this section shall be vacated upon the issuance of a permanent scheduling order under paragraph (f) of this section.

(e) An order issued under paragraph (a) of this section is not subject to judicial review.

(f) The Administrator may, by rule, issue a permanent order adding a drug or other substance to the definition of anabolic steroids if such drug or other substance satisfies the criteria for being considered an anabolic steroid under 21 U.S.C. 802(41). Such rulemaking may be commenced simultaneously with the issuance of the temporary order issued under paragraph (a) of this section.

[88 FR 50041, Aug. 1, 2023]

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