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21 U.S.C. · Food and Drugs
21 U.S.C. § 353a1

Enhanced communication

Ch. 9 — FEDERAL FOOD, DRUG, AND COSMETIC ACT
Title 21 U.S.C. ● ACTIVE Primary Source Ch. 9
Statutory Text

21 U.S.C. § 353a1 — Enhanced communication

U.S.C. Title 21 - FOOD AND DRUGS 21 U.S.C. United States Code, 2023 Edition Title 21 - FOOD AND DRUGS CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT SUBCHAPTER V - DRUGS AND DEVICES Part A - Drugs and Devices Sec. 353a-1 - Enhanced communication From the U.S. Government Publishing Office, www.gpo.gov

§353a–1. Enhanced communication

(a) Submissions from State boards of pharmacy In a manner specified by the Secretary of Health and Human Services (referred to in this section as the "Secretary"), the Secretary shall receive submissions from State boards of pharmacy— (1) describing actions taken against compounding pharmacies, as described in subsection (b); or (2) expressing concerns that a compounding pharmacy may be acting contrary to section 353a of this title. (b) Content of submissions from State boards of pharmacy An action referred to in subsection (a)(1) is, with respect to a pharmacy that compounds drugs, any of the following: (1) The issuance of a warning letter, or the imposition of sanctions or penalties, by a State for violations of a State's pharmacy regulations pertaining to compounding. (2) The suspension or revocation of a State-issued pharmacy license or registration for violations of a State's pharmacy regulations pertaining to compounding. (3) The recall of a compounded drug due to concerns relating to the quality or purity of such drug. (c) Consultation The Secretary shall implement subsection (a) in consultation with the National Association of Boards of Pharmacy. (d) Notifying State boards of pharmacy The Secretary shall immediately notify State boards of pharmacy when— (1) the Secretary receives a submission under subsection (a)(1); or (2) the Secretary makes a determination that a pharmacy is acting contrary to section 353a of this title.

(Pub. L. 113–54, title I, §105, Nov. 27, 2013, 127 Stat. 597.)

Editorial Notes

Codification Section was enacted as part of the Compounding Quality Act and also as part of the Drug Quality and Security Act, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

Source: uscode.house.gov — public domain Official Source ↗
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◈ Machine-Readable Provenance Record Root-LD v1.0 · boisestandard.org
Federation ID
BS-USC21-SEC-ED03BA
Entity Class
STATUTE / FEDERAL-CODE-SECTION
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boisestandard.org
Citation
21 U.S.C. § 353a1
Jurisdiction
Federal — United States
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PRIMARY-SOURCE
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a8521815f0ee31fe...
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The statutory text of 21 U.S.C. § 353a1 is reproduced from the official United States Code as published by the Office of the Law Revision Counsel of the U.S. House of Representatives (uscode.house.gov).
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← 21 U.S.C. § 353a 21 U.S.C. § 353b →
Ch. 9 — FEDERAL FOOD, DRUG, AND COSMETIC ACT
21 U.S.C. § 30121 U.S.C. § 32121 U.S.C. § 321a21 U.S.C. § 321b21 U.S.C. § 321c21 U.S.C. § 321d21 U.S.C. § 33121 U.S.C. § 33221 U.S.C. § 33321 U.S.C. § 333a21 U.S.C. § 33421 U.S.C. § 33521 U.S.C. § 335a21 U.S.C. § 335b21 U.S.C. § 335c21 U.S.C. § 33621 U.S.C. § 33721 U.S.C. § 337a21 U.S.C. § 34121 U.S.C. § 34221 U.S.C. § 34321 U.S.C. § 343121 U.S.C. § 343221 U.S.C. § 343321 U.S.C. § 343a21 U.S.C. § 34421 U.S.C. § 34521 U.S.C. § 34621 U.S.C. § 346a21 U.S.C. § 346b
21 U.S.C. — public domain ← All Legislation
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boisestandard.org → United States → Law → U.S. Code → Title 21 → 21 U.S.C. § 353a1