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Title 21, Food and DrugsRelease 119-73not60

§353a–1 Enhanced Communication

Title 21 › Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part A— Drugs and Devices › § 353a–1

Last updated Apr 5, 2026|Official source

Summary

The Secretary of Health and Human Services must set up a system to get reports from State boards of pharmacy about compounding pharmacies. States can send reports that describe actions they took (like warning letters, penalties, license suspension or revocation, or recalls for quality or purity problems) or say they are worried a pharmacy may be violating the federal compounding rules in section 353a. The Secretary must put this system in place with the National Association of Boards of Pharmacy. The Secretary must immediately tell State boards when a report is received about a State action or when the Secretary finds a pharmacy is acting against section 353a.

Full Legal Text

Title 21, §353a–1

Food and Drugs, Source: USLM XML via OLRC

(a)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)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)The Secretary shall implement subsection (a) in consultation with the National Association of Boards of Pharmacy.
(d)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.

Legislative History

Notes & Related Subsidiaries

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.

Reference

Citations & Metadata

Citation

21 U.S.C. § 353a–1

Title 21, Food and Drugs

Last Updated

Apr 5, 2026

Release point: 119-73not60