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Title 21, Food and DrugsRelease 119-110

§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 Sep 22, 2026|Official source

Summary

The Secretary of Health and Human Services must accept reports from State boards of pharmacy in the format the Secretary sets. Boards may report actions they took against compounding pharmacies—like warning letters, penalties or sanctions, license suspensions or revocations, or recalls for quality or purity problems—or they can tell the Secretary they are worried a compounding pharmacy might be violating section 353a. The Secretary must set this up with the National Association of Boards of Pharmacy and must immediately notify State boards when the Secretary gets such a report or finds a pharmacy is acting contrary to section 353a.

Full Legal Text

Title 21, §353a–1

Food and Drugs, Source: USLM XML via OLRC

(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.

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

Sep 22, 2026

Release point: 119-110