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Title 21 — Food and DrugsRelease 119-73

§353a–1 Enhanced communication

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

Last updated Apr 6, 2026|Official source

Summary

The Secretary of Health and Human Services must set up a way for State boards of pharmacy to send in reports. States can report actions they took against compounding pharmacies or say they are worried a pharmacy may be violating section 353a. Such actions include warning letters or penalties, losing or having a license taken away, and recalls for drug quality or purity problems. The Secretary must work with the National Association of Boards of Pharmacy and must immediately tell State boards when a report is received or when the Secretary finds a pharmacy is violating 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 6, 2026

Release point: 119-73