---
kind: "section"
citation: "21 U.S.C. § 353a–1"
title: "21"
title_heading: "Food and Drugs"
number: "353a–1"
heading: "Enhanced communication"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/353a-1"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter V — Drugs and Devices"
  - "Part A — Drugs and Devices"
---

# §353a–1. Enhanced communication

- (a) **Submissions from State boards of pharmacy—** In a manner specified by the [Secretary](/usc/21/321.md?p=d) of Health and Human Services (referred to in this section as the “[Secretary](/usc/21/321.md?p=d)”), the [Secretary](/usc/21/321.md?p=d) shall receive submissions from [State](/usc/21/321.md?p=a-1) boards of pharmacy—
  - (1) describing actions taken against compounding pharmacies, as described in [subsection (b)](#b); or
  - (2) expressing concerns that a compounding pharmacy may be acting contrary to [section 353a of this title](/usc/21/353a.md).
- (b) **Content of submissions from State boards of pharmacy—** An action referred to in [subsection (a)(1)](#a-1) is, with respect to a pharmacy that compounds [drugs](/usc/21/321.md?p=g-1), any of the following:
  - (1) The issuance of a warning letter, or the imposition of sanctions or penalties, by a [State](/usc/21/321.md?p=a-1) for violations of a [State](/usc/21/321.md?p=a-1)’s pharmacy regulations pertaining to compounding.
  - (2) The suspension or revocation of a [State](/usc/21/321.md?p=a-1)-issued pharmacy license or registration for violations of a [State](/usc/21/321.md?p=a-1)’s pharmacy regulations pertaining to compounding.
  - (3) The recall of a compounded [drug](/usc/21/321.md?p=g-1) due to concerns relating to the quality or purity of such [drug](/usc/21/321.md?p=g-1).
- (c) **Consultation—** The [Secretary](/usc/21/321.md?p=d) shall implement [subsection (a)](#a) in consultation with the National Association of Boards of Pharmacy.
- (d) **Notifying State boards of pharmacy—** The [Secretary](/usc/21/321.md?p=d) shall immediately notify [State](/usc/21/321.md?p=a-1) boards of pharmacy when—
  - (1) the [Secretary](/usc/21/321.md?p=d) receives a submission under [subsection (a)(1)](#a-1); or
  - (2) the [Secretary](/usc/21/321.md?p=d) makes a determination that a pharmacy is acting contrary to [section 353a of this title](/usc/21/353a.md).

## Source credit

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

## Notes

### 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.