2015 US Code
Title 21 - Food and Drugs (Sections 1 - 2252)
Chapter 9 - Federal Food, Drug, and Cosmetic Act (Sections 301 - 399f)
Subchapter V - Drugs and Devices (Sections 351 - 360fff-7)
Part A - Drugs and Devices (Sections 351 - 360n-1)
Sec. 353a-1 - Enhanced communication
| Publication Title | United States Code, 2012 Edition, Supplement 3, Title 21 - FOOD AND DRUGS |
| Category | Bills and Statutes |
| Collection | United States Code |
| SuDoc Class Number | Y 1.2/5: |
| Contained Within | 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 |
| Contains | section 353a-1 |
| Date | 2015 |
| Laws In Effect As Of Date | January 3, 2016 |
| Positive Law | No |
| Disposition | standard |
| Source Credit | Pub. L. 113-54, title I, §105, Nov. 27, 2013, 127 Stat. 597. |
| Statutes at Large Reference | 127 Stat. 597 |
| Public and Private Law | Public Law 113-54 |
Download PDF
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 pharmacyAn 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) ConsultationThe Secretary shall implement subsection (a) in consultation with the National Association of Boards of Pharmacy.
(d) Notifying State boards of pharmacyThe 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.)
CODIFICATIONSection 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.
Disclaimer: These codes may not be the most recent version. The United States Government Printing Office may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the US site. Please check official sources.
