21 U.S. Code § 353a–1 - Enhanced communication

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(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.

Source

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

Section was enacted 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.

This is a list of parts within the Code of Federal Regulations for which this US Code section provides rulemaking authority.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.


21 CFR - Food and Drugs

21 CFR Part 5 - ORGANIZATION

21 CFR Part 7 - ENFORCEMENT POLICY

21 CFR Part 10 - ADMINISTRATIVE PRACTICES AND PROCEDURES

21 CFR Part 11 - ELECTRONIC RECORDS; ELECTRONIC SIGNATURES

21 CFR Part 12 - FORMAL EVIDENTIARY PUBLIC HEARING

21 CFR Part 13 - PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY

21 CFR Part 14 - PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE

21 CFR Part 15 - PUBLIC HEARING BEFORE THE COMMISSIONER

21 CFR Part 16 - REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION

21 CFR Part 20 - PUBLIC INFORMATION

21 CFR Part 25 - ENVIRONMENTAL IMPACT CONSIDERATIONS

21 CFR Part 216 - HUMAN DRUG COMPOUNDING

 

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