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Current as of January 01, 2024 | Updated by Findlaw Staff
(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.
Cite this article: FindLaw.com - 21 U.S.C. § 353a-1 - U.S. Code - Unannotated Title 21. Food and Drugs § 353a-1. Enhanced communication - last updated January 01, 2024 | https://codes.findlaw.com/us/title-21-food-and-drugs/21-usc-sect-353a-1/
FindLaw Codes may not reflect the most recent version of the law in your jurisdiction. Please verify the status of the code you are researching with the state legislature before relying on it for your legal needs.
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