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Code · BILL · 113th Congress · H.R. 3204 (Engrossed in House) — To amend the Federal Food, Drug, and Cosmetic Act with respect to human drug compounding and drug supply chain securi... · Sec. 105

Sec. 105. Enhanced communication

211 words·~1 min read·/bill/113/hr/3204/eh/section-105

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

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— describing actions taken against compounding pharmacies, as described in subsection (b); or expressing concerns that a compounding pharmacy may be acting contrary to section 503A of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 353a ). An action referred to in subsection (a)(1) is, with respect to a pharmacy that compounds drugs, any of the following:
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. The suspension or revocation of a State-issued pharmacy license or registration for violations of a State’s pharmacy regulations pertaining to compounding. The recall of a compounded drug due to concerns relating to the quality or purity of such drug. The Secretary shall implement subsection
(a)in consultation with the National Association of Boards of Pharmacy. The Secretary shall immediately notify State boards of pharmacy when— the Secretary receives a submission under subsection (a)(1); or the Secretary makes a determination that a pharmacy is acting contrary to section 503A of the Federal Food, Drug, and Cosmetic Act.
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Sec. 105
Enhanced communication
U.S.C.§ 353a
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