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FDA Publishes Proposed Rule on Sections 503A and 503B Compounding | McDermott Will & Emery

NCPA provides statements on compounding at FDA annual listening session

NCPA members Cheri Garvin and Steven Hoffart made statements at the FDA’s annual drug compounding listening session on June 17. This listening session was an opportunity for stakeholders to voice their views on compounding to the FDA.

FDA compounding committee sets meeting

FDA announced that the Pharmacy Compounding Advisory Committee will meet on June 8. The committee will discuss the following four bulk drug substances nominated for inclusion on the 503A Bulks List: Ammonium tetrathiomolybdate, enclomiphene citrate, ferric subsulfate, and glutathione. NCPA will coordinate presentations on Ammonium tetrahiomolybdate, and glutathione for the June 8 meeting.

FDA tightens authorized use of J&J s Covid-19 vaccine- POLITICO

The vaccine is still available under emergency use authorization, and the CDC has already made a preferential recommendation for the mRNA vaccines over J&J’s.

FDA compounding committee sets meeting

FDA announced that the Pharmacy Compounding Advisory Committee will meet on June 8. The committee will discuss the following four bulk drug substances nominated for inclusion on the 503A Bulks List: ammonium tetrathiomolybdate, enclomiphene citrate, ferric subsulfate, and glutathione. NCPA will coordinate presentations on ammonium tetrahiomolybdate and glutathione for the June 8 meeting.

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