SEP 12 PCAC

Follow-up on discussions from previous PCAC meetings: balancing the criteria for the 503A bulk drug substance evaluation and compounding as it relates to dietary supplements.

Discussion of six bulk drug substances nominated for inclusion on the 503A Bulks List.: alpha lipoic acid, coenzyme Q10, creatine monohydrate, pyridoxal 5 phosphate, choline chloride, and quercetin

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MAR 8-9 PCAC

Nominations for the bulk drug substances allowed list: quinacrine hydrochloride, boswellia, aloe vera 200:1 freeze dried, D-ribose, chondroitin sulfate, and acetyl-L-carnitine

Nominations for the demonstrably difficult list: metered dose inhalers and dry powder inhalers

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