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Pharmacy Compounding Advisory Committee


On Monday to Tuesday, November 20-21, 2017, the Pharmacy Compounding Advisory Committee (PCAC) reviewed substances nominated for the list of bulk substances allowed for compounding (a.k.a. the 503A Bulks List of the FD&C Act) and products nominated for the difficult to compound list (a.k.a., the Difficult to Compound List under sections 503A and 503B of the FD&C Act).

·      A majority of the Committee members agreed with the FDA’s recommendation to exclude the following four bulk drug substances from the list of bulk substances allowed for compounding: astragalus extract 10:1, 7-keto dehydroepiandrosterone, epigallocatechin gallate, and resveratrol.

·      A majority of the Committee members agreed with the FDA’s recommendation to include L-citrulline on the list of bulk substances allowed for compounding.

·      A slight majority of the Committee members did not agree with the FDA’s recommendation to exclude pregnenolone from the list of bulk substances allowed for compounding.

·      A majority of the Committee members agreed with the FDA’s recommendations to include liposome drug products and drugs produced using hot melt extrusion on the products that are demonstrably difficult to compound list.

Earlier Event: November 16
Antimicrobial Drugs Advisory Committee
Later Event: November 30
Blood Products Advisory Committee