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Pharmacy Compounding Advisory Committee


On Monday and Tuesday, May 8-9, 2017, the Pharmacy Compounding Advisory Committee (PCAC) discussed and voted on substances that were nominated for the list of bulk drug substances allowed for compounding and on products that were nominated for the difficult to compound list (as per sections 503A and 503B of the Food, Drug & Cosmetic Act).

·         A majority of the Committee members agreed with the FDA’s recommendation to exclude the following 6 bulk drug substances on the substances allowed list: nicotinamide adenine dinucleotide, nicotinamide adenine dinucleotide disodium reduced, nettle, ubiquinol, vanadyl sulfate, and artemisinin.

·         A majority of the Committee members agreed with the FDA’s recommendation to include oral solid modified release drug products that employ coated systems on the products that are difficult to compound list.

·         The Committee also heard an update from the FDA in regard to inspections

Earlier Event: April 13
Antimicrobial Drugs Advisory Committee
Later Event: May 9
Science Board to the FDA