On Wednesday-Thursday, June 17-18, 2015, the Pharmacy Compounding Advisory Committee (PCAC) agreed with the FDA’s proposed revisions to the list of drug products that may not be compounded under exemptions provided by the FD&C Act because the drug products have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective. Specifically, the committee agreed to add the following products to this list: acetaminophen, aprotinin, ondansetron hydrochloride, and bromocriptine mesylate.
A majority of the Committee members agreed with the FDA’s proposal to add two substances that were nominated for inclusion on the bulk substances allowed list: Brilliant Blue G and n-acetyl-D-glucosamine.
A majority of the Committee members agreed with the FDA’s proposal to exclude two substances that were nominated for inclusion on the bulk substances allowed list: tranilast and oxitriptan (5-HTP).
The specifics that apply to some of these products are described further in the section, “Key Outcomes of Advisory Meeting.”
The Committee also discussed the criteria FDA proposes to use to evaluate those drugs identified as difficult to compound, based on sections 503A and 503B, and heard the FDA present on expanded access to investigational drug for treatment use.