The US FDA has scheduled a Pharmacy Compounding Advisory Committee (PCAC) meeting for Wednesday, June 17, 2015.
On June 17, 2015, the Committee will hear a follow up on discussions from the last meeting about the options for obtaining access to investigational new drugs and the processes for the FDA to add or remove drugs from the section 503A bulk drug substances list. The Committee will also discuss whether to add the following four drugs to the list of drugs that may not be compounded under FDCA exemptions: Aprotinin, ondansetron hydrochloride, bromocriptine mesylate, and acetaminophen. In addition, the Committee will discuss the following four bulk drug substances nominated for inclusion on the section 503A bulk drug substances list: Brilliant Blue G, tranilast, Nacetyl-D-glucosamine, and oxitriptan.
On June 18, 2015, the Committee will discuss the criteria FDA is proposing to use to evaluate drug products or categories of drug products for identification as demonstrably difficult to compound.