Briefing Summary: US FDA Posts Advisory Committee Materials About Substances Nominated for the “Bulk Substances Allowed” List – OCT 27-28, 2015 (PCAC)
The U.S. FDA has posted FDA Briefing Materials for the Tuesday-Wednesday, October 27-28, 2015 meeting of the Pharmacy Compounding Advisory Committee (PCAC). The Committee will discuss and vote on drugs that are proposed for the bulk drug substances allowed list per section 503A of the Food Drug & Cosmetic Act (FD&C Act). On October 27, the committee will consider the following nominated bulk drug substances: methylsulfonylmethane, curcumin, germanium sesquioxide, rubidium chloride, and deoxy-D-glucose. The nominators of these substances will be invited to make a short presentation supporting the nomination.
On October 28, the committee will discuss four bulk drug substances nominated for inclusion on the section 503A bulk drug substances list. FDA intends to discuss the following nominated bulk drug substances: alanyl-L-glutamine, glutaraldehyde, glycyrrhizin, and domperidone. Other nominated substances will be discussed at future committee meetings.
The previously scheduled topic to consider adding quinacrine for intrauterine administration to the withdrawn or removed list, per sections 503A and 503B of the FD&C Act, and the addition of quinacrine to the bulk drug substances allowed list, per section 503A of the FD&C Act, was cancelled.
See the SAC Tracker report