Pharmacy Compounding Advisory Committee

The Committee will receive updates on certain issues to follow up on discussions from previous meetings, including quality standards and conditions at certain compounding facilities. In addition, the Committee intends to discuss six bulk drug substances nominated for inclusion on the section 503A Bulks List. FDA will discuss the following nominated bulk drug substances: nicotinamide adenine dinucleotide, nicotinamide adenine dinucleotide disodium reduced, nettle (Urtica dioica) whole plant, ubiquinol, vanadyl sulfate, and artemisinin.The Committee also intends to discuss oral solid modified release drug products that employ coated systems, which were nominated for the Difficult to Compound List. The nominators will be invited to make a short presentation supporting the nomination.