FDA announces June PCAC meeting

Published May 14, 2021

FDA will be holding a virtual meeting of its Pharmacy Compounding Advisory Committee, open to the public, on Wednesday, June 9, 2021, from 10:00 am to 5:05 pm EDT.

Agenda: “The committee will discuss the following four bulk drug substances nominated for inclusion on the 503A Bulks List: Choline chloride, oxitriptan (also known as 5-hydroxytryptophan or 5-HTP), melatonin, and methylcobalamin.” It will also discuss adding neomycin sulfate to the Withdrawn or Removed List.

You can find more information on the announcement page, and you can submit comments on the meeting (by June 8, 2021) — follow the instructions on Regulations.gov.

APC will be developing input for the committee on at least two of the nominated substances. If you have suggestions, please direct them to scott@a4pc.org.