June 8, 2022: Meeting of the Pharmacy Compounding Advisory Committee Meeting Announcement
www.fda.gov
FDA announces Pharmacy Compounding Advisory Committee Meeting
The Food and Drug Administration will hold a
Pharmacy Compounding Advisory Committee (PCAC) meeting on June 8, 2022, to discuss four bulk drug substances nominated for inclusion on FDA’s list of bulk drug substances that can be used in compounding under section 503A of the Federal Food, Drug and Cosmetic Act (503A Bulks List) and a potential addition to the withdrawn or removed list.
The following four bulk drug substances are nominated for inclusion on the 503A Bulks List:
- ammonium tetrathiomolybdate,
- enclomiphene citrate,
- ferric subsulfate, and
- glutathione
The committee will also discuss revisions FDA is considering to the
Withdrawn or Removed List of drug products that may not be compounded under the exemptions provided by section 503A(a) or section 503B(a) of the Federal Food, Drug, and Cosmetic Act. FDA now is considering whether to amend the rule to add one more entry to the list: lorcaserin hydrochloride and all drug products containing lorcaserin hydrochloride.
The meeting will take place virtually only on:
Date: June 8, 2022
Time: 9:30 AM - 5:15 PM ET
Two days prior to the meeting, FDA will provide the live webcast link on the
2022 Meeting Materials, Pharmacy Compounding Advisory Committee webpage.
Comments can be submitted electronically to the
docket for this meeting or through mail/hand/delivery courier. Comments received on or before May 24, 2022, will be provided to the committee. Comments received after that date but by June 7, 2022, will be taken into consideration by FDA. If the meeting is cancelled, FDA will continue to evaluate any relevant applications or information, and consider any comments submitted to the docket, as appropriate.