The Food & Drug Administration (FDA) today announced a Pharmacy Compounding Advisory Committee (PCAC) meeting to  occur on November 20-21, 2017 during the week of the Thanksgiving holiday. PLEASE NOTE: The PCAC meeting will be open to the public, and you are encouraged to submit comments and attend the meeting.

The meeting will be held from 8:30 am to 5:00 pm on Monday, November 20th, and from 8:30 am to 11:30 am on Tuesday, November 21st at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-0002. 

In the Agenda portion of the notice, the FDA announced that the nominators of the following substances and products will be invited to make a short presentation supporting the nomination: astragalus, L-citrulline, pregnenolone, 7-keto dehydroepiandrosterone (DHEA), epigallocatechin gallate (EGCg), and resveratrol.

According to the FDA, it is establishing a docket for public comment on this meeting. The docket number is FDA-2017-N-5818. The docket will close on November 17, 2017. Submit either electronic or written comments on this public meeting by November 17, 2017. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before November 17, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of November 17, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

View FDA Documents and Federal Register Public Meeting Notice

Please  click here to view FDA's official meeting notice and to obtain additional comment submission instructions. This information is scheduled to publish in tomorrow's Federal Register . 

Click here to view FDA's nominator letter sent to IACP.

Click here to view the 503A Substances and Nominators which will be discussed at the November 20-21, 2017 PCAC meeting. 

"IACP just became aware of this meeting, and we currently are reviewing the nominations. The FDA essentially has provided only a three-week notice for a meeting scheduled during the week of Thanksgiving. This timing does not indicate to us that they are encouraging or making stakeholder input a priority. Pharmacists, providers and patients need more than a three weeks' notice to make travel arrangements to attend and speak during the meeting. The fact that FDA has scheduled this during Thanksgiving week makes travel for these stakeholders even more difficult. Unfortunately, we believe FDA is showing once again that they are not serious about gathering stakeholder input."