Pharmacy Compounding Advisory Committee; Meeting Announcement and Public Comment Request
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
This notice announces an upcoming meeting of the Pharmacy Compounding Advisory Committee by the FDA. The meeting will discuss the inclusion of new bulk substances for compounding under Section 503A. The public is invited to comment, and specific substances will be reviewed for various medical uses.
AI-generated summary. May contain errors. Refer to official sources for legal decisions.
Key Changes
- Upcoming public meeting of Pharmacy Compounding Advisory Committee
- Discussion on new bulk substances for Section 503A
- Public invited to submit comments
Obligations
What this law requires
Stakeholders must submit comments regarding the meeting by July 22, 2026.
The public must submit comments regarding bulk drug substances for inclusion on the Section 503A Bulk Drug Substances List by July 22, 2026.
Individuals wishing to make formal oral presentations must notify the contact person and submit details of their presentation by June 30, 2026.
Individuals who wish to make formal oral presentations at the advisory committee meeting must notify the FDA and submit a brief statement by June 30, 2026.
FDA must provide background material to the public no later than 2 business days before the advisory committee meeting.