REVISED SCHEDULE AND COMMUNITY ENGAGEMENT DETAILS: December 4, 2024: Gathering of the Pharmacy Compounding Advisory Committee – 12/04/2024

Understanding Advisory Committees

Advisory committees are panels that offer independent expert insights to the FDA on various scientific matters or specific products, aiding the agency in making informed decisions grounded in available science. They provide non-binding recommendations, which the FDA generally adheres to, although it is not mandated to do so. Additional details can be found in “Advisory Committees Give FDA Critical Advice and the Public a Voice.

Updated Information (as of 11/8/2024):

There has been a change in the meeting conclusion time from 3:00 p.m. to 3:50 p.m. Eastern Time.

The public participation procedure has also been revised:

• The date for notifying the contact person for formal oral presentations is now November 13, 2024.
• Notification by the contact person regarding requests to speak has shifted to November 14, 2024.
• The starting times for public oral presentations are now 10:00 a.m., 11:25 a.m., and 2:30 p.m. Eastern Time.

The meeting will occur at FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 2, Room 2047, Silver Spring, MD 20993-0002, with limited public seating and overflow options in Bldg. 2, Room 2058.

No further changes have been made to the information.

Center: Center for Drug Evaluation and Research

Location: The meeting will take place at FDA White Oak Campus, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, with public participation options available, and the meeting being accessible via online platforms for viewing and interaction.

Agenda

The Committee will evaluate bulk drug substances for potential inclusion on the 503A Bulks List, including AOD-9604-related substances, CJC-1295-related substances, and Thymosin alpha-1-related substances. Presenters from the nominators will support their nominations.

Meeting Materials

The FDA will make background materials and the webcast link available to the public at least two business days ahead of the meeting. If this is not possible, the materials will be accessible at the meeting and on the FDA website when the meeting occurs, featuring presentations with audio and video that emulate a physical advisory committee meeting.

Public Participation Details

Individuals may present data or views on Committee matters either orally or in writing.

Comments can be submitted electronically or in writing, with the docket number FDA-2024-N-4777, closing on December 3, 2024. Late comments will not be accepted, and electronic submissions will be accepted until 11:59 p.m. ET on that date.

You may submit comments as follows:

Electronic Submissions

Electronic comments may be submitted at:

• Federal eRulemaking Portal: https://www.regulations.gov. Follow the submission instructions; comments will be posted unchanged. Ensure confidential details are excluded from your submission.
• For confidential submissions, provide a written/paper format as detailed below.

Written/Paper Submissions

For written submissions, use:

• Dockets Management Staff (HFA-305), FDA, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• Comments with confidential designations will be treated as such except where otherwise required.

Instructions: All submissions must include Docket No. FDA-2024-N-4777. Timely comments will be made available. More on confidential submissions can be found in the regulations linked in this notice.

Docket: Access background documents or comments by visiting https://www.regulations.gov and entering the docket number.

Oral Presentations

Public oral presentations will follow FDA’s presentations, with approximately one hour allocated for the public hearing, divided for each substance. Individuals wishing to present should conform to the submission guidelines before November 8, 2024.

Webcast Details

CDER will provide a free live webcast of the advisory committee meeting, along with archived webcasts, except in cases of transmission failure. Further information will be available prior to the meeting.

Contact Information

• Takyiah Stevenson, PharmD
  Center for Drug Evaluation and Research
  FDA, 10903 New Hampshire Avenue
  WO31-2417
  Silver Spring, MD  20993-0002
  Phone: 240-402-2507
  Email: PCAC@fda.hhs.gov

• FDA Advisory Committee Information Line
  1-800-741-8138 (301-443-0572 in the Washington DC area)
  Please call for meeting updates.
• For press inquiries, reach the Office of Media Affairs at fdaoma@fda.hhs.gov or 301–796–4540.

To stay informed of any last-minute changes affecting the advisory committee meeting, it is recommended to check the FDA’s website regularly or reach out to the Committee’s Designated Federal Officer (contact details provided above). Public attendance is encouraged, and efforts will be made for accommodation of disabilities; please ensure to inform the officer at least a week before the meeting.

Details regarding questions, especially concerning disabilities, can be found at: Common Questions and Answers about FDA Advisory Committee Meetings.

FDA’s commitment to orderly conduct during meetings can be explored at Public Conduct During FDA Advisory Committee Meetings.

This meeting notice is provided in accordance with the Federal Advisory Committee Act (5 U.S.C. app.2).