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  1. Pharmacy Compounding Advisory Committee

Meeting of the Pharmacy Compounding Advisory Committee

FDA will host an advisory committee meeting before the end of February 2027

What is an advisory committee?

Advisory committees provide independent expert advice to the FDA on broad scientific topics or on certain products to help the Agency make sound decisions based on the available science. Advisory committees make non-binding recommendations to the FDA based on the expertise of their members. Please visit Advisory Committees Give FDA Critical Advice and the Public a Voice for more information.

Center: Center for Drug Evaluation and Research

Time and Location: This meeting time and location will be scheduled in the coming months. The public will have the option to participate via an online teleconferencing and/or video conferencing platform, and the advisory committee meeting will be heard, viewed, captioned, and recorded through an online teleconferencing and/or video conferencing platform.

Agenda

The Committee will discuss the following bulk drug substances being considered for inclusion on the 503A bulks list: 

  • Cathelicidin (LL-37) 
  • GHK-Cu 
  • Dihexa acetate 
  • Melanotan II 
  • Mechano Growth Factor, Pegylated (PEG-MGF).

Meeting Materials

FDA intends to make meeting materials and the link to the live webcast available no later than two business days before the meeting in the Event Materials section of this webpage. If FDA is unable to post the meeting materials on its website prior to the meeting, the meeting materials will be made publicly available on FDA’s website at the time of the advisory committee meeting and additional copies will be available at the meeting location.

The virtual portion of the meeting will include slide presentations with audio and video components to allow the presentation of materials in a manner that most closely resembles an in-person advisory committee meeting.

Public Participation Information

Interested persons may present data, information or views, orally or in writing, on issues pending before the committee.

FDA intends to publish a Federal Register notice and establish a docket for public comment on this meeting in the near future. More information regarding the docket will be available once the Federal Register notice for this meeting publishes.

Interested persons will have an opportunity to request slots to make presentations during the open public hearing session of the meeting. Additional information on such presentations, including instructions on how interested persons can submit requests for presentation slots, will be provided in FDA’s forthcoming Federal Register notice for the meeting.

Webcast Information

CDER plans to provide a live webcast of the upcoming advisory committee meeting. If there are instances where the webcast transmission is not successful, staff will work to re-establish the transmission as soon as possible. Further information regarding the webcast, including the web address for the webcast, will be made available no later than two business days before the meeting in the Event Materials section of this webpage.

CDER plans to post archived webcasts after the meeting. In cases where transmission was not successful, archived webcasts will not be available.

Contact Information

  • Takyiah Stevenson, PharmD 
    Center for Drug Evaluation and Research 
    Food and Drug Administration 
    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: 301-796-8220

    Please call the Information Line for up-to-date information on this meeting.

  • For press inquiries, please contact the HHS Press Room at HHS Press Room or 202-690-6343. 
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