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  4. October 29, 2024: Meeting of the Pharmacy Compounding Advisory Committee - 10/29/2024
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Advisory Committee Meeting | In Person

Event Title
October 29, 2024: Meeting of the Pharmacy Compounding Advisory Committee
October 29, 2024


Date:
October 29, 2024
Time:
8:00 AM - 5:00 PM ET
Location:
Event Location
FDA Headquarters
FDA headquarters in White Oak, MD

10903 New Hampshire Ave
Silver Spring, MD 20903
United States



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, which generally follows the recommendations but is not legally bound to do so. Please see, "Advisory Committees Give FDA Critical Advice and the Public a Voice," for more information.

YouTube Broadcast of the Meeting: Pharmacy Compounding Advisory Committee (PCAC) Live Video

YouTube live video link

FDA will be hosting this advisory committee meeting on October 29, 2024.

Center: Center for Drug Evaluation and Research

Time and Location 

This meeting is scheduled to start at 8 a.m. Eastern Time and will be held at FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-0002. The public will also 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:  ibutamoren mesylate, L-theanine, ipamorelin-related bulk drug substances (ipamorelin acetate and ipamorelin (free base)), and kisspeptin-10. The chart below identifies the use(s) FDA reviewed for each of the bulk drug substances being discussed at this advisory committee meeting. For nominated bulk drug substances, the nominators of these substances will be invited to make a short presentation supporting the nomination.

Bulk Drug Substance Uses Evaluated
Ibutamoren mesylate Treatment of growth hormone deficiency (GHD), osteoporosis, hip fracture, sarcopenia, obesity, and Alzheimer’s disease.
L-theanine Sleep disorders and anxiety disorders.
Ipamorelin acetate
Ipamorelin (free base)
(GHD and postoperative ileus.
Kisspeptin-10 Treatment of secondary hypogonadism in men.

The Committee will also discuss a revision FDA is considering to the Withdrawn or Removed List. Specifically, FDA is considering whether to amend § 216.24 to add an entry to the list:  hydroxyprogesterone caproate: all drug products containing hydroxyprogesterone caproate to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous birth. As previously explained in the Federal Register of July 2, 2014 (79 FR 37687 at 37689 through 37690), the list entry may specify that a drug may not be compounded in any form. Alternatively, the list entry may expressly exclude a particular formulation, indication, dosage form, or route of administration from an entry on the list, or a drug may be listed only with regard to certain formulations, indications, routes of administration, or dosage forms. FDA plans to seek the Committee’s advice concerning the inclusion of this entry on the list.

Meeting Materials

FDA intends to make background material and the link to the live webcast available to the public no later than two (2) business days before the meeting in the Event Materials section of this web page. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting and on FDA’s website at the time of the advisory committee meeting. The online presentation of materials will include slide presentations with audio and video components 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 is establishing a docket for public comment on this meeting. The docket number is FDA-2024-N-4188. The docket will close on October 28, 2024. Submit either electronic or written comments on this public meeting by October 28, 2024. Please note that late, untimely filed comments will not be considered. The regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of October 28, 2024. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date.

Comments received on or before October 15, 2024 will be provided to the Committee. Comments received after that date but by October 28, 2024 will be taken into consideration by FDA. In the event that the meeting is cancelled, FDA will continue to evaluate any relevant applications or information, and consider any comments submitted to the docket, as appropriate. 

You may submit comments as follows:  

Electronic Submissions

Submit electronic comments in the following way:

  • Federal eRulemaking Portal: regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on regulations.gov.
  • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submissions as follows:

  • Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
  • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions:  All submissions received must include the Docket No. FDA-2024-N-4188 for “Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments -- Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List; Revisions to the Withdrawn or Removed List.”  Received comments, those filed in a timely manner, will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.

  • Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” FDA will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify the information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information here.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to regulations.gov and insert the docket number FDA-2024-N-4188 into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.

Oral Presentations

Oral presentations from the public will be scheduled following FDA presentations. FDA has allotted approximately 1 hour for open public hearing presentations, which will be split to allow for public remarks on each substance. The sessions will begin at approximately 9:10 a.m., 11 a.m., 1:50 p.m., 3:15 p.m., and 4:30 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, whether they would like to present online or in-person, and an indication of the approximate time requested to make their presentation on or before October 4, 2024.

Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. FDA may also extend the time scheduled for open public hearing presentations depending on interest. Similarly, room for interested persons to participate in-person may be limited. If the number of registrants requesting to speak in-person during the open public hearing is greater than can be reasonably accommodated in the venue for the in-person portion of the advisory committee meeting, FDA may conduct a lottery to determine the speakers who will be invited to participate in-person. The contact person will notify interested persons regarding their request to speak by October 7, 2024.

Webcast Information

CDER plans to provide a free of charge, 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 (2) business days before the meeting in the Event Materials section of this web page.

CDER plans to post archived webcasts after the meeting, however, 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
1-800-741-8138 (301-443-0572 in the Washington DC area)
Please call the Information Line for up-to-date information on this meeting.

Press Inquiries
For press inquiries, please contact the Office of Media Affairs at fdaoma@fda.hhs.gov or 301–796–4540.

FDA Briefing Information for the October 29, 2024 Meeting of the Pharmacy Compounding Advisory Committee

  1. Introduction
  2. Substances Nominated for Inclusion on the 503A Bulks List (in order of discussion at the meeting)
    1. L-Theanine
    2. Ibutamoren Mesylate
    3. Ipamorelin acetate/Ipamorelin
    4. Kisspeptin-10
  3. Drug Considered for the Withdrawn or Removed List
    1. Hydroxyprogesterone caproate


A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s website or call the committee’s Designated Federal Officer (see Contact Information) to learn about possible modifications before coming to the meeting.

Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact the committee’s Designated Federal Officer (see Contact Information) at least 7 days in advance of the meeting.

Answers to commonly asked questions including information regarding special accommodations due to a disability may be accessed at: Common Questions and Answers about FDA Advisory Committee Meetings.

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).


Event Materials

Title File Type/Size Source Organization
October 29, 2024 Meeting of the Pharmacy Compounding Advisory Committee- FDA Briefing Document-6- Hydroxyprogesterone Caproate pdf (378.88 KB)
October 29, 2024 Meeting of the Pharmacy Compounding Advisory Committee- FDA Briefing Document-5- Kisspeptin-10 pdf (3.69 MB)
October 29, 2024 Meeting of the Pharmacy Compounding Advisory Committee- FDA Briefing Document-4- Ipamorelin pdf (1.82 MB)
October 29, 2024 Meeting of the Pharmacy Compounding Advisory Committee- FDA Briefing Document-3- Ibutamoren Mesylate pdf (2.00 MB)
October 29, 2024 Meeting of the Pharmacy Compounding Advisory Committee- FDA Briefing Document-2- L-Theanine pdf (4.51 MB)
October 29, 2024 Meeting of the Pharmacy Compounding Advisory Committee- FDA Briefing Document-1- Introduction pdf (238.04 KB)
October 29, 2024 Meeting of the Pharmacy Compounding Advisory Committee-, Padma Gulur, M.D. 18 U.S.C. 208(b)(3) Waiver pdf (321.59 KB)
October 29, 2024 Meeting of the Pharmacy Compounding Advisory Committee-, Padma Gulur, M.D. Disclosure Document pdf (180.88 KB)
October 29, 2024 Meeting of the Pharmacy Compounding Advisory Committee-, Kathleen Gura, Pharm.D., BCNSP 18 U.S.C. 208(b)(3) Waiver pdf (215.64 KB)
October 29, 2024 Meeting of the Pharmacy Compounding Advisory Committee-, Kathleen Gura, Pharm.D., BCNSP Disclosure Document pdf (187.66 KB)
October 29, 2024 Meeting of the Pharmacy Compounding Advisory Committee- FDA AM Presentations pdf (1.86 MB)
October 29, 2024 Meeting of the Pharmacy Compounding Advisory Committee- FDA PM Presentations pdf (2.14 MB)
October 29, 2024 Meeting of the Pharmacy Compounding Advisory Committee- Committee Roster pdf (159.66 KB)
October 29, 2024 Meeting of the Pharmacy Compounding Advisory Committee- Webcast Information pdf (146.27 KB)
October 29, 2024 Meeting of the Pharmacy Compounding Advisory Committee- Final Agenda pdf (202.96 KB)
October 29, 2024 Meeting of the Pharmacy Compounding Advisory Committee- Final Meeting Roster pdf (199.75 KB)
October 29, 2024 Meeting of the Pharmacy Compounding Advisory Committee- Final Questions pdf (146.17 KB)

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