[Federal Register Volume 91, Number 73 (Thursday, April 16, 2026)]
[Notices]
[Pages 20465-20467]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-07361]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-6895]
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
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; establishment of a public docket; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Pharmacy Compounding Advisory
Committee (the Committee). The general function of the Committee is to
provide advice and recommendations to FDA on regulatory issues. The
meeting will be open to the public. FDA is establishing a docket for
public comment on this document.
DATES: The meeting will be held on July 23, 2026, from 8:00 a.m. to
4:30 p.m. Eastern Time and July 24, 2026, from 8:00 a.m. to 3:50 p.m.
Eastern Time.
ADDRESSES: The meeting 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, and the advisory committee meeting will be heard, viewed,
captioned, and recorded through an online teleconferencing and/or video
conferencing platform.
Answers to commonly asked questions about FDA advisory committee
meetings, including information regarding special accommodations due to
a disability, visitor parking, and transportation may be accessed at:
https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2025-N-6895. The docket will close on July 22,
2026. Please note that late, untimely filed comments will not be
considered. The https://www.regulations.gov electronic filing system
will accept comments until 11:59 p.m. Eastern Time on July 22, 2026.
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 July 9, 2026, will be provided to
the Committee. Comments received after that date will be taken into
consideration by FDA. In the event that the meeting is cancelled, FDA
will continue to evaluate any relevant 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: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.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 https://www.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-2025-N-6895 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.'' Received comments, those filed in a timely
manner (see ADDRESSES), will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
https://www.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 https://www.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
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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
at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, 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.
FOR FURTHER INFORMATION CONTACT: Takyiah Stevenson, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 240-
402-2507, email: [email protected], or FDA Advisory Committee
Information Line at 301-796-8220. 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 FDA's website
at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down
to the appropriate advisory committee meeting link, or call the
advisory committee information line to learn about possible
modifications before the meeting.
SUPPLEMENTARY INFORMATION:
Background: Section 503A of the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 353a) describes the conditions that must be
satisfied for human drug products compounded by a licensed pharmacist
in a State-licensed pharmacy or a Federal facility, or a licensed
physician, to be exempt from the following three sections of the FD&C
Act: (1) section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) (concerning
current good manufacturing practice requirements); (2) section
502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with
adequate directions for use); and (3) section 505 (21 U.S.C. 355)
(concerning the approval of human drug products under new drug
applications (NDAs) or abbreviated new drug applications (ANDAs)).
One of the conditions that must be satisfied for a drug product to
qualify for the exemptions under section 503A of the FD&C Act is that
the licensed pharmacist or licensed physician compounds the drug
product using bulk drug substances (as defined in 21 CFR 207.3) that:
(1) comply with the standards of an applicable United States
Pharmacopoeia (USP) or National Formulary monograph, if a monograph
exists, and the USP chapter on pharmacy compounding; (2) if an
applicable monograph does not exist, are drug substances that are
components of drugs approved by the Secretary of Health and Human
Services (the Secretary); or (3) if such a monograph does not exist and
the drug substance is not a component of a drug approved by the
Secretary, that appear on a list developed by the Secretary through
regulations issued by the Secretary under section 503A(c) of the FD&C
Act (the 503A Bulks List) (see section 503A(b)(1)(A)(i) of the FD&C
Act).
Agenda: FDA, invited attendees, and the public will be able to
attend the meeting in-person at FDA's White Oak Campus (see ADDRESSES).
The meeting presentations will also be heard, viewed, captioned, and
recorded through an online teleconferencing and/or video conferencing
platform. On July 23, 2026, the Committee will discuss the following
bulk drug substances being considered for inclusion on the 503A Bulks
List: BPC-157-related bulk drug substances (BPC-157 (free base)/BPC-157
acetate), KPV-related bulk drug substances (KPV (free base)/KPV
acetate), TB-500-related bulk drug substances (TB-500 (free base)/TB-
500 acetate), and MOTs-C-related bulk drug substances (MOTs-C (free
base)/MOTs-C acetate). 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.
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Bulk drug substance Uses evaluated
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BPC-157 (free base), BPC-157 acetate... Ulcerative colitis (UC).
KPV (free base), KPV acetate........... Wound healing and inflammatory
conditions.
TB-500 (free base), TB-500 acetate..... Wound healing.
MOTs-C (free base), MOTs-C acetate..... Obesity and osteoporosis.
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On July 24, 2026, the Committee will discuss the following bulk
drug substances being considered for inclusion on the 503A Bulks List:
Emideltide (also referred to as delta sleeping inducing peptide
(DSIP))-related bulk drug substances (Emideltide (free base)/Emideltide
acetate), Semax-related bulk drug substances (Semax (free base)/Semax
acetate), and Epitalon-related bulk drug substances (Epitalon (free
base)/Epitalon acetate). 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.
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Bulk drug substance Uses evaluated
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Emideltide (free base), Emideltide Opioid withdrawal, chronic
acetate. insomnia, and narcolepsy.
Semax (free base), Semax acetate....... Cerebral ischemia, migraine,
and trigeminal neuralgia.
Epitalon (free base), Epitalon acetate. Insomnia.
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FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available on FDA's website at
the time of the advisory committee meeting. Background material and the
link to the online teleconference and/or video conference meeting will
be available at the location of the advisory committee meeting and at
https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll
down to the appropriate advisory committee meeting link. The meeting
will include slide
[[Page 20467]]
presentations with audio and video components to allow the presentation
of materials for online participants in a manner that most closely
resembles an in-person advisory committee meeting.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the Committee.
All electronic and written submissions to the Docket (see ADDRESSES) on
or before July 9, 2026, will be provided to the Committee. Oral
presentations from the public will be scheduled following FDA
presentations. FDA has allotted approximately one hour for open public
hearing presentations, which will be split to allow for public remarks
on each substance. The sessions will begin at approximately 10:15 a.m.,
11:50 a.m., 2:15 p.m., and 4:00 p.m. on July 23, 2026 Eastern Time. The
sessions will begin at approximately 10:20 a.m., 12:30 p.m., and 3:20
p.m. on July 24, 2026 Eastern Time. 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 amount of time requested to make
their presentation on or before June 30, 2026. 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 and the timeframe for the
presentation by July 1, 2026. Persons attending FDA's advisory
committee meetings are advised that FDA is not responsible for
providing access to electrical outlets.
For press inquiries, please contact the HHS Press Room at https://www.hhs.gov/press-room/index.html or 202-690-6343.
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 Takyiah Stevenson (see FOR FURTHER INFORMATION CONTACT) at
least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm 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. 1001 et seq.). This meeting notice also serves
as notice that, pursuant to 21 CFR 10.19, the requirements in 21 CFR
14.22(b), (f), and (g) relating to the location of advisory committee
meetings are hereby waived to allow for this meeting to take place
using an online meeting platform in conjunction with the physical
meeting room (see location). This waiver is in the interest of allowing
greater transparency and opportunities for public participation, in
addition to convenience for advisory committee members, speakers, and
guest speakers. The conditions for issuance of a waiver under 21 CFR
10.19 are met.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-07361 Filed 4-15-26; 8:45 am]
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