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

[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

[[Page 20466]]

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: PCAC@fda.hhs.gov, 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.

------------------------------------------------------------------------
          Bulk drug substance                     Uses evaluated
------------------------------------------------------------------------
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.
------------------------------------------------------------------------

    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.

------------------------------------------------------------------------
          Bulk drug substance                     Uses evaluated
------------------------------------------------------------------------
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.
------------------------------------------------------------------------

    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]
BILLING CODE 4164-01-P