Notice2024-21241
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Comments-Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List; Revisions to the Withdrawn or Removed List
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Published
September 18, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 181 (Wednesday, September 18, 2024)</title>
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[Federal Register Volume 89, Number 181 (Wednesday, September 18, 2024)]
[Notices]
[Pages 76478-76481]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-21241]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-4188]
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Substances List; Revisions to the Withdrawn or Removed List
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 October 29, 2024, from 8 a.m. to 5
p.m. eastern time.
ADDRESSES: The meeting will be held at the 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.
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:
<a href="https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm">https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm</a>.
FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2024-N-4188.
[[Page 76479]]
The docket will close on October 28, 2024. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time on 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 will be taken into
consideration by FDA. In the event that the meeting is canceled, 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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: <a href="/cdn-cgi/l/email-protection#366675777576505257185e5e4518515940"><span class="__cf_email__" data-cfemail="faaab9bbb9ba9c9e9bd4929289d49d958c">[email protected]</span></a>, or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area). 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 <a href="https://www.fda.gov/AdvisoryCommittees/default.htm">https://www.fda.gov/AdvisoryCommittees/default.htm</a> 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)).
Section 503B of the FD&C Act describes the conditions that must be
satisfied for drug products compounded in an outsourcing facility to be
exempt from: (1) section 502(f)(1), (2) section 505, and (3) section
582 (21 U.S.C. 360eee-1) (concerning drug supply chain security
requirements) of the FD&C Act.
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
[[Page 76480]]
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).
One of the conditions that must be satisfied for the compounded
drug to qualify for the exemptions under section 503A or section 503B
of the FD&C Act is that the drug that is compounded does not appear on
a list published by the Secretary of drugs that have been withdrawn or
removed from the market because such drug products or components of
such drug products have been found to be unsafe or not effective
(Withdrawn or Removed List) (see sections 503A(b)(1)(C) and 503B(a)(4)
of the FD&C Act). The Withdrawn or Removed List is codified at Sec.
216.24 (21 CFR 216.24).
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. 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.
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Bulk drug substance Uses evaluated
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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..................... GHD and postoperative ileus.
Ipamorelin (free base).................
Kisspeptin-10.......................... Treatment of secondary
hypogonadism in men.
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The Committee will also discuss a revision FDA is considering to
the Withdrawn or Removed List. Specifically, FDA is considering whether
to amend Sec. 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.
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
<a href="https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm">https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm</a>. Scroll
down to the appropriate advisory committee meeting link. The meeting
will include slide 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 October 15, 2024, will be provided to the Committee. 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 amount of 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 extent 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 October 7, 2024. 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 Office of Media Affairs at
<a href="/cdn-cgi/l/email-protection#315755505e5c50715755501f5959421f565e47"><span class="__cf_email__" data-cfemail="5c3a383d33313d1c3a383d7234342f723b332a">[email protected]</span></a> or 301-796-4540.
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 <a href="https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm">https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm</a> 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
[[Page 76481]]
committee members, speakers, and guest speakers. The conditions for
issuance of a waiver under 21 CFR 10.19 are met.
Dated: September 12, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-21241 Filed 9-17-24; 8:45 am]
BILLING CODE 4164-01-P
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