[Federal Register Volume 89, Number 181 (Wednesday, September 18, 2024)]
[Notices]
[Pages 76478-76481]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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Substances List; Revisions to the Withdrawn or Removed List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: 
https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    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 https://www.regulations.gov 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: 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.
    <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 https://www.regulations.gov 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 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 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: <a href="/cdn-cgi/l/email-protection#b4e4f7f5f7f4d2d0d59adcdcc79ad3dbc2"><span class="__cf_email__" data-cfemail="366675777576505257185e5e4518515940">[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 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)).
    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.

------------------------------------------------------------------------
          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.....................  GHD and postoperative ileus.
Ipamorelin (free base).................
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 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 
https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. 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#86e0e2e7e9ebe7c6e0e2e7a8eeeef5a8e1e9f0"><span class="__cf_email__" data-cfemail="9ff9fbfef0f2fedff9fbfeb1f7f7ecb1f8f0e9">[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 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

[[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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