[Federal Register Volume 89, Number 207 (Friday, October 25, 2024)]
[Notices]
[Pages 85219-85221]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-24828]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-4777]


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 December 4, 2024, from 8 a.m. to 3 
p.m. Eastern Time.

ADDRESSES: The meeting will be held at the FDA White Oak Campus, 10903 
New Hampshire Ave., 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-2024-N-4777. The docket will close on December 
3, 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 December 3, 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 November 19, 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 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:
    <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-4777 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.
    <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

[[Page 85220]]

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#e8b8aba9aba88e8c89c680809bc68f879e"><span class="__cf_email__" data-cfemail="2c7c6f6d6f6c4a484d0244445f024b435a">[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)).
    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.
    The Committee will discuss the following bulk drug substances being 
considered for inclusion on the 503A Bulks List: AOD-9604-related bulk 
drug substances (AOD-9604 acetate, and AOD-9604 (free base)), CJC-1295-
related bulk drug substances (CJC-1295 (free base), CJC-1295 acetate, 
CJC-1295 with drug affinity complex (DAC) (free base), CJC-1295 DAC 
acetate, and CJC-1295 DAC trifluoroacetate)), and Thymosin alpha-1-
related bulk drug substances (Thymosin alpha-1 acetate, and Thymosin 
alpha-1 (free base)). 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
------------------------------------------------------------------------
AOD-9604 (free base)..............  *Obesity.
AOD-9604 Acetate..................
CJC-1295 (free base)..............  Growth hormone deficiency.
CJC-1295 Acetate..................
CJC-1295 DAC (free base)..........
CJC-1295 DAC Acetate..............
CJC-1295 DAC Trifluoroacetate.....
Thymosin alpha-1(free base).......  Hepatitis B.
Thymosin alpha-1 Acetate..........  Hepatitis C.
                                    Human immunodeficiency virus (HIV).
                                    Coronavirus disease 2019 (COVID-19).
                                    Depressed response to vaccinations;
                                     adjuvant to flu vaccines.
                                    Malignant melanoma.
                                    Hepatocellular carcinoma (HCC).
                                    Non-small cell lung cancer (NSCLC).
                                    Sepsis.
                                    Infections after hematopoietic stem
                                     cell transplantation (HSCT).
                                    Chronic obstructive pulmonary
                                     disease (COPD).
                                    Myalgic encephalomyelitis and
                                     chronic fatigue syndrome (ME/CFS).
------------------------------------------------------------------------

    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 85221]]

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 November 19, 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 9:35 a.m., 
10:50 a.m., and 1:40 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 November 8, 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 
and the timeframe for the presentation by November 12, 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#422426232d2f23022426236c2a2a316c252d34"><span class="__cf_email__" data-cfemail="335557525c5e52735557521d5b5b401d545c45">[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 committee members, speakers, and 
guest speakers. The conditions for issuance of a waiver under 21 CFR 
10.19 are met.

    Dated: October 21, 2024.
Eric Flamm,
Acting Associate Commissioner for Policy.
[FR Doc. 2024-24828 Filed 10-24-24; 8:45 am]
BILLING CODE 4164-01-P


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