[Federal Register Volume 89, Number 146 (Tuesday, July 30, 2024)]
[Notices]
[Pages 61124-61125]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-16667]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1768]


Advisory Committee; Pharmacy Compounding Advisory Committee; 
Renewal

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; renewal of Federal advisory committee.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
announcing the renewal of the Pharmacy Compounding Advisory Committee 
by the Commissioner of Food and Drugs (the Commissioner). The 
Commissioner has determined that it is in the public interest to renew 
the Pharmacy Compounding Advisory Committee for an additional 2 years 
beyond the charter expiration date. The new charter will be in effect 
until the April 25, 2026, expiration date.

DATES: Authority for the Pharmacy Compounding Advisory Committee will 
expire on April 25, 2026, unless the Commissioner formally determines 
that renewal is in the public interest.

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 protected].

SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by 
the Department of Health and Human Services and by the General Services 
Administration, FDA is announcing the renewal of the Pharmacy 
Compounding Advisory Committee (the Committee). The Committee is a non-
discretionary Federal advisory committee established to provide advice 
to the Commissioner. The Committee advises the Commissioner or designee 
in discharging responsibilities as they relate to compounding drugs for 
human use and, as required, any other product for which FDA has 
regulatory responsibility.
    The Committee shall provide advice on scientific, technical, and 
medical issues concerning drug compounding under sections 503A and 503B 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353a and 353b), 
and, as required, any other product for which FDA has regulatory 
responsibility and make appropriate recommendations to the 
Commissioner.
    Pursuant to its charter, the Committee shall consist of a core of 
12 voting members including the Chair. Members and the Chair are 
selected by the Commissioner or designee from among authorities 
knowledgeable in the fields of pharmaceutical compounding, 
pharmaceutical manufacturing, pharmacy, medicine, and related 
specialties. These members will include representatives from the 
National Association of Boards of Pharmacy, the United States 
Pharmacopeia, pharmacists with current experience and expertise in 
compounding, physicians with background and knowledge in compounding, 
and patient and public health advocacy organizations. Members will be 
invited to serve for overlapping terms of up to 4 years.
    Non-Federal members of this committee will serve as Special 
Government Employees, representatives, or Ex-Officio members. Federal 
members will serve as Regular Government Employees or Ex-Officios 
members. The core of voting members may include one or more technically 
qualified members, selected by the Commissioner or designee, who are 
identified with consumer interests and are recommended by either a 
consortium of consumer-oriented organizations or other interested 
persons. In addition to the voting members, the Committee may include 
one or more non-voting representative members who are identified with 
industry interests. There may also be an alternate industry 
representative.
    The Commissioner or designee shall have the authority to select 
members of other scientific and technical FDA advisory committees 
(normally not to exceed 10 members) to serve temporarily as voting 
members and to designate consultants to serve temporarily as voting 
members when: (1) expertise is required that is not available among 
current voting standing members of the Committee (when additional 
voting members are added to the Committee to provide needed expertise, 
a quorum will be based on the combined total of regular and added 
members), or (2) to comprise a quorum when, because of unforeseen 
circumstances, a quorum is or will be lacking. Because of the size of 
the Committee and the variety in the types of issues that it will 
consider, FDA may, in connection with a particular committee meeting, 
specify a quorum that is less than a majority of the current voting 
members. The Agency's regulations (21 CFR 14.22(d)) authorize a 
committee charter to specify quorum requirements.
    If functioning as a medical device panel, an additional non-voting

[[Page 61125]]

representative member of consumer interests and an additional non-
voting representative member of industry interests will be included in 
addition to the voting members.
    Further information regarding the most recent charter and other 
information can be found at https://www.fda.gov/advisory-committees/pharmacy-compounding-advisory-committee/pharmacy-compounding-advisory-committee-charter or by contacting the Designated Federal Officer (see 
FOR FURTHER INFORMATION CONTACT). In light of the fact that no change 
has been made to the committee name or description of duties, no 
amendment will be made to 21 CFR 14.100.
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app.). For general information related to FDA advisory 
committees, please visit us at http://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: July 24, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-16667 Filed 7-29-24; 8:45 am]
BILLING CODE 4164-01-P