[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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