Notice2022-14346
Advisory Committee; Pharmacy Compounding Advisory Committee; Renewal
Primary source
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Published
July 6, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) 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, 2024, expiration date.
Full Text
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<title>Federal Register, Volume 87 Issue 128 (Wednesday, July 6, 2022)</title>
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[Federal Register Volume 87, Number 128 (Wednesday, July 6, 2022)]
[Notices]
[Page 40250]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-14346]
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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, Health and Human Services (HHS).
ACTION: Notice; renewal of federal advisory committee.
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SUMMARY: The Food and Drug Administration (FDA) 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, 2024, expiration date.
DATES: Authority for the Pharmacy Compounding Advisory Committee will
expire on April 25, 2024, 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, <a href="/cdn-cgi/l/email-protection#dd8d9e9c9e9dbbb9bcf3b5b5aef3bab2ab"><span class="__cf_email__" data-cfemail="baeaf9fbf9fadcdedb94d2d2c994ddd5cc">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3, 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 of Food and Drugs.
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 U.S. 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. 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.
Further information regarding the most recent charter and other
information can be found at <a href="https://www.fda.gov/advisory-committees/pharmacy-compounding-advisory-committee/pharmacy-compounding-advisory-committee-charter">https://www.fda.gov/advisory-committees/pharmacy-compounding-advisory-committee/pharmacy-compounding-advisory-committee-charter</a> 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 <a href="https://www.fda.gov/AdvisoryCommittees/default.htm">https://www.fda.gov/AdvisoryCommittees/default.htm</a>.
Dated: June 24, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-14346 Filed 7-5-22; 8:45 am]
BILLING CODE 4164-01-P
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