Document ID: FDA-2018-N-1768-0003
Agency: fda
Document Type: Notice
Title: Advisory Committee; Pharmacy Compounding Advisory Committee; Renewal
Posted Date: 2022-07-06T04:00Z

[Federal Register Volume 87, Number 128 (Wednesday, July 6, 2022)]
[Notices]
[Page 40250]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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, [email protected].

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 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 https://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: June 24, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-14346 Filed 7-5-22; 8:45 am]
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