Document ID: FDA-2018-N-1768-0002
Agency: fda
Document Type: Notice
Title: Advisory Committee; Pharmacy Compounding Advisory Committee;
Renewal
Posted Date: 2020-12-04T05:00Z

[Federal Register Volume 85, Number 234 (Friday, December 4, 2020)]
[Notices]
[Pages 78338-78339]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26696]

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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 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 April 
25, 2022.

DATES: Authority for the Pharmacy Compounding Advisory Committee will 
expire on April 25, 2022, unless the Commissioner formally determines 
that renewal is in the public interest.

FOR FURTHER INFORMATION CONTACT: Yvette Waples, Division of Advisory 
Committee and Consultant Management, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, email: 
PCAC@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3, FDA is announcing 
the renewal of the Pharmacy Compounding Advisory Committee (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.
    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 four years. Almost all 
non-Federal members of this committee serve as Special Government 
Employees. 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

[[Page 78339]]

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 document is issued under the Federal Advisory Committee Act (5 
U.S.C. app.). For general information related to FDA advisory 
committees, please check https://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: November 30, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-26696 Filed 12-3-20; 8:45 am]
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