Document ID: FDA-2018-N-1768-0001
Agency: fda
Document Type: Notice
Title: Advisory Committee; Pharmacy Compounding Advisory Committee, Renewal
Posted Date: 2018-06-11T04:00Z

[Federal Register Volume 83, Number 112 (Monday, June 11, 2018)]
[Notices]
[Pages 27009-27010]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12440]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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, 2020.

DATES: Authority for the Pharmacy Compounding Advisory Committee will 
expire on April 25, 2020, unless the Commissioner formally determines 
that renewal is in the public interest.

FOR FURTHER INFORMATION CONTACT: Cindy Chee, 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 protected].

SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by 
the Department of Health and Human Services pursuant to 45 CFR part 11 
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.
    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

[[Page 27010]]

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. 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 members who are identified 
with industry interests.
    Further information regarding the most recent charter and other 
information can be found at https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PharmacyCompoundingAdvisoryCommittee/ucm381305.htm 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: June 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12440 Filed 6-8-18; 8:45 am]
 BILLING CODE 4164-01-P