[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]
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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, 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
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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]
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