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###### Department of Health and Human Services

###### Food and Drug Administration

          - [Docket No. FDA-2018-N-1768]

# AGENCY:

Food and Drug Administration, Health and Human Services (HHS).

# ACTION:

Notice; renewal of federal 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 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,                         *PCAC@fda.hhs.gov.*

# 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]

BILLING CODE 4164-01-P