Pharmacy Compounding Advisory Committee Charter
ADVISORY COMMITTEE’S OFFICIAL DESIGNATION
Pharmacy Compounding Advisory Committee (the Committee)
AUTHORITY
The Pharmacy Compounding Advisory Committee is required by section 503A and section 503B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353a(c)(1) and 21 U.S.C. 353b(c)(2)). The committee also is authorized by 15 U.S.C. 1451 et seq.; 21 U.S.C. 321, 341, 342, 343, 343-1, 344, 345, 346, 348, 349, 350, 350a, 351, 352, 353(f), 355, 355h, 360b, 360c-j, 371, 375, 376, 378, 379e, 381, 393, 394, 881(b); 42 U.S.C. 217a, 241, 242, 242a, 262, 264; 21 CFR Part 14; and is governed by the Federal Advisory Committee Act, as amended (5 U.S.C. 1001 et seq).
OBJECTIVES AND SCOPE OF ACTIVITIES
The Committee advises and informs the Commissioner of Food and Drugs (the Commissioner) or designee(s) in discharging responsibilities as they relate to compounding drugs for human use and, as required, any other product for which the Food and Drug Administration (FDA) has regulatory responsibility. The goal of this Committee is to convene experts to provide recommendations based on their interpretation of evidence, informed by their scientific, clinical, or other relevant expertise. The recommendations of this Committee will help FDA make informed decisions about the product/s or issues under consideration. For clarity, the Committee provides advice and recommendations, but FDA retains full regulatory decision-making authority on the issues associated with the product/s or issues under consideration.
DESCRIPTION OF DUTIES
The Committee reviews and evaluates scientific, technical, and medical issues concerning drug compounding under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act and, as required, any other product for which the Food and Drug Administration has regulatory responsibility, and makes appropriate recommendations to the Commissioner of Food and Drugs. The Committee may consider the quality and relevance of FDA’s research program, which provides scientific support for the regulation of these products and makes appropriate recommendations to the Commissioner.
AGENCY OR FEDERAL OFFICIAL RECEIVING THE ADVISORY COMMITTEE'S ADVICE/RECOMMENDATIONS
The Committee provides advice to the Commissioner of Food and Drugs.
SUPPORT
Management and support services shall be provided by the Office of the Commissioner, Principal Deputy Commissioner, and / or the relevant Centers, Offices, and Programs.
ESTIMATED ANNUAL OPERATING COSTS AND STAFF YEARS
FDA estimates the following annual operating costs and staff years associated with this committee.
(1) Annual budget and expected costs: $125,736
(i) The estimated person years of Federal staff support required is 0.30 at an estimated annual cost of $59,938.
(ii) The estimated annual payments to Committee members is $13,758 for a total of 14 members, and
(iii) The estimated annual reimbursable costs, including travel and related expenses for members, is $17,540.
ESTIMATED NUMBER AND FREQUENCY OF MEETINGS
FDA will convene the Committee as needed consistent with the Agency’s needs and applicable legal and regulatory authorities.
The frequency of meetings will vary from year to year, depending on the specific issues upon which Committee’s advice and recommendations are sought. FDA is not required to convene the Committee each calendar year.
Except where legally required to conduct a closed meeting, the committee meetings will be open to the public, consistent with 5 U.S.C. §1009 and in the interest of scientific innovation, education, and transparency.
Meetings shall be open to the public except as determined otherwise by the Commissioner or designee in accordance with the Government in the Sunshine Act (5 U.S.C. 552b(c)) and the Federal Advisory Committee Act. Notice of all meetings shall be given to the public.
DURATION
Continuing.
TERMINATION
Unless renewed by appropriate action the Pharmacy Compounding Advisory Committee will become administratively inactive two years from the date the charter is filed
MEMBERSHIP AND DESIGNATION
The Committee shall consist of a core of at least 10 voting members including the Chair. Subject to legal and regulatory requirements, members and the Chair are selected by and serve at the discretion of the Commissioner or designee. Each member, including the Chair, will be selected 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 (NABP), the United States Pharmacopeia (USP), 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 terms of up to four years, or for less time in the discretion of the Commissioner or designee. Non-Federal members of this Committee will serve as Special Government Employees or representatives. Federal members will serve as Regular Government Employees or Ex-Officios. In addition to the voting members, the Commissioner or designee may identify consumer and/or industry representatives to join the Committee (or serve as alternate representatives) as non-voting representative members(s), via a process consistent with legal and regulatory requirements.
The Commissioner or designee shall have the authority to select members of other scientific and technical FDA advisory committees to serve temporarily as voting members and to designate Special Government Employees to serve temporarily as voting members when: (1) expertise is required that is not available among current voting standing members of the Committee (when additional voting members are added to the Committee to provide needed expertise, a quorum will be based on the combined total of regular and added members), or (2) to comprise a quorum when, because of unforeseen circumstances, a quorum is or will be lacking.
A quorum for the Committee is a majority of the current voting members present at the time, provided that FDA may specify a quorum that is less than a majority of the current voting members because of the size of the Committee and the variety in the types of issues that it will consider, or other reason determined appropriate in accordance with legal and regulatory requirements. 21 CFR §14.22(d).
If functioning as a medical device panel, an additional non-voting representative member of consumer interests and an additional non-voting representative member of industry interests will be included in addition to the voting members.
Members appointed to an advisory committee serve for the duration of the committee, or until their terms expire, they resign, or they are removed from membership by the Commissioner or designee. Committee members’ terms may be ended prior to their date of expiration, for reasons determined to be good cause. Good cause includes excessive absenteeism from committee meetings, a demonstrated bias that interferes with the ability to render objective advice, failure to abide by established procedures, or violation of other applicable rules and regulations.
SUBCOMMITTEE
Temporary subcommittees consisting of two or more Committee members may be established by the Commissioner or designee as needed to address specific issues within their respective areas of expertise.
If requested, subcommittees may make preliminary recommendations to the full Committee regarding specific issues for subsequent action by the full Committee. Subcommittees must report back to the parent committee and must not provide advice or work products directly to the agency or any other Federal officer.
Any subcommittee that includes individuals who are not members of the parent Committee shall require a separate establishment charter in accordance with applicable Federal Advisory Committee Act regulations.
FILING DATE
April 25, 2026
APPROVED:
Date: April 25, 2026
Dr. Sara Brenner, M.D., M.P.H.
Principal Deputy Commissioner