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Committee Detail

Note: An Annual Comprehensive Review, as required by §7 of the Federal Advisory Committee Act, is conducted each year on committee data entered for the previous fiscal year (referred to as the reporting year). The data for the reporting year is not considered verified until this review is complete and the data is moved to history for an agency/department. See the Data From Previous Years section at the bottom of this page for the committee’s historical, verified data.

Details on agency responses to committee recommendations can be found under the Performance Measures section for each committee in the fields “Agency Feedback” and “Agency Feedback Comment.”


HHS - 5220 - Pharmacy Compounding Advisory Committee - Statutory (Congress Created)
Hide Section - GENERAL INFORMATION

GENERAL INFORMATION

Committee NamePharmacy Compounding Advisory CommitteeAgency NameDepartment of Health and Human Services
Fiscal Year2022Committee Number5220
Original Establishment Date11/21/1998Committee StatusChartered
Actual Termination Date Committee URLhttp://www.fda.gov/AdvisoryCommittees/Committee...
New Committee This FYNoPresidential Appointments*No
Terminated This FYNoMax Number of Members*14
Current Charter Date4/25/2022Designated Fed Officer Position Title*Designated Federal Officer
Date Of Renewal Charter4/25/2024Designated Federal Officer Prefix
Projected Termination Date Designated Federal Officer First Name*Takyiah
Exempt From Renewal*NoDesignated Federal Officer Middle Name
Specific Termination AuthorityDesignated Federal Officer Last Name*Stevenson
Establishment Authority*Statutory (Congress Created)Designated Federal Officer SuffixPharm.D.
Specific Establishment Authority*21 U.S.C. 353aDesignated Federal Officer Phone*(240) 402-2507
Effective Date Of Authority*11/21/1998Designated Federal Officer Fax*(301) 847-8533
Exempt From EO 13875 Discretionary CmteNot ApplicableDesignated Federal Officer Email*takyiah.stevenson@fda.hhs.gov
Committee Type*Continuing
Presidential*No
Committee Function*Scientific Technical Program Advisory Board
Hide Section - RECOMMENDATION/JUSTIFICATIONS

RECOMMENDATION/JUSTIFICATIONS

Agency Recommendation*Continue
Legislation to Terminate RequiredNot Applicable
Legislation StatusNot Applicable
How does cmte accomplish its purpose?*The Committee provides advice on 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 make appropriate recommendations to the Commissioner of Food and Drugs.
How is membership balanced?*Members are authorities in the fields of pharmacy compounding, pharmaceutical manufacturing, pharmacy, medicine, and related specialties. 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 member(s) who are identified with industry interests.
How frequent & relevant are cmte mtgs?*In FY-22, the Committee held one meeting.

On June 8, 2022, the Committee discussed the following four bulk drug substances nominated for inclusion on the list of bulk drug substances that can be used to compound drug products in accordance with section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act), although they are neither the subject of an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph nor components of FDA-approved drugs (503A Bulks List): ammonium tetrathiomolybdate (ATTM), enclomiphene citrate, ferric subsulfate, and glutathione. The committee also discussed revisions FDA is considering to the list of drugs that have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective (Withdrawn or Removed List). FDA now is considering whether to amend the rule to add one more entry to the list: Lorcaserin Hydrochloride: All drug products containing lorcaserin hydrochloride. In the session regarding enclomiphene, the majority of the members (4 Yeses to 8 Noes) voted against placing enclomiphene citrate on the 503A Bulks List. In the session regarding glutathione, the majority of committee members (8 Yeses, 5 Noes, 1 abstention) voted in favor of adding glutathione to the 503A Bulks List. In the session regarding ATTM, the majority of the members (2 Yeses to 13 Noes) voted against placing ATTM on the 503A Bulks List. In the session regarding ferric subsulfate, the Committee (13 members) unanimously agreed that ferric subsulfate solid or powder should not be included on the 503A Bulks List. In the final session regarding lorcaserin hydrochloride, the Committee (10 members) unanimously agreed that lorcaserin hydrochloride: All drug products containing “lorcaserin hydrochloride” be added to the Withdrawn or Removed List for reasons of safety concerns noted in the presentations. Agency Action: The Agency is reviewing recommendations made at the meeting.

It is expected that the committee will meet 1 to 2 times during FY-23.
Why advice can't be obtained elsewhere?*Members of the Committee are drawn from academia, research and/or clinical practice. Their advice and input lends credibility to FDA regulatory decisions. The alternate means of obtaining this advice would involve the recruitment of large numbers of scientists on a full-time basis at a maximum rate of compensation.
Why close or partially close meetings?The Committee held no closed meetings in FY-22.
Recommendation RemarksThere were no reports required for this Committee in FY-22.
Hide Section - PERFORMANCE MEASURES

PERFORMANCE MEASURES

Outcome Improvement To Health Or Safety*YesAction Reorganize Priorities*Yes
Outcome Trust In GovernmentYesAction Reallocate ResourcesYes
Outcome Major Policy ChangesYesAction Issued New RegulationsYes
Outcome Advance In Scientific ResearchYesAction Proposed LegislationYes
Outcome Effective Grant MakingNoAction Approved Grants Or Other PaymentsNo
Outcome Improved Service DeliveryNoAction OtherYes
Outcome Increased Customer SatisfactionYesAction CommentFDA approves or chooses not to approve an investigational new medical product.
Outcome Implement Laws/Reg RequirementsYesGrants Review*No
Outcome OtherNoNumber Of Grants Reviewed0
Outcome CommentNANumber Of Grants Recommended0
Cost Savings*Unable to DetermineDollar Value Of Grants Recommended$0.00
Cost Savings CommentThe utilization of the Pharmacy Compounding Advisory Committee enabled the Agency to obtain required and frequently scarce professional services from medical and scientific experts not otherwise available to the Agency; and to obtain the services of these experts only on an as needed basis rather than on a full time basis. The service of the Committee resulted in advice for the improvement of the public health, for which it is difficult to assign a financial value.Grants Review CommentNA
Number Of Recommendations*91Access Contact Designated Fed. Officer*Yes
Number Of Recommendations CommentThe Committee made 91 recommendations from FY-12 through FY-22. The Committee was re-established in FY-12.Access Agency WebsiteYes
% of Recs Fully Implemented*84.00%Access Committee WebsiteYes
% of Recs Fully Implemented CommentThe function of an advisory committee is purely advisory in nature. Although the FDA most often accepts the recommendations from its committees, the advice is purely advisory in nature, therefore, the Agency has the option of not implementing the advice. This number represents an approximation of the percentage of recommendations that the agency has fully implemented or plans to fully implement.Access GSA FACA WebsiteYes
% of Recs Partially Implemented*10.00%Access PublicationsYes
% of Recs Partially Implemented CommentThe function of an advisory committee is purely advisory in nature. Although the FDA most often accepts the recommendations from its committees, the advice is purely advisory in nature, and therefore, the Agency has the option of not implementing the advice.Access OtherNo
Agency Feedback*YesAccess CommentNA
Agency Feedback Comment*When appropriate, information is made available to the public. Actions related to guidance documents or other general matters or issues are available publicly when implemented.Narrative Description*FDA’s strategic priorities in responding to the public health challenges of the 21st century are to advance regulatory science and innovation; strengthen the safety and integrity of the global supply chain; strengthen compliance and enforcement activities to support public health; expand efforts to meet the needs of special populations; advance medical countermeasures and emergency preparedness; advance food safety and nutrition; promote public health by advancing the safety and effectiveness of medical products; establish an effective tobacco regulation, prevention, and control program; and manage for organizational excellence and accountability. 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, and, as required, any other product for which the Food and Drug Administration has regulatory responsibility, and make appropriate recommendations to the Commissioner of Food and Drugs. This supports the development of safe and effective new medical technologies, and advances the status of the Agency as a science-based and science-led regulatory agency, providing global leadership in the protection of public health.
Hide Section - COSTS

COSTS

Payments to Non-Federal Members*$12,386.00Est Payments to Non-Fed Members Next FY*$11,189.00
Payments to Federal Members*$0.00Est. Payments to Fed Members Next FY*$589.00
Payments to Federal Staff*$182,810.00Estimated Payments to Federal Staff*$191,622.00
Payments to Consultants*$0.00Est. Payments to Consultants Next FY*$0.00
Travel Reimb. For Non-Federal Members*$0.00Est Travel Reimb Non-Fed Members nextFY*$0.00
Travel Reimb. For Federal Members*$0.00Est Travel Reimb For Fed Members*$0.00
Travel Reimb. For Federal Staff*$0.00Est. Travel Reimb to Fed Staff Next FY*$0.00
Travel Reimb. For Consultants*$0.00Est Travel Reimb to Consultants Next FY*$0.00
Other Costs$51,932.00Est. Other Costs Next FY*$54,199.00
Total Costs$247,128.00Est. Total Next FY*$257,599.00
Date Cost Last Modified11/18/2022 9:26 AMEst. Fed Staff Support Next FY*1.10
Federal Staff Support (FTE)*1.10Est Cost Remarks
Cost Remarks  
Hide Section - Interest Areas

Interest Areas

Category
Area
Food and Drugs
Food and Drugs
Health
Treatment
Health Care
Safety
Hide Section - MEMBERS,MEETINGS AND ADVISORY REPORTS

MEMBERS,MEETINGS AND ADVISORY REPORTS

To View all the members, meetings and advisory reports for this committee please click here
Hide Section - CHARTERS AND RELATED DOCS

CHARTERS AND RELATED DOCS

No Documents Found
Hide Section - DATA FROM PREVIOUS YEARS

DATA FROM PREVIOUS YEARS

Committee

Data from Previous Years

 
ActionCommittee System IDCommittee NameFiscal Year
 COM-040280Pharmacy Compounding Advisory Committee2021
 COM-038555Pharmacy Compounding Advisory Committee2020
 COM-036427Pharmacy Compounding Advisory Committee2019
 COM-034633Pharmacy Compounding Advisory Committee2018
 COM-001999Pharmacy Compounding Advisory Committee2017
 COM-002403Pharmacy Compounding Advisory Committee2016
 COM-004107Pharmacy Compounding Advisory Committee2015
 COM-004759Pharmacy Compounding Advisory Committee2014
 COM-005875Pharmacy Compounding Advisory Committee2013
 COM-006562Pharmacy Compounding Advisory Committee2012
 COM-015911Pharmacy Compounding Advisory Committee2003
 COM-016828Pharmacy Compounding Advisory Committee2002
 COM-017669Pharmacy Compounding Advisory Committee2001
 COM-018351Pharmacy Compounding Advisory Committee2000
 COM-019825Pharmacy Compounding Advisory Committee1999
 COM-020402Pharmacy Compounding Advisory Committee1998