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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.


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 Year2020Committee 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 Date4/25/2020Designated Fed Officer Position Title*Designated Federal Officer
Date Of Renewal Charter4/25/2022Designated 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*(301) 796-9001
Effective Date Of Authority*11/21/1998Designated Federal Officer Fax*(301) 847-8533
Exempt From EO 13875 Discretionary CmteNot ApplicableDesignated Federal Officer Email*pcac@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?*The Committee did not meet during FY-20.

It is expected that the committee will meet one to two times during FY-21.
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-20
Recommendation RemarksAlthough this Committee did not meet in FY-20, considerable time was devoted to appointing members, maintaining associated records for these activities, and streamlining paper processes within FDA. In addition, time was spent in the routine care and maintenance of the Committee: the development of a financial report for this website; updating the roster and number of vacancies on our website; completing the annual ethics report; reviewing financial disclosures of current members and providing ethics training. Since the Committee did not meet, no reporting was required.
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*81Access Contact Designated Fed. Officer*Yes
Number Of Recommendations CommentThe Committee made 81 recommendations from FY-12 through FY-20. 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*$0.00Est Payments to Non-Fed Members Next FY*$7,700.00
Payments to Federal Members*$0.00Est. Payments to Fed Members Next FY*$0.00
Payments to Federal Staff*$174,963.00Estimated Payments to Federal Staff*$177,005.00
Payments to Consultants*$0.00Est. Payments to Consultants Next FY*$1,650.00
Travel Reimb. For Non-Federal Members*$0.00Est Travel Reimb Non-Fed Members nextFY*$11,688.00
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*$1,917.00
Other Costs$43,741.00Est. Other Costs Next FY*$47,239.00
Total Costs$218,704.00Est. Total Next FY*$247,199.00
Federal Staff Support (FTE)*1.10Est. Fed Staff Support Next FY*1.10
Cost RemarksThe Committee did not meet in FY-20.Est Cost RemarksThese estimated FY-21 costs include costs for 1 projected advisory committee meeting.
Hide Section - Interest Areas

Interest Areas

Category
Area
Food and Drugs
Food and Drugs
Health
Health Care
Safety
Treatment
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-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