FACACLASSIC

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HHS - 5220 - Pharmacy Compounding Advisory Committee - Statutory (Congress Created)

GENERAL INFORMATION

Committee Name	Pharmacy Compounding Advisory Committee	Agency Name	Department of Health and Human Services
Fiscal Year	2025	Committee Number	5220
Original Establishment Date	11/21/1998	Committee Status	Chartered
Actual Termination Date		Committee URL	http://www.fda.gov/AdvisoryCommittees/Committee...
Actual Merged Date		Presidential Appointments*	No
New Committee This FY	No	Max Number of Members*	14
Terminated This FY	No	Designated Fed Officer Position Title*	Designated Federal Officer
Merged This FY		Designated Federal Officer Prefix
Current Charter Date	4/25/2024	Designated Federal Officer First Name*	Takyiah
Date Of Renewal Charter	4/25/2026	Designated Federal Officer Middle Name
Projected Termination Date		Designated Federal Officer Last Name*	Stevenson
Exempt From Renewal*	No	Designated Federal Officer Suffix	Pharm.D.
Specific Termination Authority		Designated Federal Officer Phone*	(240) 402-2507
Establishment Authority*	Statutory (Congress Created)	Designated Federal Officer Fax*	(301) 847-8533
Specific Establishment Authority*	21 U.S.C. 353a	Designated Federal Officer Email*	takyiah.stevenson@fda.hhs.gov
Effective Date Of Authority*	11/21/1998
Exempt From EO 13875 Discretionary Cmte	Not Applicable
Committee Type*	Continuing
Presidential*	No
Committee Function*	Scientific Technical Program Advisory Board

RECOMMENDATION/JUSTIFICATIONS

Agency Recommendation*	Continue
Legislation to Terminate Required	Not Applicable
Legislation Status	Not 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 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 (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. 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-25, the Committee held two meetings. On October 29, 2024, the Committee discussed the following 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): ibutamoren mesylate, L-theanine, ipamorelin-related bulk drug substances (ipamorelin acetate and ipamorelin (free base)), and kisspeptin-10. 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: hydroxyprogesterone caproate: all drug products containing hydroxyprogesterone caproate to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous birth. In the session regarding L-theanine, the majority of the members (1 Yeses to 12 Noes) voted against placing L-theanine on the 503A Bulks List. In the session regarding Ibutamoren mesylate, the majority of committee members (1 Yeses to 13 Noes) voted against placing Ibutamoren mesylate to the 503A Bulks List. In the session regarding Ipamorelin-related bulk drug substances, the majority of the members (0 Yeses, 12 Noes, 1 abstention) voted against placing Ipamorelin (free base) on the 503A Bulks List; and the majority of the members (0 Yeses, 12 Noes, 1 abstention) voted against placing Ipamorelin acetate on the 503A Bulks List. In the session regarding Kisspeptin-10, the Committee (11 members) unanimously agreed that Kisspeptin-10 should not be included on the 503A Bulks List. In the final session regarding Hydroxyprogesterone caproate, the Committee (10 members) unanimously agreed that Hydroxyprogesterone caproate: All drug products containing hydroxyprogesterone caproate to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth be ADDED to the Withdrawn or Removed List based on lack of efficacy concerns noted in the presentations. Agency Action: The Agency is reviewing recommendations made at the meeting. On December 4, 2024, the Committee discussed the following 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): AOD-9604-related bulk drug substances (AOD-9604 acetate, and AOD-9604 (free base)), CJC-1295-related bulk drug substances (CJC-1295 (free base), CJC-1295 acetate, CJC-1295 with drug affinity complex (DAC) (free base), CJC-1295 DAC acetate, and CJC-1295 DAC trifluoroacetate)), and Thymosin alpha-1-related bulk drug substances (Thymosin alpha-1 acetate, and Thymosin alpha-1 (free base)). In the session regarding CJC-1295-related bulk drug substances, the Committee (13 members) unanimously agreed that CJC-1295 (free base), CJC-1295 DAC (free base), CJC-1295 DAC acetate, and CJC-1295 DAC trifluoroacetate should not be included on the 503A Bulks List; the majority of the members (1 Yes to 12 Noes) voted against placing CJC-1295 acetate on the 503A Bulks List. In the session regarding AOD-9604-related bulk drug substances, the Committee (12 members) unanimously agreed that AOD-9604 (free base) and AOD-9604 acetate should not be included on the 503A Bulks List. In the session regarding Thymosin alpha-1-related bulk drug substances, the majority of the members (4 Yes to 17 Noes) voted against placing Thymosin alpha-1 (free base) and Thymosin alpha-1 acetate on the 503A Bulks List. 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-26.
Why advice can't be obtained elsewhere?*	Members of the Committee are drawn from academia, research and/or clinical practice. They provide advice and input that FDA considers as part of its regulatory decision-making. 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-25.
Recommendation Remarks	There were no reports required for this Committee in FY-25.

PERFORMANCE MEASURES

Outcome Improvement To Health Or Safety*	Yes	Action Reorganize Priorities*	Yes
Outcome Trust In Government	Yes	Action Reallocate Resources	Yes
Outcome Major Policy Changes	Yes	Action Issued New Regulations	Yes
Outcome Advance In Scientific Research	Yes	Action Proposed Legislation	Yes
Outcome Effective Grant Making	No	Action Approved Grants Or Other Payments	No
Outcome Improved Service Delivery	No	Action Other	Yes
Outcome Increased Customer Satisfaction	Yes	Action Comment	FDA approves or chooses not to approve an investigational new medical product.
Outcome Implement Laws/Reg Requirements	Yes	Grants Review*	No
Outcome Other	No	Number Of Grants Reviewed	0
Outcome Comment	NA	Number Of Grants Recommended	0
Cost Savings*	Unable to Determine	Dollar Value Of Grants Recommended	$0.00
Cost Savings Comment	The 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 Comment	NA
Number Of Recommendations*	106	Access Contact Designated Fed. Officer*	Yes
Number Of Recommendations Comment	The Committee made 106 recommendations from FY-12 through FY-25. The Committee was re-established in FY-12.	Access Agency Website	Yes
% of Recs Fully Implemented*	84.00%	Access Committee Website	Yes
% of Recs Fully Implemented Comment	The 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 Website	Yes
% of Recs Partially Implemented*	10.00%	Access Publications	Yes
% of Recs Partially Implemented Comment	The 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 Other	No
Agency Feedback*	Yes	Access Comment	NA
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 advances the status of the Agency as a science-based and science-led regulatory agency, providing global leadership in the protection of public health.

COSTS

1. Payments to Non-Federal Members*		1. Est Paymnts to Non-Fed Membrs Nxt FY*
2. Payments to Federal Members*		2. Est. Payments to Fed Members Next FY*
3. Payments to Federal Staff*		3. Estimated Payments to Federal Staff*
4. Payments to Consultants*		4. Est. Payments to Consultants Next FY*
5. Travel Reimb. For Non-Federal Membrs*		5. Est Travel Reimb Non-Fed Membr nxtFY*
6. Travel Reimb. For Federal Members*		6. Est Travel Reimb For Fed Members*
7. Travel Reimb. For Federal Staff*		7. Est. Travel Reimb to Fed Staf Nxt FY*
8. Travel Reimb. For Consultants*		8. Est Travel Reimb to Consltnts Nxt FY*
10. Other Costs		10. Est. Other Costs Next FY*
11. Total Costs	$0.00	11. Est. Total Next FY*	$0.00
Date Cost Last Modified	3/14/2025 9:48 AM	Est. Fed Staff Support Next FY*
Federal Staff Support (FTE)*		Est Cost Remarks
Cost Remarks

Interest Areas

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

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