U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. About FDA
  3. Partnerships: Enhancing Science Through Collaborations With FDA
  4. FDA Memoranda of Understanding
  5. Non-Profit and Other MOUs
  6. MOU 225-24-020
  1. Non-Profit and Other MOUs

MOU 225-24-020

MEMORANDUM OF UNDERSTANDING
BETWEEN
the
U.S. FOOD AND DRUG ADMINISTRATION,
CENTER FOR DRUG EVALUATION AND RESEARCH
and the
UNITED STATES PHARMACOPEIA

I. Purpose and Goals:

This Memorandum of Understanding (“MOU” or “Agreement”) provides a framework for collaborative efforts between the U.S. Food and Drug Administration, Center for Drug Evaluation and Research (“FDA” or “the Agency”) and the United States Pharmacopeia (“USP”), hereinafter jointly referred to as the Parties. FDA and USP share closely related missions to advance public health by supporting innovation and helping to ensure the quality, safety, and benefit of drugs. Collaboration between FDA and USP is essential for the development and availability of compendial quality standards that are aligned with statutory and regulatory requirements for drugs marketed in the United States. This MOU is intended to clarify roles, responsibilities, and collaborative communications primarily related to the FDA-USP Government Liaison Program (hereafter referred to as “GLP”). FDA government liaisons may be referenced as “FDA GLs.” This Agreement is not intended to limit collaborative efforts between FDA and USP to those strictly conducted through the GLP. Collaborative efforts between the Parties may take many forms and these broader efforts to promote engagement can help to ensure the success of the FDA GLP.

II. Background:

FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act, as amended (21 U.S.C. 301, et seq.). FDA promotes and protects the public health by ensuring the safety, efficacy, and security of drugs, biologics, veterinary products, and medical devices in addition to the regulation of foods, dietary supplements, and tobacco products. To accomplish its mission, FDA must stay abreast of medical and scientific developments and communicate with stakeholders about complex public health issues and efforts to ensure continued availability of high-quality drug products. Collaboration with USP generally, and via the GLP specifically, greatly contributes to FDA’s mission by enabling the development of compendial quality standards that receive FDA input through the representation of FDA GLs participating in the work of USP Expert Bodies.

USP is an independent, scientific nonprofit organization focused on building trust in the supply of quality drugs, dietary supplements, and foods. Through the application of rigorous science and the public quality standards, USP helps protect patient safety and improve the health of people around the world.

USP’s collaboration with FDA advances its public health mission by helping to ensure, where applicable, that its compendial standards are consistent with FDA’s statutory and regulatory requirements and informed by scientific and regulatory input from FDA and stakeholders. The result is sound compendial standards based on rigorous science that FDA can enforce under the Federal Food, Drug, and Cosmetic Act.

Before the execution of this MOU, the Parties have maintained a longstanding collaborative relationship by working together to establish and manage the GLP through regular interactions between FDA Compendial Operations and Standards Staff and USP staff. This MOU formalizes that relationship and is not intended to limit other collaborative efforts between the Parties.

III. Substance of Agreement:

A. Commitment to Develop “Best Practices Documents”

The Parties agree to jointly develop a set of “best practices documents” containing guidelines to maximize the collaborative potential of the GLP. Best practices documents are intended to reflect the evolving rules and procedural framework of USP and the regulatory and procedural framework of FDA, and benefit both Parties by affording flexibility to articulate operational detail on an ongoing timely basis. An initial list of best practices topics to include in the best practices documents appears in section III.B. The list is not exhaustive, and best practices topics may be added or removed as the Parties jointly decide. Best practices documents would be completed sequentially in an order mutually determined by the Parties. When completed, each best practices document would wholly incorporate the provisions and terms of the MOU by reference. Given the practical implication of the best practices documents in furthering the goals of this MOU, the Parties intend to complete and periodically update, as necessary, best practices documents in a timely manner.

B. List of Best Practices Topics for the Best Practices Documents

As of the date this MOU is executed, the Parties agree to develop best practices documents in accordance with section III.A. and pursuant to USP’s governing frameworks and FDA’s policies and routine practices. The following is an initial list of topics for consideration in the best practices documents. As noted in section III.A., this list is not intended to be exhaustive, and topics may be added or removed as the Parties jointly decide.

  • Best Practices for Distribution of Meeting Materials. Best practices guidelines will be developed to delineate how and when FDA GLs receive pre-meeting materials (e.g., meeting invites, agenda, and/or briefing materials).
  • Best Practices for Open and Closed Meetings. Best practices guidelines will be developed that: (1) delineate the framework that a USP Chair uses to decide whether an FDA GL should be precluded from participating in part or all of an Expert Body meeting; (2) set forth a model for how such decisions are communicated to FDA GLs; and (3) describe means for discussing such a decision.
  • Best Practices for Facilitating Participation From FDA Government Liaisons. Best practices guidelines will be developed that comprehensively address expectations for FDA GL participation and input at Expert Body meetings, including guidelines to facilitate FDA GL review of, and any necessary comment on, information applicable to draft standards in progress before any publication in Pharmacopeial Forum. The guidelines would also include a framework for when and how FDA broad policy issues (those impacting more than a single United States Pharmacopeia-National Formulary monograph) may be addressed and communicated to USP during the standard- setting process.

C. Responsibilities of the Parties

  • FDA agrees:
    • To review pre-meeting materials before applicable meetings, and when feasible, engage on compendial topics across the Agency before USP meetings, including Expert Body meetings, to help ensure productive dialogue at USP meetings.
    • To actively participate in USP meetings, including Expert Body meetings, and convey input, when feasible, on behalf of FDA.
    • To provide training and prepare FDA GLs to maximize collaboration effectiveness, as further articulated in a related best practices document.
    • When feasible, to respond to USP inquiries before publication of a standard in Pharmacopeial Forum, as articulated in a best practices document.
    • Where feasible, to inform and engage USP on issues that may apply to multiple monographs or other United States Pharmacopeia-National Formulary standards.
  • USP agrees:
    • To inform the appropriate FDA GL, in a timely manner, about all relevant meetings associated with the Expert Body to which the FDA GL is assigned.
    • To make Expert Body pre-meeting materials available to FDA with sufficient lead time to allow for careful review and analysis by assigned FDA GLs as further articulated in a related best practices document.
    • To clarify and make transparent its policies related to FDA GL participation during USP Expert Body meetings, as further articulated in a designated best practices document.
    • To explore and implement processes for considering FDA’s early input in the USP standard-setting process and provide feedback on the input as further articulated in a related best practices document.
    • To identify a point of contact(s) for compendial policy interactions with FDA.

D. Timing

The Parties agree to establish timelines for the completion of the best practices documents. To the extent that best practices documents require changes to the USP governing frameworks or FDA’s policies or routine practices, such changes could potentially impact the timeline for completion of the affected best practices documents.

E. Confidential Information

The Parties will not, as a part of the activities covered by this MOU, share any non- public information, including confidential commercial or financial information (21 C.F.R 20.61) or trade secret information (21 U.S.C. 360j(c)) obtained by or provided directly to FDA from a third party. Access to non-public information shall be governed by separate Confidentiality Disclosure Agreements, to include 21
C.F.R. 20.85.

F. Governing Law and Limitation of Liability

U.S. Federal law governs this MOU for all purposes, including, but not limited to, determining the validity of the MOU, the meaning of its provisions, and the rights, obligations, and remedies of the Parties. To the fullest extent permitted by Federal or other applicable law, in no event shall FDA or USP be liable for any loss, claim, damage, or liability, of any kind or nature whatsoever that may arise from or in connection with this Agreement.
 
The Parties recognize that this MOU is not intended to, and may not be relied on, to create any right or benefit, substantive or procedural by any party against FDA or USP. Nothing in this MOU alters the statutory authorities or obligations of FDA.

G. Resource Obligations

All activities undertaken pursuant to this MOU are subject to the availability of personnel, resources, and funds. The MOU does not create binding, enforceable obligations against FDA or USP.

IV. Name and Address of Participating Parties:

  • U.S. Pharmacopeia
    12601 Twinbrook Parkway
    Rockville, MD 20852
  • U.S. Food and Drug Administration
    10903 New Hampshire Avenue
    Silver Spring, MD 20993

V. Liaison Officers:

  • For USP
    12601 Twinbrook Parkway
    Rockville, MD 20852
    (301) 692-3395
  • For FDA/CDER
    10903 New Hampshire Avenue, Room 1110
    Silver Spring, MD 20993
    (301) 796-0603

VI. Period of Agreement:

This Agreement becomes effective upon acceptance by both Parties, as evidenced by their signatures below, and will continue in effect until notice of termination is tendered in writing by either party 30 days in advance of intended termination or as mutually agreed to by both Parties.

VII. Modification of Agreement:

This Agreement may not be modified except by the mutual agreement of both Parties. Any modification must be in writing and executed by the respective Parties’ duly authorized representatives.
 
By signing this Agreement below, the signatories indicate that they have read and understand the Agreement, and that they are duly authorized to sign it.

APPROVED AND ACCEPTED FOR USP

/s/
Ronald T. Piervincenzi
Date: 08/30/2024

/s/
Carrie Harney
Date: 08/30/2024

APPROVED AND ACCEPTED FOR THE FDA

/s/
Patrizia A. Cavazzoni
Date: 09/03/2024

/s/
Pallavi Nithyanandan
Date: 09/02/2024

Back to Top