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MOU 225-23-005

This memorandum replaces MOU 225-19-014.

MEMORANDUM OF UNDERSTANDING
BETWEEN UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH AND
UNITED STATES CONSUMER PRODUCT SAFETY COMMISSION

ARTICLE I. PARTIES

The Parties to this Memorandum of Understanding ("MOU") are the United States Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research ("CDER"), and the United States Consumer Product Safety Commission ("Commission" or "CPSC"), Office of the Executive Director, Safety Operations.

ARTICLE II. PURPOSE

The purpose of this MOU is to set forth the terms and conditions under which the Parties may share information concerning household substances that are subject to the Poison Prevention Packaging Act ("PPPA"), 15 U.S.C. § 1471-75, including specifically, household substances that require "special packaging," as defined by 15 U.S.C. § 1471(4), and that may also be "drugs" under the Federal Food, Drug, and Cosmetic Act ("FD&C Act") (21 U.S.C. § 321(g)(1)) ("CDER-regulated drugs"), and to promote timely communications between the Parties on issues related to such information.

ARTICLE III. AUTHORITIES

The authorities for entering into this MOU are as follows:

  1. The FDA administers the FD&C Act (21 U.S.C. §§ 301 et seq.) and is responsible for promoting and protecting the public health by ensuring the safety and efficacy of drugs.
  2. This MOU will involve the exchange of information under 21 C.F.R. § 20.85 Disclosure to other Federal Government departments and agencies. Any Food and Drug Administration (FDA) record otherwise exempt from public disclosure may be disclosed to other Federal Government departments and agencies, except that trade secrets and confidential commercial or financial information prohibited from disclosure by 21 U.S.C. 331(j), 21 U.S.C. 360j(c), 21 U.S.C. 360ll(d), 21 U.S.C. 360nn(e), and 21 U.S.C. 387f(c) may be released only as provided by those sections. Any disclosure by FDA under this section shall be pursuant to a written agreement, as outlined in section IV.A.3.a, that the record shall not be further disclosed by the other agency except with the written permission of FDA.
  3. The CPSC administers the Consumer Product Safety Act ("CPSA") (15 U.S.C. § 2051 et seq.), and is responsible for protecting the public from unreasonable risks of injury or death associated with consumer products. The CPSC also administers the PPPA and is authorized to establish special packaging standards for household substances when "special packaging is required to protect children from serious personal injury or serious illness resulting from handling, using, or ingesting such substance." 15 U.S.C. § 1472(a). The PPPA defines "household substance" to include "any substance which is customarily produced or distributed for sale for consumption or use, or customarily stored, by individuals in or about the household." 15 U.S.C. § 1471(2). The term "household substance" includes drugs as defined in the FD&C Act. See 15 U.S.C. § 1471(2)(B).
  4. This MOU will also involve the exchange of information under 15 U.S.C. § 2078(f), which provides, in part, that notwithstanding the requirements of subsections (a)(3) and (b) of section 6 (15 U.S.C. § 2055), relating to public disclosure of information, the Commission may make information obtained by the Commission available to any federal, state, local, or foreign government agency, upon the prior certification of an appropriate official of any such agency, either by a prior agreement or memorandum of understanding with the Commission or by other written certification, that such material will be maintained in confidence and will be used only for official law enforcement or consumer protection purposes, if:
    1. The agency has set forth a bona fide legal basis for its authority to maintain the material in confidence;
    2. The materials are to be used for purposes of investigating, or engaging in enforcement proceedings related to, possible violations of --
      1. laws regulating the manufacture, importation, distribution, or sale of defective or unsafe consumer products, or other practices substantially similar to practices prohibited by any law administered by the Commission; or
      2. a law administered by the Commission, if disclosure of the material would further a Commission investigation or enforcement proceeding.
  5. The Parties agree to take actions under this MOU that are consistent with existing laws and regulations. Nothing in this MOU shall be construed as a change to current requirements under the statutes and regulations administered and enforced by FDA and CPSC. If a term of this MOU is inconsistent with such authority, then that term shall be invalid, but the remaining terms and conditions of this MOU shall remain in full force and effect. This MOU shall be interpreted and implemented in a manner that respects and complies with (and does not abrogate) the statutory and regulatory responsibilities of each party.

ARTICLE IV. INFORMATION TO BE EXCHANGED

  1. Procedure Governing Information Exchanges
    1. Authorized Officials and Contact Persons: The Director of CDER, or his or her designee, shall designate one or more Authorized Officials for CDER. The Office of the Executive Director, Safety Operations of the CPSC, shall appoint one or more Authorized Officials for CPSC. The Parties will exchange a list of Authorized Officials with each other and will update such list whenever Authorized Officials change. The Authorized Officials shall also designate contact persons ("Authorized Contact Persons") to carry out the information exchanges outlined in section IV.B. The Parties will exchange a list of Authorized Contact Persons with each other and will update such list whenever Authorized Contact Persons change.
    2. Timely Sharing of Information: The Parties will endeavor to exchange information covered by this MOU in a timely manner, but acknowledge that each may be limited by agency priorities, resources, and statutory or regulatory prohibitions.
    3. Methods of Sharing Information: The Parties may share information in the following ways: in written form (including email) and verbally (including in-person meetings or by telephone, video-conferencing or other electronic means).

      1. Written Exchanges of Information
         

        When an Authorized Contact Person requests information, documents, or data, the request should be made in writing, which may include email.

        In addition, when an Authorized Contact Person requests information, documents, or data from the FDA, the request should contain all substantive requirements of 21 C.F.R. § 20.85 which includes having the following language in the written request:

        Information is being requested pursuant to CDER-CPSC Memorandum of Understanding 225-23-005. We agree not to disclose any shared information in any manner without your written permission or, if such disclosure is required by law, without advance notice to the originating agency.

        By including this statement, requestors do not have to use a particular format or include other pre-specified text.

        The party receiving a request for information, documents, or data, should confirm in writing (including via email) that the request has been received.

        The response to such request should also be in written form. The following language should be included in any such response:

        This communication acknowledges that information is being shared pursuant to CDER-CPSC Memorandum of Understanding 225-23-005. The information may not be further disclosed or shared in any manner without express written consent or, if such disclosure is required by law, without advance notice to the originating agency.

        Additionally, each written document provided in response to a request shall be marked in the following manner:

        CONFIDENTIAL/FOR OFFICIAL USE ONLY. Information shared by the Parties pursuant to CDER-CPSC Memorandum of Understanding 225-23-005. Further sharing or disclosure of this information with any other persons or entities is prohibited.

      2. Exchanges of Information in Meetings and other Verbal Communications
        The Parties may exchange information during meetings of the Parties (whether in person or by telephone, videoconference, or other electronic means). Meeting announcements and agendas, distributed background information, or meeting minutes for such inter-agency meetings will include the following language:
        Information shared during this meeting will be/was pursuant to CDER-CPSC Memorandum of Understanding 225-23-005. Such information may not be further disclosed or shared in any manner without the express written consent of the originating agency, or, if such disclosure is required by law, without advance notice to the originating agency.
    4. Prohibited Exchange of Information Between the Parties: All information exchanges between the Parties must be made in accordance with existing laws, regulations, policies, and this MOU. Any information exchanges that are not made in accordance with existing laws, regulations, policies, and this MOU, are not permitted and are considered prohibited exchanges. Any prohibited information exchanges must still be safeguarded and protected, as discussed in Article V.A of this MOU. Each Party has an affirmative obligation to notify affected personnel of their responsibilities and obligations under this MOU to prevent prohibited exchanges.
    5. Mitigation of Prohibited Exchanges: The undersigned agree that exchange or disclosure of certain non-public information (directly or indirectly (i.e., through verbal or written communication, conduct or any other means)) that is not in accordance with applicable laws, regulations, policies, and this MOU may be detrimental to agency activities and may interfere with the Parties' ability to protect personal privacy, confidential and/or trade secret information. Accordingly, if a Party becomes aware of a prohibited exchange, it will immediately notify an Authorized Official of the other Party, providing the content of the prohibited exchange or disclosure, the identity of the person by whom it was made, the identity of the person to whom it was made, and the date on which the prohibited exchange occurred. The Parties will work with one another to develop and implement a plan to remedy the prohibited exchange or disclosure, taking into consideration the Parties' responsibility to preserve documents and records in accordance with applicable law or legal process.
  2. Substance of Information to Be Exchanged Under this MOU
    1. Information to Be Shared by CPSC to CDER: CPSC will notify CDER regarding any special packaging activity that relates to, and/or affects, any CDER-regulated drug by emailing CDEREXSEC@cder.fda.gov and such other Authorized Contact Person.
      In particular, CPSC will notify CDER in the manner described for the following situations:
      1. CPSC Development of a Special Packaging Rule
        When a majority of the Commission votes to approve staff resources to develop a special packaging rule that may impact a CDER-regulated drug, CPSC will notify CDEREXSEC@cder.fda.gov and such other Authorized Contact Person.
      2. When CPSC Issues a Notice of Violation or When CPSC Identifies a Potential Compliance Issue for CDER 
        When CPSC confirms a special packaging violation by issuing a "Notice of Violation" ("NOV") that affects a CDER-regulated drug, which may or may not result in the announcement of a recall, CPSC will notify CDEREXSEC@cder.fda.gov, drugshortages@fda.hhs.govand such other Authorized Contact Person at the earliest feasible time with a copy of the NOV. CPSC may also notify CDEREXSEC@cder.fda.gov, drugshortages@fda.hhs.gov and such other Authorized Contact Person if it identifies a potential compliance issue that affects a CDER-regulated drug.
      3. When CPSC Plans to Announce a Recall
        When CPSC plans to announce a recall related to special packaging that affects a CDER-regulated drug, CPSC will notify drugshortages@fda.hhs.gov, drugshortages@fda.hhs.gov and such other Authorized Contact Person at the earliest feasible time and prior to the public announcement of the recall.
    2. Information to Be Shared by CDER to CPSC: CDER will notify RegulatoryEnforcement@cpsc.gov and such other Authorized Contact Person regarding CDER activity that relates to, and/or affects, special packaging. 
      In particular, CDER will notify CPSC in the manner described for the following situations:
      1. Semi-Annual Adverse Events Summary Reports
        Semiannually, CDER will provide CPSC with a summary report of incidents from the FDA Adverse Events Reporting System ("FAERS") concerning CDER-regulated drugs that may involve special packaging violations or compliance issues by emailing RegulatoryEnforcement@cpsc.gov and such other Authorized Contact Person. When CPSC requires individual reports from the FAERS summary report, CPSC will email its request to: CDEREXSEC@cder.fda.gov and such other Authorized Contact Person and CDER will provide the requested information at the earliest feasible time.
      2. Other Adverse Events Reports
        When CPSC requires other FAERS data, CPSC will email its request to CDEREXSEC@cder.fda.gov and such other Authorized Contact Person and CDER will provide the requested information at the earliest feasible time.
      3. When CDER Finds Potential Compliance Issues with Special Packaging
        CDER does not assess whether the packaging of CDER-regulated drugs complies with CPSC's special packaging requirements. However, if CDER discovers that the packaging for a CDER-regulated drug may not comply with CPSC's special packaging requirements, CDER may notify RegulatoryEnforcement@cpsc.gov and such other Authorized Contact Person at the earliest feasible time.
      4. When CDER Changes a Drug's Status from Prescription to Nonprescription
        When CDER has determined that an original prescription product no longer meets the criteria in section 503(b)(1) of the FD&C Act (21 U.S.C. § 353(b)(1)) for prescription use and the drug's status changes from prescription to nonprescription (commonly referred to as an "Rx to OTC switch"), CDER will notify RegulatoryEnforcement@cpsc.gov, and such other Authorized Contact Person at the earliest feasible time.
        Following notification for any of the above, CDER and CPSC will consult, as needed.

ARTICLE V. GENERAL PROVISIONS

  1. Safeguarding & Limiting Access to Shared Information
    To the extent any confidential or other non-public information will be shared pursuant to this MOU, then any such written request submitted to FDA for this information must contain all substantive requirements of 21 C.F.R. § 20.85 as set forth in section IV.A.3.a. CPSC and FDA each agree to clearly identify any such confidential information disclosed in writing; and to clearly memorialize in writing, within a reasonable time, any confidential information disclosed orally. The Parties agree not to disclose, copy, reproduce or otherwise make available in any form whatsoever to any other person, firm, corporation, partnership, association or other entity information designated as proprietary or confidential information without written consent of the other Party except as such information is subject to disclosure under the Freedom of Information Act (5 U.S.C. §§ 552), CPSC's regulations at 16 C.F.R. Part 1015, and FDA's regulations at 21 C.F.R. Part 20, or as otherwise authorized or required by law.
    The undersigned recognize that information exchanged that contains any of the following types of information must be protected from unauthorized use and disclosure:
    1. information that will permit the public to ascertain readily the identity of a manufacturer or private labeler of a consumer product, and may not be publicly disclosed pursuant to 15 U.S.C. § 2055;
    2. information specifically exempted from disclosure by statute pursuant to Exemption 3 of the Freedom of Information Act (FOIA), including, but not limited to, information covered by 15 U.S.C. § 2055;
    3. confidential commercial information, such as information that would be protected from public disclosure pursuant to Exemption 4 of the FOIA, 5 U.S.C. § 552(b)(4);
    4. personal privacy information, such as information that would be protected from public disclosure pursuant to Exemption 6 or 7(C) of the FOIA, 5 U.S.C. § 552(b)(6), (b)(7)(C);
    5. information compiled for law enforcement purposes, such as information that would be protected from public disclosure pursuant to Exemption 7 of the FOIA, § 552(b)(7)(E); or
    6. information that is otherwise protected from public disclosure by Federal statutes and their implementing regulations (e.g., Trade Secrets Act (18 USC 1905), the Privacy Act (5 USC 552a), other Freedom of Information Act exemptions not mentioned above (5 USC 552(b)), the Consumer Product Safety Act, 15 U.S.C. § 2051 et seq., the Federal Food, Drug, and Cosmetic Act (21 USC 301 et seq.), and the Health Insurance Portability and Accountability Act (HIPAA), Pub. L. 104-191).

The Parties will ensure that information shared under this MOU shall be used and disclosed solely in accordance with applicable laws, regulations, and policies. Access to the information shared under this MOU shall be restricted to authorized employees and officials of the Parties who require access to perform their official duties in accordance with the use of information as authorized by this MOU. Such personnel shall be advised of (1) the necessity to safeguard and limit access to the information, and (2) the administrative, civil, and criminal penalties for noncompliance contained in applicable federal laws.

If either Party receives a Freedom of Information Act (FOIA) request for information provided by the other Party pursuant to this MOU, the Party receiving the FOIA request will refer the request to the Party that provided the information to respond directly to the requestor. The Party that refers the request will notify the requestor that a referral has been made to the other Party and that a response will issue directly from the other Party. In such cases where a Party has incorporated another Party’s information in a responsive record, the Party should consult with the Party whose information appears in the responsive records.

Nothing in this MOU shall be construed to prevent a disclosure required by law or legal process. Notwithstanding the foregoing sentence, should information shared pursuant to this MOU be subpoenaed or otherwise ordered through a legal process, the Party to whom the subpoena or order is directed will immediately notify an Authorized Official of the other Party to provide an opportunity to seek to intervene and object to the disclosure.

Termination of this MOU does not relieve either of the Parties of their obligation to safeguard, protect, and limit access to the shared information established under section IV of this MOU.

ARTICLE VI. WAIVER AND AMENDMENT 

The requirements of this MOU may be waived or amended only by the mutual written agreement of the Director of CDER and the CPSC's Deputy Executive Director of Safety Operations in a specific circumstance, but neither Party may waive requirements or restrictions imposed by federal law. The Parties' failure to enforce or abide by any requirement of this MOU, whether once or repeatedly, is not to be construed as a waiver of the requirement and cannot be deemed to alter or amend the MOU.

VII. TERM, TERMINATION AND MODIFICATION 

This MOU, when accepted by the undersigned, will become effective from the date of the latest signature and re-evaluated every four years. This MOU will continue in effect, unless modified or terminated by mutual written consent by both Parties, or may be terminated by either Party upon a 30-day advance written notice to the other.

Approved for the Consumer Product Safety Commission

/s/
By: DeWane Ray
Deputy Executive Director
Safety Operations
Date: 12/20/2024

Approved for the Food and Drug Administration

/s/
By: Patrizia Cavazzoni, M.D.
Director
Center for Drug Evaluation and Research
Date: 01/07/2025

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