Proposed Rule: National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers April 13, 2022

Virtual | Virtual

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• Date: April 13, 2022

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ABOUT

FDA provides an overview of proposed national standards for the licensure of wholesale drug distributors and third-party logistics providers. Comments on this proposed rule are due by June 6, 2022. When final and effective, every U.S. wholesale distributor and third-party logistics facility will be held to these standards. Only those licensed according to the proposed national standards would be able to engage in transactions related to the sale and distribution of certain prescription drugs with other members of the supply chain. Where a state does not have a licensing program in accordance with the regulation, FDA would be the licensing authority.

TOPICS

• How to submit a comment on the proposed regulations
• Licensure application requirements
• Procedures surrounding pre-licensure inspection as well as denial, revocation, and suspension of licenses
• Standards for the storage and handling of prescription drugs, including facility requirements and security, inventory management, and equipment maintenance
• Personnel requirements and qualifications
• Recordkeeping and document maintenance requirements
• Requirements for written policies and procedures

INTENDED AUDIENCE

• Wholesale distributors and third-party logistics providers
• Other trading partners: Manufacturers, repackagers, dispensers (i.e., pharmacies and other health care practitioners)
• State authorities (state boards of pharmacy and licensing authorities)
• Other supply chain stakeholders (e.g., standards organizations, solution/technology providers)
• Other federal agencies

FDA SPEAKERS

Aaron Weisbuch
Senior Regulatory Advisor
Division of Supply Chain Integrity | Office of Drug Security, Integrity, and Response (ODSIR)
Office of Compliance | Center for Drug Evaluation and Research

Elizabeth Pepinsky
Regulatory Counsel
Supply Chain Security Branch | Division of Supply Chain Integrity | ODSIR | Office of Compliance | Center for Drug Evaluation and Research

Sara Kim Keller
Regulatory Counsel
Supply Chain Security Branch | Division of Supply Chain Integrity | ODSIR | Office of Compliance | Center for Drug Evaluation and Research

FDA RESOURCES

• FDA announces proposed rule: National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers
• Drug Supply Chain Security Act Law and Policies
• Federal Register Notices
  • National Standards for the Licensure of Wholesale Drug Distributors Third–Party Logistics Providers (Docket No. FDA-2020-N-1663)
  • Certain Requirements Regarding Prescription Drug Marketing; Proposed Rule Docket (Docket No. FDA-2020-N-1819)
  • Removal of Certain Requirements Related to the Prescription Drug Marketing Act; Opportunity for Public Comment; Withdrawal (Docket No. FDA-2011-N-0446)
  • Guidance: Drug Product Tracing: The Effect of Section 585 of the Federal Food, Drug, and Cosmetic Act, Questions and Answers (Docket No. FDA-2014-D-1411)
• Sign-up for email updates on the Drug Supply Chain Security Act

QUESTIONS

WDD3PLRequirements@fda.hhs.gov