Nov 7 -- The Food and Drug Administration (FDA, the Agency, or we) is announcing the following virtual public meeting entitled “Drug Supply Chain Security Act Implementation and Readiness Efforts for 2023” to allow supply chain stakeholders an opportunity to share their perspectives. The topics to be discussed are stakeholder experiences with implementation and overall readiness regarding implementation of enhanced drug distribution security requirements that will go into effect on November 27, 2023, standards for the interoperable data exchange of product tracing information, requests for product tracing information or verification from FDA for the purpose of investigating suspect or illegitimate products or for recalls, steps taken to build capacity for package-level tracing, pharmaceutical distribution supply chain best practices, and, in general, the impact that the Drug Supply Chain Security Act (DSCSA) requirements would have on public health, including patient safety and access to prescription drugs, and on stakeholders, in terms of costs, benefits, and regulatory burden.
The public meeting will be held on December 7 and 8, 2022, from 10 a.m. to 3 p.m. eastern time and will take place virtually. Either electronic or written comments on this public meeting must be submitted by February 6, 2023.
On November 27, 2013, the DSCSA (title II, Pub. L. 113-54) was signed into law. The DSCSA outlines critical steps to achieve electronic, interoperable tracing at the package level by 2023 to identify and trace certain prescription drugs as they are distributed within the United States. DSCSA requirements enhance FDA's ability to protect U.S. consumers from exposure to drugs that may be counterfeit, diverted, stolen, intentionally adulterated, or otherwise harmful by improving the detection and removal of potentially dangerous drugs from the drug supply chain.
Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-1(g)(1)) imposed requirements for enhanced drug distribution security that go into effect on November 27, 2023. Section 582(i) of the FD&C Act directs FDA to hold public meetings to enhance the safety and security of the pharmaceutical distribution supply chain and provide opportunities for comment from members of the pharmaceutical distribution supply chain and other interested stakeholders. Since enactment of the law, FDA has held multiple public meetings that address specific topics as they relate to implementation of DSCSA requirements. As the capabilities of the pharmaceutical distribution supply chain have progressed and matured, this public meeting will be used to gather stakeholder perspectives on DSCSA implementation.
Topics for Discussion at the Public Meeting
• Stakeholder experiences with implementation and overall readiness regarding implementation of enhanced drug distribution security requirements that will go into effect on November 27, 2023.
• DSCSA standards for the interoperable data exchange of product tracing information for enhanced product tracing and verification.
• FDA requests to trading partners for product tracing information, verification for the purpose of investigations of suspect or illegitimate products, or recalls to support enhanced drug distribution requirements under section 582(g) of the FD&C Act.
• Steps taken by the pharmaceutical distribution supply chain to build capacity for package-level tracing, including the ability of the healthcare system to maintain patient access to medicines, scalability of DSCSA requirements, and best practices.
• Technical capabilities and legal authorities, if any, needed to establish interoperable, electronic product tracing at the package level.
• General impact that the DSCSA requirements would have on public health, including patient safety and access to prescription drugs, and on stakeholders, in terms of costs, benefits, and regulatory burden.
If other topics are identified as appropriate, FDA will post these on the designated public meeting web page prior to the meeting.
FRN:
https://www.federalregister.gov/d/2022-24212