Drug Supply Chain Security Act Developments: What You Must Know About the Proposed Rule and Guidances – Webinar Recording/Transcript
Changes to the Drug Supply Chain Security Act (DSCSA) are coming fast and furious. To get ahead of them all, you practically have to have been a top FDA enforcer yourself.
Arnold & Porter partner Howard Sklamberg — previously a deputy commissioner for global regulatory operations and policy and director of the office of compliance — with senior associate Abraham Gitterman provides a robust overview of the FDA’s proposed rule and recent guidance documents.
Have you begun to think about the prescription drug supply-chain verification system you’ll need to implement? Or how the FDA is thinking about licensing standards for wholesale drug distributors (WDD) and third-party logistics providers (3PL).
In addition to these, there will likely be more changes between now and the November 2023 deadline.
Meaning the sooner you focus on DSCSA compliance — and its consequences on your domestic prescription drug distribution operations — the better.
Sklamberg and Gitterman reveal the implications for the biopharmaceutical industry, so you can prepare to handle product verification, identify authorized trading partners, and adopt or accommodate product identifiers and serialization with ease.
- What you must know about the regulatory and rulemaking process for the FDA’s proposed rule for WDD and 3PL licensing
- Some of the updated and new requirements for WDD and 3PL licensure, including further clarifications for licensure exemptions
- The potential implications that this law will have in preempting state and/or local laws
- How this proposed rule affects other related DSCSA requirements (e.g., use of authorized trading partners)
- Updates to the FDA’s recent guidance documents on product verification, identifying trading partners, and product identifiers and serialization
Prescription drug distribution within the U.S. is about to get a lot more complicated. If you want to stay compliant — and ensure your supply chain moves as swiftly as possible — attending this presentation is a must.
Meet Your Presenters
Howard Sklamberg, a partner at Arnold & Porter, counsels clients on a wide range of compliance and enforcement issues related to FDA regulation and policy. His experience is rooted in a deep understanding of U.S. and foreign food, drug and medical devices law and policy. His areas of expertise include inspections and warning letters, investigations, civil and criminal enforcement, medical product applications and clinical research, imports, the development of FDA policy and FDA-related legislation, and business transactions involving FDA-regulated companies.
Prior to entering private practice, Mr. Sklamberg held a variety of roles at the FDA from 2010 to 2017, including Deputy Commissioner for Global Regulatory Operations and Policy; Director of the Office of Compliance, Center for Drug Evaluation and Research; Deputy Associate Commissioner for Regulatory Affairs; and Director in the Office of Enforcement.
Abraham Gitterman, a senior associate at Arnold & Porter, focuses on FDA and healthcare matters involving pharmaceutical and medical device manufacturers. He regularly counsels clients on FDA-regulated advertising and promotion. Mr. Gitterman also assists with extensive reviews of corporate compliance programs, both generally and pursuant to Corporate Integrity Agreements for various life science companies and healthcare entities to ensure compliance with the Anti-Kickback Statute, the False Claims Act and the Federal Food, Drug, and Cosmetic Act. He also advises clients on compliance with the Drug Supply Chain Security Act and the Compounding Quality Act.
Who Will Benefit
- Regulatory professionals
- Quality professionals
- Distribution professionals
- Licensing professionals
- Warehousing professionals
- Legal/compliance professionals who focus on finished pharmaceutical products and DSCSA compliance
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Oct. 20, 2022