FDA’s New Distributor Licensing Standards – Webinar Recording/Transcript
The clock is ticking on the FDA’s 50-page proposed rule for new distributor licensing standards. The possible ways U.S. domestic prescription drug distribution — and your business — may change as a result are considerable.
This presentation — with a former senior FDA official — is your solution.
Arnold & Porter partner Howard Sklamberg and senior associate Abraham Gitterman will provide an in-depth understanding of the provisions in this long-awaited proposed rule and the potential implications for your domestic prescription drug distribution operations.
Mr. Sklamberg — both a former FDA deputy commissioner for global regulatory operations and policy and director of the Office of Compliance — and Mr. Gitterman will examine license exemptions, preemption of existing state and local laws and interaction with other Drug Supply Chain Security Act (DSCSA) requirements.
They’ll provide the information you need to adapt your operations, including submitting applications for licenses to handle and distribute drugs and dealing with a new group of organizations approved by the FDA to review those applications.
- Updated and new requirements for licensing of wholesale drug distributors (WDD) and third-party logistics providers (3PL), including further clarifications for licensure exemptions
- The proposed framework for the FDA to establish Approved Organizations to review WDD and 3PL license applications
- The potential implications that this rule would have in preempting state/local laws
- How this proposed rule affects other related DSCSA requirements (e.g., use of authorized trading partners)
- The regulatory and rulemaking process for the FDA’s proposed rule for WDD and 3PL licensing
The FDA’s new set of prescription drug distribution regulations could mean massive changes to your operations. This presentation will guide you through them.
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. 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 in the Center for Drug Evaluation and Research, deputy associate commissioner for regulatory affairs and director of the Office of Enforcement.
Abraham Gitterman, a senior associate at Arnold & Porter, focuses on FDA and healthcare regulatory compliance matters involving pharmaceutical and medical device manufacturers. He regularly counsels clients on FDA-regulated advertising and promotion, including the use of social media, compliant medical affairs activities and mobile health applications.
Who Will Benefit
Those who focus on finished pharmaceutical products and DSCSA compliance, including:
- Regulatory professionals
- Quality professionals
- Distribution professionals
- Licensing professionals
- Warehousing professionals
- Legal/compliance professionals
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May 18, 2022