Understanding the Drug Supply Chain Security Act – Webinar Recording/Transcript

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Understanding the Drug Supply Chain Security Act (DSCSA): Latest Regulatory Developments and Best Practices

Want to attend the live webinar on Dec. 2? Click here to register.

As the Drug Supply Chain Security Act’s (DSCSA) key requirements continue to take effect, FDA has begun enforcement. If you must comply with DSCSA’s implementation requirements, this webinar cannot be missed. You’ll be updated on implementation processes to gain a clear understanding of the guidelines’ nuances and tactics to avoid problem areas.

William Garvin, Esq. — a Buchanan Ingersoll & Rooney PC lawyer who assists clients daily in their interactions with FDA — will provide vital information to those involved in the manufacture, ownership, distribution or sale of prescriptions pharmaceuticals, including repackagers, wholesale distributors, dispensers and third-party logistics providers.

Webinar Takeaways:

  • Key requirements under DSCSA
    • Reporting licensure
    • Knowing how to handle suspect and illegitimate products
    • Confirming authorized trading partners
    • How to comply with important guidances including FDA’s guidance on how to exchange product tracing information (DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information)
  • Who exactly is regulated under DSCSA, such as repackagers, wholesale distributors, dispensers and third-party logistics providers
  • What the most complicated and nuanced requirements are under DSCSA, such as product serialization and exchange of transaction information, transaction history and transaction statement
  • Which areas will be regulated soon under DSCSA, such as requirements for dispensers and distributors
  • How FDA is enforcing DSCSA, recent actions including warning letters

Gain the right tactics to avoid problems with DSCSA implementation. Join us by registering today.

  • Quality Assurance Professionals
  • Regulatory Affairs Personnel
  • Supply Chain Managers

William Garvin, Esq.  is a Buchanan Ingersoll & Rooney PC Shareholder whose practice focuses on issues related to the approval, regulation, promotion, sale and reimbursement of drugs, medical devices, biologics, excipients, dietary supplements and foods. Mr. Garvin assists clients in their interactions with various federal agencies, including FDA, FTC and HHS. His experience includes reviewing and revising the labeling of drugs, medical devices, foods and dietary supplements to ensure compliance with FDA laws and regulations. He works with clients to petition the FDA to ensure the safety and effectiveness of drug products on the market, and assists in providing input to members of Congress regarding proposed legislation and highlighting arbitrary enforcement actions by federal and state agencies. Mr. Garvin is also co-head of the firm’s cannabis group, where he has helped companies work to bring FDA-approved cannabinoid drug products to market. Since 2013, Mr. Garvin has been named consecutively to the Washington, D.C. Super Lawyers Rising Stars list.