Understanding the Drug Supply Chain Security Act – Webinar Recording/Transcript
Understanding the Drug Supply Chain Security Act (DSCSA): Latest Regulatory Developments and Best Practices
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.
- 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.