FDA Publishes DSCSA Reporting Requirements for Wholesalers and 3PLs

The FDA has released their draft guidance on the annual reporting requirements by wholesale distributors and 3PLs on licensure and other information.

Entitled "DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers", the guidance addresses the kind of information required and how that data should be reported annually to the FDA.

The guidance highlights the following kinds of information to be reported by wholesale distributors:

• Facility and contact identification information for each licensed facility.
• Licensure information for each state licensed within.
• Recommended data like a unique facility identifiers, license expiration dates, and any disciplinary action details.

The guidance highlights the following kinds of information to be reported by 3PLs:

• Facility identification information for each licensed facility.
• Licensure information for each state licensed within.
• Recommended data like contact information at each facility, unique facility identifiers, license expiration dates and any disciplinary action details.

Reporting deadlines:

• Wholesale distributors: January 1, 2015 - March 31, 2015.
• 3PLs: November 27, 2014 - March 31, 2015.
• Newly licensed facilities should report w/in 30 days of State or Federal licensure.