New Q&A explains annual reporting obligations for 3PL provider facilities


The FDA clarified annual reporting requisites for 3PL provider facilities that handle prescription drugs.  The Q&A format focuses on the most frequently asked questions that commenters had about the previously published draft guidance.

The document, which was released on January ninth, clarifies who, what, when and how 3PL provider facilities should report to the FDA.

What 3PL provider facilities need to know:

Any 3PL facility that provides logistics services for a product (in dosage form), needs to report.  This includes:

  • Prescription drugs that still need to be packaged
  • Product samples


Exempt to reporting are facilities that handle:

  • Bulk drug substances (not in finished dosages)
  • Animal drugs


Drugs given to animals are regulated by the Center for Veterinary Medicine, not the FDA.  Although, a 3PL facility must report if the product is a human prescription drug, which would be considered a crossover drug when intended for use on an animal.

Even if the 3PL provider is in a state that does not have licensing requirements, they should detail their facility name and address annually during the reporting period between January 1st and March 31st.

The FDA also requests that any license suspensions or revocations be conveyed within thirty days.

How annual reporting by 3PL provider facilities affects shippers

With cargo theft on the rise and thieves utilizing increasingly sophisticated tactics, the FDA’s regulation of prescription drug supply chains strengthens shippers’ ability to vet potential 3PL partners.

The FDA’s database of wholesale distributors and third party providers allows shippers to verify the status and address of 3PL facilities.

The database does not display disciplinary actions, such as license suspensions.  However, the Department of Transportation’s Company Snapshot provides business identification, safety information, and inspection records.

When utilized together, the information provided adds an extra layer of security for shippers.