U.S. Pharmaceutical Distribution Supply Chain: Revised Draft Guidance on Verification Systems

On 09 March 2022, the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA) issued a revised draft guidance for industry entitled "Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs." This new guidance revises the first version of draft guidance for industry issued in October 2018.

The document addresses the verification systems that manufacturers, repackagers, wholesale distributors, and dispensers must have in place to comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Drug Supply Chain Security Act (DSCSA). It is intended only to provide clarity regarding existing requirements under the law.

Verifications Systems

Chapter III of the document covers the following systems:

• Systems to determine that a product is suspect
• System for suspect product quarantine and investigation
• System for cleared product notification regarding suspect products
• System for illegitimate product quarantine and disposition
• System for illegitimate/high risk of illegitimacy product notifications
• System for responding to requests for verification from authorized trading partners
• System for processing saleable returns

"Possession or Control" and " Electronic Quarantine"

Among the aspects covered in the document is also FDA’s interpretation of what "possession or control" and what "electronic quarantine" means as used throughout the DSCSA. In this regards, the documents states the following:

• "For purposes of determining compliance with the DSCSA’s verification requirements, FDA interprets the phrase 'possession or control' to include physical custody of the product, or ownership of the product."
• "FDA understands 'quarantine by electronic' means (or 'electronic quarantinè') to be an electronic system or process that designates specific products as being quarantined to prevent the sale and further distribution of the product. For example, if a trading partner places a product in quarantine using electronic means, the trading partner’s system should designate the product as quarantined so that information retrieved from the system about that product would indicate that the product is currently quarantined and should not be sold or further distributed."

Comments and suggestions regarding the new draft document should be submitted until 09 May 2022.

Here you can download the draft guidance document. Further information is available on the FDA website.