USA – Verification Systems: FDA Drafts Guidance on What to Include

To help companies understand the US Food and Drug Administration’s (FDA) recommendations for a verification system that can determine, quarantine and investigate suspect or illegitimate products, FDA on Wednesday issued new draft guidance.

The 11-page draft guidance describes FDA’s interpretation of the requirements of section 582 of the Food Drug and Cosmetic (FD&C), which set forth verification requirements that took effect on 1 January 2015 for manufacturers, wholesale distributors, dispensers and repackagers of certain drug products.

In addition to addressing how FDA recommends that trading partners submit cleared product notifications (ie. that a product is not illegitimate), this draft guidance also addresses the statutory requirements for verification, including verification of saleable returns, at the package level for product identifiers on packages and homogenous cases intended to be introduced into commerce.

“Manufacturers must have systems in place that will allow them to respond to requests  from trading partners to confirm that a particular product identifier, including the standardized numerical identifier, on the product that is the subject of the request corresponds to the product identifier that was affixed or imprinted on that product by the manufacturer of that product,” the draft says.

Under the section on systems for illegitimate product quarantine and disposition, the draft notes that products determined to be illegitimate should be kept “physically separated from products intended for distribution because of the higher level of public health risk associated with illegitimate products.”…