Verification Systems: FDA Drafts Guidance on What to Include

Regulatory NewsRegulatory News | 24 October 2018 |  By 

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system that can determine, quarantine and investigate suspect or illegitimate products, FDA on Wednesday issued new draft guidance.

The 11-page draft guidance describes FDA’s interpretation of the requirements of section 582 of the Food Drug and Cosmetic (FD&C), which set forth verification requirements that took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 that a product is not illegitimate), this draft guidance also addresses the statutory requirements for verification, including verification of saleable returns, at the package level for product identifiers on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.”

Meanwhile, trading partners must have systems in place, according to the draft, for notifying FDA and immediate trading partners of an illegitimate product and, for manufacturers, products with a high risk of illegitimacy.

And manufacturers and repackagers also must have systems in place to respond to requests for verification from trading partners within hours of receipt of a request. These systems must be in place by 27 November 2017 for manufacturers and by 27 November 2018 for repackagers.

“The systems must allow the manufacturer or repackager to notify the trading partner making the request whether the product identifier, including the standardized numerical identifier, that is the subject of the request corresponds to the product identifier affixed or imprinted by that manufacturer or repackager,” the draft says.

Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs: Draft Guidance for Industry


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