The FDA recently issued a draft guidance regarding verification* systems in accordance with the Drug Supply Chain Security Act (DSCSA).
The purpose of the guidance was to assist the industry in understanding what requirements need to be met in a variety of situations. The verification requirements apply to manufacturers, wholesale distributors, dispensers and repackagers.
The FDA insists that all trading partners in the supply chain have systems in place that allow them to comply with regulation regarding suspect or illegitimate product. The systems must be able to consistently determine the legitimacy of a product in a timely manner, to prioritize patient safety.
Trading partners should put an emphasis on tracking products that may fall into one of the defined categories of suspect product (counterfeit, diverted, stolen, intentionally adulterated, part of a fraudulent transaction, or unfit for distribution).
The FDA reserves the right request verification, that a product is legitimate, from a trading partner if they have determined that they may be in possession or control of an illegitimate product. If the product is determined to be illegitimate, the partner must identify and quarantine all related products in its possession or control.
Due to the risks that are posed by illegitimate products entering the supply chain, the FDA urges all trading partners to do their due diligence to identify these products as early as possible.
The FDA outlines specific minimum requirements for each verification system. The systems outlined in the guidance are:
- Determine the Legitimacy of a Product
- Suspect Product Quarantine and Investigation
- Cleared Product Notification Regarding Suspect Products
- Illegitimate Product Quarantine and Disposition
- Illegitimate/High Risk of Illegitimate Product Notifications
- Responding to Requests for Verification
- Processing Saleable Returns
As of today, all trading partners in the pharmaceutical supply chain must have systems in place to meet these guidelines and respond to request, within hours of a request.
Click here to read the full FDA Guidance on Verification Systems.
The FDA notes that a draft guidance does not hold legal authority.
*Verification as defined by the FDA: Determining whether the product identifier affixed to, or imprinted upon, a package, or homogenous case, corresponds to the standardized numerical identifier, or lot number, and expiration dates assigned to the product by the manufacturer, as applicable, in accordance with section 582