FDA finalises DSCSA notification guidance – almost

The FDA has issued a final version of its guide on identifying suspect medicines in the supply chain and notifying the authorities – but has left one section open for comment.

The guidance on the Drug Supply Chain Security Act (DSCSA) implementation gives trading partners in the medicines supply chain a protocol to follow if they encounter a product that may be illegitimate, for example, counterfeit, diverted or stolen.

A new section – entitled C. For Manufacturers: High Risk of Illegitimacy Notifications – is open for comment for 60 days and covers cases where there is a high risk that a product is illegitimate.

Three specific scenarios are detailed, namely:

  1. High risk of Illegitimacy notification for products that the manufacturer has reason to believe are in an immediate trading partner's possession;

  2. Specific high risks that could increase the likelihood of an illegitimate product entering the US pharmaceutical distribution supply chain; and

  3. Other high risks as determined by FDA: high risk of illegitimacy notification where a manufacturer has reason to believe the product has entered the pharmaceutical distribution supply chain.

In all these cases there is a requirement to notify the agency within 24 hours, says the guidance, which also provides information on scenarios that increase the risk of potential suspect product entering the supply chain, recommendations on how to identify suspect product and termination of notification procedures.

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