FDA Finalizes Drug Supply Chain Guidance, Seeks Comment on New Section

The Food and Drug Administration (FDA) issued final guidelines on the implementation of the Drug Supply Chain Security Act (DSCSA) on Thursday, but also asks for comments on a new section describing when manufacturers should notify the FDA High risk that an illegitimate product is

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According to the new section, which is distributed "for comment only", the Agency offers its interpretation of paragraph 582 (b) (4) (B) (ii) of the Food, Drugs and (FD & C Act) , Which obliges manufacturers to make notifications under certain circumstances for products that present a high risk of illegitimacy.

"The FDA interprets this provision as requiring manufacturers to notify (1) the FDA and (2) the manufacturer's immediate business partners (which the manufacturer has reason to believe possesses in the possession of the trading partner a manufactured product or purported to be A product Manufactured by the manufacturer) in three general scenarios:

1. Within 24 hours of the determination or notification by the FDA or a trading partner that there is a high risk that the manufacturer has reason to believe in the possession of an immediate trading partner is a Product.
2. Within 24 hours of the determination or notification by the FDA or a trading partner that there is a specific high risk that could increase the likelihood that the illegitimate product will enter the supply chain of the US pharmaceutical distribution.
3. Within 24 hours of the determination or notification by the FDA or a trading partner that there is "other high risk" as determined by the FDA in the guidelines under paragraph 582 (h).

The new section, "For manufacturers: high risk of notifications of illegitimacy", also offers examples of scenarios involving high risks of illegitimacy in which the manufacturer should make a notification.

In addition to the added section, the FDA says it has made minor changes to FDA Form 3911 and instructions for completing the form.

The finalized parts of the guide, written for the first time in June 2014, are intended to help companies rapidly remove illegitimate drugs from the US market by notifying the FDA and trading partners after manufacturers determine or are notified by the FDA or the FDA Business Partner That there is a high risk that an illegitimate product is.

And as of next November, pharmaceutical companies will have to mark their products with National Drug Code (NDC), serial number, batch number and expiration date in both machine-readable and human-readable formats