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

Regulatory News | 08 December 2016 | By Zachary Brennan

The US Food and Drug Administration (FDA) on Thursday released final guidance on the implementation of the Drug Supply Chain Security Act (DSCSA), though it’s also seeking comment on a new section describing when manufacturers should notify FDA of a high risk that a product is illegitimate.

Under the new section, which FDA says is being distributed “for comment purposes only,” the agency offers its interpretation of Section 582(b)(4)(B)(ii)(II) of the Food, Drugs and Cosmetics Act (FD&C Act), which requires manufacturers to make notifications in certain circumstances for products that pose a high risk of illegitimacy.

“FDA interprets this provision to require manufacturers to notify (1) FDA and (2) the manufacturer’s immediate trading partners (that the manufacturer has reason to believe may have in the trading partner’s possession a product manufactured by, or purported to be a product manufactured by, the manufacturer) in three general scenarios:

1. Within 24 hours after determining or being notified by FDA or a trading partner that there is a high risk that a product that the manufacturer has reason to believe is in an immediate trading partner’s possession is an illegitimate product.
2. Within 24 hours after determining or being notified by FDA or a trading partner that there is a specific high risk that could increase the likelihood that illegitimate product will enter the U.S. pharmaceutical distribution supply chain.
3. Within 24 hours after determining or being notified by FDA or a trading partner that there exists an ‘other high risk’ as determined by FDA in guidance pursuant to subsection 582(h).”

The new section, entitled “For Manufacturers: High Risk of Illegitimacy Notifications,” also offers examples of scenarios involving high risks of illegitimacy in which a manufacturer should make a notification.

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

The finalized portions of the guidance, first drafted in June 2014, aim to help companies remove illegitimate medicines from the US market promptly by notifying FDA and trading partners after the manufacturers determine or are notified by FDA or a trading partner that there is a high risk that a product is illegitimate.

And beginning next November, pharmaceutical companies will be required to mark their products with a National Drug Code (NDC), serial number, lot number and expiration date in both machine-readable and human-readable formats.

Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification Guidance for Industry