Drugs

Supply Chain Suspect Product Guidance Out

FDA has issued a guidance, Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification, to aid “trading partners” (manufacturers, repackagers, wholesale distributors, and dispensers) in identifying a suspect product as defined in the Drug Supply Chain Security Act (DSCSA) and terminating notifications. The document says that as of 1/1/15, a trading partner that determines a product in its possession or control is an illegitimate product as defined in the act must notify FDA and certain immediate trading partners as required by the law.

Manufacturers are also required to notify FDA and certain immediate trading partners after the manufacturer determines or is notified by FDA or a trading partner that there is a high risk that a product is illegitimate.

“This guidance identifies specific scenarios that could significantly increase the risk of a suspect product entering the pharmaceutical distribution supply chain; provides recommendations on how trading partners can identify a product and determine whether a product is a suspect product as soon as practicable; and sets forth the process by which trading partners should notify FDA of illegitimate products or products with a high risk of illegitimacy, and how they must terminate the notifications, in consultation with FDA,” the document says.

FDA says the guidance does not address all provisions of the DSCSA relating to suspect and illegitimate products. It says that as it works to implement other provisions of the law, it will issue additional information to support efforts to develop standards, issue guidance and regulations, establish pilot programs, and conduct public meetings.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome