FDA Issues Guidance on Drug Supply Chain Security Act | Practical Law

FDA Issues Guidance on Drug Supply Chain Security Act | Practical Law

The Food and Drug Administration (FDA) has released guidance entitled Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification. The guidance is intended to help trading partners identify suspect products and prevent or remove them from the pharmaceutical distribution supply chain.

FDA Issues Guidance on Drug Supply Chain Security Act

Practical Law Legal Update w-004-9383 (Approx. 4 pages)

FDA Issues Guidance on Drug Supply Chain Security Act

by Practical Law Commercial Transactions
Law stated as of 13 Dec 2016 • USA (National/Federal)
The Food and Drug Administration (FDA) has released guidance entitled Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification. The guidance is intended to help trading partners identify suspect products and prevent or remove them from the pharmaceutical distribution supply chain.
On December 9, 2016, the Food and Drug Administration released accompanying guidance for the Drug Supply Chain Security Act, which was signed into law on November 27, 2013. The law and related guidance are designed to prevent and eliminate suspect products from the pharmaceutical distribution supply chain. The Food, Drug, and Cosmetic Act (FD&C Act) defines a suspect product as a product that:
  • Is reasonably believed to be potentially:
    • counterfeit, diverted, or stolen.
    • intentionally adulterated such that the product would result in serious adverse health consequences or death to humans.
    • the subject of a fraudulent transaction.
  • Appears otherwise unfit for distribution such that the product would result in serious adverse health consequences or death to humans.
The FD&C Act requires trading partners, upon determining that a product in their possession or control is a suspect product, to:
  • Quarantine the product.
  • Promptly investigate whether the product is an illegitimate product, defined as a suspect product that has been proven to be so by credible evidence.
The FD&C Act further requires that if a trading partner determines that a product in its possession or control is an illegitimate product, it must notify the FDA and its immediate trading partners.
The accompanying 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 suspect products as soon as practicable.
  • Describes when manufacturers should notify the FDA of a high risk that a product is illegitimate.
  • Sets forth the process by which trading partners must terminate notifications in consultation with the FDA.
  • Informs trading partners on how they should notify the FDA if they determine:
    • a product has a high risk of illegitimacy; or
    • a product in their possession or control is an illegitimate product.
For more information on the FDA's regulation of medical devices, see Practice Note, FDA Medical Devices Regulations.