In June, FDA issued the first draft guidance under the DSCSA, Guidance for Industry: Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification.
This guidance “is intended to aid trading partners (manufacturers, repackagers, wholesale distributors, or dispensers) in identifying a suspect product and terminating notifications regarding illegitimate product.”
If you don’t already have an SOP addressing security of the supply chain, you may be able to use your Product Hold SOP with some modifications. The guidance states that as of January, 2015, trading partners must notify FDA through the internet, and complete and submit Form FDA 3911 attached to the guidance document as part of the requirement for a 24 hour notification to FDA upon determination of a high risk of illegitimacy of their drug product.
Counterfeit drug sales have reached over $75 billion globally as of 2010, an increase of over 92% from 2005.