In June 2014, the FDA published a draft guidance intending to aid manufacturers, re-packagers, distributors or dispensers in identifying a suspect product and terminating notifications regarding illegitimate products. With effect from 1st January 2015, an organization that determines that a product in its possession or control is an illegitimate products must notify the FDA and specific trading partners under the terms of the FD&C Act as added by the Drug Supply Chain Security Act (DSCSA).
This new guidance identifies specific scenarios that could significantly increase the risk of a suspect product entering the pharmaceutical distribution supply chain as well as providing recommendations on how trading partners can identify the product and determine whether it is suspect. It also sets out the process by which the FDA should be notified of the illegitimate product along with all other follow up activities regarding termination activities.
The guidance does not address all provisions of the DSCSA related to suspect and illegitimate products. As the FDA works to implement other provisions of the DSCSA, the Agency intends to issue additional information to support efforts to develop standards, issue guidance and regulations, establish pilot programs and conduct public meetings.
The guidance in full can be found here. GxP Systems will bring you a more detailed analysis of the final guidance on publication by the FDA, which is expected later on towards the end of the yea