It is expected that, in compliance with the modifications to the DSCSA, trading partners will develop secure electronic systems to verify the status of a pharmaceutical product and create processes to ensure that appropriate quarantine, investigation, and reporting requirements are met if a product is determined to be illegitimate or suspect.
Concerns over improper pharmaceutical products entering commerce are not new. However, it does appear that the new mandates increase the attention required to protect the public and impose requirements on supply-chain stakeholders to assist in identification of improper pharmaceutical products.
In an effort to provide specific recommendations, FDA recently published its draft “Guidance for Industry Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification.” The agency has requested that comments to the draft be submitted by August 11, 2014.
In the document, FDA identified numerous scenarios that should lead to scrutiny regarding the authenticity of pharmaceutical products. While not all inclusive, the specific examples provided in the guidance document are a helpful demonstration of how FDA views the issues.