FDA suggests 1-year delay on serialization rules for pharma supply chains

The Food and Drug Administration (FDA) may delay enforcement of the product identifier rules within the Drug Supply Chain Security Act (DSCSA) by one year, according to a draft guidance recently released by the agency.The DCSCA requires "each package and homogenous case of product" within pharmaceutical supply chains contain a human- and machine-readable identifier, including a standardized number, lot number and expiration date for the product. Originally, the rule would have been enforced by November 27, 2017 for manufacturers. However, the FDA notes industry stakeholders are concerned about the readiness, due to a limited number of vendors capable of offering the product identifier technology, and the capacity of upstream contract manufacturers to comply with the regulation.