The text of the Drug Supply Chain Security Act (DSCSA) was developed last year by Congressional staff in consultation/negotiation with various lobbying organizations—primarily the Prescription Drug Security Alliance (PDSA). The effect of the legislation is to create a way of protecting the U.S. pharmaceutical supply chain that relies primarily on product identifier authentication (PIA) for at least the first 10 years and possibly beyond.
Manufacturers must be capable of responding to “requests for verification” using the lot number and expiration date or the Standard Numerical Identifier (SNI) by Nov. 27, 2017, but because wholesale distributors are not required to perform verification of saleable returns and “suspect product” using the SNI until Nov. 27, 2019, the verification service offered by manufacturers may not be heavily loaded until about that time. Dispensers must begin making use of that service using the SNI to verify at least 10% of the homogeneous cases or individual packages of suspect product, beginning in Nov. 2020.
