Manufacturers must place a unique product identifier on each package and homogeneous case.
- The original November 27, 2017 serialization deadline remains unchanged. Cardinal Health expects that GS1 standards and HDA industry guidelines for barcodes and serialization are followed.
- The FDA, recognizing that some manufacturers may need additional time to ensure products are properly labeled with a product identifier, has indicated they will grant a one year delay in the enforcement of manufacturer’s obligation to affix product identifiers.
- Enforcement discretion is for product “intended to be introduced in a transaction into commerce” before November 26, 2018. The guidance implies that if a manufacturer sells product after November 26, 2018 it must be serialized, not if a manufacturer serializes it by November 2018 they can sell it afterwards.
- Based on this, Cardinal Health would expect that when we receive DSCSA product from a manufacturer on or after November 27, 2018, it will have a 2D product identifier on it, unless future FDA guidance on grandfathering indicates otherwise.
Manufacturers must provide the Transaction Information, Transaction History and Transaction Statement (TI TH TS) in electronic format.
- Enforcement discretion does not apply to this requirement. Cardinal Health has required lot-based DSCSA transaction data electronically via EDI ASNs since January 2015. Some manufacturers have continued to provide paper packing lists in lieu of electronic information. This will no longer be acceptable beginning November 27, 2017. Product received without electronic TI TH TS information will be returned to the manufacturer.
Please send any questions or requests for additional information to firstname.lastname@example.org.