FDA highlights upcoming DSCSA guidance in 2017 agenda

The FDA's schedule for 2017 suggests there will be nine new guidance documents issued this year to help implement the US medicine traceability laws.

The regulator's Guidance Agenda for 2017 includes the following entries related to the Drug Supply Chain Security Act (DSCSA), although a blog post from Baymark Consulting notes that six of these were originally due for publication last year:

• Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers:
  Questions and Answers (now available here).

• Grandfathering Policy for Packages and Homogenous Cases of Product without a Product Identifier

• Product Identifier Requirements under the Drug Supply Chain Security Act – Compliance Policy

• Standardization of Data and Documentation Practices for Product Tracing

• The Product Identifier for Human, Finished, Prescription Drugs: Question and Answers

• Waivers, Exceptions and Exemptions from the Requirements of Section 582 of the Federal Food, Drug and Cosmetic Act

• Verification Systems under the Drug Supply Chain Security Act for Certain Prescription Drugs

• Identifying Trading Partners under the Drug Supply Chain Security Act

• Fees Incurred under the Drug Supply Chain Security Act

There is now just 11 months to go before 100 per cent of medicine packs sold in the US must be marked with a product identifier, serial number, lot number and expiration date using a 2D datamatrix barcode, although the full provisions of the DSCSA – including a full unit-level requirement to electronically track packs through the supply chain – are not due to come into effect until 2023.

The FDA is required to generate a series of guidance documents in the coming months and years to flesh out details on elements such as product identification, product tracing, product verification, detection and response, notification, wholesaler licensing and third-party logistics company licensing.