CDER Issues Updated CY2017 Guidance Agenda


Monitoring and Reporting Group

CDER has issued their updated CY2017 Guidance Agenda (issued February 15, 2017), which outlines new and revised draft guidances CDER plans to publish during the year.

Specifically related to supply chain security, this list includes the following planned guidances:

  • Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers (issued January 10, 2017)
  • Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier
  • Identifying Trading Partners Under the Drug Supply Chain Security Act
  • Information on How to Apply for a CDER Certification of Pharmaceutical Product (CPP) Export Certificate
  • 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
  • Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs
  • Waivers, Exceptions and Exemptions from the Requirements of Section 582 of the Federal Food, Drug and Cosmetic Act
  • Fees Incurred Under the Drug Supply Chain Security Act
  • Repackaging of Certain Drug Products by Pharmacies and Outsourcing Facilities