FDA Issues Proposed DSCSA Guidance Agenda for 2018
On January 19, the FDA published its annual agenda of draft guidances it expects to publish from the Center for Drug Evaluation and Research (CDER) in 2018. As part of the FDA, CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs and it maintains primary responsibility for guiding the implementation of DSCSA across the industry.
The 2018 agenda includes procedural topics that are expected to affect how companies will need to comply with DSCSA regulations. Some of the guidances are new and some are either carried over from the 2017 plan or are in current draft form awaiting commentary and finalization:
- Definitions of Suspect Product and Illegitimate Product or Verification Obligations
- Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier
- Proposed Accreditation Program Under the Drug Supply Chain Security Act
- Proposed Licensing Program Under the Drug Supply Chain Security Act
- 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
As manufacturers, distributors, and pharmacies prepare for serialization and item-level traceability deadlines in 2019, 2020, an 2023, TraceLink will continue to monitor all upcoming FDA draft guidance related to DSCSA compliance and will post updates as the guidance becomes available.
Download the 2018 Guidance Agenda New & Revised Draft Guidances