FDA Issues New Guidelines for Pharmaceutical Repackaging

by Ken Allen, on February 26, 2016

The FDA recently announced new guidance documents for compounding pharmacies and "outsourcing facilities," focused on product repackaging. According to JD Supra, the four draft guidance documents and memorandum of understanding provide insight into the FDA's implementation of the pharmaceutical compounding provisions of the Drug Quality and Security Act (DQSA), as well as state-licensed compounding pharmacies.

"The draft guidance documents provide information to pharmacies, outsourcing facilities, health care entities, and others about these FDA-proposed policies, which are critical to protecting the public health," said Janet Woodcock, MD, director of FDA's Center for Drug Evaluation and Research, in a statement.

The four documents will update guidance on the repackaging of pharmaceutical products and ensuring labeling regulations are properly carried over. They also clarify the distinction between compounding and repackaging to ensure appropriate traceability in each procedure and ease of compliance with the regulations that effect both.

Once finalized, these guidance documents on repackaging will supersede section 506F of the FDCA as applied to repackaging of single-dose vials in hospital-based pharmacies. They will also supersede interim criteria for repackaging drugs implemented by Congress as part of the Food and Drug Administration Safety and Innovation Act of 2012.

The last guidance document also covers reporting obligation of adverse affects for Registered Outsourcing Facilities, as well as investigation requirements.

These documents will have a lasting effect on pharmaceutical labeling requirements, particularly for supply chain track and trace capabilities. It will be critical to ensure labeling solutions are updated and capable of conforming with the new guidance as it becomes approved, establishing the necessary changes along with other compliance updates.

Topics:PharmaceuticalsSupply ChainRegulatoryTransportation & Logistics