FDA offers guidance as track-and-trace rules loom

With the deadline for new track and trace requirements kicking in Jan. 1 for drugmakers and wholesalers, the FDA has issued new guidance to help them understand what they are up against. According to Regulatory Focus, the agency has issued draft guidance on what information companies are supposed to exchange under the Drug Quality and Security Act (DQSA), which Congress passed last year. It also clarifies that the rules initially apply only to human prescription drugs, not veterinary products, unfinished human pharmaceuticals, blood or blood components intended for transfusion, radioactive drugs, imaging drugs, intravenous products, medical gases, homeopathic drugs, compounded pharmaceuticals or over-the-counter (OTC) drugs. The second draft guidance is about what information companies must report to the FDA each year. Story | Guidance | Guidance | More