The Drug Supply Chain Security Act (DSCSA), which is Title II of the Drug Quality and Security Act (DQSA), and which amended the Food, Drug and Cosmetics Act (FD&C) of the U.S. Code of Federal Regulations (CFR)
U.S. Department of Health and Human Services (HHS), Food and Drug Administration (US FDA)
Industry is currently in a stabilization period
11/27/2023 deadline, stabilization period 11/27/2024
Waivers beyond stabilization period
EPCIS, Tracing, ATP
Prescription drug in finished dosage form such as, capsules, tablets, lyophilized products before reconstitution
We offer powerful serialização e rastreabilidade functionality to help you meet global pharmaceutical regulations. Schedule a consultation now!
Takeaways from the recent FDA announcement on not extending the stabilization period
In Part 1 of this two-part blog series, we discuss the challenges involved in labeling the medicinal products used in clinical trials.
In part 2 of this 2-blog series we talk about how T11 Mark & Verify offers a cost-effective solution for label printing for IMPs.
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