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
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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