To amend the Federal Food, Drug, and Cosmetic Act to modernize the methods of authenticating controlled substances in the pharmaceutical distribution supply chain, and for other purposes.
This bill modernizes how controlled prescription drugs are authenticated in the pharmaceutical supply chain by requiring manufacturers to add physical chemical identifiers to solid oral medications like pills and tablets. The requirement applies to controlled substances manufactured five years after the bill becomes law, giving the pharmaceutical industry time to implement the new technology. A physical chemical identifier is a unique substance or combination of substances embedded in or on each dose that can be machine-read to verify the drug is authentic and hasn't been counterfeited or tampered with. The bill amends the Federal Food, Drug, and Cosmetic Act to define these new identifiers alongside existing product tracking methods and clarifies how verification of pharmaceuticals will work going forward. This measure affects drug manufacturers, pharmacies, and ultimately patients by adding an additional security layer to prevent counterfeit drugs from entering the legitimate medication supply.
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