A new law that was widely described as strengthening Food and Drug Administration powers over approved drugs contains a spotlight on packaging that, among other things, will soon require unique numbering of individual packages of prescription drug products. In the FDA Amendments Act of 2007, little-noticed section 913 adds a new section to the law called "Pharmaceutical Security" that calls for federal government officials to "develop standards and validate effective technologies" to secure the drug supply chain against "counterfeit, diverted, subpotent, substandard, adulterated, misbranded, or expired drugs."
Well now, these have been the goals of many in packaging for years. What's new here is that Congress has ordered that standards be set for these technologies, perhaps leading to government sanctions of some devices, methods, or products. Congress wants the Secretary of Health and Human Services (who will probably delegate the jobs to the FDA and others) to huddle with the Departments of Justice, Homeland Security, Commerce and others, as well as industry members all along the supply chain, to develop the standards that will help with "identification, validation, authentication, and tracking and tracing of prescription drugs." They are explicitly told to examine "promising technologies,” including RFID, nanotechnology, encryption, and others.
As for the numbering system, the law says that within the next 2 1/2 years, the FDA will have to create a system of "standardized numerical identifiers" for prescription drugs to be applied "at the point of manufacturing and repackaging…at the package or pallet level". These unique numbers will allow "identification, validation," etc., of the product.
--By Eric F. Greenberg, Attorney-at-Law
Eric F. Greenberg, PC
