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Drug Supply Chain Security Act: Title II

In order to maintain the U.S. drug supply chain as the world's safest, Congress enacted the Drug Supply Chain and Security Act (DSCSA) in 2013. The Act has specific requirements to prevent threats to the supply chain and maintain the integrity of drugs that are distributed within the U.S.

The new law does away with piecemeal and inconsistent state laws and establishes national standards for all entities within the drug supply chain. Some new requirements for the identification, tracing and tracking of pharmaceutical products will take effect beginning January 1, 2015, with 10 years allowed for full implementation.

The FDA safeguards are intended to prevent substandard, altered or counterfeit drugs from entering the distribution chain. The safeguards also will provide consumers with access to drugs which are safe and effective. Cargo theft will be thwarted and counterfeiting identified. When recalls are necessary, an efficient system will be in place.

Overview of Title II of the Drug Supply Chain Security Act

The new regulations apply to all entities involved in the drug supply chain, beginning with the manufacturers and ending with the dispensers. Repackagers and wholesale distributors are included. Some of the new DSCSA provisions that are to be in place by the end of ten years include, but are not limited to:

  • Identification measures: Packages for certain prescription drugs need to have easily readable but unique bar codes.
  • Tracing provisions: All entities in the chain must establish a way that the drugs can be tracked for each step in the process, including who handled the specific drug each time it was transferred from one entity to another in the chain including where and when it was sold.
  • Implement verification measures: Ways must be established to verify the drug is what it claims to be. Within 24 hours of a request from the dispenser to the manufacturer or repackager, the entity must be able to confirm that the product identifier is accurate.
  • Methods to detect and respond to suspected drugs: Standards for identifying potentially dangerous or counterfeit drugs that are not approved must be developed. The suspect drug must be quarantined for further investigation.
  • FDA notification: If a counterfeit, unsafe or unapproved drug is detected, procedures for notification of the FDA must be implemented.
  • Licensing of wholesale distributors: All must report the status of their licenses to the FDA which will be stored in a database accessible by the public.
  • Third party logistics providers must be licensed: Third party logistics providers are those that warehouse, store or ship drugs. This will be the first time they have been required to be licensed.

The Pew Charitable Trusts has published a timeline for covered entities to consult. It provides an overview of each regulation, the entity that must comply with the regulation and the date required for the implementation of the specific regulation.