Drugmakers have 13 months to revamp how they track drugs after the Senate voted Nov. 18 to send to President Barack Obama’s desk a measure that would establish a nationwide track-and-trace requirement for prescription drugs.
H.R. 3204, the Drug Quality and Security Act, was approved by a voice vote without amendments following House passage in late September.
Once signed into law, H.R. 3204 will immediately preempt all state laws concerning track and trace, including California’s strict e-Pedigree measure set to go into effect in 2015.
The legislation sets a number of important deadlines for manufacturers.
By Jan. 1, 2015, all finished-dose forms of prescription drugs must include a lot-level transaction history that documents each step a product takes from manufacturer to final sale. Manufacturers face the same deadline for establishing a system to quarantine, investigate and validate via the history record a product suspected of being counterfeit, adulterated or stolen.
The bill also states that four years after enactment drugmakers must affix product identifiers to each package and case of a product that includes a numerical identifier, lot number and expiration date. When a manufacturer receives a returned product that it intends to redistribute, that manufacturer must verify the product identifier on each package beginning four years after enactment.
Ten years after enactment, manufacturers must develop an electronic traceability system that identifies products down to the sales-unit level.
The bill also directs HHS to seek public and industry input and issue guidance that:
Defines the circumstances in which a manufacturer can infer that drugs in a large container are what they purport to be. HHS must hold a public meeting on the issue and then issue a guidance 18 months after that meeting;
Explains how drugmakers and other supply chain stakeholder can get a waiver from any of the law’s requirements. The guidance is to be issued no later than two years from the date of enactment;
Helps drugmakers establish mechanisms to identify a suspect product and what to do after it is identified as such. This guidance must be published no later than 180 days after enactment; and
Provides detail on how to grandfather products that were already distributed in the supply chain when the bill became effective. This guidance is to be issued no later than two years from the date of enactment.
The agency is also tasked with creating standards for the interoperable and secure electronic exchange of data along the supply chain. The standards must be available 18 months after a public meeting on the electronic system.
HHS must hold at least five public meetings in all to solicit feedback on how to implement the law, and at least one pilot project that evaluates unit-level traceability and the use of the product identifier.
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