The first phase of a new “track and trace” law to help manufacturers, distributors, wholesalers and pharmacists better monitor the pharmaceutical supply chain goes into effect Jan. 1.
The Drug Quality and Security Act, which became law in 2013, will take a phased approach to the rollout of a national drug-tracking system using serial numbers. Starting in 2015, drugs making their way through the supply chain will be required to have new information, including lot numbers, the names and addresses of buyers and sellers, and a transaction history. The law also sets out new requirements for compounding pharmacies.
The act is expected to boost security and lessen concerns about counterfeit and substandard drugs ending up in the supply chain. Manufacturers and providers should be able to “understand how that drug traveled” through the supply chain and improve the recall process, said Gabrielle Cosel, manager of the drug-safety project at the Pew Charitable Trusts.
The act pre-empted a California law scheduled to take effect in 2015 that was considered the most comprehensive state law addressing drug supply-chain security. It would have required electronic records of drugs. Most states regulate drug supply chains but not all of them required drug pedigrees, which track a drug from the manufacturer to the pharmacist who then dispenses it to the patient.
Recent drug shortages triggered renewed calls for a tracking system because hospitals started buying drugs in short supply from secondary distributors, which raised questions about safety and quality as well as federal oversight of that system.