Under the Drug Quality and Security Act, manufacturers by 2015 will have to create electronic tracking systems to find and root out suspect or counterfeit drugs. The tracking system will enable companies to investigate supply chain partners more closely, and will be required to keep records of investigations into suspect products for at least six years following the investigations.
House Energy and Commerce Committee Chairman Fred Upton (R-Mich.) said, “This legislation would also create a uniform national standard for drug supply chain security to protect Americans against counterfeit drugs while eliminating needless government red tape.”
Support from the bill is coming from industry, as well, which will be hit with the cost of putting such a standard in place.
In a letter of support for the bill, Pfizer added, “This bill will increase the security of the United States’ already strong drug supply chain by creating a national traceability system and replacing the patchwork of state laws now in place. Specifically, this bill provides greater safeguards for patients by requiring the placement of unique serial numbers on each drug package, and tracking them as they move through the distribution system, lessening the threat of illicit and counterfeit medicines entering the drug supply chain.”
A number of other associations offered letters of support for the bill, which will bypass committee hearings and move straight to the Senate floor this week.
Details of the Bill
Beginning four years after the Drug Supply Chain Security Act is enacted, manufacturers will have to provide electronic transactions information and histories. In addition, they will have to affix a product identifier to each package and keep the identifier on the package for a minimum of six years after the date of the transaction.
The transaction information will have to include:
— The proprietary or established name or names of the product;
— The strength and dosage form of the product;
— The National Drug Code number of the product;
— The container size;
— The number of containers;
— The lot number of the product;
— The date of the transaction and the date of the shipment; and
— The business name and address of the person from whom ownership is being transferred and the business name and address of the person to whom ownership is being transferred.
The legislation introduced last week would also preempt state laws such as California’s e-pedigree law, which is calling on companies to implement the tracking tags between 2015 and 2017.
The draft will also replace existing draft legislation under consideration in the Senate and a bill that already passed the House in June.