The prospect of federal track and trace legislation has leapt forward with the passage on Saturday by the House of Representatives of a bill negotiated between House and Senate committee leaders last week.
Approved by voice vote in the House, H.R. 3204, the Drug Quality and Security Act, creates a federal uniform traceability requirement, combined with an overhaul of regulation of pharmaceutical compounding.
H.R. 3204 replaces H.R. 1919 in which the House Energy and Commerce Committee proposed its initial version of track and trace requirements. H.R. 3204 conforms in key provisions with the Senate's Health, Education, Labor, & Pensions (HELP) committee bill on traceability, S. 959.
Requirements include that manufacturers affix the standard numerical identifier (SNI) to unit level packaging four years after enactment. Supply chain deployment of interoperable electronic tracing of product at the package level must be in place after ten years.
"Now that the House of Representatives has passed legislation to strengthen the security of the pharmaceutical supply chain, only the Senate's imminent vote stands in the way of establishing a federal uniform traceability framework for prescription medicines," said HDMA presdient and CEO John Gray in a press release.
"For nearly a decade, HDMA has worked to replace the 50-state patchwork of rules and regulations with a federal solution that ensures regulatory clarity and consistency, helps prevent counterfeits, discourages gray market activities, and enhances the safety and securtity of the pharmaceutical supply chain for all Americans," Gray said.
H.R. 3204 reflects a bipartisan, bicameral effort on the issues of traceability and compounding, the HELP committee said in a press release announcing the compromise agreement last week.
“This legislation will improve the safety of compounded drugs by clarifying the oversight responsibilities of the FDA over large volume compounders and by holding facilities to high quality standards. The bill also calls for an unprecedented tracing system that will track prescription drugs from manufacturing to distribution. I commend the bipartisan spirit that brought this compromise proposal together,” said committee chairman Tom Harkin (D-IA).
“We have developed a uniform system for tracking and tracing drugs to prevent counterfeits from entering the supply chain that maintains the strengths of the groundbreaking California system,” said House Energy and Commerce committee ranking member Henry A. Waxman (D-CA).
A provision in H.R. 1919 that called for electronic labeling of the professional package insert—that was strongly opposed by the specialty printing industry--is eliminated in H.R. 3204.
In a press release after the House vote on Saturday, House Energy and Commerce committee chairman Fred Upton ( R-MI) commented: “I am proud to say that this piece of legislation is a product of true bipartisan and bicameral work. The Senate and the House, Republicans and Democrats, came together to produce a bill that will protect American patients by ensuring they receive safe drugs.”