Track and Trace Legislation Resource Page
H.R. 3204, The Drug Quality and Security Act (DQSA) was signed by President Obama on November 27, 2013.
H.R. 3204 is a two-part bill that amends the Federal Food, Drug and Cosmetic Act. Title I, the Compounding Quality Act, improves regulation and oversight of the production of compounded drugs. Title II, the Drug Supply Chain Security Act, establishes national requirements to improve the tracking of prescription drugs through the entire pharmaceutical distribution supply chain.
Requirements of the Drug Supply Chain Security Act phase in between January 1, 2015 and November 2019. The act requires the Department of Health and Human Services to develop a guidance document establishing national standards for the interoperable, electronic exchange of transaction documentation. It goes on to articulate the responsibilities of manufacturers, wholesalers, dispensers and third party logistics providers with regard to verification of the legitimacy of trading partners, labeling and tracking of pharmaceuticals, investigation and quarantine of suspicious products and information-sharing within the supply chain and with the government.
The act brings much needed standardization at the national level, and will help FDA and the pharmaceuticals industry protect Americans by better detection and recall of illegitimate products.
Why was Federal Legislation Needed?
- The regulatory disarray of varied state laws governing wholesale distribution of medicine provided ample opportunity for exploitation by dishonest middlemen.
- FDA did not have authority at the national level to enforce rules to keep prescription drugs safe and effective.
- U.S. patients were under increasing threat of exposure to counterfeit and substandard prescription drugs.
Read the Law:
- H.R 3204 Drug Quality and Security Act: Passed the House on September 28, 2013 and the Senate on November 18, 2013. Signed by President Obama on November 27, 2013.
- A list of recent drug safety incidents that could have been prevented by such a program.
- A presentation about the dangers of counterfeits and supply chain breaks designed for patient advocates.
What People are Saying about National Track and Trace Legislation
People who study patient safety and health care policy agreed that it was long past time for a national track and trace system. Supporters of reform included Forbes, the members of the supply chain that distribute pharmaceuticals, both research and generic pharmaceutical manufacturers and independent medical experts like the Pew Charitable Trust and the Institute of Medicine.
- A rare endorsement from the Pharmaceutical Research and Manufacturers of America, the Healthcare Distribution Management Association and the Generic Pharmaceutical Association represented all parts of the distribution supply chain.
- Forbes health care policy reporter endorsed legislation to fix the problem.
- The Institute Of Medicine recent report recommended a national track and trace program.
- Statement of Janet Woodcock, MD, Director, Center for Drug Evaluation and Research, FDA, Before the Subcommittee on Health, Committee on Energy and Commerce, U.S. House of Representatives, “Securing Our Nation’s Prescription Drug Supply Chain,” April 25, 2013.
- Transcript, Subcommittee on Health, Committee on Energy and Commerce, U.S. House of Representatives, “Securing Our Nation’s Prescription Drug Supply Chain,” April 25, 2013.
- “Countering the Problem of Falsified and Substandard Drugs,” Institute of Medicine, Consensus Report, February 13, 2013, at 189.
- Statement of Allan Coukell, Director of Drugs and Medical Devices, The Pew Charitable Trusts, Before the Subcommittee on Health, Committee on Energy & Commerce, U.S. House of Representatives, April 25, 2013.
- House to Pass Bill Setting Nationwide Rules for Pharmaceutical Distribution. The Hill. May 31, 2013
- Congressman Pushing Legislation that Tracks Fake Prescription Drugs. NorthwestOhio.com. June 2, 2013
- Protecting American Families from Counterfeit Pharmaceuticals. Representative Bob Latta. The Hill. June 3, 2013.
- House passes “track and trace” bill to fight counterfeit drugs. Health and Science Dispatch. June 5, 2013.