H.R. 3204: To Amend the Federal Food, Drug, and Cosmetic Act with Respect to Human Drug Compounding and Drug Supply Chain Security, and for Other Purposes

H.R. 3204

To Amend the Federal Food, Drug, and Cosmetic Act with Respect to Human Drug Compounding and Drug Supply Chain Security, and for Other Purposes

Sponsor
Rep. Fred Upton

Date
September 28, 2013 (113th Congress, 1st Session)

Staff Contact
Communications

Floor Situation

On Saturday, September 28, 2013, the House will consider H.R. 3204, a bill to Amend the Federal Food, Drug, and Cosmetic Act with Respect to Human Drug Compounding and Drug Supply Chain Security, and for Other Purposes.  The bill was introduced on Friday, September 27, 2013 by Rep. Fred Upton (R-MI) and referred to the House Committee on Energy and Commerce.

Bill Summary

H.R. 3204 addresses the issues affecting the quality and security of America’s drug supply by clarifying the laws related to human drug compounding, and strengthening the prescription drug supply chain in order to protect American families against drug counterfeiting.

Title I protects traditional pharmacies while clarifying the FDA’s authority over the compounding of human drugs, and requires the agency to coordinate with states to ensure that drug compounding occurs in a safe manner.  The bill would: (1) eliminate the unconstitutional provision of Section 503A of the Federal Food, Drug, and Cosmetic Act created the uncertainty surrounding compounding laws; (2) require the FDA to engage in two-way communications with state regulators; (3) and permit entities who engage in drug compounding to voluntarily register as “outsourcing facilities,” making them subject to good manufacturing practices, risk-based inspection, and other standards.  Title I is based upon H.R. 3089, the Compounding Clarity Act of 2013 introduced by Rep. Morgan Griffith (R-VA), in addition to the Energy and Commerce’s investigation of the meningitis outbreak of 2012. 

Title II creates a uniform national standard for drug supply chain security in order to protect Americans from counterfeit drugs and eliminate government red tape.  Specifically, it creates a new framework for drug security, and establishes a 10-year transition to a unit-level tracking system that would increase security.  Moreover, Title II eliminates duplicative government regulations on American drug manufacturers, wholesale distributors, pharmacies, re-packagers, and third-party logistic providers.  Finally, it creates floor and ceiling licensure standards for wholesale distributors, while preserving the authority of state to issue licenses and collect fees.  Title II is based upon H.R. 1919, the Safeguarding America’s Pharmaceuticals Act of 2013 introduced by Rep. Bob Latta (R-OH).

Cost

CBO estimates that H.R. 3204 will authorize the collection of $27 million in user fees for FY2014-2018 and will have no impact on the deficit.

Additional Information

For questions or further information contact the GOP Conference at 5-5107.