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H.R. 3204, The Drug Quality and Security Act

Sep 27, 2013
Authored by Rep. Fred Upton (R-MI)

The Drug Quality and Security Act would address two important issues affecting the quality and security of America’s drug supply. First, the bill would protect traditional pharmacies and clarify laws related to human drug compounding in response to the nationwide meningitis outbreak – one of the largest public health crises in recent memory. Second, the bill would strengthen the prescription drug supply chain in order to defend American families against counterfeit drugs and protect jobs. The bill is supported by the National Community Pharmacists Association, U.S. Chamber of Commerce, UPS, PhRMA, GPhA, BIO, HDMA, HIDA, NACDS and many other organizations.

Title I - Compounding Quality Act

Title I of the Drug Quality and Security Act, which is based on Rep. Morgan Griffith’s (R-VA) H.R. 3089 and the Energy and Commerce Committee’s investigation of the meningitis outbreak (including four committee hearings), would clarify FDA’s authority over the compounding of human drugs while requiring the agency to engage and coordinate with states to ensure the safety of compounded drugs. The bill would:

  • Preserve and protect the practice of traditional pharmacy compounding occurring in community pharmacies.
  • Eliminate the unconstitutional provisions of Section 503A of the Federal Food, Drug, and Cosmetic Act (FFDCA) that created uncertainty regarding the laws governing compounding and require FDA to engage in two-way communication with state regulators – a major deficiency in FDA’s response to the meningitis outbreak.
  • Permit entities engaged in the compounding of sterile drugs to register as "outsourcing facilities."

Title II – Drug Supply Chain Security Act

Title II of the Drug Quality and Security Act, which is based on Rep. Bob Latta’s (R-OH) H.R. 1919, would create a uniform national standard for drug supply chain security to protect Americans against counterfeit drugs while eliminating needless government red tape. The bill also would help prevent increases in drug prices, avoid additional drug shortages and eliminate hundreds of millions of dollars worth of duplicative government regulations on American drug manufacturers, wholesale distributors, pharmacies, repackagers and third-party logistic providers. The bill would:

  • Create a new framework for securing our prescription drug supply chain. The bill also would establish a 10-year transition to a unit level tracking system for enhanced security.
  • Eliminate the patchwork of red tape, like California’s pedigree law, on drug manufacturers, wholesale distributors, pharmacies, repackagers, and third-party logistic providers (3PLs).  These changes would help alleviate drug shortages and reduce government-imposed costs on prescription drugs.
  • Create floor and ceiling licensure standards for wholesale distributors and 3PLs while preserving state authority for licensure issuance and fee collection.

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