Drug Quality and Security Act

Floor Speech

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Mr. LATTA. I thank the chairman for yielding.

Mr. Speaker, I rise today in support of the Drug Quality and Security Act of 2013.

Title II of this legislation, Drug Supply Chain Security, is based on H.R. 1919, the Safeguarding America's Pharmaceuticals Act of 2013, which I introduced along with Congressman Matheson. H.R. 1919 was passed on the floor by a voice vote on June 3 of this year.

Title II of this bill relates to the drug supply chain, and I am pleased that a bipartisan, bicameral agreement was reached to secure our drug supply chain and protect patients. Securing our Nation's pharmaceutical supply chain is extremely important, and passage of this bill is an important step forward in protecting America's families.

Pharmaceutical distribution occurs nationwide, and it is estimated that within the United States there are more than 4 billion prescriptions filled each year. By replacing the current patchwork of multiple State laws with a uniform national standard, we're improving safety, eliminating duplicative regulations, and creating certainty for all members of the pharmaceutical supply chain. When anyone takes a prescribed medication, he or she should have full confidence that the medication is as prescribed and that no counterfeit or adulterated drug has entered the supply chain.

To protect patient safety, the bill creates a uniform national standard for securing the drug distribution supply chain, thereby preventing duplicative State and Federal requirements relating to tracing. No State can impose additional or inconsistent regulations related to tracing products on supply chain members. The bill increases security of the supply chain by establishing tracing requirements for manufacturers, wholesale distributors, pharmacies, and repackagers based on the changes in ownership. The bill also establishes a collaborative, transparent process between the FDA and stakeholders to study ways to even further secure the drug supply chain through public meetings and pilot projects.

I was successful in including language in the FDA user fee law to allow hospital systems to repackage drugs within a hospital system in the instance of a drug shortage.

The SPEAKER pro tempore. The time of the gentleman has expired.

Mr. UPTON. I yield the gentleman an additional 30 seconds.

Mr. LATTA. I will continue working with hospital systems on the issue of permitting these systems to prepare batches of compounded drugs in advance of a specific physician prescription or order.

Mr. Speaker, I want to especially thank Chairman Upton and Subcommittee Chairman Pitts for all their assistance in advancing this legislation. I want to thank the Health Subcommittee staff, especially my legislative director, Allison Witt, for all their hard work.

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