On the recordNovember 18, 2013
as Senator Alexander has indicated, we have been working together for a long time to develop legislation that will ensure that patients have access to the compounded drug products they need and that they can have greater confidence that their compounded drugs are safe. We ultimately landed on a package that preserves current law for traditional compounders but creates a new option for entities that choose to operate outside the bounds of traditional pharmacy practice to allow them to serve as safe sources of the compounded drugs that providers and their patients need. We have worked very hard to craft a proposal that preserves patient access to clinically necessary medications while helping to ensure that providers have access to safe sources of compounded drugs. As Senator Alexander noted, section 503A of the current Federal Food, Drug, and Cosmetic Act governs traditional compounding. This bill preserves current 503A but removes the unconstitutional advertising provisions so 503A is the uniform policy nationwide. Similarly, we do not change current law regarding repackaging or biologics. The Senate bill established a new regulatory regime for repackaging and biologics, but ultimately, after our bipartisan, bicameral discussions, we made no changes to current law on those subjects nor do we change current law on the compounding of animal drugs. The existing restrictions on animal drug compounding have not been rigorously enforced.…
