[Update: After unanimously passing the Senate on November 18, 2013, H.R. 3204–the Drug Quality and Security Act–is set to become law after an expected signature from President Obama. President Obama signed into law on November 27, 2013.]
On November 12, 2013, the Senate voted to close debate on and advance a compounding pharmacy bill–H.R. 3204–aimed at tightening government oversight of pharmacy compounding and creating a national tracking system for prescription drugs. The 97-1 vote indicated overwhelming bipartisan support for the proposal, which passed the House in September. The lone dissenter, Sen. David Vitter, objected to a final Senate vote on the proposal because he wanted the Senate to first vote on a measure that he proposed to require lawmakers to disclose which of their aides are signing up for health insurance under the Affordable Care Act and which are remaining in the Federal Employee Benefit Program.
Originally introduced in the House by Rep. Fred Upton, H.R. 3204–the Drug Quality and Security Act–seeks to address two major concerns regarding the safety and quality of the U.S. drug supply. First, and in response to last year’s deadly meningitis outbreak, the Bill seeks to strengthen government oversight of compounding pharmacies. More specifically, Title I–the Compounding Quality Act–would amend the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) as to the regulation of compounding pharmacies, which have historically been regulated by state pharmacy boards. Under the proposal, pharmacies that perform traditional, small-scale compounding will continue to be regulated by state pharmacy boards. Additionally, drugs compounded by or under the direct supervision of a licensed pharmacist in a facility can elect to register as an outsourcing facility. In doing so, these drugs would be exempt from the FD&C Act’s labeling, new-drug, and proposed track-and-trace requirements if certain conditions were met, including: (1) proper registration of the facility; (2) no compounding using bulk drug substances; (3) compounding with ingredients that comply with applicable standards; (4) no compounding of drugs that have been withdrawn or removed due to lack of safety or efficacy; (5) no compounding of drugs that are essentially a copy of one or more approved drugs; (6) no compounding of drugs that have been identified as ones that present demonstrable difficulties for compounding; (7) no sale or transfer of the compounded drug by any entity other than the outsourcing facility; and (8) appropriate labeling.
The Bill also seeks to increase protection of the prescription-drug supply chain. More specifically, Title II–the Drug Supply Chain Security Act–will establish requirements to establish a track-and-trace system that will follow prescription drugs from manufactures to retail pharmacies. This national system should facilitate greater protection against counterfeiting, earlier detection of possible drug shortages, simpler recalls of defective drugs, and other drug supply-chain issues. While there will be certain waivers and exemptions, the proposal would require drugmakers to affix a product identifier on each package and case of product intended to be introduced in a transaction into commerce. Ten years after enactment, the Bill adds an electronic-tracing requirement. The Bill will require FDA to publish guidelines: (1) establishing standards for the interoperable exchange of transaction information, transaction history, and transaction statements; and (2) establishing the process by which companies may obtain waivers, exceptions, and/or exemptions to the product-identifier requirements. The national track-and-trace program will also preempt all state and local requirements regarding tracing drugs through the supply channels.