For decades, FDA and the States’ jurisdiction over compounding were at odds. Compounding has traditionally been governed by the States, and pharmacists could supply patients with compounded drugs without needing FDA’s approval. The controversial Drug Quality and Security Act (DQSA), recently passed by the House and Senate, sparked public debates about its effectiveness among stakeholders.
Gunning after mass-volume compounders and API suppliers, this drug compounding legislation is intended to protect the public from future deadly outbreaks due to tainted compounded medications. Unfortunately, it is doomed to fail.
Surprised? This bill addressed the regulatory gap and clarified FDA’s authority over and responsibilities for large-volume compounders, right? The ugly truth is: this new bill will only lead to more confusion over pharmacy regulations. Enforcing it will require substantial FDA resources, and mass-compounding pharmacies will have little incentive to voluntarily join the program. “Congress thinks that they approved a bill that expanded federal authority on drug compounding and improved overall compounded-drug safety. In reality, the compounding industry will likely ignore it, leaving FDA with only a few more options than it already has without the bill,” said Ben England, Founder and CEO of FDAImports.com. Here’s how Mr. England deciphers the law:
Drug compounding refers to a process by which a pharmacist or doctor combines, mixes, reconstitutes or changes a drug (usually an API) to create personalized prescriptions based on the health needs of an individual patient. It is generally used to prepare drugs that are not commercially available and is a traditional pharmacy practice. The practice of compounding is as old as alchemy – much older than FDA or its authorizing statutes. And recently, with the expansive reach of the internet, the industry has grown into a huge market opportunity, where pharmacies compound drugs in a far cheaper price for consumers than large branded drug companies and at sometimes surprising quantities.
This bill will not make drugs safer. In fact, it doesn’t really change anything – at least, not in the way that Congress wants you to believe it will. Congress is aching for some good press – something Obama will sign and both branches can claim as a victory. Otherwise, how does a House bill fly through the Senate and get to Obama at all? In this climate? Forget it. Spend some time reading this bill, and it becomes clear that it is largely useless for the industry and the consumer. It shows a typical misunderstanding of how the industry even works. “No offense to the staffers, but they fail to understand the problems; thus, they fail to solve them. Period.” says England. In a few days, we’ll explain some of the myths and truths about the DQSA – stay tuned!
