A few weeks ago, Congress passed a bill inspired in part by last year’s fungal meningitis outbreak that originated at a compounding pharmacy on the east coast. Tainted steroid injections produced by the pharmacy ultimately killed 64 people and made approximately 700 additional patients ill. These defective drugs could potentially have been kept out of the hands of patients had they been produced by large manufacturers which are subject to regulatory oversight that compounding pharmacies are not.
In response to this unacceptable patient safety loophole, Congress passed The Drug Quality and Security Act. The director of drugs and medical devices at Pew Charitable Trusts recently praised the passage of this legislation when he noted that, “Congress can still come together to pass meaningful legislation to protect the public’s health. This legislation will help protect lives and alleviate these costs by ensuring that prescription drugs are safe, effective and of the highest quality.”
However, some patient safety experts are not convinced that the new legislation will actually improve patient safety and a safe pharmaceutical culture. For starters, the new bill allows compounding pharmacies to register with the federal Food and Drug Administration (FDA) on a voluntary basis. The choice to adhere to stricter quality testing and sterility measures is also voluntary rather than mandatory, according to the bill. The bill also effectively legalizes large scale compounding without specific prescriptions.
Please do not be misled by the positive reviews of this bill. It is entirely possible that the compounding pharmacy legislation will make these operations even more unsafe than they were before the bill passed.
Source: ABC News, “Compounding Pharmacy Bill Might Not Make Drugs Safer,” Sydney Lupkin, Nov. 18, 2013