Properly implemented CGMP should not be seen as a regulatory burden but a remedy to poorly compounded drugs.
In the minds of many pharmacists, the FDA’s Current Good Manufacturing Practices (CGMP) have unduly raised the bar of compliance under the authority and jurisdiction of state boards of pharmacies (SBOP).
But compared with the potential financial- and safety-related consequences of noncompliance, CGMPs should not be seen as a regulatory burden but as a reliable safeguard against disastrous outcomes, a point made clear in 2012 when improper compounding at the New England Compounding Pharmacy sparked an outbreak of fungal meningitis. The outbreak resulted in 64 deaths and 751 injuries.1 As of November 2017, no studies had been published that provided financial data on the impact of CGMPs on drug-compounding pharmacies’ compliance or the significance to protecting the health of the public. But the FDA’s SBOP data provide compelling evidence that, for the most part, compounding pharmacies do not realize the importance that CGMPs have on sustaining compounded medicines as a viable resource to patients.2
Although much work still needs to be done to eliminate the risk of exposing the public to poorly compounded drugs, education is the best mechanism for changing risky behavior by compounding pharmacists. With the right knowledge about what the FDA and the public require from quality compounded drug products, the FDA’s mission can be realized in a way that works to everyone’s benefit. Compounding pharmacists should consider these questions to understand the risks of failing to adopt CGMPs throughout their organizations: How do CGMPs apply to compounding? How does a compounding pharmacy comply with CGMPs? How does the FDA assess the state of CGMP compliance once implemented? Rather than contending that regulators are misapplying the rules and that the FDA, in the words of Congress, is “overstepping” its regulatory authority, educating and implementing appropriate strategies that enhance patient safety while making economic sense will best serve compounding pharmacies in the long run.
The Law and Compounding Pharmacies
A debate has been brewing between compounding pharmacists and the FDA. Following the New England Compounding Center tragedy in 2012, Congress acted quickly to promulgate new rules codified in the Drug Quality and Security Act (DQSA) that gave the FDA regulatory oversight of drug compounding activity in the United States and its territories.
Since then, some statutory practices that had evolved over the past 25 years are being questioned when applied to drug compounding. These concerns have been further accelerated by an FDA now more proactive in its initiative to bring its operations into the 21st century. CGMPs are the cornerstone of the Food, Drug and Cosmetic (FD&C) Act. CGMPs provide a mechanism for drug manufacturers to produce effective, pure, and safe drug products and for the FDA to inspect and issue observations, warnings, injunctions, and consent decrees to drug manufacturers that fail to comply with the CGMP rules.
Since the DQSA was passed in 2013, the FD&C Act has been extended to additional drugs for humans and for veterinary compounding.
The FDA’s list of inspections, recalls, and other enforcement actions shows that regulators not only intend to make good on this initiative but are actively doing so. With many pharmacies not registered as outsourcing facilities, it is certain that the FDA will continue to leverage its enforcement of CGMPs on compounding pharmacies to protect the public from poorly compounded drugs.
Gary E. Ritchie is president of GER Compliance in Fenton, Missouri.