Many people don’t realize that pharmacists compound drugs. My unscientific survey of several of my non-healthcare-affiliated friends revealed that almost all had no idea that pharmacists were still engaged in “chemistry,” as one friend put it. One person responded, “mortar and pestle?” which I still believe he got from Dr. Google.
As you are aware, the practice of drug compounding remains widespread, especially within the LTC pharmacy community.
For years, the practice of drug compounding was loosely regulated and responsibility for enforcement was roughly split between states and the FDA. It wasn't until 2012 that a tragic event forever changed how pharmacies practiced the art and science of drug compounding. Read on to learn more.
I assume that defining drug compounding is not necessary for the vast majority of people reading this post. For those of you who are not familiar with this practice, check out the FDA definition.
While there is little data on pharmacy practice prior to the enactment of the Food, Drug and Cosmetic Act (FD&C) of 1938, it is safe to say that the majority of drugs dispensed before this landmark legislation were locally compounded.
With the passage of the FD&C Act, the pharmaceutical industry became more regulated, but the practice of compounding was left to state authorities.
It went on like this through the 1940s, all the way to 1997, when Congress passed the FDA Modernization Act (FDAMA). Congress created two classifications of pharmacy practices related to drug compounding.
Pharmacies that prepared compounded drugs in response to a request for a specific patient and did not engage in large-scale compounding for inventory or distribution were considered 503(a) compounding pharmacies, which would be overseen by state boards of pharmacy.
Pharmacies that compounded large quantities of medications (not intended for a specific patient) were classified as 503(b) pharmacies. The “503” refers to Section 503 of the FD&C Act, where the provisions are spelled out.
Despite the addition of the FD&C Act Section 503 additions, things went along pretty much as they always had. States regulated the 503(a) practices of pharmacies, and the FDA laid out some guidelines on Good Manufacturing Processes for 503(b) facilities, but resource constraints hindered the agency from robust compliance verification.
In the fall of 2012, an unusual strain of fungal meningitis broke out, ultimately resulting in the death of 64 people and serious illness of hundreds more. The source of the outbreak was traced back to contaminated lots of preservative-free methylprednisolone acetate produced by the New England Compounding Center. Suddenly, everyone seemed to be paying attention to how pharmacies compound drugs.
In 2013, Congress passed the Drug Quality and Security Act (DQSA), which imposed tougher standards on both 503(a) and 503(b) compounders. The law also requires 503(a) pharmacies to comply with USP Chapters 795 (non-sterile compounding) and 797 (sterile compounding). The 503(b) standards under Good Manufacturing Processes are much higher.
Prior to the NECC tragedy, there wasn’t much tracking of drug compounders, but since the enactment of the DQSA, oversight has been more active, and the 503(b) industry has not had a repeat of that regrettable incident. It’s safe to say that more agencies are watching and that’s a good thing.
What's more, compounding practices have become more commonplace within the pharmacy industry. Whether we’re talking retail, hospital, or long-term care, compounding practices have found their way into just about all pharmacy models. With the help of these current regulations and advancements in pharmacy software, compounding pharmacy’s place in the industry is bigger than ever.
Interested in more? Check out the FDA’s web page on FD&C Provisions that apply to drug compounding, FDA’s web page on Human Drug Compounding, and FDA’s Drug Compounding Program.
