Having a prescription filled is one of the routine things most of us do for our health. That simple activity is anything but routine for the millions of individuals who can’t tolerate medicines made for the masses. They may have an allergy to an ingredient, require a drug of a different strength than is commercially available, require an injectable medicine rather than one in pill form, or need a drug that is no longer manufactured by a pharmaceutical company.
That’s where compounding pharmacies come in. These companies customize medications, often mixing raw ingredients into preparations that can be taken orally, applied to the skin as a lotion or cream, placed under the tongue as a lozenge or, in the case of sterile compounding, injected into the body or placed in an intravenous line.
Thousands of companies across the United States specialize in compounded medicine. They were long overseen solely by their state boards of pharmacy. That changed in the wake of the New England Compounding Center tragedy. In September 2012, tainted spinal steroid injections made in this compounding pharmacy caused a multistate outbreak of fungal meningitis that injured more than 750 people and killed 64. More than 400 lawsuits have been filed on behalf of those harmed by the medicine.
Federal regulations put in place as part of the Drug Quality and Security Act of 2013 aim to make drugs produced at compounding facilities safer than ever before.
These new regulations have generated significant pushback from the compounding community. They have also placed many of these pharmacies at a crossroads: they must choose either to limit what they produce to lessen federal oversight or invest in a higher quality, larger-scale operation so they can offer a greater range of solutions for patients and providers.
The 2013 law essentially created two classes of compounding pharmacies: “503A” for so-called traditional compounding pharmacies that fill patient-specific prescriptions (one drug prepared at a time for one patient) and “503B” for sterile compounding outsourcing facilities that produce large quantities of medications, including those prepared for “office use” and those sold directly to hospitals and physicians.
As a compounding pharmacy CEO, I believe that, whether registered as 503A or 503B, pharmacies must do everything possible to provide the safest, highest-quality medications to the people who need them. When it comes to sterile medications, the quality — whether manufactured commercially by a pharmaceutical company, or prepared in the clean room of a compounding pharmacy or outsourcing facility — must be unassailable. There is no such thing as “good enough.” Sterile medications, such as those injected or infused into a patient, bypass the body’s first lines of defense and any contamination can create serious harm and even death.
The 503A compounding pharmacies follow the traditional pharmacy standards set by the United States Pharmacopeia. They will continue to be overseen mainly by state boards of pharmacy. The 503B outsourcing facilities, however, must abide by the Food and Drug Administration’s more rigorous current Good Manufacturing Practices. These are the same practices that drug manufacturers must follow. They are also the standard for FDA inspection and enforcement.
My company, Empower Pharmacy, opened in 2009 as a small compounding pharmacy in Houston. We gradually grew as more patients and physicians turned to us to fulfill their health and wellness needs. As our pharmacy grew, we had to balance the cost of producing drugs with the cost of expanding and meeting demand. To invest too much in more advanced, higher-capacity equipment didn’t initially make sense, but neither did limiting what we could produce.
In response to the 2013 law, we chose the 503B outsourcing facility route. It was a difficult decision because of the tremendous amount of time and capital required, but it seemed to be the only path forward if we wanted to truly serve the needs of our growing patient base.
In our new facility, the clean room walls are completely seamless to prevent contaminants from getting trapped; we sample for microbes daily; and we continuously monitor particulate matter, temperature, and humidity. All of our operators are encapsulated within sterilized coveralls, hairnets, face masks, goggles, and booties. Fully automated filling lines process injectables with little human intervention, minimizing the risk of contamination. The Empower facility looks no different than a factory that mass produces medication.
An engineer by training, my goal has always been achieving the highest level of quality in manufacturing. I strongly believe that my colleagues in the compounding profession should have the same goal. When it comes to public health, there can be no going half-way.
Many of my colleagues grouse about the Drug Quality and Security Act. I think it has worked as public policy should: it spurred changes that were needed by the public — and are achievable by practitioners — to ensure that facilities producing sterile medications on a large scale will provide patients who use compounded medicines with the same sense of confidence that comes with opening a manufactured medication.
It will also help improve the image of a profession that was deeply damaged four years ago.
Shaun Noorian is the CEO of Empower Pharmacy, an FDA-registered 503B outsourcing facility in Houston, Texas.
Great information!