Compounding Pharmacy Regulation: A Matter of Life and Death

When deciding whether to prescribe a medicine to a patient, a doctor will worry about whether it is the best treatment for the situation. And the patient will worry about whether the treatment will work and what the side effects might be. But neither the doctor nor the patient will think about whether or not the medicine that is dispensed is truly what the label says it is, or whether it might harbor a dangerous contaminant.

Doctors and patients simply trust that medicines are pure. This is how it should be. But the recent meningitis outbreak caused by contaminated vials of steroid solution shipped nationally from the New England Compounding Center (NECC) of Framingham, MA has brought national attention to a dangerous loophole in our drug production system.

NECC was operating as a compounding pharmacy. The basic assumption in these types of facilities is that they comprise individual pharmacists creating specific formulations in response to doctors’ prescriptions for particular patients. This is a needed function in hospitals and street-corner pharmacies. However, some compounding “pharmacies” (like NECC) are really operating as pharmaceutical manufacturers, filling batches of thousands of units and then offering them for sale to doctors, often at deep discounts compared to medicines produced by actual manufacturers.

Unlike pharmaceutical manufacturers, these mass-production compounding pharmacies are not required to adhere to Current Good Manufacturing Practices (cGMPs), a system required by FDA that establishes processes and procedures that assure consistently high quality drugs, as well as reactive programs to promptly detect and then prevent recurrences of problems. Instead compounding pharmacies are subject to widely varying state-by-state regulations.

Instead of cGMPs, the U.S. Pharmacopoeia (USP) chapter <797> is the recognized standard of practice for compounding pharmacies manufacturing sterile products in the US, but USP <797> is far less rigorous than the expectations of cGMPs and is really appropriate only for small pharmacies filling specific prescriptions for specific patients, not for large-scale production. Additionally, only 23 states currently require compliance with USP chapter <797>, and even in the states that do require compliance, it is unclear whether the states have the resources to enforce the regulations. The result is that tens of thousands of Americans are unwittingly being exposed to potentially dangerous medicines.

cGMPs may be, at times, difficult to maintain, and sometimes seem overly proscriptive, but they provide a common set of expectations for the establishment and maintenance of controls over product quality that require care and attention. It is vastly superior to the dangers of unregulated pharmaceutical products.

In an industry dependent on trust, manufacturers and the public both need commonly accepted practices to guide production as well as someone to police the less educated and prepared manufacturer. This is a national issue, as the medicines are shipped nationwide where they are needed. We have to be able to have confidence in the strength, quality and safety of our medicines. cGMP is the rulebook by which this confidence is encouraged and all mass producers of medicines, whether they are traditional pharmaceutical manufacturers or compounding pharmacies, should be required to play by these rules.
 

Scott Sutton, Ph.D., is the Principal of Microbiology Network, Inc., a company he started in 1996 as a means to encourage training and communications within the microbiological community. He is a recognized consultant and trainer with emphasis in GMP, investigations, Environmental Monitoring and contamination control (both aseptic manufacturing and non-sterile production facilities) as well as microbiology laboratory audits and operations. The Microbiology Network supplies consulting, training, webinars and e-mail discussion groups. Dr. Sutton is an active author and speaker for the industry, supports PDA and has served with the USP Analytical Microbiology Committee of Experts since 1993. The views expressed in this post are his own alone and do not reflect those of any other entity.

The author may be reached at scott.sutton@microbiol.org.

An expanded version of this article may be found at American Pharmaceutical Review.