Drug Compounding

The Food and Drug Administration campus is located in Silver Spring, Md. Compounded medicines are not subject to FDA approval.

Prescription pharmaceuticals have the ability to change and even save people’s lives by providing the body with the correct balance of chemicals to do anything from fighting illnesses, to balancing hormones, to managing blood pressure and so much more. The research and development and rigorous standards that these drugs go through ensure that they are well-regulated, safe and sterile before they reach the end consumer. Compounded drugs, however, don’t face such strict scrutiny and can therefore be easily botched or contaminated by the pharmacists that process them.

Drug compounding was originally established as a means of creating alternative medicines for those with allergies or specific needs for drugs that are not currently on the market. These bespoke drugs are supposed to be made on an individual basis at the discretion of the patient’s pharmacist. The reality is that compounding pharmacists have begun profiting off the lax regulatory oversight of compounding pharmacies and compounding drugs illegally to pad their wallets.

Rather than simply creating a unique medicine for one patient, it has become common practice for compounding pharmacies to produce large batches of medicines and sell them with huge profit margins. Compounded medicines are not subject to FDA approval, so skipping the approval process keeps the cost of creating these drugs way down for the pharmacies, which allows for these large profit margins. However, this also opens the drugs up to many possible issues because the facilities are not subject to strict process and product testing by the FDA.

These practices are not just unethical, but illegal. Traditional compounding pharmacies are registered as 503A facilities under the Compounding Quality Act, and therefore restricted to producing one-time, patient-specific compounded drugs. They are not permitted to mass produce a compounded medicine to sell to future patients. While there are some compounding pharmacies that are regulated as 503B facilities and are allowed to produce drugs in bulk, they are subject to much harsher requirements by the FDA in order to ensure the drugs produced there are safe for consumption.

Since 503A pharmacies do not fall under the jurisdiction of the FDA, they instead are regulated by state agencies. A recent Pew report shows that state government bodies are letting too many facilities fall through the cracks and operate unregulated. According to the report, the number of compound pharmacies per state pharmacy inspector ran as high as 900, with an average of 230 pharmacies per inspector. The responsibility of one individual to hold that many pharmacies accountable is negligible. It would take a single inspector years to get through the entire allotment of inspections just once. This is unacceptable.

The overwhelming lack of will or ability from state governments has allowed for compounding pharmacies to pass as small, patient-specific facilities while actually producing high-volume, unregulated bulk medicines for far too long. The New England Compounding Center (NECC) was found guilty of this after being investigated as the cause of a meningitis outbreak back in 2012. As a 503A facility, it was illegally stockpiling medicines to sell to clinics and doctors’ offices in bulk batches. Without regulation from a reliable government body, it stored these medicines in less-than-sterile conditions, leading to contamination. This ultimately led to 64 deaths and more than 800 sickened.

We would be remiss to let this mistake happen in vain. Compounded medicines are a vital aspect of our nation’s health care system when created using safe, legal practices. However, bad actors in this space are taking advantage of the lack of regulation surrounding these facilities, putting patients at risk and defrauding taxpayers. The FDA and state governments must increase their oversight of compounding pharmacies and be vigilant in prosecuting those who practice illegally. The safety of patients dependent upon compounding pharmacies should be a priority to those who have a duty to uphold the law.

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Christopher M. Day is a trial attorney in Northern Virginia. He was an assistant attorney general in the commonwealth for four years and serves as treasurer of the National Center for Police Defense, Inc., a voluntary position. Contact him at: cmday@jurisday.com

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