During the past few months, hospitals have been flooded with patients afflicted by COVID-19. One of the side effects of this sudden change is the heightened demand for drugs used to treat the virus. In order to keep up with the needs of hospitals, the FDA has introduced a temporary policy that allows hospitals to obtain these drugs through compounders. But what is compounding, and why are the laws pertaining to it a subject of interest?
According to the FDA, drug compounding can be defined as “the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient.” This process can be executed by licensed pharmacists or physicians and is most often carried out in pharmacy. Compounding may also occur in outsourcing facilities, which are defined as any location that produces sterile drugs and has registered itself with the FDA. Compounded drugs are most often used to treat patients with certain conditions (such as allergies) who may be unable to consume commercially available medications.
Consuming Compounded Drugs
While compounding certainly helps many people, there are certain risks associated with consuming compounded drugs. For instance, compounded drugs are not FDA approved, which means they are not screened for safety and quality standards before being consumed. Although the government takes measures to inspect compounding facilities to ensure safe practices, there have been many incidents in the past where poor conditions and practices have led to the distribution of unsafe drugs. The most notable instance of this occurred in 2012, when a Massachusetts pharmacy released a compounded medication that was contaminated with fungus. Over 750 patients that consumed the drug contracted fungal infections, and at least 60 of these died from further complications. After this incident, the government made it a priority to reevaluate the laws that regulated drug compounding.
The Food, Drug and Cosmetic Act and the Drug Quality and Security Act
Currently, there are two main acts that govern drug compounders: The Food, Drug and Cosmetic Act and the Drug Quality and Security act, the latter having been passed in response to the fungal outbreak in 2012. One of the provisions in the FD&C Act states that compounded drugs can only be produced after a pharmacist receives a specific prescription for the drug. This provision also dictates that pharmacies can not produce unjustified quantities of medications that are “essentially copies” of those that are already commercially available. However, in light of the coronavirus pandemic, the FDA has made the decision to temporarily relax these conditions. In April of 2020, the agency issued a policy which stated that no legal action would be taken against pharmacies that compounded “essentially a copy” drugs or that distributed compounded medications to hospitals without obtaining a prescription. The policy also specifies that hospitals must make a reasonable effort to obtain the FDA-approved drugs as well as compounded drugs from outsourcing facilities (which are generally held to stricter quality standards than pharmacies). A similar policy has also been issued for the distribution of compounded hand sanitizers, which may be used by healthcare professionals and consumers alike.