Opportunities to Improve the Compounding Quality Act

Patrick M. Carpenter

ABSTRACT

Pharmaceutical manufacturers produce and distribute medicines by seeking approval from the U.S. Food and Drug Administration (FDA) pursuant to the Federal Food, Drug, and Cosmetic Act (FDCA). The FDCA and FDA regulations set quality standards for production and require medicines to be safe and effective as demonstrated by animal and human testing prior to sale. Compounding pharmacies, regulated by states, produce medicines for patients intolerant to FDA-approved, manufactured products or for patients for whom no FDA-approved medicine exists. While medicines produced by compounding pharmacies are technically covered within the FDCA, enforcement of all the FDCA’s requirements on compounding pharmacies would be prohibitively expensive considering the small market of patients requiring these compounded medicines. These compounded products have no FDA premarket approval and are not required to be demonstrated as safe and effective prior to being dispensed to a patient. A proper regulatory framework must allow access for patients who need compounded medicines, but also protect the new drug approval process for pharmaceutical manufacturers because of the safety and medical advancements created by pharmaceutical manufacturers. Congress and FDA have struggled to strike a balance between safety and access along with drawing clear lines between what power belongs to the federal government and what power belongs to the states. In 2012, a compounding pharmacy’s contaminated compounded sterile drug gave rise to a fungal meningitis outbreak that killed sixty-four people and injured hundreds more, spurring Congress to pass the Compounding Quality Act (CQA or the Act). The CQA attempts to delineate federal and state power along with creating an entirely new type of drug-producing entity called an outsourcing facility. Among pharmaceutical manufacturers, outsourcing facilities, and compounding pharmacies, each has strengths and weaknesses. The CQA is still in the process of being implemented. Outsourcing facilities face considerable ongoing regulatory uncertainty. This paper explains the regulatory framework and offers suggestions to improve or amend the Compounding Quality Act and the overall regulation of compounded medicines.