Compounding Pharmacy Update: Drug Quality and Security Act

This week, Congress took the final step in approving the Drug Quality and Security Act, a bill that amends the Federal Food, Drug and Cosmetic Act with respect to the regulation of human drug compounding and drug supply chain security.

The bill addresses the practice of compounding which has expanded drastically over the past two decades and seeks identify and more closely monitor compounding pharmacies that have moved beyond the business of compounding medicines for individual patients and have become “mini-manufacturers.”

Historically, compounding pharmacies were subject to state law, but this bill seeks to clarify regulatory confusion surrounding compounding and give the Food and Drug Administration (FDA) more power to police compounding pharmacies who are engaged in manufacturing.

The bill, a direct response to the horrific fungal outbreak of 2012 which killed over 60 people and sickened hundreds of others, would allow compounding pharmacies that mass-produce drugs to register with the FDA as “outsourcing facilities” and be subject to tighter quality control rules, more federal inspections and greater government oversight. Compounding pharmacies that do not wish to register as an outsourcing facility would be allowed to continue compounding medications for individual patients on the basis of patient-specific prescriptions and would continue to be regulated per state pharmacy laws.

While the bill does not force compounding pharmacies operating as manufacturers to register with the FDA, many experts argue that market forces will likely press most compounding pharmacies into registering since a large percentage of hospitals outsource some part of their sterile compounding and these hospitals would likely prefer to buy from an FDA approved compounding facility. An additional market pressure is thought to be centered around product liability insurance, which is generally available only to FDA approved manufacturers and not to ordinary pharmacies.

Compounding groups such as the International Academy of Compounding Pharmacists (IACP) oppose the bill in its current form and believe the bill will not protect the American public as proposed since the bill does not provide key definitions to govern compounding practices and does not take into account any of the input from the compounding profession that was provided to Congress last year. Additional IACP concerns include the fact that the bill (1) will result in patients’ inability to obtain access to needed medications, (2) grants the FDA unprecedented authority to determine what pharmacies can compound and (3) fails to define or properly address anticipatory compounding, the practice of making medications available in adequate supply ahead of expected needs. Read IACPs statement here.