NEW ORLEANS (CN) – Pharmacies can compound prescription drugs to meet the individual needs of patients without obtaining FDA approval for the “new” drugs, the 5th Circuit ruled.
Medical Center Pharmacy and nine other pharmacies sought declarative relief to ensure that the Food and Drug Administration would not outlaw drug compounding, a practice of tailoring medicine to the patient that dates back to 1820.
The courts have been largely silent on the practice since Congress passed the federal Food Drug and Cosmetic Act of 1938. That changed in 1997, when Congress allowed compounded drugs with certain restrictions on compounding practices and advertising.
Judge Smith disagreed with the district court, siding with the FDA that compounded drugs are “new” drugs.
However, Smith ruled that the drugs are neither universally approved nor universally prohibited. It all depends on the FDA’s enforcement – or lack thereof.
“The FDA did not enforce the new drug requirement against traditional compounding for decades,” Smith noted. “The FDCA explicitly permits the FDA to decline enforcement of ‘minor violations.'”