All pharmacies, including compounding pharmacies, have long been regulated by state pharmacy boards, many of which date back to the 19th century. At that time nearly all drugs dispensed in the U.S. were individually compounded by pharmacists. The law that created the FDA in 1938 gave the agency strict authority over drug manufacturers, which quickly eclipsed pharmacists as the main producers of prescription medicines.
For decades, the state-federal divide persisted, with states overseeing compounding pharmacies and the FDA policing drug manufacturers.
But in the 1990s, FDA regulators began to more closely scrutinize compounding pharmacies, as their number multiplied and some grew into big businesses. Instead of making individualized products based on a physician's prescription, companies began mass-producing products and promoting them broadly.
"When you get into that situation, pharmacy compounding can be a disguise for unregulated manufacturing," said Michael Labson, a food and drug attorney in Washington. Recent drug shortages caused by consolidation among drug manufacturers, among other factors, have only increased demand for compounded alternatives.
In recent years some compounding pharmacies have been blamed for outbreaks caused by contaminated medicines. Two people were blinded in Washington in 2005. Three died in Virginia in 2006 and three more in Oregon the following year. Twenty-one polo horses died in Florida in 2009. Earlier this year, 33 people in seven states developed fungal eye infections.
Compounding experts, including the president of the leading compounding pharmacy trade group, believe the New England Compounding Center crossed the line into full-scale manufacturing. Indeed, the FDA had warned the company in 2006 about compounding and distributing anesthetic "for general distribution" rather than for individual prescriptions.
FDA officials said they followed up with the company after sending the warning letter but did not re-inspect it.
"They assured us they were adequately protecting patients and complying with applicable laws and regulations," Autor said. "We took some action, but it's very complicated — our ability to take action here."