October 23, 2012 — The Massachusetts Department of Health has released hundreds of pages of documents which show that New England Compounding Pharmacy had a history of violations that went back to April 1999. One of the most commonly cited issues was the company’s practice of faxing orders for “custom” medicines to doctors’ offices without the names of specific patients, and then updating their records as the products were used.
Most states require specific licenses for mass-producing pharmaceutical drugs, but they only require a pharmacy license for making custom medications for specific customers. Furthermore, Drug Enforcement Administration (DEA) regulations require that compounding pharmacies register with the DEA. According to an October 16, 2012 conversation between Congressman Markey’s staff and the DEA, NECC was not registered with the DEA as a manufacturer.
The House committee has also said that Massachusetts public health officials said that NECC was inspected in 2002 and 2003 by the FDA after there were complaints about preservative-free methylprednisolone acetate, a steroid injection that has been linked to more than 300 fungal meningitis infections and 23 deaths in 17 states.
Last year, the FDA also expressed concern about compounding pharmacies using potentially tainted ingredients from foreign countries, such as China. As much as 80% of the ingredients used in pharmaceuticals come from other countries. The FDA was concerned that the drugs might be substandard or contain unapproved ingredients. In In recent years, several compounding pharmacies have been indicted for unlawfully selling human growth hormone and steroids made in China.
Drugs made by compounding pharmacies are supposed to be custom-made for specific patients (for example, making a solid medicine liquid for a patient who can’t swallow). They aren’t often tested for quality unless someone files a complaint. This is very different from pharmaceutical companies, which are subject to “Good Manufacturing Practices” — rules requiring strict quality control guidelines, inspections, and more. Compounding pharmacies, on the other hand, operate in a regulatory gray area between the FDA and fifty state pharmacy boards.
Problems can arise when compounding pharmacies start mass-producing medications (like epidural steroid injections) and selling them across state lines. In a sense, they act like small pharmaceutical companies, but with less government oversight. In states like Texas and Missouri, compounding pharmacies are subject to random tests. In Texas, the pharmacy board found that one-fourth of compounded drugs failed a potency test. In Missouri, potency varied by 300%.