October 23, 2012 — Hundreds of pages of documents released by the Massachusetts Department of Health have revealed a long history of violations associated with New England Compounding Center (NECC). The violations go back to April 1999, one year after NECC opened. In 2002 and 2003, NECC was also investigated for complaints associated with methylprednisolone acetate, the epidural steroid shot that has been linked to an outbreak of fungal meningitis associated with 307 illnesses and 23 deaths in 17 states.
The documents also revealed that a frequent issue was the company’s practice of faxing order forms for “custom” medications to their customers without putting the name of the specific patient on the order form. They would update their own records with the name of the patient when the medication was used.
Compounding pharmacies are like modern-day apothecaries, responsible for mixing custom medications. For example, they might remove an ingredient from a medication for a patient who has an allergy. NECC created thousands of medications and shipped them throughout the United States. The company has been accused of mass-producing medications — operating like a small drug company, essentially, but subject to far less oversight.
Drug companies must conform to “Good Manufacturing Practices,” which are rules established to ensure sterility and safety of drugs that are mass-produced for interstate commerce. Compounding pharmacies do not need to undergo routine inspections or have their products tested for safety — except in states like Texas and Missouri, where state pharmacy boards do randomly inspect compounded drugs for potency. They have found alarming results. In Texas, up to one-fourth of medicines failed potency tests (either too much or too little of the drug), and in Missouri, potency varied by as much as 300%.
In most cases, compounding pharmacies are supposed to make drugs for specific customers, unless they obtain special manufacturing licenses in each state where they want to sell their product. Furthermore, the Drug Enforcement Administration (DEA) require compounding pharmacies to register with the DEA if they intend to manufacture drugs. NECC was never registered with the DEA, according to a conversation between Congressman Markey’s staff and the DEA, described in an October 16, 2012 letter to Eric Holder, U.S. Attorney General.
The FDA has also expressed concerns about compounding pharmacies using tainted ingredients from overseas. In the last few years, several companies have been prosecuted for illegally importing steroids and Human Growth Hormone (HGH) from China. As much as 80% of the ingredients that are used in American pharmaceuticals are manufactured overseas. The FDA is concerned that these ingredients could be tainted, substandard, or contain unapproved ingredients, which could potentially spark a health crisis.