WebMD Medical News
Daniel J. DeNoon
Louise Chang, MD
Oct. 10, 2012 -- How did a single pharmacy in Massachusetts put 13,000 people in 23 states at risk of deadly fungal meningitis?
New England Compounding Center (NECC) is a compounding pharmacy. It has now recalled the 2,410 different drugs it sold in all 50 states. Fungal contamination of at least one product -- single-shot syringes filled with a steroid preparation -- is responsible for the meningitis outbreak.
This raises serious questions about compounding pharmacies, which make some 3% of drugs dispensed in the U.S.
The traditional role of compounding pharmacies is to make drugs prescribed by doctors for specific patients with needs that can't be met by commercially available drugs, says Linda D. Bentley, JD, chair of the FDA practice group at the Boston offices of Mintz, Levin, Cohn, Ferris, Glovsky, and Popeo P.C.
Bentley offers two examples:
In such cases, a compounding pharmacy would make the proper dosage and form of the drug without any offending ingredients.
In recent years, the role of compounding pharmacies has expanded, says David Miller, RPh, CEO of the International Academy of Compounding Pharmacists (IACP), the trade group representing the compounding industry.
"In the last two to three years there has been an upsurge in an old function of compounding pharmacies, to step in on a local basis to fulfill drug shortage issues," Miller says. "What we have seen is on a large scale, important drugs being in shortage and not for short periods as before. Now it's in the months-to-years range. So compounding pharmacies are being looked to on a larger scale as we try to address drug manufacturing problems."
According to the IACP, there are 56,000 community-based pharmacies in the U.S. About half of them directly serve local patients and doctors.
Some 7,500 compounding pharmacies specialize in what the IACP calls "advanced compounding services." Some 3,000 of these pharmacies make sterile products. The tainted steroid shots made by NECC were supposed to have been sterile.
The FDA traditionally regulates drug manufacturers. But states regulate pharmacies.
Even so, Miller says three government agencies regulate compounding pharmacies:
The independent Pharmacy Compounding Accreditation Board (PCAB) offers its official seal of approval to pharmacies that voluntarily pass strict inspections and other rigid requirements. Miller says some 180 compounding pharmacies have this strict PCAB accreditation. The NECC, the company at the heart of the fungal meningitis outbreak, was not PCAB accredited.
But there's a grey area. As some compounding pharmacies get larger, they begin to act like small drug manufacturers. So when does a large compounding pharmacy regulated by a state pharmacy board become a small drug manufacturer regulated by the FDA?
"There's no bright line," Miller says.
A 1997 law extending the FDA's authority over compounding pharmacies was largely struck down by a 2002 Supreme Court decision. Later in 2002, the FDA issued a guidance in which it says it can regulate compounding pharmacies under certain circumstances. These include:
However, this guidance is not an official FDA regulation and does not have the force of law.
The NECC has taken down its web site and issued a statement: "For the foreseeable future, NECC staff and professionals will be singularly focused on providing full cooperation with relevant public agencies and carrying out this recall professionally and expeditiously."
Regular pharmacies do not fill prescriptions for compounded drugs. If your doctor writes you a prescription for a compounded drug, you must fill it at a compounding pharmacy.
If you receive medicines at a clinic, hospital, or doctor's office, ask whether the medication came from a compounding pharmacy. It would also be a good idea to ask whether that pharmacy has PCAB accreditation.
SOURCES:Linda D. Bentley, JD, member at Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.; chair of the Mintz Levin FDA Practice Group; and member, Corporate & Securities Section and the Life Sciences Practice Group, Boston.David G. Miller, RPh, executive vice president and CEO, International Academy of Compounding Pharmacists.IACP web site.PCAB web site.FDA web site.United States Court of Appeals for the Fifth Circuit, No. 06-51583, July 18, 2008.FDA, Compliance Policy Guides Manual, CPG 460.200, May 2002.News release, NECC.
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