In other words, if a compounding pharmacy has an idea of how much demand it expects for a drug, it can make that much in advance without a prescription.
Defined that way, “compounding for office use” could allow pharmacies to produce thousand-dose batches of drugs week after week — just like pharmaceutical factories but without the standards required of them.
An official with the Centers for Disease Control and Prevention says health workers continue to see meningitis cases, given the incubation period for the disease can be long. A Mass. pharmacy is blamed for tainted injections, so far killing 28.
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Risks of medications made at compounding pharmacies have been known for years.
Fatal meningitis outbreak will go down as one of the biggest drug disasters in American history.
They describe an archaic regulatory apparatus that hampered their ability to keep pace with changes.
State boards failed to regulate safety at specialty pharmacies, congressional report finds.
Hospitals and doctors increasingly depend on the growing number of drug compounding facilities.
Defenders of the practice say this expansive view of compounding is necessary. Compounding is an essential part of American medicine and compounding pharmacies need to have their products on hand when doctors order them, they say.
“It is almost impractical to have it any other way,” said Jeffrey Gibbs, a Washington lawyer who was associate chief counsel for enforcement at the FDA from 1980 to 1984.
Others feel differently.
“I just don’t have any confidence in the compounding pharmacies,” said Burt Place, 59, an anesthesiologist at the Pinehurst pain clinic both now and during the 2002 outbreak. “I think anybody would be insane to use them.”
The aftermath
Few people in South Carolina are willing to talk about pharmaceutical compounding or the 2002 outbreak that’s a miniature version of the current one.
One who is willing is Davis C. Hook Jr., a 71-year-old pharmacist who served a six-year term on the Board of Pharmacy, leaving in 2009. He said that “15 to 20” pharmacies compound for office use in South Carolina today. Hawthorne Pharmacy in Columbia, where he works part time, is one. It supplies compounded sterile injectables to about 15 pain clinics, orthopedists and ophthalmologists.
“I just hate it, because it just gives a black eye to compounding,” he said of the current outbreak.
The FDA ultimately identified Exophiala fungus in three lots of methylprednisolone made by Urgent Care Pharmacy. How it got there is unknown.
Urgent Care’s supervising pharmacist, R. Ken Mason Jr., was fined $10,000 and put on probation by the Board of Pharmacy for four years. He now works at a drug store in Boiling Springs, S.C., and wouldn’t talk to a reporter. He does not do compounding. The owner of the long-shuttered pharmacy, W. Ray Burns, has an inactive pharmacy license and didn’t answer phone messages.
Mason’s insurance policy reportedly had a $1 million cap. Vivian Conrad’s survivors got about $900,000 in damages, according to her daughter. From that, lawyer’s fees and payments to Medicare were deducted. Conrad’s husband also paid for two months of voriconazole, the antifungal medicine, at $10,000 a month before Pfizer, the drug’s makers, agreed to give it to her for free.
Prestwood recalled that at the settlement conference “my request was an apology from them because I would never see my mother smile again. I was told that the man realized what his actions had done. But there was never an apology.”
Alice Crites contributed to this report.
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