Pharmacy compounding, the mixing of drugs for individual patients, was once a quaint activity depicted on drug-store calendars from the 1950s. It has roared back in the 21st century, driven by the rise of out-of-hospital surgical care, the high prices and shortages of drugs, and the real or imagined benefit of "personalized medicine."
Today, nearly every place medical care occurs — hospitals, doctor's offices, home-health companies — gets at least some of its drugs in forms that aren't available off the shelf from pharmaceutical houses.
The practice burst into the national spotlight this month when cases of a rare brain infection called fungal meningitis were linked to a drug mixed by a compounding pharmacy.
The New England Compounding Center in Framingham, Mass., shipped nearly 18,000 vials of methylprednisolone acetate, a steroid injected around the spinal cord to relieve pain, to 23 states. About 14,000 people have been injected from the three tainted lots.
Whether that volume of sales tipped the company out of the category of "compounding pharmacy" and into that of "drug manufacturer" is a matter of dispute.
What's not in dispute is how much U.S. medicine has come to rely on this little-known, little-regulated part of the economy.
"It's like buying your electricity from a different supplier. It looks like you're getting the same stuff, but evidently you're not," says a physician at one of the seven outpatient treatment centers in Maryland that received methylprednisolone from a contaminated lot.
In a guidance document issued in 2002, the FDA says the distinguishing feature of compounding pharmacies is that they make "drug products ... on a customized basis for an individual patient." A similar assertion appears in the warning letter the agency sent to the New England Compounding Center in 2006.