Pharmacists voice concerns over new drug regulations

Compound pharmacies make custom medications for patients.
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The Indiana Department of Health has confirmed two more cases of fungal meningitis linked to injections of a recalled back and joint pain steroid. That brings Indiana's total to 30, including two Indiana patients that have died.

Investigators have tied the outbreak to large specialty pharmacy in New England. Lawmakers are demanding tougher federal oversight of the nation's so-called "compounding pharmacies." Those pharmacies, many of them small, fear new rules would leave patients with nowhere to go for special medications they rely on.

Pharmacists laboring inside the CustomMed Apothecary don't count pills, they make them, along with scores of other prescription drugs mostly unavailable through large commercial suppliers. The Indianapolis business is one of thousands of compounding pharmacies across the country alarmed by calls to put them under the same federal regulations as drug manufacturers.

"If they come in here and want us to meet those requirements," said pharmacist and owner Jeff Jackson, "there is a lot of people, they aren't going to be able to get the medications they need."

Jackson contends federal regulations and approvals could delay some prescriptions for weeks and make some unavailable. This pharmacy has very few drugs on the shelf. Instead, the shelves are filled with the raw materials used to make drugs and fill prescriptions for patients doctors and hospitals.

FDA approved and commonly used drugs are custom made in small quantities to meet patients' specific needs.

"It's not the medication they can't tolerate, but some component they can't tolerate," Jackson said.

Dyes, flavoring and other additives may be left out to accommodate allergies or digestive problems. Instead of receiving pills, a patient who can't swallow receives the same medication in a cream. Medicated lollipops, drug-dispensing baby bottles and special dispensers for blind patients are also available.

Both the prescriptions and packaging, Jackson says, aren't made by drug manufacturers or available at most retail pharmacies.

Compounding pharmacies are state-regulated. The Indiana Board of Pharmacy says there are no large, high-volume pharmacies here like the one in New England that is suspected of producing contaminated steroids, responsible for the meningitis outbreak.