Sources: FDA snooping out compounding culprits
NAPA, Calif. - The FDA has reportedly begun cracking down on pharmacists who continue to compound albuterol and ipratropium rather than furnish patients with Dey's DuoNeb, which premixes both drugs in one vial.
Reports of the unannounced FDA audits come about seven months after Dey launched DuoNeb. The FDA prohibits compounding without a medical justification when a premixed drug is available. But because Medicare reimbursement doesn't cover the wholesale price of the DuoNeb, some Rxs continue to compound. Dey charges providers $1.65 a dose for DuoNeb versus the 47 cents pharaciespay for albuterol (17 cents) and ipratropium (30 cents).
"About three or four months ago Dey was using its inside sales force and doing telemarketing and mentioning to pharmacies that they knew they were compounding, and it unnerved the pharmacies pretty bad," said Mickey Letson, president of the Decatur, Ala.-based Letco Medical, a distributor of respiratory medicines. "I started getting phone calls from them asking, 'How would they know I was compounding?'"
Dey officials did not return phone calls.
There are two ways Dey could discover that a provider continues to compound ipratropium and albuterol, say industry watchers. A pharmacy that carries DuoNeb may report a pharmacy that continues to compound illegally. A Dey sales rep may also discover the infraction while on his rounds.
For a first offense, the FDA generally just says stop it, said Jeff Baird, a healthcare attorney with Brown & Fortunato in Armarillo, Texas.
"If the FDA feels the pharmacy has crossed the line, it will issue a warning letter, that says you are doing this, quit it, and confirm to us that you have quit it," Baird said.
It's permissible to compound albuterol and ipratropium, provided a doctor requests a mixture that is in someway different from DuoNeb.
"Until Dey comes out with a better reimbursement for DuoDeb, you are going to see all these companies out there compounding, calling up their physicians saying, 'I can't fill this prescription. Can you add to the prescription no preservative required or preservative free," said one industry watcher. HME