Rotech responds to FDA warning

Sunday, August 20, 2006

ORLANDO, Fla. - In response to an FDA warning, Rotech plans to "immediately" scale back the compounding of commercially available drugs and switch patients to clinically appropriate alternatives.

The FDA issued its warning letter Aug. 10. The letter states that Rotech's compounding of formulations of budesonide, albuterol/ipratropium, and formoterol/budesonide exceeds the scope of a pharmacy. As such, Rotech is operating as a pharmaceutical manufacturer--not a pharmacy engaged in extemporaneous compounding, the FDA stated.

Rotech disagreed with the charge, but agreed last week, in partnership with its patient's physicians, to begin switching patients currently "taking these compounded products to drug products that are commercially available, where clinically appropriate," the company stated in a release.

Rotech also reported that it will not accept any new prescriptions for these compounded products. The company estimates that the process of switching approximately 30,000 patients to commercially available drug products will take several months to complete.

The FDA issues similar letters to CCS Medial and Reliant Pharmacy--a Lincare subsidiary. Officials at those companies declined on Friday to comment on the FDA's warning.

The FDA alleges that Rotech's compounding operations relating to these products are not in compliance with all applicable regulatory requirements. Based on the warning letter, the FDA could require the Rotech to discontinue its compounding activities for these and other products, and Rotech could be subject to enforcement action, including temporary or permanent suspension of part or all of its compounding operations or seizure of part or all of its compounded formulations.

Generally, states oversee pharmacies. The FDA steps in when problems arise, such as product contamination or when pharmacies cross into manufacturing.