FDA ISSUES WARNING LETTERS ON DRUG COMPOUNDING
The FDA moved to stop several pharmacies from manufacturing compounded inhalation drugs in the agency's latest attempt to curb a practice that it believes to be unsafe.
The FDA warned three firms, Rotech Healthcare, CCS Medical and Reliant Pharmacy Services, to stop manufacturing and distributing thousands of doses of compounded, unapproved inhalation drugs. Compounding is a practice in which pharmacists manufacture prescription drugs from bulk ingredients. Inhalation drugs are used to treat diseases including asthma, emphysema, bronchitis and cystic fibrosis.
The letters are part of a "frontal assault" by the agency to stop what it considers illegitimate compounding, David Adams, chair of the law firm Venable's FDA Practice Group and former director of the policy staff in the Office of the Commissioner at the FDA, said. The agency is trying to "target large-scale operations that are clearly not based on necessity" and wants to set a bright line for what is and what is not legitimate compounding.
While the agency said that it is "not targeting" compounding by issuing these letters, the warnings are based on the FDA's limits on the practice. The agency also takes pains to explain its position on compounding, including concerns with the practice. "Compounded inhalation drugs are not reviewed by the FDA for safety and effectiveness, often are not produced according to good drug manufacturing practice and typically are not sterile. This may expose patients to unnecessary risk," Steven Galson, director of the FDA's Center for Drug Evaluation and Research, said.
"FDA will not tolerate drug manufacturing disguised as pharmacy compounding," an agency official said. "Firms that mass-compound drugs that are basically copies of FDA-approved drugs are at risk for agency enforcement."
But the International Academy of Compounding Pharmacists, a compounding advocacy group, argues that enforcement is within the jurisdiction of the states, not the federal government, spokesman Joshua Wenderoff said.