Unsafe practices found at compounding pharmacies
After a crash inspection program, federal regulators said Thursday that they had found numerous unsafe practices at about 30 compounding pharmacies, the same type of facility responsible for the tainted drug that caused a deadly meningitis outbreak last year.
Among the problems found were unidentified black particles floating in vials of supposedly sterile medicines, rust and mold in clean rooms where such drugs are made, improper air flow, and clothing that left workers’ skin exposed.
Howard Sklamberg, director of the office of compliance for the drug division of the Food and Drug Administration, said such unsafe practices could cause contamination of drugs. He said the number of problems found at the compounding pharmacies, which were in 18 states, was higher than what is typically seen at conventional pharmaceutical manufacturers.
FDA officials also said the agency had to get a warrant from federal court to inspect one of the 30 compounding pharmacies. Four other operations resisted being inspected but gave in without a court order, agency officials said.
“It may surprise some people to know that, even in light of the recent tragic events, some of the firms we inspect still challenge our authority to conduct full inspections of their facilities,” Dr. Margaret A. Hamburg, the FDA commissioner, wrote in a post on the agency’s blog on Thursday.
Sklamberg said the FDA was exploring actions it might take against the pharmacies if the problems were not corrected.
More than 50 people died from fungal meningitis and another 680 were sickened after receiving injections last year of a contaminated steroid made by the New England Compounding Center. Compounding pharmacies originally made specialized formulations of drugs for patients with particular needs, like a liquid form of a medicine for someone who cannot swallow a pill. But in recent years, the number of compounders has multiplied, and some have become essentially mass manufacturers, distributing huge quantities of medicines all over the country.
A House subcommittee will hold a hearing on Tuesday at which Hamburg is expected to be asked whether the FDA could have prevented the meningitis outbreak by better policing the compounding pharmacies.
The agency maintains that it has limited legal authority to oversee compounders, which are regulated by state boards of pharmacy even though many ship drugs across state lines.