A third compounding pharmacy in a week has recalled sterile injectable products as the FDA works its way through inspections of more than 30 high-risk compounders. As it does, FDA Commissioner Margaret Hamburg is again calling for new legislation that would give her agency specific powers to regulate the largest operators and that would put out of bounds the most complicated medications.
"The magnitude and complexity of these operations have outpaced the current patchwork of state laws that differ in prescription requirements and quality control rules," Hamburg says on her blog. She said some of the operators continue to resist having their records reviewed, pointing to the need for a law that spells out that authority.
Pallimed Compounding Pharmacy in Boston has voluntarily halted production and yesterday voluntarily recalled all of its sterile compound products sold since the first of the year. The moves came after inspectors found foreign matter in vials of injectable drugs, the Boston Globe reports. On March 18, Med Prep Consulting, a New Jersey compounder, recalled all of its products after fungus was found in 5 bags of sulfate intravenous solution. Three days later, Clinical Specialties Compounding Pharmacy of Augusta, GA, recalled its products because of reports that 5 patients had developed serious eye infections after receiving injections of Avastin compounded by the pharmacy.
The inspections and stepped-up concern started with last year's outbreak of fungal meningitis tied to compounded drugs that sickened hundreds and killed more than 50. The FDA was criticized by some members of Congress for not having prevented that outbreak.
Hamburg pointed out that despite these problems, some of the compounders are still resisting inspectors who want to see records. She said the FDA is working with a Senate committee to craft legislation that would require the largest operators to register with the FDA so it knows who they are, to follow FDA standards "appropriate for the compounding of riskier products" and to report adverse reactions. Hamburg said the FDA needs the authority to inspect the records of all compounders in the event of another episode like the meningitis outbreak. And she wants to consider having them meet labeling requirements.
"We must be able to identify dangerous practices before they result in actual harm and, when necessary, intervene to minimize the damage and prevent such tragedies in the future," Hamburg wrote.
- read Hamburg's blog
- read the Boston Globe story
- here's the Pallimed release
- here's the Med Prep recall notice