The FDA warned doctors in March that 5 bags of magnesium sulfate intravenous solution made by Med Prep Consulting were found to have mold. The New Jersey compounding pharmacy voluntarily shut down while the FDA and the state took a closer look. Now, the FDA would like to make sure it stays closed as it takes a more aggressive posture against compounders whose sterile drugs are contaminated.
The agency is seeking a permanent injunction against the firm and its owner Gerald R. Tighe, pointing out the company has a history of problems, Pharmalot reports. It has a link to the lawsuit. The legal filing points to warning letters that Med Prep received in 2001 and 2010 for not following FDA regulations. It also says inspections in March and April found filthy and unsanitary conditions and, through sampling, discovered other drugs with microbial contamination. The 14-page lawsuit says because there are so many problems at the facility, all of its products can be considered contaminated.
In March, the pharmacy recalled all of its sterile drugs and closed under an "Interim Voluntary Consent Order" with the state of New Jersey, but following a hearing it was told by the state it could reopen if it met certain criteria. The FDA expected that to happen last month, but it has not yet, the filing says.
The new attention to compounders stems from the deadly fungal meningitis outbreak tied to a steroid manufactured last year by the now defunct New England Compounding Center. Criticized by Congress for not having taken a more aggressive stance against problems with compounders, the FDA launched inspections of the 30 largest, and many have been ordered to recall products. The agency also is seeking legislation to give it specific powers over the largest compounders, which traditionally have been overseen by state authorities.
- read the Pharmalot post