Regulators Seek Bill Allowing Inspections of Out-of-State Pharmacies
California regulators are seeking authority to inspect out-of-state pharmacies that sell special-order prescription drugs to state health care providers in response to a national meningitis outbreak in 2012, the Los Angeles Times reports (Lifsher, Los Angeles Times, 1/1).
Details of Outbreak
As of mid-October 2012, there were 137 meningitis cases linked to recalled batches of the pain medication methylprednisolone acetate.
Federal officials said the batches -- manufactured by The New England Compounding Center in Massachusetts -- likely were contaminated with fungus.
Meningitis cases linked to the contamination caused 12 deaths in 10 states. None of the deaths were reported in California.
CDC said that about 600 California patients last year were treated with steroid shots from the recalled batches.
According to CDC, California facilities that received the recalled batches of medication were:
- Cypress Surgery Center in Visalia;
- Encino Outpatient Surgical Center;
- Ukiah Valley Medical Center; and
- Universal Pain Management in Palmdale (California Healthline, 10/11/12).
Regulators Seeking New Authority
This year, the California Board of Pharmacy plans to sponsor a bill that would give state regulators the authority to make unannounced on-site inspections of out-of-state pharmacies that the board licenses to ship sterile medications to California health care providers.
Virginia Herold -- executive officer of the state Board of Pharmacy -- said, "We want to make sure that if the product is coming into California, it meets the requirements of California law."The Pharmacy Compounding Accreditation Board and the International Academy of Compounding Pharmacies have expressed support for the measure. According to Herold, FDA also supports the goal of such legislation (Los Angeles Times, 1/1). This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.