California Seeks To Strengthen Regulation of Out-of-State Drugs
In the wake of a national meningitis outbreak linked to contaminated drugs from Massachusetts, California officials are considering ways to strengthen regulation of products shipped from out-of-state compounding pharmacies, U-T San Diego reports (Lavelle, U-T San Diego, 10/10).
About the Outbreak
About 600 California patients were treated with steroid shots from recalled batches of pain medication that have been linked to the outbreak.
The New England Compounding Center manufactured the batches of methylprednisolone acetate, which federal officials suspect were contaminated with fungus (California Healthline, 10/10).
As of Wednesday afternoon, there were 137 meningitis cases linked to the outbreak and 12 deaths in 10 states (Schneider, Atlanta Journal-Constitution, 10/11).
No deaths related to meningitis have been reported in California.
According to CDC, four California facilities that received the recalled batches of medication are:
- Cypress Surgery Center in Visalia;
- Encino Outpatient Surgical Center;
- Ukiah Valley Medical Center; and
- Universal Pain Management in Palmdale (California Healthline, 10/10).
California Officials Eye Tougher Regulations
Unlike drug manufacturers, which are regulated by FDA, compounding pharmacies are licensed by states.
The California Board of Pharmacy is responsible for licensing pharmacies in California, as well as out-of-state pharmacies that ship products into California.
Virginia Herold -- executive officer of the California Board of Pharmacy -- said state regulators are working on proposals that would strengthen licensing requirements for out-of-state compounding pharmacies that ship products into California.
For example, the regulations could require that accrediting agencies use California inspection standards for out-of-state manufacturers that ship to California, according to Herold.
She said, "If we're going to accept their accreditation, it should be to our standards."
Herold said she plans to present the proposed legislation at the board's Oct. 25 meeting (U-T San Diego, 10/10).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.