In the wake of the growing number of meningitis infections linked to a
Massachusetts compounding pharmacy, many are questioning what can be done
to prevent a similar outbreak. Although no one in California has developed
the fungal disease, four California clinics received shipments of the
contaminated steroid drug.
As San Diego injury lawyers, we were pleased to learn that California regulators
are already looking at ways to increase oversight of drugs shipped from
other states. Proposals on the table are said to include strict licensing
requirements for out-of-state compounding pharmacies that ship to California.
According to the
San Diego Union-Tribune, the California Board of Pharmacy will consider new legislation as early
as this week. Virginia Herold, executive officer of board, said the regulations
could require, among other things, that accrediting agencies use California
inspection standards for any out-of-state manufacturers who ship to California.
“If we’re going to accept their accreditation it should be
to our standards,” she said.
Compounding pharmacies make customized medications for specific patients
in doses or forms not otherwise available. For instance, they can add
flavors for children or remove certain agreements for patients with allergies.
However, the industry has grown in recent years with many compounding
pharmacies producing large shipments of drugs that are shipped across
Unfortunately, regulatory oversight has not increased accordingly. Unlike
major drug companies, compounding pharmacies are licensed by states. The
California Board of Pharmacy currently licenses 463 non-resident sterile
compounding pharmacies to ship products to California. The New England
Compounding Center, which made the tainted drugs, was licensed until the
state enacted a ban on future shipments.