The Food and Drug Administration (FDA) is cracking down on compounding pharmacies after a nationwide fatal outbreak of fungal meningitis was found in contaminated steroid injections made at the New England Compounding Center (NECC).
Now a Georgia compounding pharmacy, Clinical Specialties Compounding Pharmacy (CSCP) of Augusta, has voluntarily recalled all lots of sterile syringes loaded with the cancer drug Avastin. The recall was undertaken after an FDA inspection revealed sterility concerns.
At least five people have serious eye infections associated with the Avastin drug that was repackaged from vials into syringes by CSCP. The condition is called endophthalmitis, which the FDA reports occurs inside the eyeball and can lead to permanent blindness. The link to the syringes was brought to the federal agency’s attention by the Centers for Disease Control and Prevention (CDC).
The FDA is playing catch-up after 48 people died from a contaminated epidural steroid injection. Over 700 patients continue to be treated for fungal infections and hundreds of lawsuits have been filed against NECC, which has filed for bankruptcy.
Historically, compounding pharmacy regulation has fallen outside of FDA radar and states have not been picking up the slack. There is a move to increase the FDA’s authority over compounders and the surprise plant visits are part of the plan.
Meanwhile the voluntary recalls continue with three announced during one week in March.
Med Prep Consulting of Tinton Falls, New Jersey voluntarily recalled 83 types of antibiotics and drugs used during surgery because of a possible mold contamination, which was visible to the eye. Regional hospitals in New Jersey, Connecticut, Delaware and Pennsylvania received the infusion bags, glass vials and plastic syringes linked to the mold.
An inspection at Pallimed Compounding Pharmacy of Massachusetts led to the recall of all sterile products made at the plant in an “abundance of caution” even though there had been no injuries reported. The FDA inspectors indicated there were “deficiencies” but the recall does not include the facility’s non-sterile products.
The state took the next step and issued a “limited Cease and Desist Order” to prevent the sale of 16 sterile compounded products. Last December, the Boston Globe reports the company had been ordered to stop compounding Viagra because of “improper components.”
Originally, compounding pharmacies were developed to mix small batches of custom ordered drugs. Depending on the individual state’s regulations, they were not intended to become full-blown mini-pharmaceutical manufacturing facilities, but that is the role many have undertaken.
State laws vary and the FDA is seeking additional authority over the growing industry, however, as we’ve seen so many times, the agency does not have enough funding to oversee about one-quarter of the consumer products used by Americans.
One proposal has the compounding companies pay a user fee to cover the cost of FDA inspections.
Bottom line – inspect the products coming from a compounding facility. In the case of the mold, a nurse, not FDA regulators, noticed the contamination problem which led to the recall.