Consumer Safety Group Wants FDA to Re-Inspect Compounding Pharmacies with Previous Violations


Consumer Safety Group Wants FDA to Re-Inspect Compounding Pharmacies with Previous ViolationsOverview: Public Citizen, a consumer watchdog group, is asking the U.S. Food and Drug Administration (FDA) to re-inspect over a dozen pharmacies with previous violations. The group’s request was conducted in light of the deadly fungal meningitis outbreak that resulted from contaminated steroid injections.

  • Public Citizen has asked to the FDA to re-inspect 16 compounding pharmacies that received warning letters from 2003 to 2012
  • The request was fueled by the meningitis outbreak, which has been attributed to tainted products manufactured by the New England Compounding Center
  • So far, the outbreak has sickened more than 500 people and killed 36

Public Citizen says FDA Needs to Follow-Up

According to a report in the Washington Post, Public Citizen sent the FDA a letter last week asking the agency to revisit 16 compounding pharmacies who received warning letters for violations between 2003 and 2012. The consumer safety group says that the FDA often does not follow up on companies after warning letters to see if the issues have been addressed. The 16 specialty pharmacies now implicated had received warning letters for a number of violations. Among other things, the agency found that the companies had produced compounded drugs with a prescription from a doctor, produced copies of FDA-approved drugs and producing drugs from materials not approved by the FDA. According to Public Citizen, five of the warning letters cited injuries or deaths allegedly linked to the pharmacies’ products.

Compounding Pharmacy Causes Meningitis Outbreak by Distributing Contaminated Products

Compounding companies are supposed to mix custom medications for patients with specialized medical needs, based on doctor’s instructions. As they are not considered manufacturers, these companies manage to dodge FDA regulations normally enforced for manufacturers. The issue is that some of these specialty pharmacies have grown into large businesses over the years.

A recent congressional report showed that the FDA visited NECC three times before the outbreak and sent the company a warning letter in 2006, reprimanding the company for several violations, such as mass-producing drugs without doctors’ prescriptions and repackaging FDA-approved medications in smaller doses.

The New England Compounding Center is held responsible for the fungal meningitis outbreak that has killed 36 people and sickened over 500 more. The company had distributed over 17,000 vials of methylprednisone acetate across the country, many of them tainted with fungal meningitis.