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FDA Works With States to Help Protect the Public From Dangerous Drugs

David W. Hodges
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Partner at Kennedy Hodges LLP practicing pharmacy error, medical malpractice and personal injury law
Posted on Apr 30, 2013

Prior to the contaminated steroid injections that were responsible for sickening over 700 people and killing 51 people in several states nationwide, the Food and Drug Administration (FDA) didn’t regularly inspect compounding pharmacies. Since there are over 7,000 compounding pharmacies nationwide, the FDA visited some facilities and sometimes even waited years before following up with the facilities it had its eye on.

The FDA admitted that it does not have the power to control compounding pharmacies and didn’t do much to regulate compounding pharmacies in the past. Now, the FDA is working with states to inspect compounding pharmacies in the hopes of helping to protect the public from dangerous drugs. FDA commissioner Dr. Margaret Hamburg wrote, “[w]e are currently deploying resources to work with states to inspect certain state-licensed pharmacies that produce sterile drug products that we believe may present the highest risk.”

This effort has already led to the inspection of over 30 compounding pharmacies over two months. Some of the results of these FDA inspections include:

  • Sending a warning letter to Medi-Fare Drug & Home Health Center, Inc. of Blacksburg, South Carolina, stating that it wasn’t preparing products that match prescriptions and that there were serious deficiencies that could put patients at risk.
  • The FDA pointed out rust patches at a St. Petersburg, Florida compounding pharmacy.
  • The FDA pointed out sloppy sterility practices at a Swedesboro, New Jersey compounding pharmacy.

Since compounding pharmacies are becoming increasingly similar to drug manufacturers due to the fact that they mix prescriptions for large-scale production, federal officials believe they should be regulated as manufacturers. However, critics are stating that the nation will have to wait and see what comes of the citations the FDA is issuing to these compounding pharmacies that are engaging in unsafe practice.

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