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Tabitha Woodruff,
Ohio PIRG

New Report Documents a Decade of Safety Violations by Compounding Pharmacies

For Immediate Release

 

COLUMBUS, May 23 – The contaminated drug that caused last fall’s fungal meningitis outbreak and sickened 20 Ohioans (killing one) and killed 55 people nationally is just the tip of the iceberg of an industry-wide problem, according to a new report released today by Ohio PIRG. The meningitis outbreak was simply the latest and deadliest in a long line of errors and risky practices by compounding pharmacies.

“Consumers should always be confident that their drugs are safe and effective, regardless of whether their drugs are manufactured at a compounding facility or a pharmaceutical company. Our prescription drugs should not lead to the illness and death of our loved ones,” said Tabitha Woodruff, Advocate for Ohio PIRG.

Traditionally, compounding pharmacies have engaged in the practice of customizing a medication for a particular patient – such as altering the dosage or turning a pill into a liquid for patients who have difficulty swallowing. But now, large compounding pharmacies are behaving exactly like drug manufacturers. Although they manufacture drugs in bulk, large compounding pharmacies do not conduct rigorous testing, nor do they adhere to safe manufacturing processes that pharmaceutical companies are required to implement. Instead they are exploiting legal loopholes in the law to escape the necessary safety standards and oversight. 

The report, “Prescription for Danger,” analyzed more than 40 warning letters issued by the Food and Drug Administration (FDA) to compounding pharmacies from January 2002 to December 2012. Each firm was cited for multiple violations of the Food, Drug, and Cosmetic Act, such as making new drugs that have not been tested for safety and effectiveness, and making drugs in unsanitary conditions.

“Congress must give the FDA the authority it needs to ensure that drugs made in compounding pharmacies are safe,” said Woodruff. “We must never repeat the avoidable tragedy of having contaminated and unsafe drugs on the market again.”

The report highlights some of the most blatant violations by compounding pharmacies, including:

  • In 2004, Gentere, Inc. in Willoughby, Ohio was found to be in violation of good manufacturing practices related to sterile compounding procedures by the FDA. The firm was producing large volumes of injectable drugs without approval from the FDA and without valid prescriptions from patients. The firm was violating both state and federal law and did not have proper procedures in place to prevent microbiological contamination of the drugs made.
  • In 2002, consumers complained about arthritis pain relief injections produced by Lee Pharmacy in Fort Smith, Arkansas. The FDA analyzed the injections and found they were contaminated with penicilliium rugulosum, a potentially lethal fungus.
  • In 2009, Hopewell Pharmacy in Hopewell, New Jersey, was found to be using a solvent called diethylene glycol monoethyl ether in sterile injections used for the treatment of varicose veins. This ingredient is normally used in industrial cleaners and is not approved by the FDA for use in drug manufacturing.
  • In 2005, University Pharmacy in Salt Lake City, Utah, was investigated because a 25-year-old woman lapsed into a coma and died from using Photocaine, a topical anesthetic cream produced by the pharmacy without the approval of the FDA.

                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            The report is available at [Link]

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