New Report Documents a Decade of Safety Violations by Compounding Pharmacies

Baltimore, May 23 – The contaminated drug that caused last fall’s fungal meningitis outbreak and killed 55 people is just the tip of the iceberg of an industry-wide problem, according to a new report released today by Maryland 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 Jenny Levin, Advocate for Maryland 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 Levin. “We should 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 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.
• According to a state pharmacy board investigation, in September 2005, three patients died and several others were sickened at a Virginia hospital after receiving drugs made at a compounding pharmacy in Maryland. The drugs were recalled after the FDA found contamination in remaining samples.
• The 2012 fungal meningitis outbreak linked to a contaminated drug produced and distributed by a compounding pharmacy in Massachusetts, the New England Compounding Center. 14,000 people in 23 states were exposed to the drug. The states that had the most consumers affected were Florida, Michigan, Indiana, Maryland, North Carolina, New Jersey, Ohio, Tennessee, and Virginia according to the U.S. Centers for Disease Control.
• The report is available here.

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Maryland PIRG, the Maryland Public Interest Research Group, is a nonprofit, nonpartisan public interest advocacy organization that takes on powerful interests on behalf of its members, working to win concrete results for our health and well-being.