New Report Documents a Decade of Safety Violations by Compounding Pharmacies

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 U.S. 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 Nasima Hossain, Public Health Advocate for U.S. 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.

"As the U.S. PIRG report accurately points out, this 'shadow industry' of compounding pharmacies recklessly puts Americans' lives at risk by ignoring basic standards for safety and cleanliness when performing large-scale compounding operations," said U.S. Senator Richard Blumenthal (CT). "I hope the FDA will assert its full authority over large-scale compounders to protect the public from unsafe and untested drug products. These pharmacies currently exist in a legal netherworld - outside the bounds of state and federal oversight - and need to be heavily regulated by the agency."

"This report gives a clearer picture of what has been going on at compounding pharmacies. Although the FDA didn't do enough, they documented major violations involving different types of unsafe drugs, not just contaminated ones," said Diana Zuckerman, President of the National Research Center for Women & Families Cancer Prevention and Treatment Fund. "This shows that Congress needs to make major improvements in the law to protect all types of patients - those with cancer, heart disease, diabetes, asthma, eye diseases, anything that requires safe and effective medications."

"Congress must give the FDA the authority it needs to ensure that drugs made in compounding pharmacies are safe," said Hossain. "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 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 penicillium 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 for download here.