Report blasts compounding pharmacies; AG’s office retains expert consultant

TRENTON – A public-interest advocacy group released a report Thursday harshly critical of compounding pharmacies, including ones in New Jersey.

N.J. Public Interest Research Group released its study that claimed compounding pharmacies – which do things such as customizing medicines – are not following federal regulations.

The report, “Prescription for Danger,” analyzed more than 40 warning letters issued by the Food and Drug Administration 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, according to the report.

In New Jersey, the report cited instances such as these.

*In 2009, Hopewell Pharmacy in Hopewell 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, NJPIRG stated.

*In 2006, Pharmacy Creations was discovered to be illegally producing adenosine-5-monophosphate, a drug that can be used for nerve pain. This drug was withdrawn from the U.S. Market in 1973 by the FDA as it was not considered safe or effective. The pharmacy was also found to be producing Domperidone capsules and Polidocanol injections under unsterile manufacturing conditions, potentially producing contaminated drugs, the report found.

“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 Jen Coleman, NJPIRG Advocate, in a release accompanying the report.

The state responded quickly to the report’s release.

The Division of Consumer Affairs in the Attorney General’s office reported it has retained the National Association of Boards of Pharmacy as an expert consultant to assist with the Division’s ongoing investigations and evaluations of New Jersey’s compounding pharmacies.

“There is a significant presence of large-scale compounding pharmacies in New Jersey.  Recent events have made clear that we must remain vigilant in our inspection and analysis of their operations,” Attorney General Jeff Chiesa said in a release. 

“This partnership with NABP enables our inspectors to draw upon a greater body of expertise and experience to address this growing industry.  We are taking a comprehensive look at New Jersey’s compounding pharmacies, and will act immediately on any violations that appear to threaten the public’s health and safety.” Report blasts compounding pharmacies; AG’s office retains expert consultant