Group Asks FDA to Re-Inspect Compounding Pharmacies

November 29, 2012 — The consumer advocacy group Public Citizen has published an open letter calling on the U.S. Food and Drug Administration (FDA) to re-inspect 16 compounding pharmacies that have been cited for safety violations since 2003. Public Citizen says the warnings “reveal a thriving [drug making] industry … being carried out under the guise of compounding.” Contaminated medicines from a compounding pharmacy in Massachusetts, New England Compounding Pharmacy, have been linked to a non-contagious outbreak of fungal meningitis that has sickened more than 500 people and caused 36 deaths in 19 states.

The FDA has previously claimed that it lacks the authority to adequately regulate the compounding industry. These small-scale pharmacies are supposed to mix custom medications for specific patient prescriptions, but in recent years, some have begun mass-producing drugs like mini pharmaceutical companies.

Public Citizen reviewed publicly available data, which showed that from 2003 until 2012, the FDA sent at least 18 warning letters to 16 compounding pharmacies in 15 states. Five warning letters involved injuries or deaths caused by defective medicines. The rest of the warning letters involved manufacturing or safety deficiencies.

Violations included mass-producing medications without a license, producing copies of commercially-available drugs, and making drugs from ingredients that were not approved by the FDA.

The review found that the FDA received 70 complaints possibly related to an injectable steroid with incorrect amounts of a preservative. One report involved a 25 year-old woman who died after using an anesthetic skin cream because the instructions failed to warn about the risk of toxic overdoses. Other adverse event reports involved injections that were contaminated with bacteria or other organisms.

Public Citizen also expressed concern about a lack of further action after the FDA sent the warning letters, making it impossible to tell whether the pharmacies corrected violations. The group is also asking the FDA to “initiate a systematic program to determine whether other compounding pharmacies are engaged in illegal practices.”

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