Compounding Pharmacies Face Tougher Rules After More Contaminated Product Identified

The Food and Drug Administration (FDA) is sending out a warning to patients and health care facilities not to use a preparation for nasal irrigation that may be contaminated. The Compounding Shop in St. Petersburg, Florida created the solution. The 1000 ml bottle of budesonide contained white floating material observed by FDA inspectors after complaints were called into the pharmacy. That was identified as fungus and the concern is other preparations from The Compounding Shop may also be contaminated. The agency warns the nasal inhalant should not be used. Proposed federal legislation would give the U.S. Food and Drug Administration (FDA) greater oversight over compounding pharmacies after a meningitis outbreak last year highlighted the regulatory limbo they operate under.

A common nasal irrigation system sold in pharmacies.

Introduced by Iowa Senator Tom Harkin, the legislation has bipartisan support and is focused on creating a tracking system to track prescription drugs from their source, the manufacturer, to distribution. Granting the FDA wider regulatory powers, the agency would be able to monitor compounding pharmacies in a similar way to drug manufacturers, including inspections. Presumably counterfeit and stolen drugs that enter the supply could be more easily identified through series numbers and the ability to electronically trace the source.

The federal oversight would replace the various state boards of pharmacy which have created a patchwork of inconsistent oversight. The New England Compounding Center in Framingham Massachusetts is now closed after a meningitis outbreak that originated with a compounded product killed at least 64 people and sickened hundreds more in 20 states.

Compounding pharmacies mix customized medicines or medications that are only required in small batches. The industry is responsible for about four billion prescriptions a year, reports Modern Health care.

The bill would allow a compounding pharmacy to register as an outsourcing facility. The FDA could then track their products and receive adverse event reports and conduct inspections. But registering is not mandatory and any compounding pharmacy could choose to stay under state board regulations.

The thought is that FDA-registered facilities might offer purchasers of customized drug products from a compounding pharmacy some assurance of safety.

While the law will give the FDA greater control, it is uncertain if it would, in reality, make formulations coming from compounding pharmacies any safer.