FDA to pharmacies: Stop compounding topical anesthetics

January 1, 2007

Rockville, Md. - The Food and Drug Administration (FDA) has warned five firms to stop compounding and distributing standardized versions of topical anesthetic creams marketed for general distribution.

Rockville, Md. - The Food and Drug Administration (FDA) has warned five firms to stop compounding and distributing standardized versions of topical anesthetic creams marketed for general distribution.

The action follows two deaths reportedly connected to use of the creams.

Warning letters were sent to Triangle Compounding Pharmacy, University Pharmacy, Custom Scripts Pharmacy, Hal's Compounding Pharmacy and New England Compounding Center.

Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research, noted that compounded drugs are not reviewed by the FDA for safety and effectiveness and are not FDA-approved.

The FDA has advised consumers who have questions or concerns about compounded topical anesthetic creams to contact their healthcare providers.

While the FDA normally permits traditional pharmacy compounding, the agency "is concerned that the five firms receiving warning letters are behaving like drug manufacturers, not traditional compounding pharmacies," because they produce standardized versions of topical anesthetic creams for general distribution, the news release states.