The Food and Drug Administration (FDA) is warning five firms—Triangle Compounding Pharmacy, University Pharmacy, Custom Scripts Pharmacy, Hal’s Compounding Pharmacy, and New England Compounding Center—to stop compounding and distributing standardized versions of topical anesthetic creams that are marketed for general distribution rather than responding to the medical needs of individual patients.
Firms that do not resolve violations in FDA warning letters risk enforcement actions, such as injunctions against continuing violations and seizure of illegal products.
FDA is concerned about the serious public health risks related to compounded topical anesthetic creams. Exposure to high concentrations of local anesthetics, can cause grave reactions, including seizures and irregular heartbeats. Two deaths have been connected to compounded topical anesthetic creams made by Triangle Compounding Pharmacy and University Pharmacy, two of the pharmacies that received warning letters. Similar anesthetic creams are compounded by the other firms, and the action serves as a general warning to firms that produce standardized versions of these creams.
“Compounded topical anesthetic creams, like all compounded drugs, are not reviewed by FDA for safety and effectiveness, and are not FDA-approved. These high-potency drugs may expose patients to unnecessary risk, especially when they are used without proper medical supervision,” says Steven Galson, MD, director of FDA’s Center for Drug Evaluation and Research.
The five firms warned by FDA have stated that they produce their topical anesthetic creams as part of the practice of pharmacy compounding. Traditional pharmacy compounding typically involves pharmacies preparing drugs that are not commercially available, such as a unique medicine for a patient who is allergic to an ingredient in an FDA-approved drug. This type of compounding follows a physician’s decision that his or her patient has a special medical need that cannot be met by FDA-approved drugs.
FDA normally permits such traditional pharmacy compounding and the agency’s action is not targeting this practice. By contrast, FDA 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.
FDA is advising consumers who have questions or concerns about compounded topical anesthetic creams to contact their health care providers.
[www.fda.gov, December 5, 2006]