FDA Warns CustomRX Facility for Cleanroom, Potency Testing

The FDA issued a warning to CustomRX of Wichita, Kansas, for serious deficiencies identified during an inspection of its compounding facility, including inadequate cleanroom conditions and product testing.

The agency conducted a July-August 2017 inspection and found the facility failed to qualify for a waiver from agency oversight for its current good manufacturing practices, its labeling of directions for use, and the requirement for FDA approval prior to marketing.

Specifically, the firm lacked valid prescriptions for individually identified patients for a portion of the drug products it made. It also compounded products using dinitrochlorobenzene or magnesium glycinate — two bulk substances that do not qualify for exemptions from FDA oversight under section 503A of the Food, Drug and Cosmetic Act.