FDA Hits Compounder Over Sterility, Lack of Prescriptions

A compounding operation in North Carolina landed an FDA warning letter for compounding drugs without prescriptions and for sterility concerns.

Health Innovations Pharmacy was cited after a 2015 inspection revealed the company’s facility in Southern Pines, N.C., was producing misbranded drugs because they were compounded without prescriptions for specific patients.

For failing to follow this mandate for smaller compounders under the FD&C Act, the agency also accused the company of producing adulterated drugs and labeling violations.