CDER Statement: FDA alerts pharmacies to concerns with testing conducted by Front Range Laboratories
[8/21/13] The U.S. Food and Drug Administration is advising pharmacies of concerns about the adequacy of testing performed by Front Range Laboratories, Inc., in Loveland, Colo., a testing laboratory used by more than 100 pharmacies in 32 states, to verify quality, sterility, and expiration dating.
In a recent inspection, FDA investigators observed that methods used by Front Range to assess sterility and other qualities (e.g., strength and stability) may have resulted in pharmacies receiving inaccurate laboratory test results. FDA has concerns that results obtained from Front Range are not reliable. FDA recommends that pharmacies not use this firm for sterility and other quality attributes testing at this time.
Front Range Labs is an independent laboratory performing quality control testing primarily for compounding pharmacies. FDA is working with Front Range to notify its customers and to determine if certain drugs should be removed from the market due to safety concerns. The FDA will update the public as new information becomes available or if products are being recalled.
We ask health care professionals and consumers to report any adverse reactions to the FDA’s MedWatch program:
- Complete and submit the report online at www.fda.gov/medwatch/report.htm
- Download and complete the form (PDF - 1.65MB), then submit it via fax at 1-800-FDA-0178