U.S. Food and Drug Administration Advisory Notice
Dear Colleagues,
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. Here’s a link to the statement issued: http://www.fda.gov/Drugs/DrugSafety/ucm365920.htm.
We thank you for your continued support of our mission.
Best regards,
Anna
Anna M. Fine, PharmD, MS
Director, Health Professional Liaison Program
Office of Health and Constituent Affairs
Office of External Affairs/Office of the Commissioner
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Anna.Fine@fda.hhs.gov
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. Here’s a link to the statement issued: http://www.fda.gov/Drugs/DrugSafety/ucm365920.htm.
We thank you for your continued support of our mission.
Best regards,
Anna
Anna M. Fine, PharmD, MS
Director, Health Professional Liaison Program
Office of Health and Constituent Affairs
Office of External Affairs/Office of the Commissioner
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Anna.Fine@fda.hhs.gov
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