Recently, the U.S. Food and Drug Administration (“FDA”) inspected Front Range Laboratories. This inspection was not prompted by any inaccurate laboratory test results, safety concerns, serious adverse event reports or quality issues related to products tested by our lab for our compounding pharmacy clients.
Front Range Laboratories provides testing services and support to compounding pharmacies. We are not in the business of drug manufacturing and do not knowingly conduct business or provide testing services to entities that manufacture finished drug products. We are not aware that any of our clients are registered with FDA as drug manufacturers, nor have we knowingly tested manufactured drug products. Yet, FDA inspected our testing procedures and operations against FDA’s Current Good Manufacturing Practice (“cGMP”) regulations which, by definition, do not legally apply to compounding pharmacies unless they are acting as drug manufacturers. cGMP also do not apply to facilities such as Front Range Laboratories, whose business is the testing of drug products compounded by pharmacies.
For over 10 years of operation, Front Range Laboratories has relied on state law (i.e., boards of pharmacy) and United States Pharmacopeia (“USP”) guidance when performing all of our product testing. Specifically, the methods we use to assess sterility and other quality attributes are established by USP. Patient health and safety is an ongoing and primary concern within our industry, and Front Range Laboratories has always been extremely diligent in adhering to applicable guidelines including those put forth by the organizations that govern the compounding pharmacy community. Our exceptional and unblemished safety record over the past decade demonstrates our commitment to patient health and safety.
Notwithstanding our compliance with state law and compounding industry expectations, we are cooperating with FDA. We have voluntarily committed to certain changes in our operations that will address use of cGMP in our testing operations. In addition, in the next few days, we will be sending a letter to our clients detailing the findings of the inspection and our plans for serving our compounding pharmacy clients moving forward.
In the meantime, please don’t hesitate to contact us with any questions or concerns. As always we are committed to the industry of compounding pharmacy and consider ourselves your partner in patient safety and care.
Michael Travis and the entire Front Range Labs Staff