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Here for you… yesterday, today and tomorrow |
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As a longstanding partner of the compounding pharmacy community, Front Range Laboratories has always been extremely diligent in adhering to applicable guidelines including those put forth by the organizations that govern our industry. Our exceptional and unblemished safety record over the past decade demonstrates our commitment to patient health and safety. We want to emphasize to you that quality testing and patient safety continue to be our highest priority. We are not alone in our industry in having been asked by the FDA to submit to a different set of standards than those that have governed our scientific operations for years. Most of our competitors have decided to fight the FDA on this type of testing. Front Range Laboratories has taken a proactive stance on the issue. We presume that FDA will enforce this type of testing on compounding sooner rather than later, and in the interest of supporting our clients’ businesses, we are moving forward with the transition and assisting our clients however we can as we move through it ourselves. While we encourage you to transition to the new validation, verification and suitability testing system, ultimately the choice is yours. We will do our best to facilitate this process from both a logistical and financial standpoint. As always, we encourage you to please contact us with any questions or concerns you may have in relation to this letter or otherwise. We continue our commitment to you as your partner in patient safety and care. Michael Travis, President Please take a moment to review our response to the FDA: |
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Facts About Front Range Laboratories’ August 2013 FDA Inspection |
The FDA inspection of Front Range was a routine inspection and was not prompted by any inaccurate laboratory test result, safety concerns, serious adverse event reports, or quality issues related to products tested in their labs. |
In spite of the recall notices issued by the FDA, to date, there is no evidence that a compounded preparation tested as passed by Front Range Laboratories was inaccurate for potency or bacterial endotoxins ; nor have any medications been found to be non-sterile that were deemed sterile by Front Range testing. |
The FDA’s observations and resulting actions against Front Range Laboratories were due to the fact that Front Range was inspected against a set of standards called cGMP, the use of which is not required by the agencies that currently regulate the compounding pharmacy community and their contract testing labs. These cGMP standards are manufacturing standards that are used by the pharmaceutical industry. The compounding pharmacy industry is currently legally accountable to standards created by State Boards of Pharmacy and the United States Pharmacopeia (USP), which were the standards being meticulously followed by Front Range. |
Even though not legally required, Front Range Laboratories immediately agreed to and began implementation of cGMP standards as per FDA guidance, while many of their competitors and clients in similar situations have decided to fight the FDA on these cGMP standards. Additionally, Front Range has taken their compliance a step further and is in process of FDA registration. |
Front Range Laboratories has done everything requested by the FDA and has taken all steps necessary to address its concerns. There is no current evidence that would cause doubt regarding the quality of testing being performed in their laboratory. |
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