Another FDA Salvo Against Compounding?
Last week, the Food and Drug Administration issued a national statement advising pharmacies of concerns about the adequacy of testing performed by Front Range Laboratories, Inc., located in Loveland, Colo., a testing laboratory used by more than 100 pharmacies in 32 states, to verify quality, sterility, and expiration dating. According to the agency, 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.
Additionally, the FDA recommended that pharmacies not use this firm for sterility and other quality attributes at this time. Since that announcement, the agency has contacted many compounding pharmacies specifically requesting a recall of sterile medications tested by Front Range. Several IACP members have conducted additional in-house testing on their lots -- all showing and confirming that the Front Range results were aligned with their own.
In a statement to its clients, Front Range Laboratories stated: "We are not in the business of manufacturing and do not conduct business with entities that manufacture finished drug products. We are not aware of a single client registered with the FDA as a drug manufacturer. Yet, during this recent inspection, our operations were inspected against the FDA's Current Good Manufacturing Practice (or cGMP) regulations which, by definition, do not legally apply to compounding pharmacies unless they are acting as manufacturers."
Front Range adds that: "For over 10 years of operation, Front Range Laboratories has relied on state law (boards of pharmacy) and United States Pharmacopeia (USP) guidance when performing all of our testing. Specifically, the methods we use to assess sterility and other quality attribute testing are put forth by USP. Patient safety is an ongoing and primary concern within our industry, and Front Range Laboratories has always been extremely diligent in adhering to applicable guidelines as put forth by the organizations that govern the compounding pharmacy community. Our exceptional safety record is proof positive of our actions."
Once again, the FDA is applying a different rulebook to inspections, this time to laboratories that specifically service compounding pharmacies. Rather than inspecting pharmacies to USP standards, as required by many state laws and pharmacy practice acts, the FDA has issued inspection reports citing pharmacies' violations of cGMPs. Now the laboratories are being held accountable to cGMP standards. Front Range is not the first testing lab to have been inspected in the past few months. And shortly, final regulations will be put in place to further enable the agency to halt the importation of APIs including those which are not components of FDA approved drugs.
To date, there has been no evidence whatsoever that a compounded preparation tested by Front Range failed to meet USP standards nor have any medications been deemed sterile that have in actuality found to be non-sterile. IACP members should continue to use the laboratory of their choice and raise any concerns about previous or ongoing inspections of those labs with the operators.
IACP Members: If you have questions or concerns, please contact us at email@example.com, or call 281/933-8400.