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.