There are some hot issues on new compounding regulations and how they affect the Compounding Quality Act signed into law in 2013 and the FDA's increased audits and inspections of outsourcing facilities or pharmacies who may not be properly classified. Compounding pharmacies are having issues in determine whether they fall within the 503A and 503B rules and are complying with the federal regulations.
The U.S. District Court for the Northern District of Texas entered a consent decree on January 11, 2016, for permanent injunction against Downing Labs LLC, Ashley Michelle Downing, Christopher Van Downing and Roger E. Mansfield to prevent them from distributing adulterated drugs in interstate commerce.
Downing Labs was a state pharmacy regulated by the state. When Downing was named in a news investigation of having billed for compounding creams and gels not delivered to patients, they became a target of investigation. In addition, Downing decided to obtain FDA approval as an outsourcing facility and after inspection did not agree to recall drugs as demanded by the FDA.
The
department filed a complaint in the U.S. District Court for the Northern
District of Texas on Jan. 4, 2016, at the request of the FDA. According to the complaint, Downing  Labs
manufactures, packs, labels and distributes drugs in interstate commerce.
As noted in the complaint, Downing Labs has been engaged in manufacturing drugs
that, by virtue of their labeling and/or route of administration, purport to be
or are intended to be sterile. The complaint alleges that Downing Labs
has a long history of manufacturing drug products under conditions that fall short
of the minimum requirements to ensure safety and quality.
The
federal Food, Drug, and Cosmetic Act defines adulterated drugs as those that
are prepared or held under conditions where the drugs may become contaminated or may become injurious to health. The Act also defines drugs
as adulterated if the facilities or controls used for the drugs’ manufacture
are not in conformity with current good manufacturing practices (CGMP).
The
complaint alleges, among other things, that Downing Labs, its owners - Ashley
and Christopher Downing - and pharmacist-in-charge, Roger E. Mansfield, violate
the Act by introducing or delivering for introduction into interstate commerce
sterile drugs that are adulterated in that they are prepared, packed, or held
under insanitary conditions whereby they may have been contaminated with filth
and/or rendered injurious to health. The complaint also alleges that
defendants violate the Act by introducing or delivering for introduction into
interstate commerce drugs that are adulterated in that the methods used in, or
the facilities or controls used for, their preparation do not comply with CGMP
requirements.
According
to the complaint, the FDA conducted multiple inspections of Downing Labs and
its predecessor, NuVision Pharmacy Inc. (NuVision), during the past three
years. These inspections revealed numerous deficiencies, many of which
had to do with the firm’s sterile drug production. The complaint alleges,
for example, that test records obtained from the company pursuant to a
September to October 2015 inspection showed excessively high levels of
endotoxins in recently manufactured drug products. These products were
not distributed. Endotoxins are substances found in certain bacteria that
can cause a wide variety of serious reactions in humans, including high fever
and shock.
FDA
identified additional sterility problems during inspections in 2013 and 2014,
according to the complaint. In 2014, Downing Labs’ records showed that 19
lots of supposedly sterile drugs had tested positive for various
microorganisms, including the pathogens Staphylococcus haemolyticus, which
can cause septicemia, peritonitis and urinary tract infections and Nocardia
nova, which can cause pneumonia, sinusitis and skin infections. These
products were not distributed. According to the complaint, however, FDA
found that the company had failed to adequately investigate the cause of the
sterility problems in the 19 lots.
Attorney Notes: Sterile compounding can still be outsourced to compounding pharmacies as long as certain conditions are met. These conditions include (1) outsourcing drugs are mixed per product labeling or compound follows USP, and (2) in receipt of a prescription for each patient, and (3) not on FDA's prohibited list, and (4) state has MOU (memorandum of understanding) or distribution does not exceed 5 percent.
We see pharmacies that often fail to follow a number of these requirements and frequently the prescription requirement for each individual patient. The Board of Pharmacy has increased its audits for compounding pharmacies since numerous pharmacies do not seem familiar with the strict laws and regulations. If your pharmacy is compounding, now is the time to become compliant with state and federal laws. Failure to do so can cause business issues and well as licensing problems.
Posted by Tracy Green, Esq.
Office: 213-233-2260
Attorney Notes: Sterile compounding can still be outsourced to compounding pharmacies as long as certain conditions are met. These conditions include (1) outsourcing drugs are mixed per product labeling or compound follows USP, and (2) in receipt of a prescription for each patient, and (3) not on FDA's prohibited list, and (4) state has MOU (memorandum of understanding) or distribution does not exceed 5 percent.
We see pharmacies that often fail to follow a number of these requirements and frequently the prescription requirement for each individual patient. The Board of Pharmacy has increased its audits for compounding pharmacies since numerous pharmacies do not seem familiar with the strict laws and regulations. If your pharmacy is compounding, now is the time to become compliant with state and federal laws. Failure to do so can cause business issues and well as licensing problems.
Posted by Tracy Green, Esq.
Office: 213-233-2260
