Thursday, January 14, 2016

Dallas Compounding Pharmacy and Three Individuals Agree to Consent Decree With Permanent Injunction to Prevent Distributing Adulterated Drugs

Compounding pharmacies have been under scrutiny, and a recent case shows the difficulties compounding pharmacies are having complying with recent changes in the law and regulations. Compoung pharmacies are also under scrutiny due to billing issues with insurance which has also put them under the spotlight.  A recent case shows what happens when retail pharmacies engage in compounding with regulation by the state and what happens when the U.S. Food and Drug Administration (FDA) alleges the drugs are adulterated.

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&nbsp 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


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