{"id":19218,"date":"2016-01-11T17:36:12","date_gmt":"2016-01-12T01:36:12","guid":{"rendered":"https:\/\/cjnotebook.com\/?p=19218"},"modified":"2016-01-11T17:36:12","modified_gmt":"2016-01-12T01:36:12","slug":"pharmaceutical-laboratory-agree-to-stop-distributing-adulterated-drugs","status":"publish","type":"post","link":"https:\/\/cjnotebook.com\/?p=19218","title":{"rendered":"Business Agrees to Stop Distributing Unsafe Adulterated Drugs"},"content":{"rendered":"

TEXAS<\/strong><\/p>\n

\n
\"Downing
Downing Labs President Christopher Van Downing<\/figcaption><\/figure>\n

A Dallas compounding pharmacy and three people agreed to stop distributing adulterated drugs that federal officials allege are unsafe, according to officials.<\/span><\/p>\n

According to the complaint, Downing Labs LLC<\/strong> \u00a0manufactures, packs, labels and distributes drugs in interstate commerce. \u00a0Noting,\u00a0Downing Labs has been engaged in manufacturing drugs that, by virtue of their labeling are intended to be sterile.<\/span><\/p>\n

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, according to officials.<\/span><\/p>\n

\u201cThe permanent injunction requires Downing Labs and the individual defendants to bring their processes into compliance with the law, which is essential to ensuring that Downing Labs\u2019 \u00a0drug products are safe for the American public,\u201d said Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department\u2019s Civil Division<\/strong>.\u00a0 \u201cThe Department of Justice will remain vigilant in protecting consumers from pharmaceutical drugs that do not meet the safety protections provided under federal law.\u201d<\/span><\/p>\n

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 with filth or may become injurious to health.<\/span><\/p>\n

The Act also defines drugs as adulterated if the facilities or controls used for the drugs\u2019 manufacture are not in conformity with current good manufacturing practices.<\/span><\/p>\n

The department filed a complaint in the U.S. District Court in Texas last week \u00a0at the request of the U.S. Food and Drug Administration, according to officials.<\/span><\/p>\n

The complaint alleges that Downing Labs, its owners \u2014\u00a0Ashley<\/strong> and Christopher Downing<\/strong> – and pharmacist-in-charge, Roger E. Mansfield \u2014<\/strong>violate the federal law by delivering into interstate commerce sterile drugs that are adulterated.<\/span><\/p>\n

Drugs prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth and\/or rendered injurious to health, according to officials.<\/span><\/p>\n

According to the complaint, the FDA conducted multiple inspections of Downing Labs and its predecessor, NuVision Pharmacy Inc.<\/strong>, \u00a0during the past three years.<\/span><\/p>\n

These inspections revealed numerous deficiencies, many of which had to do with the firm\u2019s sterile drug production.<\/span><\/p>\n

The complaint alleges that test records obtained from the company after a September to October 2015 inspection showed excessively high levels of endotoxins<\/strong> in recently manufactured drug products.<\/span><\/p>\n

These products were not distributed.<\/span><\/p>\n

Endotoxins<\/a> are substances found in certain bacteria that can cause a wide variety of serious reactions in humans, including high fever and shock.<\/span><\/p>\n

FDA identified additional sterility problems during inspections in 2013 and 2014, according to the complaint.<\/span><\/p>\n

In 2014, Downing Labs\u2019 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.<\/span><\/p>\n

Also Downing Labs, which was formed in December 2013, purchased NuVision in January 2014 and obtained its pharmacy license from the state of Texas in June 2014.<\/span><\/p>\n

Defendant Ashley Michelle Downing<\/strong> serves as Downing Labs\u2019 director and vice-president.\u00a0 She is responsible for all operations of the company.\u00a0 She previously held several positions at NuVision, including director, production manager, and quality manager.<\/span><\/p>\n

Defendant Christopher Van Downing<\/strong>, husband of Ashley Michelle Downing<\/strong>, is Downing Labs\u2019 president, with responsibilities that include overall business management and compliance.<\/span><\/p>\n

Defendant Roger E. Mansfield<\/strong> became the pharmacist-in-charge at Downing Labs on Dec. 30, 2014, and is responsible for all pharmacy operations, including sterile drug production and oversight.<\/span><\/p>\n

He was a staff pharmacist at Downing Labs prior to becoming the pharmacist-in-charge.<\/span><\/p>\n

The permanent injunction entered by U.S. District Judge Sam A. Lindsay<\/strong> enjoins the defendants from manufacturing, holding, or distributing drugs manufactured at their Texas facility\u00a0unless the defendants comply with the federal rules.<\/span><\/p>\n

In addition, officials said the permanent injunction authorizes the FDA to order Downing Labs to stop drug manufacturing should FDA determine that Downing Labs has violated the terms of the decree.<\/span><\/p>\n

The decree also authorizes the FDA to order Downing Labs to recall drugs that have been distributed by the firm or to destroy drugs that are in the process of being manufactured.<\/span><\/p>\n

Certain provisions of the injunction do not apply to drugs that defendants manufacture for animal use.<\/span><\/p>\n

(Downing Labs Promotional Video Dated 2014<\/strong>)<\/p>\n