Compounding pharmacy enjoined from manufacturing until remedial measures are implemented

Isomeric Pharmacy Solutions LLC (Isomeric) and three executives are permanently enjoined from manufacturing and distributing drugs considered adulterated in violation of the federal Food, Drug and Cosmetic Act (FDC Act) (21 U.S.C. §301 et seq.). The injunction was entered in the Utah district court following a complaint entered by the Department of Justice (DOJ) after finding that Isomeric, a compounding pharmacy, was producing drugs under insanitary conditions.

Isomeric

Isomeric manufactures, labels, and distributes drugs, particularly injectable hormones and corticosteroids, as well as ophthalmic drops. Most of the drugs are directly distributed to physicians. The company initiated three recalls in 2016 involving three types of injectable drugs. In April 2017, Isomeric recalled all lots of non-expired drug products that should have been sterile and were compounded between October 4, 2016 and February 7, 2017.

Complaint

According to the complaint, the FDA found that Isomeric repeatedly found several types of microorganisms in the air and on surfaces that should have been sterile. Products that were manufactured in these areas were prepared in insanitary conditions. The FDA found that Isomeric deviated from current good manufacturing practice requirements, and failed to thoroughly review discrepancies or failures found in batches of drugs.

The injunction was entered through a consent decree as part of a settlement. Isomeric and its chief executive officer, chief sales officer, and chief operating officer will not resume manufacturing, holding, or distributing drugs until proper remedial measures have been taken.