Pharmaceutical

Compounding pharmacy barred from making drugs

pharmacy 252x210 Compounding pharmacy barred from making drugs Compounding pharmacy Medistat RX LLC, its CEO Mark Acker, production manager Timothy Finkling, and pharmacist-in-charge V. Elaine Waller were barred from making or distributing pharmaceuticals until they comply with federal law, an Alabama federal judge ordered, according to Law360.

The pharmacy was accused by the Food and Drug Administration (FDA) of failing to clean up microbial contamination in its sterile areas, which led to a 2015 outbreak of staph infections. The Rhode Island Department of Health traced the outbreak to drugs compounded by the pharmacy.

The FDA promptly investigated the situation and found that Medistat’s own documents had pinpointed several types of microorganisms in the air and on surfaces meant for processing of sterile products. However, the company did not investigate or try to clear up the contamination. The agency also claimed that the workers didn’t use sterile wipes to clean surfaces in the facility and that Medistat didn’t follow any system for ensuring its equipment was sterile.

In 2015, Medistat agreed to recall all unexpired sterile drugs distributed since November 2014 and shut down its sterile and non-sterile drug operations.

Under the terms of the consent degree of permanent injunction, Medistat cannot produce drugs again until it complies with the Federal Food, Drug and Cosmetic Act. U.S. District Judge William H. Steele’s signing of the decree ends a lawsuit brought by the U.S. Department of Justice on behalf of the FDA.

Source: Law360