Citing a risk of drug injury, the Food and Drug Administration (FDA) has closed an Alabama compounding pharmacy that sold contaminated steroids. Unlike regular pharmaceutical manufacturers, compounding pharmacies make drugs from scratch to suit the needs of individual patients.
MedistatRx, located in Foley, Alabama, manufactured specialty drugs such as testosterone creams, injectable vitamins, steroids, and hormones. The distributed the drugs throughout the United States to more than 5,000 doctors’ offices and clinics. The pharmacy also supplied prescriptions to 25,000 individual patients. Officials say that the company had failed safety inspections over the years and citing it for unsanitary conditions that could lead to drug injury
Unsanitary Conditions Lead to Drug Injury
In 2014, an FDA inspection found that MedistatRx “manufactured and distributed purportedly sterile drug products that were adulterated because the drugs were made under unsanitary conditions and in violation of current good manufacturing practice requirements.” The government also charged that MedistatRx did not have FDA approval for drugs that it manufactured and sold. The company also put labels on prescription containers that didn’t tell users how to take the drugs in the right way.
In 2015, the FDA received a complaint from the Rhode Island Department of Health. The complaint charged that MedistatRx had sold contaminated steroids, leading to an outbreak of staph infections in the state. The government then conducted another inspection, finding the same safety problems as before. The company was still making drugs in unsafe, unclean conditions.
Following that inspection, the company agreed to voluntarily recall all of its products. The company cannot manufacture or sell any drugs until they fix all of the safety problems.
Sources:
http://www.courthousenews.com/wp-content/uploads/2017/05/Contaminated.pdf
https://www.justice.gov/opa/pr/district-court-enters-permanent-injunction-against-alabama-pharmacy-and-individuals-prevent
https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/UCM472103.pdf
