To manufacture and market prescription drugs, a manufacturer’s laboratory and manufacturing facility should ensure certain sterility for the products produced. Good manufacturing practices as well as good laboratory practices help maintain the integrity of prescription drugs. Recently, the federal government unsealed a 37-count indictment charging Med Prep Consulting Inc. for sterility issues. Med Prep has been charged with wire fraud and violations of the Federal Food, Drug and Cosmetic Act.
Med Prep, and its principal decision makers, owner and president, Gerald Tighe, and pharmacist-in-charge, Stephen Kalinoski, allegedly introduced adulterated and misbranded drugs into the commerce stream and misbranded drugs with the intent to defraud and mislead FDA and Med Prep’s customers. Those customers included hospitals and other healthcare providers. In an effort to gain market share, Med Prep repeatedly misrepresented that it adhered to, and in some areas exceeded, industry standards and laws applicable to sterile drug preparation. The indictment alleges that Med Prep produced drugs in a facility that created a risk to the health of already ill patients, and lied to healthcare providers about basic sterility practices.
For example, Med Prep halted its production of drugs in the summer of 2013 following an incident in which it had distributed IV drugs containing visible mold to a Connecticut hospital. Soon after the mold was discovered, a FDA inspection of Med Prep’s facility resulted in documentation of numerous incidents of microbiological contamination in the company’s finished drug products. Apparently, in evaluating the quality of its prescription drugs, sterility was not included.