The FDA is continuing to penalize compounding pharmacies who are found to be in violation of regulatory guidelines concerning the safety and security of patients.
Pharmacist Glenn Chin, of New England Compounding Center was recently sentenced to eight years in prison and two years of supervised release for his role in the heartbreaking 2012 nationwide fungal meningitis outbreak. The outbreak killed 64 patients and caused infections in 793 others.
According to United States Attorney Andrew E. Lelling, as quoted in a Department Of Justice press release about the sentencing, “Mr. Chin acted with complete disregard for the health and safety of patients. Mr. Chin will now be held responsible for producing contaminated drugs that killed dozens and grievously harmed over 750 people across the country.”
This action highlights how serious the FDA and other agencies are concerning the safety of compounded products. This reiterates the FDA’s earlier guidance that compounding not be used if approved alternatives exist.
FDA Commissioner Scott Gottlieb, M.D. is quoted in the press release as reiterating that “a key aspect of the FDA’s mission is to ensure that drugs are made under high quality conditions so that no patient is at risk of harm due to poorly compounded products. In response to episodes where patients were harmed by poorly compounded drugs, Congress passed a new set of laws to improve the FDA’s oversight of these products. We’re committed to the efficient, timely and robust implementation of that framework to help make sure patients can trust the reliability and safety of compounded drugs, recognize the benefits of pharmacy compounding, and that we protect consumers from harm.”
Read the full press release here:
Spironolactone tablets are on the NIOSH List of Hazardous Drugs in Healthcare Settings, and are subject to legally enforceable regulatory guidelines such as USP-797 and the upcoming USP-800 when crushed or compounded.
CaroSpir, a liquid oral suspension of spironolactone, does not appear on the NIOSH list and does not have a black box warning. The guidelines for handling hazardous drugs like spironolactone tablets do not apply to CaroSpir.
To find out more about CaroSpir’s advantages over crushed/compounded spironolactone, visit CaroSpir.com