Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary
Compounding Law; Health Care; Awareness of all Types of Compounding Issues;
Pharmacy Benefit Managers (PBMs), Outsourcing Facilities
Food and Drug Administration and Compliance Issues
Friday, November 1, 2019
Statement from Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research on new testing results, including low levels of impurities in ranitidine drugs
Americans deserve to have confidence in the quality of drugs the U.S. Food and Drug Administration regulates – from the prescription medicines they take to the over-the-counter (OTC) products they use in their daily lives. Helping assure the quality and safety of these products is one of our greatest responsibilities. Over the past several weeks, the FDA has been investigating the detection of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications, commonly known by the brand name Zantac.
We set out to fully understand this issue and provide actionable information for Americans who use these medications. The information we’ve gathered as part of our ongoing ranitidine investigation has been vital to answering the questions we’ve received about the potential risk of these products. Throughout this process, we’ve been updating our...