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
Tuesday, June 16, 2020
FDA Warns Four Manufacturers of Unapproved Injectable Drugs Labeled as Homeopathic Drugs Pose Serious Risks to Patient Health and Violate Federal Law
FDA Warns Four Manufacturers of Unapproved Injectable Drugs Labeled as Homeopathic
Drugs Pose Serious Risks to Patient Health and Violate Federal Law
The U.S. Food and Drug Administration has issued warning letters to four companies for selling unapproved injectable drug products labeled as homeopathic that can pose serious risks to patient health and violate federal law, as part of the agency’s efforts to protect Americans from potentially harmful products that are labeled as homeopathic.
The FDA is particularly concerned about unapproved injectable drug products labeled as homeopathic because they are injected directly into the body, often directly into the bloodstream and bypass some of the body's key natural defenses against toxins, toxic ingredients and dangerous organisms that can cause serious and life-threatening harm. Additionally, unapproved drugs that claim to cure, treat or prevent serious conditions may cause consumers to delay or stop medical treatments that have been found safe and effective through the FDA review process.
“The FDA’s drug approval requirements are designed to protect patients by ensuring, among other things, that drugs are safe and effective for their intended uses. These unapproved injectable drugs are particularly concerning because they inherently present greater risks to ...