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
Thursday, October 17, 2019
FDA is expanding criminal enforcement operations!!
Expanding Criminal Enforcement Operations Globally to Protect Public Health
The American public relies on the U.S. Food and Drug Administration to help ensure the quality and safety of FDA-regulated products available to consumers, many of which are sourced or manufactured overseas. As the volume of globally produced products and suppliers expands daily, the risk of fraudulent, intentionally adulterated, and/or other illegal products shipping into the U.S. also increases.
Every day, thousands of illicit products are shipped to the U.S. from overseas, across the spectrum of things the FDA regulates, including unapproved opioids, counterfeit medicines, fake medical devices, bogus vaccines, imitation cosmetics, adulterated foods and components of illicit vaping products. These products can be outright forgeries of items produced for the American market, as well as “gray market” products manufactured for use in another country but shipped illegally to the U.S. These products are unsafe: they may contain contaminants or be adulterated, and are not shipped and handled under conditions designed to preserve product stability and sterility.