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, February 2, 2018
Question of the Day February 2, 2018 Rep. Buddy Carter (R-GA) alleges is the agency's use of guidance documents as the basis for compounding enforcement actions. What will be the results in criminal and/or civil actions if FDA guidance is not used? What will be the results for victims? What will be the results for compounders? Could DOJ bring more prosecutions using strictly the statutes with no guidance or warning to compounders? For example, any compounder who makes inordinate amounts of office use compounds be prosecuted for violating the statute without any definition from DOJ or the FDA as to what inordinate amount means and a jury making this determination? Why or why not?