The Law of Compounding Medications And Drugs
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
Wednesday, October 20, 2021
Doesn't the ruling that the percentage of compounded drugs sold interstate was arbitrary force the FDA to then use the amount selected by Congress which is 5% or more? Why or why not? More importantly doesn't it just fortify the argument that the federal government/FDA should regulate any compounded drugs sold in interstate commerce? Why or why not?
| HotHead Vapor | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||
| DENTON VAPE SHOPPE | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||
| E-Cig Mania LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||
| Jon B. Cole, MD | Center for Drug Evaluation and Research | CDER | Failure to obtain Investigational New Drug Applications | |||
| Lauren R. Klein, MD, M.S. | Center for Drug Evaluation and Research | CDER | Failure to obtain Investigational New Drug Applications | |||
| AriBio H&B Co., Ltd. | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated/Misbranded | |||
| The Camel Milk Co. LLC dba Camel Culture | Office of Human and Animal Foods Operations – Division West 4 | New Drug/Misbranded | |||
| Magnolia Medical Technologies, Inc. | Office of Medical Devices and Radiological Health, Division 3 | CGMP/QSR/Medical Devices/Adulterated | |||
| Sircle Laboratories, LLC | Office of Pharmaceutical Quality Operations, Division II | CGMP/Finished Pharmaceuticals/Adulterated | |||
| Marcus Research Laboratory, Inc. | Division of Pharmaceutical Quality Operations III | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
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