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, September 24, 2021
Laboratorio Pharma International SRL | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | ||||
Furley Bioextracts SDN BHD | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | ||||
Nanomateriales QuĂmicos Avanzados, S.A. de C.V. | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | ||||
Fibromyalgia Treatment Group - FTG, LLC | Division of Human and Animal Food Operations West VI | New Drug/Misbranded | ||||
FMT Services, LLC | Center for Food Safety and Applied Nutrition (CFSAN) | Foreign Supplier Verification Program (FSVP) |
6 hours ago — The corporate “has refused to recall all unexpired compounded drug merchandise meant to be sterile or to stop compounding of all sterile medication,” the FDA ...
Will there be a government appeal to a higher court?
3 days ago — Compounded drugs are customized medications used by patients with special needs, such as those with allergies to inactive ingredients in FDA-approved products.
"Eleven lots of the compounded intravenous antibiotic Cefazolin have been recalled after manufacturer IntegraDose Compounding Services said there was “a lack of sterility assurance resulting from compounding in a newly installed biologic safety cabinet without completing dynamic smoke study testing.”A recalled antibiotic might not be sterile. That can cause ‘life-threatening’ infections BY DAVID J. NEAL SEPTEMBER 22, 2021 10:15 AM
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