03/05/2018 | 3013736415 | SCA Pharmaceuticals, LLC. | 483 | CT | Outsourcing Facility | 03/26/2018 |
02/28/2018 | Clover Custom Blending LLC | Dallas District Office | CGMP/Finished Pharmaceuticals/Adulterated | Not Issued * |
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
02/28/2018 | Clover Custom Blending LLC | Dallas District Office | CGMP/Finished Pharmaceuticals/Adulterated | Not Issued * |
03/01/2018 | Pharmacy Resources Incorporated | Los Angeles District Office | Compounding Pharmacy/Adulterated Drug Products | Not Issued * |
03/08/2018 | Medaus, Inc. | Dallas District Office | Compounding Pharmacy/Adulterated Drug Products | Not Issued |
03/15/2018 | Keshava Organics Pvt. Ltd. | Center for Drug Evaluation and Research | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | Not Issued |
FDA takes key step in advancing oversight of drug compounding and implementing new laws ...
FDA Commissioner Scott Gottlieb, MD, announced Friday a key step forward in implementing the Drug Quality and Security Act (DQSA) and section 503B of the Federal Food, Drug, and Cosmetic Act. Among other things, the provisions limit the bulk drug substances that outsourcing facilities can use in ...
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