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
Monday, August 10, 2020
Wednesday, August 5, 2020
The U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response to the COVID-19 pandemic:
- The FDA issued its first warning letter to New Life International and its second warning letter to Fishman Chemical of North Carolina, LLC, both of which distribute chloroquine phosphate products intended to treat disease in aquarium fish. Chloroquine phosphate intended to treat disease in aquarium fish has not been approved, conditionally approved, or indexed. Although neither company identified in today’s warning letters made claims about these products’ use by people, the agency is concerned that consumers may mistake, and have mistaken, unapproved chloroquine phosphate animal drugs for the human drug chloroquine phosphate. People should not take any form of chloroquine unless it has been prescribed by a licensed health care provider.
- Testing updates:
- To date, the FDA has currently authorized 203 tests under EUAs; these include 166 molecular tests, 35 antibody tests, and 2 antigen tests.
| 07/23/2020 | 07/21/2020 | 21st Century LaserMed Pain Institute d/b/a Create Wellness Clinics | Center for Biologics Evaluation and Research (CBER) | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
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