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
Thursday, February 24, 2022
Wednesday, February 23, 2022
| Smart Surgical, Inc dba Burst Biologics | Office of Biological Products Operations – Division 2 | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) | ||||
| Extrapharmacy.ru | Center for Drug Evaluation and Research | CDER | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet | ||||
| rxshopmd.com | Center for Drug Evaluation and Research | CDER | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet | ||||
| CytoDyn, Inc. | The Office of Prescription Drug Promotion (OPDP) | New Drug/Labeling/Misbranded | ||||
| Toxikon Corporation/Labcorp Bedford LLC | Center for Biologics Evaluation and Research | Good Laboratory Practice (GLP) |
Tuesday, February 22, 2022
And on a unrelated but important topic---
- On Feb. 18, the FDA alerted the public that several categories of FDA-regulated products purchased from Jan. 1, 2021, through the present from Family Dollar stores in Alabama, Arkansas, Louisiana, Mississippi, Missouri and Tennessee may be unsafe for consumers to use. The impacted products originated from the company’s distribution facility in West Memphis, Arkansas, where an FDA inspection found insanitary conditions, including a rodent infestation, that could cause many of the products to become contaminated. The FDA worked with the company to initiate a voluntary recall of the affected products.
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