https://currently.att.yahoo.com/att/cm/drugs-recalled-due-mix-erectile-173514442.html
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, December 10, 2020
HHS proposes changing HIPAA privacy rules
The proposed updates to Health Insurance Portability and Accountability Act rules aim to improve care coordination and give patients more access to their health information. President-elect Joe Biden takes office next month, making it likely the proposed rule would be significantly changed before taking effect. |
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Tuesday, December 8, 2020
| 12/08/2020 | 11/20/2020 | Natures Boost LLC | Division of Human and Animal Food Operations West VI | New Drug/Misbranded | ||
| 12/08/2020 | 11/24/2020 | Mexi-Land Inc. | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) | ||
| 12/08/2020 | 11/30/2020 | Valentus, Inc. | Division of Human and Animal Food Operations West I | New Drug/Misbranded | ||
| 12/08/2020 | 12/01/2020 | Corporativo Bureli S.A. de C.V. | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | ||
| 12/08/2020 | 12/01/2020 | Mushroom Revival, Inc. | Division of Human and Animal Food Operations East I | New Drug/Misbranded | ||
| 12/08/2020 | 12/07/2020 | Paradigm RE LLC | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | ||
| 12/03/2020 | 12/02/2020 | Rat's Army | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
Monday, December 7, 2020
5 days ago — laboratory companies; pharmacies that primarily compound drugs or primarily dispense compounded drugs; manufacturers of devices or medical supplies; ...
Pharmacies that primarily compound drugs or primarily dispense compounded drugs are all ineligible to use these new safe harbors in AKS and Stark Law Regulations
" Pharmaceutical manufacturers, distributors, and wholesalers; pharmacy benefit managers; laboratory companies; pharmacies that primarily compound drugs or primarily dispense compounded drugs; manufacturers of devices or medical supplies; entities or individuals that sell or rent durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) (other than a pharmacy or a physician, provider, or other entity that primarily furnishes services); and medical device distributors and wholesalers are all ineligible to use these new safe harbors." quoted from https://www.mintz.com/insights-center/viewpoints/2146/2020-12-07-hhs-finalizes-highly-anticipated-final-rules-amending
14 hours ago — ... pharmacies that primarily compound drugs or primarily dispense compounded drugs; manufacturers of devices or medical supplies; entities or individuals that
5 days ago — NICHOLASVILLE, Ky. (WKYT) - A Nicholasville-based compounding pharmacy, and its owner, admitted in federal court on Thursday to the unlawful distribution .
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