Why your drug store is closing By Nathaniel Meyersohn, CNN

 Why your drug store is closing | CNN Business

 

10/01/2024

09/13/2024

Far East Summit LLC

Division of Human and Animal Food Operations West VI

Unapproved New Drugs/Misbranded

 

10/08/2024

09/30/2024

Mexicanrxpharm.com

Center for Drug Evaluation and Research (CDER)

Notice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the Internet

FDA Says Compounding Pharmacies Can Keep Making Weight-Loss Med Tirzepatide, for Now Story by Robin Foster HealthDay Reporter •

 FDA Says Compounding Pharmacies Can Keep Making Weight-Loss Med Tirzepatide, for Now (msn.com)

FDA shakes up weight loss market as Mounjaro shortage ends Story by Joseph Choi •

 

FDA shakes up weight loss market as Mounjaro shortage ends (msn.com)

 Today, the FDA has issued an immediately-in-effect guidance, Temporary Policies for Compounding Certain Parenteral Drug Products, for compounders to help fill the gaps from the impact of Hurricane Helene on Baxter International’s North Cove facility.  The FDA also added three new drug products to the Drug Shortages Database as a result of Hurricane Helene. The agency now considers Dextrose 70% IV solution, Lactated Ringers IV Solution, and Peritoneal Dialysis Solution to not be commercially available in adequate supply to meet national demand.

The FDA is working continuously to address the shortages and supply disruptions to ensure patients have access to certain parenteral drugs, including IV solutions. For the most recent information on drug and biologic products that were impacted by Hurricane Helene, please see FDA’s Baxter Recovery webpage.

Compounders sue FDA for removing Eli Lilly's tirzepatide from shortage

 Compounders sue FDA for removing Eli Lilly's tirzepatide from shortage 

 The state of Texas is accusing major PBMs and drug companies of colluding to raise the cost of insulin. Texas alleged drug manufacturers Eli Lilly, Novo Nordisk and Sanofi raise the price of insulin and then pay an undisclosed amount back to PBMs, as Noah Tong reports.

 October 2, 2024

• FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize

 

• On Wednesday, the FDA’s Office of Criminal Investigations, as co-lead on an investigation with the Department of Health and Human Services Office of Inspector General, was involved in an indictment in the District of Puerto Rico charging 27 individuals with conspiracy to introduce misbranded drugs and to defraud the United States, as well as unlicensed wholesale distribution and various violations of the Drug Supply Chain Security Act (DSCSA). The defendants included unlicensed wholesale distributors and pharmacy owners and employees who, in violation of the Federal Food, Drug, and Cosmetic Act (FDCA) and the DSCSA, conspired to sell  misbranded and diverted prescription drugs from unauthorized trading partners to pharmacy customers, without the customers’ knowledge that the products were misbranded and diverted. The scheme was identified, investigated and dismantled through the efforts of FDA-OCI, HHS OIG and the U.S. Attorney’s Office, District of Puerto Rico. The co-conspirators and others engaged in this scheme unlawfully generated revenue in an amount exceeding $13,000,000 by selling and distributing misbranded and diverted prescription drugs and billing insurance, costing Medicare and Medicaid over $7.6 million.