Buchanan Ingersoll & Rooney PC

https://www.bipc.com › tirzepatide-fda-and...

Tirzepatide, FDA, and Compounding: Understanding the Current …

2 days ago · The removal of tirzepatide from the drug shortage list of the Food and Drug Administration (FDA) list in late 2024 marked a significant turning point for compounders in both 503A and 503B industries.…

a4pc.org

https://a4pc.org › fda-to-continue...

FDA to continue enforcement discretion on compounded tirzepatide

5 days ago · This applies to situations where: The compounded product is similar to a commercially available drug Bulk drug substances are used for compounding tirzepatide …

Big Pharma has already raised the prices of hundreds of drugs this year Story by Bruce Gil • 13h

 Big Pharma has already raised the prices of hundreds of drugs this year

 

Lilly sues two medical spas over copycat weight-loss drugs

Reuters

https://www.reuters.com › healthcare-pharmaceuticals › l...

2 days ago — Compounding facilities create medicines by combining, mixing or altering drug ingredients. Federal regulations allow compounded versions to be sold to meet ...

 

Weight Loss Drug Compounding Enforcement Unlikely to ...

6 days ago — Lawsuits and enforcement actions against pharmaceutical compounders producing copies of popular diabetes and weight loss drugs, such as semaglutide ...

 

California Pharmacy Board delays vote on compounded ...

4 days ago — “The BOP's proposed regulations will deny access to compounded drugs that people with chronic illnesses rely on. Cancer patients undergoing chemo and people ...

 

Pharmacy Alert: FDA Issues Final Interim Guidances ...

Frier Levitt

https://www.frierlevitt.com › Articles

2 days ago — On January 7, 2025, FDA released Guidances on compounding using bulk drug substances for both 503A pharmacies and 503B outsourcing facilities.

 

Under New Policy, FDA Will Cut Off 'Interim' Compounding ...

Inside Health Policy

https://insidehealthpolicy.com › daily-news › under-new...

7 days ago — FDA will limit the drug substances that can be compounded by 503A and 503B outsourcing facilities after being proposed for, but not yet approved for, ...

 

01/07/2025	11/12/2024	HDFrenchies LLC dba Bully Baum	Center for Veterinary Medicine	New Animal Drug/Adulterated
01/07/2025	11/12/2024	Veterinary Select Formula dba Allergic Pet	Center for Veterinary Medicine	New Animal Drug/Adulterated
01/07/2025	11/12/2024	Intermarket Industries Inc. dba Doc Ackerman Pet Products	Center for Veterinary Medicine	New Animal Drug/Adulterated
01/07/2025	11/12/2024	Energetic Essences, LLC dba Pet Essences	Center for Veterinary Medicine	New Animal Drug/Adulterated
01/07/2025	12/16/2024	Indoco Remedies Limited	Center for Drug Evaluation and Research (CDER)	CGMP/Finished Pharmaceuticals/Adulterated
01/07/2025	12/12/2024	XO Biologix, LLC	Center for Biologics Evaluation and Research (CBER)	Unappro

“ The FTC released its second interim report on pharmacy benefit managers on Tuesday, claiming that CVS Caremark, Express Scripts and OptumRx dramatically markup specialty generic drugs to affiliated pharmacies, reaping $7.3 billion in excess revenue.”

 On Monday, the FDA published the blog, “FDA Spearheads Global Efforts on Informal Markets and Substandard/Falsified Medical Products.” This blog is the latest in the “From A Global Perspective” series and discusses the FDA’s role in leading WHO efforts to address knowledge gaps regarding the global distribution of substandard and falsified medical products through informal/unregulated markets.