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Enforcement Actions Drug Compounding

Foley & Lardner LLP

GLP-1 Drugs: Ohio Board of Pharmacy Issues FAQs for Compounders

Foley & Lardner LLP on

Share on Twitter Print Share by Email Share Back to top In spring 2025, the Food and Drug Administration (FDA) resolved and ended the GLP-1 medications shortage, subsequently releasing declaratory orders that neither...more

Hendershot Cowart P.C.

GLP-1 Shortage Ended: Can You Still Legally Prescribe or Compound Semaglutide and Tirzepatide?

Hendershot Cowart P.C. on

For the past several years, physicians and compounding pharmacies have stepped in to address critical patient access gaps during U.S. Food and Drug Administration (FDA) shortage declarations for semaglutide (Ozempic, Wegovy)...more

McDermott Will & Schulte

GLP-1 Update: Court Backs FDA in Tirzepatide Compounding Case

On May 7, 2025, the US District Court for the Northern District of Texas upheld the US Food and Drug Administration’s (FDA’s) decision to remove two tirzepatide injection medications from the FDA’s drug shortage list. This...more

Foley & Lardner LLP

GLP-1 Compounded Medications Targeted by Connecticut Attorney General

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On May 21, 2025, the Connecticut Office of the Attorney General released a statement and sent letters to Connecticut weight loss clinics, med spas, medical practices and other businesses regarding allegedly or potentially...more

Harris Beach Murtha PLLC

GLP-1 Weight-Loss Drugs Off Shortage List; Deadlines to Stop Compounding

Glucagon-like peptide-1 agonists, a class of medications known as GLP-1s, have grown in popularity, initially for the treatment of type 2 diabetes and more recently for obesity and other labeled and off-label indications for...more

Hendershot Cowart P.C.

FDA Update: Current Guidelines for Semaglutide and Tirzepatide Compounding

Hendershot Cowart P.C. on

Weight loss clinics, telehealth companies, physicians, and pharmacies that have been prescribing or dispensing compounded GLP-1 medications must prepare for significant changes following the Food and Drug Administration’s...more

Foley & Lardner LLP

Compounded GLP-1 Drugs: Texas Judge Denies PI Motion and Request for Stay of FDA’s Declaration that Tirzepatide Shortage is...

Foley & Lardner LLP on

On March 5, 2025, one U.S. District Court ruled unequivocally in the Food & Drug Administration’s (FDA) favor in the case, Outsourcing Facilities Ass’n, et. al. v. U.S. Food and Drug Admin., et. al., 4:24-cv-0953-P, slip op.,...more

Wilson Sonsini Goodrich & Rosati

FDA Can Keep Tirzepatide off the Drug Shortage List, Judge Says

On March 5, 2025, the U.S. District Court for the Northern District of Texas denied the Outsourcing Facilities Association’s motion for a preliminary injunction to prevent the U.S. Food and Drug Administration (FDA) from...more

McDermott Will & Schulte

Semaglutide Shortage Resolved

On February 21, 2025, the US Food and Drug Administration (FDA) revised its shortage categorization of semaglutide, a glucagon-like peptide 1 (GLP-1) medication, marking the shortage as “resolved” for all presentations of the...more

Fuerst Ittleman David & Joseph

The GLP-1 Saga Continues: FDA Ends the Tirzepatide Shortage: Frequently Asked Questions

On December 19, 2024, FDA formally announced the end of the tirzepatide shortage in a Declaratory Order issued to Eli Lilly & Co. (“Lilly”). Lilly is tirzepatide’s patentholder and the manufacturer of the two branded versions...more

Gardner Law

FDA Issues Numerous Warning Letters

Gardner Law on

The U.S. Food and Drug Administration (FDA) uses warning letters to notify manufacturers that they have violated the FDA’s regulations or federal law. Manufacturers that receive warning letters must respond promptly, and they...more

Burr & Forman

Eleventh Circuit Affirms Convictions Against Florida Physician, Pharmacist for Violating Anti-Kickback Statute

Burr & Forman on

Prosecutions related to the submission of claims to Tricare for compounded pain creams continue. The Eleventh Circuit Court of Appeals affirmed convictions against a Florida pharmacist, physician, and Navy veteran for their...more

Robinson+Cole Health Law Diagnosis

Marketer in Kickback Scheme Involving Compound Pharmacies Sentenced to Probation and Order to Pay $3.3 Million

On March 30, 2022, the United States Department of Justice (DOJ) announced that Manual J. Bojorquez, the owner of a marketing company, was sentenced to 36 months’ probation and ordered to pay restitution of $3.3 million for...more

Bradley Arant Boult Cummings LLP

The Clock is Ticking: The Countdown to Final Compounding Pharmacy Prosecutions

Many compound pharmacists who participated in the TRICARE program learned, in the most painful of ways, that the Department of Justice (DOJ) casts a very long shadow when large amounts of money pour out of a government...more

Wilson Sonsini Goodrich & Rosati

FDA Announces Unprecedented Recall of Dietary Supplements

Recently, a New York-based dietary supplement manufacturer (and its subsidiaries) issued a nationwide recall of all lots of dietary supplement products manufactured and sold between January 2013-November 2019. Because the...more

McDermott Will & Schulte

Healthcare Enforcement Quarterly Roundup - Q4 2019

In this installment of the Healthcare Enforcement Quarterly Roundup we cover several topics that have persisted over the past few years and identify new issues that will shape the scope of enforcement efforts in 2020. In this...more

ArentFox Schiff

Investigations Newsletter: Kentucky Hospital Agrees to Pay $10 Million to Resolve False Claims Act Allegations

ArentFox Schiff on

Headlines that Matter for Companies and Executives in Regulated Industries - Kentucky Hospital Agrees to Pay $10 Million to Resolve False Claims Act Allegations - Jewish Hospital & St. Mary’s Healthcare Inc. d/b/a...more

Robinson+Cole Health Law Diagnosis

DOJ Reaches $21.36 Million Agreement with Compounding Pharmacy, Two of its Executives, and Managing Private Equity Firm to Resolve...

On September 18, 2019, the Department of Justice (DOJ) announced a $21.36 million settlement with compounding pharmacy Patient Care America (PCA), as well as PCA’s Chief Executive, PCA’s former Vice President of Operations,...more

Akin Gump Strauss Hauer & Feld LLP

FDA Finalizes Criteria, and First Two Exclusions, for Outsourcing Facility Compounding with Bulk Drug Substances

• Five years after passage of the DQSA, FDA issued final decisions prohibiting the use of two bulk substances by outsourcing facilities, and finalized criteria for ongoing evaluations of other bulk substances that are...more

Holland & Knight LLP

FDA Commissioner Speaks Out on Compliance and Enforcement

Holland & Knight LLP on

On Dec. 12, 2018, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced tougher compliance and enforcement policies for drug manufacturers, dietary supplement manufacturers, stem cell clinics and...more

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