News & Analysis as of

Enforcement Actions Health Care Providers Drug Compounding

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

Foley & Lardner LLP

GLP-1 Compounded Medications Targeted by Connecticut Attorney General

Foley & Lardner LLP on

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

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

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

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

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

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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