FDA News

FDA regulatory updates, guidance documents, enforcement actions, and policy changes affecting peptides.

FDA News March 10, 2026

Why Did Peptide Sciences Shut Down? Timeline, FDA Pressure, and What It Means for the Industry

Peptide Sciences, the largest gray-market research peptide vendor in the U.S., voluntarily shut down on March 6, 2026. A breakdown of the FDA enforcement actions, pharmaceutical lawsuits, and new legislation that led to the closure.

FDA News March 10, 2026

FDA Peptide Category 1 vs Category 2: Complete List and What It Means for Access

Understanding the FDA's Category 1 and Category 2 bulk drug substance classifications for peptides, which compounds fall into each group, and how 2026 reclassification proposals could reshape compounding pharmacy access.

FDA News March 10, 2026

Are Peptides Legal for Veterinary Use? FDA, DEA, and State Regulations

A detailed look at the legal framework governing peptide use in animals, including FDA animal drug rules, extra-label use under AMDUCA, DEA scheduling considerations, and state veterinary board regulations.

FDA News March 10, 2026

Peptide Patent Wars: Novo Nordisk, Eli Lilly, and the Fight Over GLP-1 Compounding

An analysis of the ongoing legal battles between pharmaceutical giants Novo Nordisk and Eli Lilly and the compounding pharmacy industry over GLP-1 receptor agonist patents, FDA shortage declarations, and patient access.

FDA News February 25, 2026

FDA Peptide Naming and Labeling Requirements: How Mislabeling Leads to Enforcement

FDA peptide labeling requirements are strict and frequently enforced. Learn how mislabeled peptide products trigger warning letters, seizures, and injunctions.

FDA News February 18, 2026

FDA's Evolving Stance on GHK-Cu and Cosmetic Peptide Ingredients

The FDA's regulatory approach to cosmetic peptides like GHK-Cu demonstrates the blurry line between cosmetics and drugs, with enforcement implications for the growing peptide skincare industry.

FDA News February 18, 2026

Are Peptide Supplements FDA Approved? What Consumers Need to Know

Most peptide supplements on the market are not FDA approved, and many are illegally marketed. Learn which peptides have FDA approval, how to identify legal products, and what "FDA approved" really means.

FDA News February 11, 2026

FDA Peptide Regulations 2026: What You Need to Know

Comprehensive overview of FDA peptide regulations in 2026, including bulk drug substance categories, compounding restrictions, and how recent actions affect peptide access.

FDA News February 11, 2026

Telehealth Peptide Prescribing Laws: State and Federal Guide

Navigate the legal framework for telehealth peptide prescribing, including federal regulations, state-by-state requirements, and provider and patient considerations.

FDA News February 11, 2026

Compounding Pharmacy Regulations: 503A vs 503B Explained

Understand the critical differences between 503A and 503B compounding pharmacies, how they affect peptide access, quality assurance, and regulatory compliance.

FDA News February 5, 2026

FDA Ruling: Peptides BPC-157 & TB-500 Impacted

FDA Category 2 Peptides: An Analysis of the 2023 Ruling and Its Impact on BPC-157, TB-500, and the Peptide Industry In 2023, the Food and Drug Administration (FDA) implemented a ruling with significant ramifications for the peptide industry, particularly impacting the availability and sourcing o...

FDA News February 5, 2026

DEA Scheduling of Peptides: Which Peptides Are Controlled Substances?

FDA Regulation and Peptide Scheduling: A Deep Dive into DEA Control Overview of the Regulatory Action The Drug Enforcement Administration (DEA) plays a crucial role in regulating peptides in the United States, primarily through its scheduling authority under the Controlled Substances Act (CSA).

FDA News February 3, 2026

Semaglutide: Prescription Laws by Country

Semaglutide Legal Status: A Global Analysis of Prescription Requirements and Regulatory Implications Overview of the Regulatory Action Semaglutide, marketed under the brand names Ozempic (for type 2 diabetes) and Wegovy (for weight management), has experienced a surge in global demand.

FDA News February 3, 2026

Mounjaro Legal? 2024 Prescription Guide

Here is the requested analysis: Tirzepatide (Mounjaro) Legal Status and Prescription Requirements in 2024: A Regulatory Analysis Tirzepatide, marketed as Mounjaro, has rapidly gained prominence in both diabetes management and, increasingly, weight loss.

FDA News January 26, 2026

FDA Warning Letters to Peptide Suppliers: 2024-2025 Trends

In recent years, the peptide industry has witnessed significant growth, fueled by the potential therapeutic benefits of peptides in treating a wide array of conditions.

FDA News January 26, 2026

FDA Crackdown on Compounded Semaglutide: What You Need to Know

The increasing popularity of semaglutide, a medication initially developed to treat type 2 diabetes and later approved for weight management, has led to a surge in its use and a corresponding rise in the compounding of this peptide by pharmacies.

FDA News January 26, 2026

How FDA Defines "Drug" vs "Research Chemical" for Peptides

In an era where scientific advancements have propelled peptides to the forefront of medical research, the distinction between a "drug" and a "research chemical" becomes crucial for researchers, pharmaceutical companies, and regulatory bodies.

FDA News January 26, 2026

GLP-1 Drug Shortage and FDA Compounding Guidelines Explained

In recent years, the pharmaceutical landscape has been significantly impacted by the emergence of GLP-1 receptor agonists, a class of drugs primarily used to treat type 2 diabetes and obesity.

FDA News January 26, 2026

FDA Enforcement Actions Against Peptide Sellers: Case Studies

In recent years, the peptide industry has witnessed significant growth, driven by advancements in biotechnology and increased interest in personalized medicine.

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