Regulatory & Legal15 min read
Peptide Clinical Trial Regulation: IND Process
**Every FDA-approved peptide drug — from insulin to semaglutide to tirzepatide — started with the same application: an Investigational New Drug filing.
Regulatory & Legal
FDA, legal, and compliance content.
Regulatory & Legal11 min read
FDA GRAS Status & Peptides: Supplement Pathway
**If you've spent any time looking into peptide supplements, you've probably encountered the term "GRAS." It sounds reassuring — Generally Recognized as Safe.
Regulatory & Legal17 min read
Peptide Quality Standards: USP, EP, and Beyond
When you look at a certificate of analysis for a peptide and see "98.5% purity by HPLC," what does that number actually mean? Who decided what counts as pure? What tests were run, and against what reference standard?
Regulatory & Legal12 min read
How the DSHEA Affects Peptide Supplements
The Dietary Supplement Health and Education Act of 1994 reshaped the American supplement industry overnight. It gave consumers direct access to vitamins, minerals, herbs, and amino acids without requiring FDA pre-approval.
Regulatory & Legal18 min read
Timeline: History of Peptide Regulation in the US
**The story of peptide regulation in America starts with a dying 14-year-old boy in Toronto, a bottle of murky pancreatic extract, and a discovery that changed medicine forever.
Regulatory & Legal14 min read
Consumer Rights When Peptides Are Restricted
**When the FDA moved 17 therapeutic peptides to Category 2 of the bulk drug substance list in 2023 and 2024, thousands of patients lost access to treatments their doctors had been prescribing through compounding pharmacies.
Regulatory & Legal14 min read
Canada Peptide Regulations: Access & Legal Status
Canada occupies an unusual position in global peptide regulation. It is about to become the first country where affordable generic semaglutide may be available — Novo Nordisk's key patent expired on January 4, 2026, and Health Canada is actively reviewing generic applications.
Regulatory & Legal14 min read
International Peptide Regulation: EU, UK, Australia
Peptide regulation in the United States gets most of the attention, but the reality is that regulatory frameworks differ dramatically from one country to the next. What is a prescription-only medicine in Australia may be a legal research purchase in the United Kingdom.
Regulatory & Legal14 min read
Peptide Patents & Market Exclusivity Explained
When Novo Nordisk's semaglutide costs $936 per month in the United States and $169 in Japan for the same drug, patents are the reason. When a biosimilar version of a GLP-1 agonist could slash prices by 60–70% but won't reach American pharmacies until the early 2030s, patent strategy is why.
Regulatory & Legal15 min read
DEA Classification of Peptides: Current Status
One of the most common questions in the peptide space is deceptively simple: are peptides controlled substances? The short answer is no — the vast majority of peptides do not appear on any DEA schedule.
Regulatory & Legal16 min read
State Medical Board Positions on Peptide Therapy
If you're a physician prescribing peptide therapy — or a patient receiving it — the FDA is only one of the regulators you need to worry about.
Regulatory & Legal14 min read
FDA Warning Letters to Peptide Companies: Analysis
The FDA's warning letter database tells a story about where peptide regulation is heading — and it's not subtle.
Regulatory & Legal14 min read
Peptide Advertising Regulations: FTC & FDA Rules
If you sell peptides, market a peptide clinic, or run a telehealth platform that prescribes them, the rules about what you can say are stricter than most people realize.
Regulatory & Legal14 min read
Peptide Import Laws: Customs & Personal Use
**Ordering peptides from overseas sounds simple until your package doesn't arrive.** U.S. Customs and Border Protection screens international shipments for pharmaceutical products, and peptides — whether labeled "research chemicals" or not — regularly get flagged, detained, and seized.
Regulatory & Legal13 min read
Peptides in Professional Sports: Doping Regulations
**Every major professional sports league in North America bans peptide hormones and growth hormone secretagogues.
Regulatory & Legal14 min read
FDA 503A vs. 503B Compounding: Peptide Implications
If you've followed the [peptide regulatory crackdown](/regulatory/fda-peptide-compounding-crackdown-what-it-means/), you've probably seen the terms "503A" and "503B" thrown around — often without much explanation.
Regulatory & Legal13 min read
Telehealth Peptide Prescriptions: Legal Framework
Getting peptides through telehealth sounds simple. You hop on a video call, describe your goals, and a provider writes a prescription.
Regulatory & Legal14 min read
GLP-1 Drug Shortages: Causes, Status & Alternatives
**For nearly three years, millions of patients couldn't fill their prescriptions for Ozempic, Wegovy, Mounjaro, and Zepbound.** The shortage stretched from early 2022 through early 2025, driven by demand that overwhelmed manufacturing capacity.
Regulatory & Legal13 min read
Online Peptide Sales: Legal Risks & Consumer Protection
**The internet makes buying peptides easy. It does not make it safe or legal.** A search for "buy BPC-157" returns dozens of vendors offering vials with next-day shipping.
Regulatory & Legal12 min read
Peptides & WADA: Anti-Doping Rules for Athletes
**If you compete in any sport governed by the World Anti-Doping Agency, the rules around peptides are strict, specific, and unforgiving.** A single vial of BPC-157 or a cycle of ipamorelin can end a career.
Regulatory & Legal13 min read
GLP-1 Compounding Ban: What Happened & What's Next
For roughly three years, millions of Americans accessed [compounded semaglutide](/comparisons/compounded-semaglutide-vs-brand-name/) — a fraction of the cost of brand-name Ozempic or Wegovy — through compounding pharmacies that filled a gap the drug manufacturers couldn't.
Regulatory & Legal13 min read
BPC-157 Legal Status: FDA Position & Updates
There's one significant problem: BPC-157 is illegal to compound for human use in the United States, banned in competitive sports worldwide, and has never been approved by any government health authority on Earth for any human condition.
Regulatory & Legal12 min read
Research Use Only Peptides: Legal Gray Area Explained
You've seen the label. It's on nearly every peptide product sold online outside of a pharmacy: "For research use only. Not for human consumption."
Regulatory & Legal14 min read
Peptide Legality Around the World: Global Guide
**Every country regulates peptides differently.** What you can buy over the counter in Thailand might land you a fine in Australia or a prescription requirement in Germany.
Regulatory & Legal20 min read
Are Peptides Legal? State-by-State Guide (2026)
The short answer: it depends on which peptide, how you got it, and what you plan to do with it.
Regulatory & Legal17 min read
FDA Peptide Compounding Crackdown: What It Means
For years, compounding pharmacies were the primary way Americans accessed peptides like BPC-157, thymosin alpha-1, CJC-1295, and ipamorelin. A doctor wrote a prescription. A compounding pharmacy mixed the peptide from bulk powder.
Regulatory & Legal15 min read
Which Peptides Are FDA-Approved? Complete List
When someone mentions "peptides," the conversation often drifts toward research compounds -- BPC-157, CJC-1295, TB-500, and the like. But these are not FDA-approved drugs. They occupy a legal gray area that the FDA has been closing rapidly since 2024.
Regulatory & Legal16 min read
FDA Peptide Regulation: Complete 2025-2026 Timeline
The FDA's approach to peptide regulation shifted dramatically starting in late 2023. What had been decades of relative tolerance toward compounded peptides gave way to a rapid-fire sequence of category designations, shortage declarations, enforcement actions, and lawsuits that rewrote the rules for