Quick answer: the history of peptide regulation in the U.S. starts with insulin, discovered in 1921, and runs through eight key laws: the 1938 FD&C Act (safety), the 1962 Kefauver-Harris Amendments (effectiveness), the 1983 Orphan Drug Act, the 1984 Hatch-Waxman Act (generics), DSHEA in 1994 (supplements), FDAMA in 1997 (section 503A compounding), the BPCI Act in 2010 (biologics) and the DQSA in 2013 (section 503B).[1][2] On March 23, 2020, peptides longer than 40 amino acids moved under biologics law, and from 2023 to 2026 compounding of unapproved peptides became the main battleground.[7][8]
For the latest chapter in detail, see our FDA peptide regulation timeline and FDA peptide ban 2026. The FDA & Regulation hub lists every related guide.
At a glance: the key dates
| Year | Event | Why it matters for peptides |
|---|---|---|
| 1921 | Insulin discovered in Toronto | First peptide medicine |
| 1938 | Federal Food, Drug, and Cosmetic Act | New drugs must be shown safe before sale |
| 1953 | Oxytocin synthesized | First peptide hormone made in the lab |
| 1962 | Kefauver-Harris Amendments | New drugs must also be shown effective |
| 1983 | Orphan Drug Act | Incentives for rare-disease drugs, including many peptides |
| 1984 | Hatch-Waxman Act | Generic pathway and patent-term restoration |
| 1994 | DSHEA | Created the dietary supplement category |
| 1997 | FDAMA adds section 503A | Federal rules for pharmacy compounding |
| 2010 | BPCI Act | Biosimilar pathway; protein products shift to biologics |
| 2013 | DQSA adds section 503B | Outsourcing facilities created |
| 2020 | “Deemed to be a license” transition | Peptides over 40 amino acids become biologics |
| 2023–2026 | Category 2, GLP-1 shortages, PCAC reviews | Compounded peptides restricted, then partly reopened |
1921–1938: insulin and the first drug safety law
Frederick Banting and Charles Best extracted insulin in 1921, and in January 1922 it was first given to a 14-year-old boy with type 1 diabetes in Toronto.[1] Insulin, made of two short amino acid chains, became the model for every peptide drug that followed.
At the time, the 1906 Pure Food and Drugs Act only banned adulterated and misbranded drugs. The 1938 Federal Food, Drug, and Cosmetic Act (FD&C Act) went further: new drugs had to be shown safe before marketing, and FDA gained factory inspection powers.[2] The FD&C Act is still the backbone of drug law today.
In 1953, Vincent du Vigneaud synthesized oxytocin, the first peptide hormone made in a lab, work that earned him the 1955 Nobel Prize in Chemistry.[3] Our oxytocin profile covers the hormone itself.
1962–1984: effectiveness, rare diseases and generics
The Kefauver-Harris Amendments of 1962 required makers to prove a drug works, not just that it is safe, before it can be sold.[2] This is why “promising animal data” is not enough for FDA approval of any peptide today.
The Orphan Drug Act of 1983 offered incentives for rare-disease drugs.[2] Many rare-disease peptide drugs approved since then have used orphan designation.
The Drug Price Competition and Patent Term Restoration Act of 1984, known as Hatch-Waxman, let generics be approved without repeating safety and efficacy trials and restored some patent time lost to FDA review.[2] Synthetic peptides such as liraglutide and teriparatide can have generic or follow-on versions through these routes. See peptide patents and exclusivity.
1994: DSHEA and the supplement question
The Dietary Supplement Health and Education Act of 1994 (DSHEA) classified supplements as a type of food and set labeling rules.[2] Some sellers have tried to market peptides as supplements, but injectable products and products marketed to treat disease do not fit that definition. Our guide to DSHEA and peptide supplements explains the limits.
1997–2013: compounding gets its own rules
The FDA Modernization Act of 1997 (FDAMA) added section 503A to the FD&C Act, setting conditions for pharmacists who compound drugs for individual patients.[2] In 2002, the Supreme Court struck down 503A’s advertising restrictions in Thompson v. Western States Medical Center as a violation of free speech.[4]
In 2012, contaminated injections from a Massachusetts compounding pharmacy caused more than 750 infections and more than 60 deaths in 20 states. Congress responded with the Drug Quality and Security Act (DQSA), enacted November 27, 2013, which removed the struck-down advertising provisions from 503A and created section 503B for “outsourcing facilities.”[5]
Under 503A, a pharmacy can compound with a bulk ingredient only if it has a USP monograph, is part of an approved drug, or is on FDA’s 503A bulks list, codified at 21 CFR 216.23.[6] That list is the gateway for peptides such as BPC-157 today. See 503A vs 503B compounding.
2010–2020: when peptides became biologics
The Biologics Price Competition and Innovation Act (BPCI Act), passed in 2010 as part of the Affordable Care Act, created a biosimilar pathway and moved “protein” products to biologics law under the Public Health Service Act after a 10-year transition.[8]
In February 2020, FDA defined a protein as any amino acid chain with a specific sequence of more than 40 amino acids.[7] On March 23, 2020, approved drug applications for such products, including insulins, human growth hormone and some reproductive hormones, were “deemed to be” biologics licenses.[8]
| Size | Regulated as | Examples |
|---|---|---|
| 40 amino acids or fewer | Drug (FD&C Act) | Semaglutide, tirzepatide, teriparatide, oxytocin |
| More than 40 amino acids | Biologic (PHS Act) | Insulins, growth hormone, tesamorelin |
The 40 amino acid cutoff explains why a 39-amino-acid peptide like tirzepatide is approved as a drug, while 44-amino-acid tesamorelin is now listed as a biologic.
2023–2026: the compounding battle
Peptide drug approvals kept growing, with more than 80 peptide drugs approved worldwide by 2021.[9] At the same time, unapproved “wellness” peptides spread through compounding pharmacies and online sellers.
- 2023: FDA placed many nominated peptides, including GHRP-2, GHRP-6 and kisspeptin-10, in Category 2, its list of bulk substances with significant safety risks.[10]
- 2024–2025: shortages of semaglutide and tirzepatide ended, closing the door on mass-compounded copies.
- April 2026: FDA removed 12 peptides from Category 2 after their nominations were withdrawn, and the Federal Register set advisory committee meetings for July 23–24, 2026.[11]
Why this history matters to you
Whether a peptide is an approved drug, a biologic, a compounded product or an unregulated “research chemical” decides what quality checks it has had. Before using any peptide, ask whether it is FDA-approved for your condition; our FDA-approved peptides list is a good starting point.
This is general information, not legal advice.
