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. From that moment in 1922 to the FDA's compounding crackdowns a century later, the regulatory framework around peptides has been shaped by disasters, breakthroughs, political battles, and a growing tension between access and safety.

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Table of Contents

• The Pre-Regulatory Era: 1920s-1930s
• Building the Modern Drug Framework: 1938-1962
• The Peptide Pharmaceutical Boom: 1970s-1980s
• The Generic Drug Revolution and DSHEA: 1984-1994
• Modernization and Compounding Rules: 1997-2003
• The NECC Disaster and Its Aftermath: 2012-2013
• The Biologics Boundary: 2010-2020
• The GLP-1 Revolution: 2017-2024
• The Compounding Crackdown: 2023-2025
• The Current Moment: 2025-2026
• Complete Regulatory Timeline
• FAQ
• The Bottom Line
• References

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The Pre-Regulatory Era: 1920s-1930s

1921-1923: Insulin Changes Everything

On May 17, 1921, Frederick Banting and Charles Best began their experiments at the University of Toronto, extracting a substance from dog pancreases that they called "isletin." By September, they had demonstrated that the extract could lower blood sugar in diabetic dogs.

In January 1922, 14-year-old Leonard Thompson became the first human to receive insulin. He was near death from type 1 diabetes. The first injection caused a sterile abscess and did little, but after biochemist J.B. Collip purified the extract, subsequent injections dropped Thompson's blood glucose, cleared his ketosis, and pulled him back from the edge.

By 1923, Eli Lilly and Company had developed a commercial manufacturing process, and insulin became the first peptide drug approved by the FDA. Banting and J.J.R. Macleod received the Nobel Prize in Physiology or Medicine that same year.

This is worth pausing on. In 1921, type 1 diabetes was a death sentence. By 1923, it was a manageable condition. No other class of therapeutics had produced anything like that transformation, and the regulatory framework that existed at the time — essentially, none — was entirely unprepared for the implications.

1937: The Sulfanilamide Disaster

In 1937, a pharmaceutical company in Tennessee dissolved the antibiotic sulfanilamide in diethylene glycol — a sweet-tasting solvent that happened to be toxic — and marketed it as "Elixir Sulfanilamide." Over 100 people died, including many children, across 15 states.

The disaster wasn't directly about peptides, but it reshaped the regulatory framework that all drugs — including peptide therapeutics — would operate under. The public outcry was immediate and bipartisan.

1938: The Federal Food, Drug, and Cosmetic Act

President Franklin Roosevelt signed the Federal Food, Drug, and Cosmetic Act (FD&C Act) on June 25, 1938, in direct response to the sulfanilamide tragedy. For the first time, drug manufacturers were required to demonstrate safety before marketing a product. The law created the New Drug Application (NDA) process and gave the FDA the enforcement tools it still uses today.

This was the foundation. Every peptide drug approved since 1938 has gone through a process rooted in this legislation.

Building the Modern Drug Framework: 1938-1962

1950s-1960s: Synthetic Peptide Hormones Arrive

The mid-20th century saw the isolation and characterization of several peptide hormones — oxytocin, vasopressin, ACTH (adrenocorticotropic hormone), and glucagon. As chemical synthesis techniques advanced, researchers learned to produce these peptides in the laboratory rather than extracting them from animal tissues.

Vincent du Vigneaud's group synthesized oxytocin and vasopressin in the 1950s, earning du Vigneaud the 1955 Nobel Prize in Chemistry. Synthetic oxytocin entered clinical use for labor induction, and synthetic vasopressin became a treatment for diabetes insipidus.

These early synthetic peptides were regulated under the existing NDA framework, and the regulatory apparatus kept pace. But a catastrophe was about to force another massive overhaul.

1961-1962: The Thalidomide Crisis and the Kefauver-Harris Amendment

Thalidomide, marketed in Europe as a sleeping pill and treatment for morning sickness, caused thousands of severe birth defects. The drug was never approved in the United States, thanks largely to FDA medical officer Frances Kelsey, who refused to approve the application because she had concerns about the drug's safety data.

Kelsey's decision — and the horror of what happened in countries that did approve thalidomide — generated overwhelming public support for stronger drug regulation. On October 10, 1962, President Kennedy signed the Kefauver-Harris Amendment (also called the Drug Efficacy Amendment).

The amendment's requirements were transformative. For the first time, drug manufacturers had to prove both safety and efficacy through "adequate and well-controlled investigations" (i.e., clinical trials) before receiving FDA approval. Informed consent became mandatory for clinical trial participants. Adverse drug reactions had to be reported to the FDA. The amendment also triggered the Drug Efficacy Study Implementation (DESI), a retrospective review of all drugs approved between 1938 and 1962. By the early 1970s, approximately 600 drugs had been categorized as "ineffective" and removed from the market.

This was the birth of the modern clinical trial system. Every peptide drug that has received FDA approval since 1962 — from leuprolide to semaglutide — has been required to demonstrate efficacy in controlled human studies.

The Peptide Pharmaceutical Boom: 1970s-1980s

1970s-1980s: Recombinant DNA Technology

The development of recombinant DNA technology in the 1970s changed peptide drug manufacturing permanently. Instead of extracting insulin from pig and cow pancreases — a process that produced limited quantities and occasionally caused allergic reactions — manufacturers could engineer bacteria to produce human insulin.

In 1982, the FDA approved Humulin (recombinant human insulin), produced by Eli Lilly using Genentech's recombinant DNA technology. It was the first recombinant pharmaceutical product ever approved. This wasn't just a manufacturing milestone — it established that genetically engineered peptides could be regulated through the existing NDA framework.

The 1980s also saw the development of peptide analogs — modified versions of natural peptides with improved stability, potency, or selectivity. Octreotide (a somatostatin analog), leuprolide (a GnRH analog), and desmopressin (a vasopressin analog) all emerged from this period and are still prescribed today.

1983: The Orphan Drug Act

The Orphan Drug Act provided financial incentives — tax credits, research grants, and seven years of market exclusivity — for developing drugs for rare diseases affecting fewer than 200,000 Americans. Several peptide drugs for rare endocrine and metabolic disorders benefited from this legislation.

The Generic Drug Revolution and DSHEA: 1984-1994

1984: The Hatch-Waxman Act

The Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act) created the modern generic drug approval pathway. Generic drug manufacturers could now file Abbreviated New Drug Applications (ANDAs), demonstrating bioequivalence to reference products without repeating clinical trials.

For peptide drugs, Hatch-Waxman had a specific consequence: it defined the pathway through which generic versions of small peptide drugs (40 or fewer amino acids) would eventually reach market. Peptide drugs too large to be classified as traditional drugs would later be governed by a different framework.

The numbers tell the story. When Hatch-Waxman was enacted, generics accounted for 19% of prescriptions filled in the US. Today, that figure exceeds 90%.

1992: The Prescription Drug User Fee Act (PDUFA)

PDUFA authorized the FDA to collect fees from pharmaceutical companies to fund the drug review process. This accelerated review timelines and has been renewed every five years since. For peptide drug developers, faster FDA review meant shorter times between NDA submission and market launch.

1994: The Dietary Supplement Health and Education Act (DSHEA)

DSHEA defined dietary supplements as a category of food (not drugs) and listed the ingredients that qualify: vitamins, minerals, herbs or botanicals, amino acids, and dietary substances used to supplement the diet.

The word "amino acids" in that definition would become a point of intense debate in the peptide world. Amino acids are dietary supplement ingredients. But peptides — chains of amino acids — aren't explicitly listed. Are short peptides (dipeptides, tripeptides) amino acids for regulatory purposes? The FDA has generally said no, at least for synthetic peptides intended for therapeutic use.

DSHEA also established the New Dietary Ingredient (NDI) notification process. Any supplement ingredient not marketed before October 15, 1994, must be the subject of an NDI notification filed with the FDA at least 75 days before marketing. The manufacturer must provide evidence of safety, but the FDA doesn't "approve" NDIs — it simply issues a response letter.

DSHEA created the regulatory framework that natural peptide supplements (like collagen peptides) operate under. But it also created a gray zone that some companies have exploited to market synthetic peptides as supplements, leading to decades of FDA enforcement actions.

Modernization and Compounding Rules: 1997-2003

1997: The FDA Modernization Act (FDAMA)

FDAMA was a sweeping update to the FD&C Act. Among its many provisions, it codified Section 503A of the FD&C Act, creating a federal framework for pharmacy compounding. Under 503A, compounding pharmacies could prepare customized medications for individual patients based on prescriptions — with specific exemptions from the NDA approval process, GMP requirements, and labeling rules that apply to drug manufacturers.

This was the legal foundation for compounded peptide therapy. For the first time, a pharmacy could legally compound a peptide (if it met certain criteria) for a patient with a doctor's prescription. 503A compounding was overseen primarily by state boards of pharmacy, not the FDA.

FDAMA also established the fast-track designation program for drugs treating serious conditions, and it allowed drug companies to share peer-reviewed journal articles about off-label uses of their products.

2002: The Western States Medical Center Decision

In Thompson v. Western States Medical Center (2002), the Supreme Court struck down a provision of Section 503A that restricted compounding pharmacies from advertising their services. The court ruled that this restriction violated the First Amendment.

The decision created legal uncertainty about Section 503A's validity. For several years, the FDA and lower courts debated whether the entire section was enforceable. During this period, compounding pharmacies operated with less federal oversight than Congress had originally intended.

The NECC Disaster and Its Aftermath: 2012-2013

2012: The New England Compounding Center Outbreak

In September 2012, a contaminated batch of methylprednisolone acetate from the New England Compounding Center (NECC) in Framingham, Massachusetts, caused an outbreak of fungal meningitis. By the time the scope was fully documented, 64 people had died and more than 750 had been sickened across 20 states.

NECC had been operating in a regulatory gray zone — compounding large batches of drugs without patient-specific prescriptions, functioning effectively as a drug manufacturer but claiming the exemptions of a compounding pharmacy. State and federal regulators had received warnings about NECC's practices years before the outbreak but lacked clear authority to shut it down.

2013: The Drug Quality and Security Act (DQSA)

Congress responded to the NECC tragedy with the Drug Quality and Security Act, signed by President Obama on November 27, 2013. The DQSA had two major components.

Title I: The Compounding Quality Act created Section 503B of the FD&C Act, establishing "outsourcing facilities" as a new category of compounder. Unlike 503A pharmacies, 503B outsourcing facilities could produce larger batches without patient-specific prescriptions — but they were required to register with the FDA, comply with current Good Manufacturing Practices (cGMP), undergo FDA inspections, and report adverse events.

Title II: The Drug Supply Chain Security Act established requirements for tracking pharmaceutical products through the distribution chain.

The DQSA was the most significant change to compounding regulation in American history. For peptide compounding, it meant that large-scale peptide producers had to choose: operate as a 503A pharmacy (patient-specific prescriptions, state oversight, limited batches) or register as a 503B outsourcing facility (larger batches, but full FDA oversight and GMP compliance).

The Biologics Boundary: 2010-2020

2010: The Biologics Price Competition and Innovation Act (BPCIA)

The BPCIA, enacted as part of the Affordable Care Act, created the biosimilar approval pathway — the biologics equivalent of the Hatch-Waxman Act's ANDA pathway for generic drugs.

For peptides, the BPCIA drew a critical line. The law defined biologics as proteins, but specifically excluded "any chemically synthesized polypeptide." The FDA interprets this to mean that peptides of 40 or fewer amino acids remain regulated as drugs under the NDA pathway, while larger proteins are biologics regulated under the BLA pathway.

This distinction matters. The NDA pathway (for peptides) and the BLA pathway (for biologics) have different data requirements, different market exclusivity periods (5 years for NDA drugs vs. 12 years for biologics), and different generic/biosimilar pathways.

2020: The BPCIA Transition

On March 23, 2020 — exactly 10 years after the BPCIA's enactment — the transition period ended. Products previously approved as drugs under NDA applications that met the BPCIA's definition of a biologic were required to transition to BLA applications. Insulin products, despite being peptide-based, were affected by this transition because they had historically been regulated as drugs rather than biologics. The insulin biosimilar pathway officially opened.

The GLP-1 Revolution: 2017-2024

2017: Semaglutide's Emergence

The FDA approved semaglutide injection (Ozempic) for type 2 diabetes in December 2017. Developed by Novo Nordisk, semaglutide was a once-weekly GLP-1 receptor agonist with a lipidated structure that gave it a half-life of approximately one week — solving the classic peptide problem of rapid degradation.

Within a few years, semaglutide would become one of the most commercially successful peptide drugs in history and would trigger a regulatory chain reaction that is still unfolding.

2019-2021: The GLP-1 Expansion

Semaglutide oral tablets (Rybelsus) received FDA approval in 2019 — the first oral GLP-1 agonist, using an absorption enhancer (SNAC) to survive the gut. Semaglutide injection at higher doses (Wegovy) was approved for chronic weight management in June 2021, marking a turning point in obesity treatment.

2022: Tirzepatide Arrives

The FDA approved tirzepatide (Mounjaro) for type 2 diabetes in May 2022. As a dual GIP/GLP-1 receptor agonist, tirzepatide represented a new class of multi-agonist peptide drugs. Tirzepatide for obesity (Zepbound) was approved in November 2023.

2022-2024: The Shortage Crisis

The explosive demand for GLP-1 drugs created widespread shortages. The FDA added semaglutide and tirzepatide to its Drug Shortage Database, which had an unintended consequence: under Section 503A, compounding pharmacies are permitted to compound copies of FDA-approved drugs during official shortages.

Compounding pharmacies began producing compounded semaglutide and tirzepatide at a fraction of the brand-name price. By late 2023, compounded semaglutide had become a massive market, with telehealth companies like Hims & Hers generating hundreds of millions in revenue from compounded GLP-1 prescriptions.

The GLP-1 compounding controversy would become one of the highest-profile pharmaceutical regulatory battles in a generation.

The Compounding Crackdown: 2023-2025

October 2023: The Category 2 Bombshell

On September 29, 2023, the FDA updated the interim 503A bulks list, adding numerous therapeutic peptides to Category 2 — the designation for substances that "raise significant safety risks." By early 2024, 17 commonly used peptides had been placed on Category 2, including BPC-157, CJC-1295, ipamorelin, TB-500 (thymosin beta-4 fragment), AOD-9604, thymosin alpha-1, selank, semax, KPV, melanotan II, and kisspeptin-10.

The effect was immediate. Compounding pharmacies across the country stopped filling prescriptions for these peptides. Patients who had been receiving treatment — many for chronic conditions — were cut off. Clinics that had built their practices around peptide therapy scrambled to adapt.

2024: Lawsuits and Advisory Committee Reviews

The restrictions triggered legal challenges. Evexias Health Solutions and Farmakeio, a compounding pharmacy, sued the FDA, arguing the agency had violated proper procedure and transparency when adding peptides to Category 2.

In September 2024, the FDA removed five peptides (AOD-9604, CJC-1295, ipamorelin acetate, thymosin alpha-1, and selank acetate) from Category 2 after their nominators withdrew. But this was procedural, not a reversal. The PCAC met in October and December 2024 to review these peptides — and voted against adding any of them to the approved bulks list. Every one was rejected.

February 2025: The Semaglutide Shortage Ends

The FDA officially resolved the semaglutide shortage in February 2025, triggering the end of the compounding exemption. The agency gave compounders until May 2025 to wind down compounded semaglutide production. Companies that had built business models around compounded GLP-1 drugs faced an existential crisis.

Hims & Hers continued operations, rebranding "compounding" as "personalization" and launching an oral semaglutide formulation using alternative absorption technology. The legal and regulatory battle over compounded GLP-1 drugs continues.

January 2025: Category Restructuring

The FDA eliminated Categories 2 and 3 from the interim 503A bulks list, streamlining the system. Category 1 substances remain available for compounding. Substances that had been on Categories 2 and 3 remain prohibited. Any new substance must go through the PCAC process to be added to the official bulks list.

The Current Moment: 2025-2026

The Political Dimension

The regulatory environment in 2025-2026 is shaped by politics as much as science. HHS Secretary Robert F. Kennedy Jr. posted before his appointment that the "FDA's war on public health is about to end," listing peptides among the suppressed products. The FDA under his authority removed several experts from the compounding advisory panel.

Whether this translates into actual policy change remains an open question. As of early 2026, no formal regulatory reversals have been finalized regarding the peptide restrictions.

GRAS Reform

The FDA is pursuing major changes to the GRAS (Generally Recognized as Safe) system, including the potential elimination of the self-affirmed GRAS pathway. Proposed rules published in late 2025 would require mandatory GRAS notice submission and FDA review for all new GRAS determinations. The "Better Food Disclosure Act of 2025" in the Senate would require FDA to maintain a public GRAS list.

NDI Guidance Finalization

The FDA has committed to finalizing New Dietary Ingredient guidance in 2026, which will clarify the pathway for supplement ingredients marketed after October 1994 — relevant for natural peptide supplements.

The GLP-1 Market Explosion

Oral semaglutide (Wegovy pill) launched in January 2026. Orforglipron, a non-peptide oral GLP-1 agonist from Eli Lilly, could receive FDA approval in 2026. Retatrutide, a triple GIP/GLP-1/glucagon agonist, is in Phase III trials with results expected throughout 2026. Medicare coverage for obesity treatments expands, with coverage beginning by at least July 2026 for 40 million beneficiaries.

FDA Modernization

The FDA is exploring AI-assisted review processes, and Commissioner Makary has signaled plans to reduce animal safety testing requirements for IND applications under the FDA Modernization Act 2.0 (signed December 2022). Pre-IND meeting wait times have stretched to 6 months, prompting the agency to seek solutions.

Complete Regulatory Timeline

Year	Event
1921	Banting and Best isolate insulin at the University of Toronto
1922	First human insulin injection — 14-year-old Leonard Thompson
1923	Eli Lilly commercializes insulin; FDA approves first peptide drug; Nobel Prize to Banting and Macleod
1937	Elixir Sulfanilamide disaster kills 107 people
1938	Federal Food, Drug, and Cosmetic Act creates NDA process; safety testing required before marketing
1953	Vincent du Vigneaud synthesizes oxytocin (Nobel Prize, 1955)
1955	Synthetic vasopressin enters clinical use
1962	Kefauver-Harris Amendment — drugs must prove efficacy; clinical trials required; informed consent mandated
1963-1970s	DESI review removes ~600 ineffective drugs from market
1970s	Recombinant DNA technology developed; synthetic peptide analogs emerge
1982	FDA approves Humulin (recombinant human insulin) — first recombinant pharmaceutical
1983	Orphan Drug Act provides incentives for rare disease drug development
1984	Hatch-Waxman Act creates generic drug (ANDA) pathway and patent term restoration
1985	FDA approves leuprolide (Lupron) — GnRH analog for prostate cancer and endometriosis
1988	FDA approves octreotide (Sandostatin) — somatostatin analog for acromegaly
1992	Prescription Drug User Fee Act (PDUFA) — industry fees fund faster FDA reviews
1994	DSHEA defines dietary supplements; amino acids included as dietary ingredients; NDI process created
1996	FDA approves insulin lispro (Humalog) — first rapid-acting insulin analog
1997	FDA Modernization Act (FDAMA) creates Section 503A for pharmacy compounding; fast-track designation program established
2002	Supreme Court's Western States Medical Center decision creates uncertainty about 503A enforceability
2005	FDA approves exenatide (Byetta) — first GLP-1 agonist
2010	BPCIA enacted; defines peptides (40 or fewer amino acids) as drugs, larger proteins as biologics; biosimilar pathway created
2010	FDA approves liraglutide (Victoza) for type 2 diabetes
2012	NECC fungal meningitis outbreak — 64 deaths, 750+ cases
2012	FDA Safety and Innovation Act establishes breakthrough therapy designation
2013	Drug Quality and Security Act creates Section 503B outsourcing facilities
2014	FDA approves liraglutide for obesity (Saxenda)
2017	FDA approves semaglutide injection (Ozempic) for type 2 diabetes
2018	Federal Right to Try Act signed into law
2019	FDA approves oral semaglutide (Rybelsus) — first oral GLP-1 agonist
2020	BPCIA transition period ends; insulin products begin transition to BLA pathway
2021	FDA approves semaglutide injection for obesity (Wegovy)
2022	FDA approves tirzepatide (Mounjaro) for type 2 diabetes; FDA Modernization Act 2.0 signed
2022-2024	GLP-1 drug shortages trigger compounding exemptions; compounded semaglutide market explodes
2023	FDA approves tirzepatide for obesity (Zepbound); FDA places 17 peptides on Category 2 of 503A bulks list
2024	PCAC reviews and rejects peptides for approved bulks list; Evexias lawsuit settles; semaglutide shortage resolved
2025	FDA eliminates Categories 2 and 3; expands Import Alert 66-78; compounded semaglutide wind-down begins; GRAS reform proposed; FDA approves generic liraglutide
2025-2026	Oral Wegovy launches; retatrutide Phase III results expected; GRAS overhaul advances; NDI guidance expected; Medicare obesity coverage expands

FAQ

When did peptide drugs first become regulated in the US?

Insulin, the first peptide drug, was approved by the FDA in 1923. But the modern regulatory framework didn't take shape until the FD&C Act of 1938 (safety requirement) and the Kefauver-Harris Amendment of 1962 (efficacy requirement). Since 1962, all peptide drugs have been required to demonstrate both safety and efficacy through controlled clinical trials.

Why is compounding at the center of the peptide regulation debate?

Compounding pharmacies were never designed to be an alternative drug approval pathway — they were designed to prepare customized medications for individual patients when FDA-approved drugs don't meet a specific need. But as interest in therapeutic peptides grew, compounding became the primary access route for peptides like BPC-157 and CJC-1295 that had never gone through the NDA process. The FDA's 2023-2024 crackdown is an attempt to reassert the boundary between compounding and drug manufacturing.

Are peptides supplements or drugs?

It depends on the peptide. Natural food-derived peptides (like collagen fragments) can qualify as dietary supplements under DSHEA, particularly if they were marketed before October 1994 or if an NDI notification has been accepted. Synthetic therapeutic peptides are almost always classified as drugs. The FDA has consistently enforced this distinction, and the DSHEA framework was never intended to cover synthetic peptides designed for therapeutic use.

What is the DEA's role in peptide regulation?

The DEA has a limited but growing role. In 2025, the DEA reclassified certain growth hormone secretagogues under controlled substance review due to misuse in sports medicine. Most peptides are not scheduled controlled substances, but the DEA's involvement signals that enforcement agencies beyond the FDA are paying attention to the peptide market.

How many peptide drugs are FDA-approved?

Approximately 80 to 100 peptide drugs have been approved by the FDA, with over 110 approved worldwide as of 2024. The number continues to grow, with multiple peptide candidates in Phase III clinical trials as of 2026.

Could the political environment reverse the compounding restrictions?

It's possible but uncertain. HHS Secretary Kennedy's statements suggest interest in loosening peptide restrictions, and the removal of PCAC members could lead to more favorable advisory committee compositions. However, no formal regulatory changes have been finalized as of early 2026. The regulatory timeline remains in flux.

The Bottom Line

A century of peptide regulation in the United States tells a consistent story: access and safety exist in permanent tension, and the balance shifts in response to specific events. The sulfanilamide disaster produced the FD&C Act. Thalidomide produced the Kefauver-Harris Amendment. The NECC outbreak produced the Drug Quality and Security Act. And the explosion of unregulated peptide compounding produced the Category 2 crackdown.

Each regulatory response was imperfect. The system has always lagged behind the science, and the gap between what peptide research can produce and what regulation allows patients to access has never been wider than it is today.

But the trajectory is knowable. More peptide drugs will be approved — the pipeline is the largest it's ever been. The GLP-1 revolution proves that peptides can be blockbuster therapeutics when they go through proper development. And the regulatory framework, for all its flaws, exists because the alternative — unregulated drugs entering the market without evidence of safety or efficacy — has historically produced disasters.

Understanding this history won't solve the access problem. But it does clarify what we're actually arguing about, and why the answers are never as simple as either side claims.

References

1. PMC. "History of insulin." Indian Journal of Endocrinology and Metabolism. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3714061/

2. Nature. "Therapeutic peptides: current applications and future directions." Signal Transduction and Targeted Therapy. https://www.nature.com/articles/s41392-022-00904-4

3. PMC. "100 years of insulin: celebrating the past, present and future of diabetes therapy." https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8802620/

4. FDA. "Part III: Drugs and Foods Under the 1938 Act and Its Amendments." https://www.fda.gov/about-fda/changes-science-law-and-regulatory-authorities/part-iii-drugs-and-foods-under-1938-act-and-its-amendments

5. PMC. "Reform, Regulation, and Pharmaceuticals — The Kefauver-Harris Amendments at 50." New England Journal of Medicine. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4101807/

6. NCBI Bookshelf. "Federal Regulation of Medication Production." StatPearls. https://www.ncbi.nlm.nih.gov/books/NBK572098/

7. NIH Office of Dietary Supplements. "Dietary Supplement Health and Education Act of 1994." https://ods.od.nih.gov/About/DSHEA_Wording.aspx

8. Congress.gov. "H.R.3204 — Drug Quality and Security Act." https://www.congress.gov/bill/113th-congress/house-bill/3204

9. PMC. "The Drug Quality and Security Act." American Journal of Health-System Pharmacy. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4252230/

10. FDA. "Implementation of the Biologics Price Competition and Innovation Act of 2009." https://www.fda.gov/drugs/guidance-compliance-regulatory-information/implementation-biologics-price-competition-and-innovation-act-2009

11. Frier Levitt. "Regulatory Status of Peptide Compounding in 2025." https://www.frierlevitt.com/articles/regulatory-status-of-peptide-compounding-in-2025/

12. Holt Law. "Deep Dive: Regulatory Status of Popular Compounded Peptides." https://djholtlaw.com/deep-dive-regulatory-status-of-popular-compounded-peptides/

13. PMC. "Exploring FDA-Approved Frontiers: Insights into Natural and Engineered Peptide Analogues." Biomolecules. https://pmc.ncbi.nlm.nih.gov/articles/PMC10968328/

14. FDA. "40th Anniversary of the Generic Drug Approval Pathway." https://www.fda.gov/drugs/cder-conversations/40th-anniversary-generic-drug-approval-pathway