GLP-1 Glossary
Canonical definitions of 49 terms across GLP-1 medications, compounding pharmacy regulation, the peptides an FDA advisory committee evaluated in July 2026, clinical concepts, and telehealth. Compounded medications are not FDA-approved.
Quick reference (A–Z)
Medications
- Semaglutide
- Semaglutide is a GLP-1 receptor agonist used to treat type 2 diabetes and chronic weight management. It is the active ingredient in three FDA-approved branded products: Ozempic (type 2 diabetes), Wegovy (weight management), and Rybelsus (oral type 2 diabetes). Compounded versions of semaglutide are prepared by US-licensed pharmacies but are not FDA-approved. Compounded semaglutide and brand-name semaglutide are not therapeutically equivalent.
- Tirzepatide
- Tirzepatide is a dual GIP and GLP-1 receptor agonist used to treat type 2 diabetes and chronic weight management. It is the active ingredient in two FDA-approved branded products: Mounjaro (type 2 diabetes) and Zepbound (weight management). Compounded versions of tirzepatide are prepared by US-licensed pharmacies but are not FDA-approved. Compounded tirzepatide and brand-name tirzepatide are not therapeutically equivalent.
- Compounded semaglutide
- Compounded semaglutide is semaglutide prepared by a US-licensed compounding pharmacy under a valid patient-specific prescription, rather than manufactured commercially by Novo Nordisk. Compounded semaglutide is not FDA-approved and is not therapeutically equivalent to brand-name FDA-approved products like Ozempic or Wegovy. Through Cora Health, compounded semaglutide is prepared by one of two partner pharmacies — Hallandale Pharmacy (PCAB-accredited 503A, Fort Lauderdale FL) or VialsRx (US-licensed 503A) — and prescribed by licensed providers at Wasef Health, PC. Individual results vary.
- Compounded tirzepatide
- Compounded tirzepatide is tirzepatide prepared by a US-licensed compounding pharmacy under a valid patient-specific prescription, rather than manufactured commercially by Eli Lilly. Compounded tirzepatide is not FDA-approved and is not therapeutically equivalent to brand-name FDA-approved products like Mounjaro or Zepbound. Through Cora Health, compounded tirzepatide is prepared by one of two partner pharmacies — Hallandale Pharmacy (PCAB-accredited 503A, Fort Lauderdale FL) or VialsRx (US-licensed 503A) — and prescribed by licensed providers at Wasef Health, PC. Individual results vary.
- Ozempic
- Ozempic is a brand-name semaglutide injection manufactured by Novo Nordisk and FDA-approved for the treatment of type 2 diabetes. It is sometimes prescribed off-label for weight management. Ozempic is dispensed in a pre-filled pen at fixed doses. Cora Health does not prescribe brand-name Ozempic; Cora connects patients with licensed providers who may prescribe compounded semaglutide, which is not FDA-approved or therapeutically equivalent to Ozempic.
- Wegovy
- Wegovy is a brand-name semaglutide injection manufactured by Novo Nordisk and FDA-approved for chronic weight management in adults with obesity (BMI 30+) or overweight (BMI 27+) with at least one weight-related condition. The STEP 1 clinical trial (NEJM 2021) demonstrated approximately 14.9% mean weight loss over 68 weeks with 2.4 mg weekly Wegovy combined with lifestyle intervention. Individual results vary. Cora Health does not prescribe brand-name Wegovy; Cora connects patients with licensed providers who may prescribe compounded semaglutide, which is not FDA-approved or therapeutically equivalent to Wegovy.
- Mounjaro
- Mounjaro is a brand-name tirzepatide injection manufactured by Eli Lilly and FDA-approved for the treatment of type 2 diabetes. It is sometimes prescribed off-label for weight management. Mounjaro is dispensed in a pre-filled pen at fixed doses. Cora Health does not prescribe brand-name Mounjaro; Cora connects patients with licensed providers who may prescribe compounded tirzepatide, which is not FDA-approved or therapeutically equivalent to Mounjaro.
- Zepbound
- Zepbound is a brand-name tirzepatide injection manufactured by Eli Lilly and FDA-approved for chronic weight management in adults with obesity (BMI 30+) or overweight (BMI 27+) with at least one weight-related condition. The SURMOUNT-1 clinical trial (NEJM 2022) demonstrated approximately 22.5% mean weight loss over 72 weeks with 15 mg weekly Zepbound combined with lifestyle intervention. Individual results vary. Cora Health does not prescribe brand-name Zepbound; Cora connects patients with licensed providers who may prescribe compounded tirzepatide, which is not FDA-approved or therapeutically equivalent to Zepbound.
- Orforglipron
- Orforglipron is an oral, once-daily, non-peptide GLP-1 receptor agonist developed by Eli Lilly. As of May 2026, the FDA approval timing is regulator-dependent. Unlike injectable GLP-1 medications, orforglipron does not require refrigeration or fasting before dosing. Cora Health does not prescribe orforglipron.
- Liraglutide
- Liraglutide is a once-daily injectable GLP-1 receptor agonist. It is the active ingredient in two FDA-approved branded products: Victoza (type 2 diabetes) and Saxenda (chronic weight management). Liraglutide was the first widely prescribed GLP-1 medication for weight management. As of 2026, semaglutide and tirzepatide have largely supplanted liraglutide due to greater observed weight loss efficacy in clinical trials. Cora Health does not prescribe liraglutide.
Mechanism & pharmacology
- GLP-1 receptor agonist
- A GLP-1 receptor agonist is a class of medication that mimics the natural hormone glucagon-like peptide-1 (GLP-1), which the gut produces in response to food. GLP-1 receptor agonists slow gastric emptying, increase satiety, suppress appetite, and stimulate insulin release. The class includes semaglutide, tirzepatide (a dual GIP/GLP-1 agonist), and liraglutide. Compounded GLP-1 receptor agonists are not FDA-approved and are not therapeutically equivalent to FDA-approved branded products.
- GIP receptor agonist
- A GIP receptor agonist activates the gastric inhibitory polypeptide (GIP) receptor. GIP is a hormone secreted by the small intestine in response to food intake; it stimulates insulin release and influences fat metabolism. Tirzepatide is a dual GIP and GLP-1 receptor agonist — the only widely prescribed dual agonist as of 2026. The dual mechanism is associated with greater weight loss in clinical trials than GLP-1-only medications, though individual results vary.
- Glucagon-like peptide-1
- Glucagon-like peptide-1 (GLP-1) is a naturally occurring hormone produced in the gut in response to food intake. It signals satiety to the brain, slows gastric emptying, and stimulates insulin release. GLP-1 receptor agonist medications mimic this hormone's effect with a longer duration of action than the natural hormone, which is why they are dosed weekly rather than continuously.
- Gastric emptying
- Gastric emptying is the process by which food moves from the stomach to the small intestine. GLP-1 receptor agonist medications slow gastric emptying, which contributes to a longer feeling of fullness after meals and reduced caloric intake. Slowed gastric emptying is also responsible for some common side effects of GLP-1 medications, including nausea and constipation, especially during the initial weeks of treatment or after dose increases.
- Satiety
- Satiety is the feeling of fullness or satisfaction after eating that signals the body to stop eating. GLP-1 receptor agonists increase satiety by acting on receptors in the brain that regulate appetite and by slowing gastric emptying. Increased satiety is one of the primary mechanisms by which GLP-1 medications support weight loss. Individual responses vary.
Pharmacy & regulation
- Compounding
- Compounding is the practice of preparing a customized medication for an individual patient based on a valid prescription from a licensed healthcare provider. Compounded medications are made by US-licensed compounding pharmacies and are not FDA-approved as finished drug products. Compounding is regulated under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act. Compounded GLP-1 medications are not therapeutically equivalent to FDA-approved branded products.
- 503A pharmacy
- A 503A pharmacy is a state-licensed compounding pharmacy operating under section 503A of the Federal Food, Drug, and Cosmetic Act. 503A pharmacies prepare compounded medications for individual patients with valid patient-specific prescriptions. They are regulated primarily by state boards of pharmacy. Cora Health partners with two US-licensed 503A compounding pharmacies — Hallandale Pharmacy (PCAB-accredited, Fort Lauderdale FL, operating since 2003) and VialsRx (US-licensed 503A). Compounded medications from 503A pharmacies are not FDA-approved.
- 503B pharmacy
- A 503B pharmacy is an FDA-registered outsourcing facility operating under section 503B of the Federal Food, Drug, and Cosmetic Act. 503B facilities can produce compounded medications in larger volumes than 503A pharmacies and are subject to FDA inspection and current Good Manufacturing Practice (cGMP) requirements. As of May 2026, the FDA has proposed excluding semaglutide, tirzepatide, and liraglutide from the 503B bulks list. Compounded medications from 503B facilities are not FDA-approved.
- FDA approval
- FDA approval is the regulatory process by which a new drug is reviewed for safety, effectiveness, and manufacturing quality before it can be marketed in the United States. FDA-approved drugs go through clinical trials and post-market monitoring. Compounded medications are not FDA-approved as finished drug products — the active pharmaceutical ingredients may be FDA-approved, but the compounded preparation is not subject to FDA review for safety, effectiveness, or quality before dispensing.
- FDA shortage list
- The FDA drug shortage list identifies medications experiencing supply constraints. While a drug is on the shortage list, US-licensed compounding pharmacies (503A and 503B) may legally compound versions of the medication under specific conditions. The FDA declared the tirzepatide shortage resolved in December 2024 and the semaglutide injection shortage resolved in February 2025. After shortage resolution, the legal basis for routine compounding narrowed significantly.
- Therapeutically equivalent
- Therapeutic equivalence is an FDA designation indicating that two products are pharmaceutical equivalents and can be expected to have the same clinical effect and safety profile under the labeled conditions. Compounded medications are not FDA-approved and are not therapeutically equivalent to FDA-approved branded products. Two compounded versions of the same active ingredient from different pharmacies are also not necessarily therapeutically equivalent to each other.
- PCAB accreditation
- PCAB (Pharmacy Compounding Accreditation Board) is an independent accreditation program for compounding pharmacies. PCAB-accredited pharmacies undergo regular audits of their sterility procedures, quality testing, and operational controls. PCAB accreditation is voluntary and is considered a baseline trust signal for compounded medications, though it does not constitute FDA approval. PCAB-accredited pharmacies still produce medications that are not FDA-approved.
- LegitScript certification
- LegitScript is an independent healthcare compliance certification used by payment processors, advertising platforms (including Google, Meta, and TikTok), and industry observers to verify that a telehealth platform operates within applicable regulations. Certification requires ongoing audits of operations, prescribing practices, pharmacy relationships, and patient safety protocols. Cora Health holds active LegitScript certification, publicly verifiable on the LegitScript website. An estimated 30-40% of telehealth GLP-1 platforms hold LegitScript certification as of 2026.
- Hallandale Pharmacy
- Hallandale Pharmacy (legal name: Pharmcore Inc. dba Hallandale Pharmacy) is a PCAB-accredited 503A compounding pharmacy located at 2666 SW 36th St, Fort Lauderdale, FL 33312. Operating since 2003 from a 60,000 sq ft facility and following USP 797 sterile compounding standards, Hallandale is one of two US-licensed 503A pharmacy partners for Cora Health (the other is VialsRx). Hallandale prepares compounded semaglutide and tirzepatide for Cora Health patients under valid patient-specific prescriptions issued by licensed providers at Wasef Health, PC. Compounded medications prepared by Hallandale are not FDA-approved.
- VialsRx
- VialsRx is a US-licensed 503A compounding pharmacy and one of two 503A pharmacy partners for Cora Health (the other is Hallandale Pharmacy). VialsRx prepares compounded semaglutide and compounded tirzepatide for Cora Health patients under valid patient-specific prescriptions issued by licensed providers at Wasef Health, PC. VialsRx operates in compliance with FDA guidelines and USP sterile compounding standards. Compounded medications prepared by VialsRx are not FDA-approved.
Peptides & regulatory status
- Peptide
- A peptide is a short chain of amino acids — shorter than a protein — that the body uses as a signaling molecule. Some peptides are the active ingredients in FDA-approved medicines: the GLP-1 medications semaglutide and tirzepatide are both peptide-based. Compounded semaglutide and compounded tirzepatide are not FDA-approved and are not therapeutically equivalent to FDA-approved branded products. Other peptides, including BPC-157, TB-500, KPV, and MOTS-c, are not FDA-approved drugs in the United States. In July 2026 the FDA's Pharmacy Compounding Advisory Committee evaluated seven of them for possible addition to the Section 503A bulk drug substances list. None of the seven is FDA-approved, and none is legal to compound today. Cora Health does not sell, prescribe, or compound peptides.
- Pharmacy Compounding Advisory Committee (PCAC)
- The Pharmacy Compounding Advisory Committee (PCAC) is the federal advisory committee that advises the FDA on compounding questions, including which bulk drug substances should be placed on the Section 503A list that pharmacies may compound from. Its votes are non-binding recommendations: the FDA can adopt them, modify them, or decline them, and adoption still requires a separate rulemaking. At its July 23-24, 2026 meeting the committee evaluated seven peptides and recommended six — BPC-157, KPV, and TB-500 (8-6-1 each) and MOTS-c (7-5) on July 23; Semax (8-5) and Epitalon (7-5-1) on July 24 — while rejecting Emideltide, also called DSIP (6-7-1). The FDA's own career staff scientists had recommended against listing all seven; the committee voted against that advice on the six it recommended, and agreed with staff only in rejecting Emideltide. None of the seven peptides is an FDA-approved drug, none is on the Section 503A bulks list, and none is legal to compound today. Cora Health does not sell, prescribe, or compound peptides.
- 503A bulks list
- The 503A bulks list is the FDA's list of bulk drug substances that licensed pharmacies may legally use to compound medications under section 503A of the Federal Food, Drug, and Cosmetic Act. Adding a substance is a multi-step process: nomination, FDA review, an advisory committee (PCAC) recommendation, and then formal rulemaking — a proposed rule, a public comment period, and a final rule the agency can decline to issue. Historically that rulemaking has taken 12 to 24 months. Being placed on the list would permit compounding under a valid patient-specific prescription; it would not make the substance an FDA-approved drug, and it does not confer therapeutic equivalence. None of the seven peptides PCAC evaluated in July 2026 is on the list today.
- BPC-157
- BPC-157 is a peptide studied for tissue and gut repair. It is not an FDA-approved drug. On July 23, 2026, the FDA's Pharmacy Compounding Advisory Committee voted 8-6-1 to recommend adding BPC-157 to the Section 503A bulks list for ulcerative colitis — a non-binding advisory recommendation made against the FDA's own staff scientists, who cited insufficient human data (the located human evidence is a single small, decades-old abstract). A recommendation is not FDA approval, and it does not make BPC-157 legal to compound: that requires a completed FDA rulemaking that has not happened. Cora Health does not sell, prescribe, or compound BPC-157.
- TB-500
- TB-500 is a thymosin beta-4 fragment; the use the FDA evaluated was wound healing. It is not an FDA-approved drug, and it is prohibited by the World Anti-Doping Agency. On July 23, 2026, the FDA's Pharmacy Compounding Advisory Committee voted 8-6-1 to recommend adding TB-500 to the Section 503A bulks list for wound healing, against the recommendation of FDA staff scientists, who cited the absence of human data — no human clinical studies of TB-500 were located in the sources reviewed. A non-binding recommendation is not FDA approval and does not make TB-500 legal to compound today. Cora Health does not sell, prescribe, or compound TB-500.
- KPV
- KPV is a fragment of the hormone alpha-MSH; the uses the FDA evaluated were wound healing and inflammatory conditions. It is not an FDA-approved drug. On July 23, 2026, the FDA's Pharmacy Compounding Advisory Committee voted 8-6-1 to recommend adding KPV to the Section 503A bulks list for those uses, against FDA staff scientists, who cited an absence of human data — no human clinical trials of KPV were located in the sources reviewed. The vote was a non-binding advisory recommendation: it is not FDA approval, and KPV is not legal to compound today. Cora Health does not sell, prescribe, or compound KPV.
- MOTS-c
- MOTS-c is a mitochondrial-derived peptide and the only weight-related substance among the seven peptides the FDA's Pharmacy Compounding Advisory Committee evaluated in July 2026; the uses the FDA evaluated were obesity and osteoporosis. It is not an FDA-approved drug, and it is prohibited by the World Anti-Doping Agency. On July 23, 2026, the committee voted 7-5 to recommend adding MOTS-c to the Section 503A bulks list, against FDA staff scientists, and no human clinical data for MOTS-c was located in the sources reviewed. A non-binding recommendation is not FDA approval, MOTS-c is not legal to compound today, and it is not an alternative to a prescribed GLP-1 medication. Cora Health does not sell, prescribe, or compound MOTS-c.
- Semax
- Semax is a peptide evaluated by the FDA's Pharmacy Compounding Advisory Committee for cerebral ischemia, migraine, and trigeminal neuralgia. It is not an FDA-approved drug. On July 24, 2026, the committee voted 8-5 to recommend adding Semax to the Section 503A bulks list, against the recommendation of FDA staff scientists, who recommended against listing all seven peptides under review. Human clinical data for Semax was not detailed in the sources reviewed. A non-binding advisory recommendation is not FDA approval, and Semax is not legal to compound today. Cora Health does not sell, prescribe, or compound Semax.
- Epitalon
- Epitalon is a peptide evaluated by the FDA's Pharmacy Compounding Advisory Committee for insomnia. It is not an FDA-approved drug. On July 24, 2026, the committee voted 7-5-1 to recommend adding Epitalon to the Section 503A bulks list, against FDA staff scientists. No human clinical data for Epitalon was located in the sources reviewed, and FDA staff cited no published efficacy data for the proposed insomnia use as well as immunogenicity and impurity risks. A non-binding advisory recommendation is not FDA approval, and Epitalon is not legal to compound today. Cora Health does not sell, prescribe, or compound Epitalon.
- Emideltide (DSIP)
- Emideltide, also known as delta sleep-inducing peptide (DSIP), was evaluated by the FDA's Pharmacy Compounding Advisory Committee for opioid withdrawal, chronic insomnia, and narcolepsy. It is not an FDA-approved drug. On July 24, 2026, the committee voted 6-7-1 against adding Emideltide to the Section 503A bulks list — the only rejection of the two-day meeting, and the only vote that agreed with FDA staff scientists, who cited a lack of safety and efficacy data, inadequate characterization of the substance, and existing approved therapies for the proposed uses. A committee rejection is not an FDA final decision either. Emideltide is not legal to compound today — and neither is any of the six peptides the committee recommended, because none is on the Section 503A bulks list and no rulemaking has been completed. Cora Health does not sell, prescribe, or compound Emideltide.
- Compounded peptide
- A compounded peptide would be a peptide prepared by a US-licensed compounding pharmacy for an individual patient under a valid patient-specific prescription. For the seven peptides the FDA's Pharmacy Compounding Advisory Committee evaluated in July 2026, that pathway does not exist today: none is on the Section 503A bulks list, and the rulemaking that could add any of them has not been completed. Because none of these seven peptides is on the 503A bulks list, any of them sold online today as a "legal compounded peptide" is not being prepared under the patient-specific-prescription pathway described here. Cora Health does not sell, prescribe, or compound peptides; licensed independent providers at Wasef Health, PC prescribe compounded semaglutide and compounded tirzepatide, prepared by Hallandale Pharmacy or VialsRx, both US-licensed 503A pharmacies. Compounded medications are not FDA-approved.
Clinical & dosing
- BMI
- Body Mass Index (BMI) is a measure calculated from height and weight (BMI = weight in kg / height in meters squared). FDA-approved GLP-1 medications for weight management are indicated for adults with a BMI of 30 or higher (obesity), or a BMI of 27 or higher (overweight) with at least one weight-related comorbid condition such as type 2 diabetes, hypertension, or dyslipidemia. Eligibility for compounded GLP-1 treatment is determined by a licensed provider on an individual basis.
- Type 2 diabetes
- Type 2 diabetes is a chronic metabolic condition characterized by insulin resistance and elevated blood glucose. FDA-approved GLP-1 medications including Ozempic (semaglutide) and Mounjaro (tirzepatide) are approved for the treatment of type 2 diabetes. Compounded GLP-1 medications are not FDA-approved for any indication and are not therapeutically equivalent to brand-name GLP-1 medications approved for type 2 diabetes.
- STEP 1 trial
- The STEP 1 trial (Semaglutide Treatment Effect in People with obesity, NEJM 2021) was the pivotal Phase 3 randomized controlled trial that established efficacy data for semaglutide for chronic weight management. In adults with overweight or obesity, 2.4 mg weekly semaglutide (Wegovy) combined with lifestyle intervention produced a mean weight loss of approximately 14.9% over 68 weeks, compared with approximately 2.4% in the placebo group. The trial studied brand-name FDA-approved semaglutide. Compounded semaglutide has not been studied in equivalent trials. Individual results vary.
- SURMOUNT-1 trial
- The SURMOUNT-1 trial (Tirzepatide Once Weekly for the Treatment of Obesity, NEJM 2022) was the pivotal Phase 3 randomized controlled trial that established efficacy data for tirzepatide for chronic weight management. In adults with overweight or obesity (without type 2 diabetes), 15 mg weekly tirzepatide (Zepbound) combined with lifestyle intervention produced a mean weight loss of approximately 22.5% over 72 weeks. The trial studied brand-name FDA-approved tirzepatide. Compounded tirzepatide has not been studied in equivalent trials. Individual results vary.
- Titration
- Titration is the process of gradually increasing a medication's dose over time to allow the body to adjust and to minimize side effects. GLP-1 medications are typically titrated upward over 4 to 16 weeks from a starting dose to a maintenance dose. The titration schedule for compounded GLP-1 medications is determined by the prescribing provider based on individual response, side effect profile, and clinical goals. Cora Health's pricing is flat across dose levels — the price does not increase as the patient titrates up.
- Maintenance dose
- The maintenance dose is the long-term therapeutic dose at which a medication is most effective for the patient. For semaglutide, the FDA-approved maintenance dose for chronic weight management is 2.4 mg weekly; for tirzepatide, dosing typically reaches 10-15 mg weekly depending on individual response and tolerance. Compounded GLP-1 maintenance doses are determined by the prescribing provider based on individual clinical evaluation. Compounded medications are not FDA-approved.
- Off-label use
- Off-label use is the prescription of an FDA-approved medication for a use, dose, or patient population not specifically approved by the FDA but supported by clinical evidence. For example, Ozempic and Mounjaro are FDA-approved for type 2 diabetes but are sometimes prescribed off-label for weight management. Off-label prescribing is legal and common when supported by medical judgment. Compounded medications are a separate regulatory category and are not FDA-approved.
Telehealth & platform
- Telehealth
- Telehealth is the delivery of healthcare services through telecommunications technology, typically online or by video. Telehealth GLP-1 platforms connect patients with licensed healthcare providers for medical evaluation and prescription, with medications shipped from a licensed pharmacy. Cora Health is a telehealth platform that connects patients with licensed providers at Wasef Health, PC. Cora Health does not prescribe medication; licensed providers make all prescribing decisions based on individual clinical evaluation.
- Asynchronous consultation
- An asynchronous (or async) telehealth consultation is one in which the patient completes an online health assessment that a licensed provider reviews independently, rather than during a real-time video call. The provider's evaluation, prescription decisions, and ongoing communication occur via secure messaging. Asynchronous consultations are common in telehealth GLP-1 programs because most prescription decisions are based on documented health history rather than physical examination findings.
- HIPAA
- The Health Insurance Portability and Accountability Act (HIPAA) is the US federal law that establishes standards for the protection of personal health information. HIPAA-compliant telehealth platforms use encrypted communication, secure data storage, and access controls that meet federal requirements. Cora Health is fully HIPAA compliant and uses bank-level encryption to protect patient personal and medical information.
- NPI (National Provider Identifier)
- The National Provider Identifier (NPI) is a unique 10-digit identification number issued by the Centers for Medicare and Medicaid Services (CMS) to healthcare providers in the United States. NPI numbers are publicly searchable through the NPPES NPI Registry and can be used to verify a provider's credentials, specialty, and practice address. Cora Health's clinical providers are at Wasef Health, PC. Dr. Michael Wasef MD's NPI is publicly searchable in the NPI Registry.
- Wasef Health, PC
- Wasef Health, PC is the independent medical practice that provides clinical services for Cora Health. Licensed providers at Wasef Health, PC, led by Michael Wasef MD (board-certified internal medicine), conduct individual medical evaluations and make all prescribing decisions for Cora Health patients. Wasef Health PC is located at 5260 78th Ave N, PO Box 1697, Pinellas Park, FL 33780. Cora Health does not prescribe medication; Wasef Health PC providers do.
References & sources
All definitions in this glossary are grounded in the regulatory, clinical, and pharmacological sources listed below. Sources include the US Food and Drug Administration (including its Pharmacy Compounding Advisory Committee meeting materials), the New England Journal of Medicine, the Centers for Medicare & Medicaid Services (NPPES Registry), the US Department of Health and Human Services, the Pharmacy Compounding Accreditation Board, LegitScript, and contemporaneous reporting from Reuters and the Regulatory Affairs Professionals Society (RAPS).
- FDA — Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)
- FDA — Bulk Drug Substances Nominated for Use in Compounding Under Section 503A
- FDA — Compounders policies as national GLP-1 supply stabilizes
- FDA — Compounding Laws and Policies
- FDA — Concerns with Unapproved GLP-1 Drugs Used for Weight Loss
- FDA — Development & Approval Process (Drugs)
- FDA — Drug Shortages Database
- FDA — Human Drug Compounding
- FDA — July 23-24, 2026 Meeting of the Pharmacy Compounding Advisory Committee (agenda and uses evaluated)
- FDA — Mounjaro approval (May 2022)
- FDA — Pharmacy Compounding Advisory Committee (PCAC)
- FDA — Registered Outsourcing Facilities (503B)
- FDA — Section 503A of the Federal Food, Drug, and Cosmetic Act
- FDA — Wegovy approval (June 2021)
- FDA — Zepbound approval (November 2023)
- HHS — HIPAA
- Jastreboff et al., SURMOUNT-1 trial — New England Journal of Medicine (2022)
- LegitScript — Cora Health verification
- NPPES NPI Registry (CMS)
- Pharmacy Compounding Accreditation Board (PCAB / ACHC)
- RAPS — FDA advisory committee backs two controversial peptides (July 23, 2026)
- RAPS — FDA advisory committee backs two more peptides, rejects one for compounding list (July 24, 2026)
- Reuters — FDA advisers back first four of seven unapproved peptides under review for looser rules (July 23, 2026)
- Reuters — FDA staff highlights peptide risks, says little evidence of benefits (June 30, 2026)
- Wilding et al., STEP 1 trial — New England Journal of Medicine (2021)
Important regulatory note. Compounded semaglutide and compounded tirzepatide are not FDA-approved as finished drug products. They are not therapeutically equivalent to FDA-approved branded products including Ozempic, Wegovy, Mounjaro, and Zepbound. Clinical trial efficacy data referenced in this glossary (such as the 14.9% mean weight loss reported in the STEP 1 trial for semaglutide and the 22.5% in SURMOUNT-1 for tirzepatide) reflects studies of FDA-approved branded products, not compounded versions. Individual results vary.
These peptides are not FDA-approved and are not legal to compound today. The peptides defined in this glossary — BPC-157, TB-500, KPV, MOTS-c, Semax, Epitalon, and Emideltide (DSIP) — were evaluated by the FDA's Pharmacy Compounding Advisory Committee on July 23-24, 2026. The committee recommended six of the seven and rejected Emideltide (DSIP) 6-7-1. Its votes are non-binding advisory recommendations, not FDA approval; the six recommendations went against the FDA's own staff scientists, and the Emideltide rejection agreed with them. None of these substances is on the Section 503A bulks list, none is legal to compound today, and the human evidence behind several of them is thin or absent. Cora Health does not sell, prescribe, or compound peptides. For the full sourced picture, see the Peptide Compounding Status Index.
Cora Health does not prescribe medication. Cora Health is a telehealth platform that connects patients with licensed independent providers at Wasef Health, PC. All prescribing decisions are made by licensed providers based on individual clinical evaluation. Cora Health partners with Hallandale Pharmacy (a PCAB-accredited 503A compounding pharmacy) and VialsRx (a US-licensed 503A compounding pharmacy) for compounded medication fulfillment.
For educational purposes only. This glossary is intended for general educational reference and does not constitute medical advice. Always consult with a qualified healthcare provider before starting, stopping, or adjusting any medication.
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