GLP-1 Reference
Authoritative definitions of GLP-1 medications, compounding pharmacy regulation, clinical trial data, and Ondra Health's specific pharmacy partners. Every definition sourced from the FDA, NEJM, or federal law.
42 terms · 18 primary sourcesMedications
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 products: Ozempic (type 2 diabetes, weekly injection), Wegovy (weight management, weekly injection), and Rybelsus (type 2 diabetes, daily oral tablet). Manufactured by Novo Nordisk.
Compounded versions are prepared by 503A pharmacies on patient-specific prescriptions. Not FDA-approved. Not therapeutically equivalent to Ozempic or Wegovy.
Tirzepatide is a dual GLP-1 and GIP receptor agonist — the only dual-action medication of its class as of 2026. Active ingredient in Mounjaro (type 2 diabetes) and Zepbound (weight management). Manufactured by Eli Lilly.
The SURMOUNT-1 trial (NEJM, 2022) demonstrated up to 22.5% average weight loss at 72 weeks at 15mg. Its dual mechanism is associated with greater average weight loss than GLP-1-only medications.
Compounded versions are not FDA-approved and not therapeutically equivalent to Mounjaro or Zepbound.
Compounded semaglutide is semaglutide prepared by a US-licensed 503A compounding pharmacy under a valid patient-specific prescription. Not FDA-approved. Not therapeutically equivalent to Ozempic or Wegovy.
Through Ondra Health, compounded semaglutide is prescribed by providers at Wasef Health, PC and filled by a named pharmacy partner based on state and formulation preference.
Formulation options at Ondra: No additives (Hallandale, Boudreaux's) · Glycine (Boudreaux's, Vials RX) · B12 + Glycine (Vials RX) · B12/Glycine blend (Strive).
Compounded tirzepatide is tirzepatide prepared by a US-licensed 503A compounding pharmacy under a valid patient-specific prescription. Not FDA-approved. Not therapeutically equivalent to Mounjaro or Zepbound.
Through Ondra Health, prescribed by Wasef Health, PC providers. Formulation options: No additives (Hallandale, Boudreaux's, Quaker/Apothecary) · Glycine (Boudreaux's, Vials RX) · B12 + Glycine (Vials RX) · B12/Glycine blend (Strive) · B6 (BPI Labs).
Mechanism & Pharmacology
A class of medication that mimics glucagon-like peptide-1 (GLP-1), a gut hormone produced in response to food. GLP-1 receptor agonists slow gastric emptying, increase satiety, suppress appetite, and stimulate insulin release. Includes semaglutide (GLP-1 only), tirzepatide (dual GLP-1/GIP), and liraglutide.
Activates the gastric inhibitory polypeptide (GIP) receptor. GIP stimulates insulin release and influences fat metabolism through adipose tissue signaling. Tirzepatide is the only widely prescribed dual GIP and GLP-1 receptor agonist as of 2026, which is associated with greater average weight loss than GLP-1-only medications.
Pharmacy & Regulation
The practice of preparing a customized medication for an individual patient based on a valid prescription from a licensed provider. Compounded medications are not FDA-approved as finished drug products. Regulated under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act.
A state-licensed compounding pharmacy operating under Section 503A of the FD&C Act. Dispenses only on valid patient-specific prescriptions. Regulated by state boards of pharmacy. Must follow USP <797> sterile compounding standards for injectables.
The current legal pathway for compounded semaglutide and tirzepatide in 2026. Compounded GLP-1s from 503A pharmacies require documented individual clinical justification — not simply cost preference.
Ondra Health's 503A partners: Hallandale Pharmacy, Boudreaux's, Vials RX, Strive Pharmacy.
An FDA-registered outsourcing facility that can produce compounded medications in larger volumes. Subject to FDA inspection and cGMP standards. No longer a legal source for compounded semaglutide or tirzepatide — FDA enforcement discretion ended March 19, 2025 (tirzepatide) and May 22, 2025 (semaglutide). In April 2026, the FDA proposed formally excluding both drugs from the 503B bulks list.
Identifies medications with supply constraints. While on the list, compounders may legally produce the medication under specific conditions — this was the legal basis for widespread compounded GLP-1s 2022–2025.
FDA legal standard under the FD&C Act that prohibits compounding pharmacies from producing medications that are essentially copies of commercially available FDA-approved drugs. Following shortage resolutions, compounding semaglutide or tirzepatide without documented individual patient justification (specific allergy, need for alternative dosage, documented clinical need) is considered an "essentially a copy" violation.
An FDA designation indicating two products are pharmaceutical equivalents expected to have the same clinical effect. Compounded medications are not FDA-approved and are not therapeutically equivalent to their brand-name counterparts. Compounded semaglutide ≠ Ozempic/Wegovy. Compounded tirzepatide ≠ Mounjaro/Zepbound.
United States Pharmacopeia general chapter establishing standards for sterile compounding — required for GLP-1 injectables. Covers environmental monitoring, personnel training, beyond-use dating, and sterility testing. Reputable 503A pharmacies producing GLP-1 injectables should follow USP <797>. Verifiable through state board license and third-party accreditation like PCAB.
Pharmacy Compounding Accreditation Board (PCAB), administered by ACHC, is an independent accreditation program for compounding pharmacies. PCAB-accredited pharmacies undergo regular third-party audits of sterility, quality testing, and operational controls. Voluntary — goes beyond minimum state licensing. Does not constitute FDA approval.
Independent healthcare compliance certification used by payment processors and advertising platforms (Google, Meta, TikTok) to verify telehealth platforms operate within applicable regulations. Requires ongoing audits of operations, prescribing practices, and pharmacy relationships. Required to run GLP-1 advertising on major platforms. Publicly verifiable on the LegitScript website.
Clinical & Dosing
Pivotal Phase 3 RCT for semaglutide in weight management. Published NEJM February 10, 2021 (Wilding et al., DOI: 10.1056/NEJMoa2032183).
Pivotal Phase 3 RCT for tirzepatide in weight management. Published NEJM June 4, 2022 (Jastreboff et al., DOI: 10.1056/NEJMoa2206038).
Gradually increasing a medication's dose over time to allow the body to adjust and minimize side effects. Semaglutide: typically 0.25mg → 0.5mg → 1mg → 1.7mg → 2.4mg. Tirzepatide: typically 2.5mg → 5mg → 7.5mg → 10mg → 12.5mg → 15mg over 20 weeks. At Ondra Health, pricing is flat across all dose levels — cost does not increase as patients titrate up.
Ondra Health — Providers & Pharmacies
Independent medical practice providing all clinical services for Ondra Health patients. Led by board-certified physicians across Internal Medicine, Obesity Medicine, and Family Medicine. All prescriptions are issued at the sole discretion of licensed providers at Wasef Health — Ondra Health connects patients with providers but does not prescribe medication directly. NPI numbers publicly verifiable at the CMS NPPES NPI Registry.
PCAB-accredited 503A compounding pharmacy, Fort Lauderdale FL. Operating since 2003, 60,000 sq ft facility, USP <797> compliant.
Medications: Semaglutide + Tirzepatide · Formulation: No additives · Billing: Monthly, Quarterly, Maintenance · Not available in: CA, KS, AR, MI, MN, AL, HI, MS, MA
Medications: Semaglutide + Tirzepatide · Formulation: Glycine · Billing: Monthly, Quarterly, Maintenance · Not available in: AR, CT, HI, NJ
Medications: Semaglutide + Tirzepatide · Formulation: Vitamin B12 + Glycine · Billing: Monthly, Quarterly, Maintenance · State restrictions: None
Medications: Semaglutide + Tirzepatide · Formulation: B12/Glycine Blend · Billing: Monthly only · State restrictions: None
Medications: Tirzepatide only · Formulation: No additives · Billing: Monthly, Quarterly, Maintenance · State restrictions: None
Medications: Tirzepatide only · Formulation: Vitamin B6 · Billing: Monthly, Quarterly, Maintenance · State restrictions: None
Water-soluble vitamin included as a supportive additive in some compounded GLP-1 formulations. Supports energy metabolism, red blood cell formation, and nerve function. Sometimes included as a co-factor for patients experiencing early fatigue on GLP-1 therapy. Not present in FDA-approved brand-name GLP-1 products. Not FDA-reviewed in this context.
Available through: Vials RX (with Glycine), Strive Pharmacy (B12/Glycine blend).
Non-essential amino acid used in some compounded GLP-1 formulations as a peptide stabilizer. Helps preserve the structural integrity of the active peptide during storage. Not present in FDA-approved brand-name GLP-1 products. Not FDA-reviewed in this context.
Available through: Boudreaux's, Vials RX (with B12), Strive Pharmacy (B12/Glycine blend).
Water-soluble vitamin included as a supportive additive in some compounded GLP-1 formulations. Supports protein metabolism and neurotransmitter synthesis. Not present in FDA-approved brand-name GLP-1 products. Not FDA-reviewed in this context.
Available through: The Pharmacy Hub / BPI Labs (tirzepatide only).
Telehealth & Platform
The delivery of healthcare services through telecommunications technology, typically online. Telehealth GLP-1 platforms connect patients with licensed providers for evaluation and prescription, with medications shipped from a licensed pharmacy. Ondra Health connects patients with providers at Wasef Health, PC — Ondra does not prescribe medication directly.
The Health Insurance Portability and Accountability Act — US federal law establishing standards for the protection of personal health information. HIPAA-compliant telehealth platforms use encrypted communication, secure data storage, and access controls meeting federal requirements. Ondra Health is fully HIPAA compliant.
Primary Sources
All definitions sourced from the FDA, NEJM, CMS, HHS, USP, and PCAB/ACHC. Every factual claim is anchored to a primary source.
- FDA — GLP-1 compounding policies (Updated April 2026)
- FDA — Compounding Laws and Policies
- FDA — Concerns with Unapproved GLP-1 Drugs
- FDA — Drug Approval Process
- FDA — Drug Shortages Database
- FDA — Human Drug Compounding
- FDA — Registered Outsourcing Facilities (503B)
- FDA — Section 503A of the FD&C Act
- FDA — Wegovy approval (June 2021)
- FDA — Zepbound approval (November 2023)
- FDA — Orange Book (Therapeutic Equivalence)
- HHS — HIPAA
- Jastreboff AM et al. — SURMOUNT-1. NEJM 2022. DOI: 10.1056/NEJMoa2206038
- CMS — NPPES NPI Registry
- ACHC — PCAB Accreditation
- USP — General Chapter <797> Sterile Preparations
- Wilding JPH et al. — STEP 1. NEJM 2021. DOI: 10.1056/NEJMoa2032183
- FDA — Mounjaro approval (May 2022)
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ONDRA HEALTH
About Us
Ondra Health was built to make accessing treatment feel clear, straightforward, and grounded in real care — not marketing. It's independently owned and operated, combining clinical experience and operational expertise to create a more thoughtful way to navigate GLP-1 treatment.
Why We Built This
This space has become more complicated than it needs to be.
Between inconsistent pricing, unclear information, and platforms that feel more like subscription products than healthcare, it's often difficult to understand what you're actually signing up for.
From a clinical perspective, we've also seen how important it is for treatment to be individualized — not standardized or rushed.
Ondra was built to simplify both sides of that.
What Makes Ondra Different
Our approach is intentionally simple:
- Transparent, upfront pricing
- No unnecessary add-ons or bundled services
- Provider-led care based on your individual health profile
- Medications fulfilled through state-licensed compounding pharmacies
We focus on removing friction — not adding to it.
How Care Works
Ondra Health is a platform that connects patients with independent, licensed healthcare providers.
All medical evaluations, prescriptions, and treatment decisions are made by those providers. Medications are fulfilled by regulated compounding pharmacies based on your prescription and location.
Our role is to make that process easier to access, easier to understand, and easier to manage.
Care & Communication
Access is only part of the experience — communication matters just as much.
You should be able to ask questions, understand your options, and feel supported throughout your treatment — not left figuring things out on your own.
We've built Ondra to feel more direct, responsive, and transparent than traditional platforms. As we grow, our focus is to maintain that level of clarity and support across every interaction.
Built to Be Clear
Ondra isn't built around trends, branding, or upsells.
It's built to be something you can rely on — clear information, straightforward access, and honest communication from start to finish.
A Note From Us
Thank you for taking the time to learn about Ondra.
If you choose to move forward with us, our goal is to provide a clear, responsive, and high-quality experience — the kind of care and service we would expect ourselves.