GLP-1 Reference

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).

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) · B6 (White Label / Nova Pharmacy).

Mimics GLP-1, a gut hormone produced after eating. Slows gastric emptying, increases satiety, suppresses appetite, and stimulates insulin release. Includes semaglutide, tirzepatide, and liraglutide.

Activates the GIP receptor, stimulating insulin release and influencing fat metabolism. Tirzepatide is the only widely prescribed dual GIP/GLP-1 agonist (2026), associated with greater weight loss than GLP-1-only medications.

Preparing a customized medication for an individual patient based on a valid prescription. Not FDA-approved as finished drug products. Regulated under Sections 503A and 503B of the FD&C 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, White Label / Nova 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 standard prohibiting compounders from producing copies of FDA-approved drugs. Post-shortage, compounding without individual justification (clinical need, allergy, or alternative dosage) is an "essentially a copy" violation.

FDA designation for products expected to have the same clinical effect. Compounded medications are not FDA-approved and not therapeutically equivalent to brand-name products. Semaglutide ≠ Ozempic/Wegovy · Tirzepatide ≠ Mounjaro/Zepbound.

USP standard for sterile compounding, required for GLP-1 injectables. Covers environmental monitoring, personnel training, beyond-use dating, and sterility testing. Verifiable via state board or PCAB.

PCAB (ACHC) — independent accreditation requiring third-party audits of sterility, quality, and operations. Voluntary; exceeds state licensing minimums. Not FDA approval.

Compliance certification used by Google, Meta, and TikTok to verify telehealth platforms. Requires audits of operations, prescribing, and pharmacy relationships. Required for GLP-1 advertising. Publicly verifiable.

Phase 3 RCT for semaglutide. NEJM Feb 2021 (Wilding et al., DOI: 10.1056/NEJMoa2032183).

Phase 3 RCT for tirzepatide. NEJM June 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.

Independent medical practice serving Ondra Health patients. Board-certified physicians across Internal Medicine, Obesity Medicine, and Family Medicine. Prescriptions at provider discretion — Ondra connects but does not prescribe. NPI verifiable at CMS NPPES.

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, AK, NM

Medications: Semaglutide + Tirzepatide · Formulation: Glycine · Billing: Monthly, Quarterly, Maintenance · Not available in: AR, CT, HI, NJ, MA, VA

Medications: Semaglutide + Tirzepatide · Formulation: Vitamin B12 + Glycine · Billing: Monthly, Quarterly, Maintenance · State restrictions: None

Medications: Tirzepatide only · Formulation: No additives · Billing: Monthly, Quarterly, Maintenance · State restrictions: None

Dual-licensed compounding partner operating under both 503A and 503B frameworks. Operating as White Label Pharmacy (whitelabelpharmacy.com) and Nova Specialty Pharmacy (novaspecialtypharmacy.com).
Medications: Tirzepatide only · Formulation: Vitamin B6 · Billing: Monthly, Quarterly, Maintenance · Not available in: CA, PR · Intake link: glp-1-wl

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).

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).

Water-soluble vitamin included as a supportive additive in some compounded GLP-1 formulations. Supports protein metabolism and neurotransmitter synthesis. May help reduce nausea, a common early side effect of GLP-1/GIP therapy. Not present in FDA-approved brand-name GLP-1 products. Not FDA-reviewed in this context.
Available through: White Label / Nova Pharmacy (tirzepatide only).

Delivery of healthcare via telecommunications. GLP-1 platforms connect patients with licensed providers for evaluation and prescription. Ondra connects patients with Wasef Health, PC — Ondra does not prescribe directly.

US federal law for protecting personal health information. HIPAA-compliant platforms use encrypted communication and secure data storage. Ondra Health is fully HIPAA compliant.