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) reported approximately 20.9% 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.

At Ondra, independent licensed providers may prescribe it; pharmacy fulfillment varies by state and formulation.

Formulation options at Ondra: No additives (Hallandale) · Glycine (Boudreaux's, Vials RX, Drug Crafters) · B12 (Vials RX) · B6 (Southend, Drug Crafters) · B3 (Niacinamide) (Optio RX). One additive per formulation.

Compounded tirzepatide is tirzepatide prepared by a US-licensed 503A compounding pharmacy or 503B outsourcing facility under a valid prescription. Not FDA-approved. Not therapeutically equivalent to Mounjaro or Zepbound.

At Ondra, independent licensed providers may prescribe it. Formulation options: No additives (Hallandale, Hyalo Pharmacy) · Glycine (Boudreaux's, Vials RX, Drug Crafters) · B12 (Vials RX, Drug Crafters) · B6 (Southend) · B3 (Niacinamide) (Optio RX). One additive per formulation.

FDA-approved semaglutide injection (Novo Nordisk) for type 2 diabetes, once weekly. Not approved for weight management — that is Wegovy. Compounded semaglutide is not therapeutically equivalent to it.

FDA-approved semaglutide injection (Novo Nordisk) for chronic weight management, once weekly, titrated to 2.4mg. Approved June 2021 on the STEP 1 trial. Compounded semaglutide is not therapeutically equivalent to it.

FDA-approved tirzepatide injection (Eli Lilly) for type 2 diabetes, once weekly. Approved May 2022. Not approved for weight management — that is Zepbound.

FDA-approved tirzepatide injection (Eli Lilly) for chronic weight management, once weekly, titrated up to 15mg. Approved November 2023; the formulation studied in SURMOUNT-1. Compounded tirzepatide is not therapeutically equivalent to it.

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.

The rate at which food leaves the stomach for the small intestine. GLP-1 receptor agonists slow it, prolonging fullness after a meal — and it is why nausea is most common in the first weeks and at each dose increase.

The sensation of fullness that ends a meal and delays the return of hunger. GLP-1 medications increase it via appetite-regulating receptors in the brain and by slowing gastric emptying.

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, Southend Pharmacy, Drug Crafters Pharmacy, Optio RX.

An FDA-registered outsourcing facility that can produce compounded medications in larger volumes without a patient-specific prescription. Subject to FDA inspection and cGMP standards — a different regulatory framework from a state-licensed 503A pharmacy, not a stricter version of one.

FDA enforcement discretion for GLP-1 compounding by outsourcing facilities ended March 19, 2025 (tirzepatide) and May 22, 2025 (semaglutide). Compounding from bulk substances now depends on each drug's status on the FDA 503B bulks list. In April 2026, the FDA proposed formally excluding both drugs from that list.

Ondra Health's 503B partner: Hyalo Pharmacy (tirzepatide only).

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).

A screening figure from weight and height (kg/m²), commonly used as an eligibility threshold in weight-management prescribing — typically 30 or above, or 27 or above with a weight-related condition. It does not measure body composition and is not a diagnosis on its own.

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 → 1.5mg → 2.5mg. 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.

The dose a patient settles on once titration is complete. Not always the maximum dose — a provider may hold a patient lower if response is good or side effects are limiting. A clinical decision, not a billing plan.

Independent medical practice with board-certified physicians serving Ondra patients in all 50 U.S. states and Puerto Rico. Meet Our Providers.

Licensed providers serve patients in all 50 U.S. states. Meet Our Providers.

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, 3-month, 6-month, 12-month · Not available in: AL, AR, CA, HI, KS, MA, MI, MN, MS

Medications: Semaglutide + Tirzepatide · Formulation: Glycine · Billing: Monthly, 3-month · Not available in: AR, CT, HI, MA, NJ, VA, PR

Medications: Semaglutide + Tirzepatide · Formulation: Vitamin B12 or Glycine · Billing: Monthly, 3-month, 6-month, 12-month · State restrictions: None

Medications: Semaglutide + Tirzepatide · Formulation: B3 (Niacinamide) · Billing: Monthly, 2-month · Not available in: Puerto Rico (PR). Start Optio RX Intake.

Medications: Semaglutide + Tirzepatide · Formulation: Vitamin B6 · Billing: Monthly, 3-month · Not available in: AL, AR, CA, CT, IN, MA, MI, NC, NJ, NV, SC, PR

Medications: Semaglutide + Tirzepatide · Formulation: semaglutide — B6 or Glycine; tirzepatide — B12 or Glycine · Billing: Monthly, 3-month · Not available in: AL, CA, KY, LA, MD, MN, MS, NE, NV, OH, OR, VA

FDA-registered 503B outsourcing facility — the only Ondra partner under the 503B framework rather than state licensure, with fulfillment through Quaker Community Pharmacy / New Life RX.
Medications: Tirzepatide only · Formulation: No additives · Billing: Monthly, 3-month · Not available in: Puerto Rico (PR)

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 (semaglutide and tirzepatide), Drug Crafters Pharmacy (tirzepatide).

Niacinamide, also called nicotinamide, is a form of vitamin B3. Optio RX offers it with compounded semaglutide or tirzepatide. These compounded formulations are not FDA-approved.

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, Drug Crafters Pharmacy.

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: Southend Pharmacy (semaglutide and tirzepatide), Drug Crafters Pharmacy (semaglutide).

Healthcare delivered remotely. Ondra connects patients with independent licensed providers; Ondra does not prescribe.

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