Prescribing Compounded Semaglutide & Tirzepatide: A Provider’s Guide to Safety, Legality, and Best Practices
Essential regulatory, clinical, and quality assurance information for healthcare professionals considering custom GLP-1/GIP therapies.
The rapid adoption of GLP‑1 receptor agonists, such as Semaglutide (Wegovy, Ozempic) and Tirzepatide (Zepbound, Mounjaro), has fundamentally changed metabolic health management. Cost, insurance coverage, and periodic drug shortages have driven healthcare providers to consider compounded alternatives.
Vivmeds specializes in providing high-quality, patient-specific compounded formulations, offering prescribers a safe, compliant, and personalized option to optimize therapy.
The Current Regulatory Environment: Customization as the Legal Basis
The legal permissibility of compounded GLP‑1/GIP therapies depends on a key FDA distinction: after a drug shortage is resolved, pharmacies may no longer produce a product that is “essentially a copy” of an FDA-approved drug. Both the Semaglutide and Tirzepatide shortages were resolved in 2025.
| Drug | FDA Shortage Status | Legality of “Essentially a Copy” | Legality of Custom Formulation |
|---|---|---|---|
| Semaglutide | Resolved (Feb 2025) | Not permitted | Permitted only with documented patient-specific need |
| Tirzepatide | Resolved (late 2024 / early 2025) | Not permitted | Permitted only with documented patient-specific need |
Following these resolutions, the only legal pathway for prescribing compounded Semaglutide or Tirzepatide is through personalized formulations that meet a documented patient need. Vivmeds ensures every compounded prescription meets this legal requirement while maintaining strict clinical standards.
Documenting Medical Necessity
Vivmeds works closely with prescribers to ensure each prescription has a clear clinical justification. Acceptable reasons include:
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Custom dose requirement: patient requires a dose not commercially available (e.g., 0.3 mg or 3.5 mg of Semaglutide) for precise titration.
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Intolerance or allergy: patient exhibits a sensitivity to excipients in branded pens.
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Titration schedule optimization: slower or more granular titration to improve gastrointestinal tolerance and adherence.
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Combination therapy: inclusion of supportive agents (e.g., L-Carnitine, NAD⁺) to enhance therapeutic outcomes, with clinical justification.
Quality Assurance Standards: 503A vs. 503B Facilities
Prescribing compounded sterile injectables requires partnering with a pharmacy that adheres to the highest regulatory oversight.
Vivmeds operates as a licensed 503A compounding pharmacy in multiple states (AZ, CO, FL, MI, NY, TX, UT), prioritizing patient-specific formulations under USP <797> sterile compounding standards.
| Facility Type | Regulatory Oversight | Best Use |
|---|---|---|
| 503A Compounding Pharmacy (Vivmeds) | State board oversight + USP <797>; patient-specific prescriptions only | Ideal for personalized dose adjustments, multi-ingredient formulations, and combination therapy |
| 503B Outsourcing Facility | FDA oversight + cGMP; bulk production | Suitable for office stock; limited use for personalized prescriptions post-shortage |
Vivmeds also provides additional quality assurances for prescribers:
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Certificate of Analysis (COA): each batch undergoes third-party testing for potency and sterility.
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API source verification: Vivmeds uses only FDA-registered active pharmaceutical ingredient sources.
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Accreditation and oversight: Vivmeds holds additional accreditation (PCAB/ACHC), demonstrating a commitment to quality beyond legal minimums.
Clinical Best Practices and Therapeutic Benefits
Compounded GLP‑1/GIP therapies from Vivmeds allow prescribers to optimize dosing and manage side effects more effectively than standard branded therapies.
Optimizing Tolerance Through Custom Titration
Gastrointestinal intolerance is a common cause of therapy discontinuation. Vivmeds’ compounded protocols allow slower titration and smaller increments to improve adherence and minimize adverse events.
| Therapy Phase | Semaglutide (Vivmeds Custom Protocol) | Tirzepatide (Vivmeds Custom Protocol) |
|---|---|---|
| Start (Weeks 1–4) | 0.25 mg once weekly | 2.0–2.5 mg once weekly |
| Increment Steps | +0.25 mg every 4 weeks as needed | +1.0 mg or 2.5 mg every 4 weeks as needed |
| Maximum | Up to 5.0 mg/mL | Up to 20 mg |
Use of Combination Therapy
Vivmeds can incorporate additional active ingredients to enhance therapy:
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GLP‑1/GIP + L-Carnitine: supports mitochondrial fatty acid transport and mitigates fatigue.
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GLP‑1/GIP + NAD⁺: supports cellular energy metabolism and metabolic vitality.
Conclusion and Practice Integration
Compounded Semaglutide and Tirzepatide from Vivmeds are highly personalized, patient-specific medicines that overcome barriers of cost, access, and tolerance. Prescribers partnering with Vivmeds can ensure:
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Compliance with FDA and state regulations for 503A pharmacies.
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Transparent verification of potency, sterility, and API sources.
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Clinical consultation for complex cases and access to Master Formulation Records (MFRs).
Vivmeds is committed to providing the highest standard of compounded GLP‑1/GIP therapies, supporting healthcare providers in delivering safe, effective, and legally compliant patient care.