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Custom GLP-1 Compounding for Your Weight Management Patients
GLP-1 Receptor Agonist Compounding for Providers The regulatory landscape has changed. Here is what you need to know before you prescribe.
GLP-1 receptor agonists have become one of the most discussed categories in all of medicine. The clinical data on semaglutide and tirzepatide for weight management is compelling, patient demand is substantial, and prescribers across internal medicine, endocrinology, obesity medicine, and primary care are actively building or refining protocols for these medications. Compounding has played a significant role in patient access over the past several years, and the regulatory environment around it has evolved substantially.
Pharmacy Solutions has been preparing compounded GLP-1 receptor agonist formulations for patient-specific prescriptions as directed by licensed prescribers. The regulatory landscape governing compounded GLP-1 preparations has changed as the FDA has updated its shortage determinations for semaglutide and tirzepatide. What is available, and under what circumstances, is no longer a single straightforward answer. It depends on the specific drug, your patient’s specific clinical situation, the state in which your patient receives care, and current regulatory guidance at both the federal and state level.
This page explains the clinical context, the regulatory framework as it currently stands, and how Pharmacy Solutions supports prescribers who are navigating GLP-1 compounding for appropriate patients. If you have questions about current availability for a specific patient, the most accurate answer is a direct conversation with our pharmacists.
GLP-1 Receptor Agonists: The Clinical Background
GLP-1 receptor agonists are a class of medications that mimic the action of glucagon-like peptide-1, a hormone released in response to food intake. These medications slow gastric emptying, suppress appetite, and modulate insulin and glucagon secretion in a glucose-dependent manner. They were originally developed and approved for the management of type 2 diabetes, and have since received FDA approval for chronic weight management in adults with obesity or overweight with at least one weight-related comorbidity.
The active pharmaceutical ingredients in this class that are most frequently discussed in the context of compounding include semaglutide, tirzepatide, liraglutide, and dulaglutide. Semaglutide and tirzepatide are the two APIs for which compounding pharmacy access has been most actively regulated, and both have been the subject of FDA shortage determinations that have changed over time.
The Regulatory Landscape for Compounded GLP-1 Preparations
The availability of compounded semaglutide and tirzepatide from 503A compounding pharmacies has been directly tied to FDA shortage designations. When the FDA places a drug on its drug shortage list, Section 503A of the Federal Food, Drug, and Cosmetic Act permits licensed 503A compounding pharmacies to prepare patient-specific compounded preparations of that drug under applicable conditions. When the FDA removes a drug from the shortage list, that pathway closes.
The FDA removed semaglutide and tirzepatide from the drug shortage list in 2025, ending the general shortage-based compounding pathway for these APIs. This means that the broad-access compounding of semaglutide and tirzepatide that many prescribers and patients came to rely on during the shortage period is no longer supported by the shortage exemption.
What remains available is more limited and more patient-specific. Patient-specific compounding of certain drugs may still be appropriate under circumstances that fall outside the general shortage framework, including documented patient-specific needs for alternative dosage forms, strengths, or formulations that the commercially available product cannot provide. The appropriateness of compounding for a given patient in a given state under current guidance is a determination that requires a direct conversation between the prescriber, the patient, and the compounding pharmacy.
Other GLP-1 receptor agonists that may still have active shortage or availability considerations, including liraglutide and dulaglutide, are subject to their own regulatory status at any given time. Pharmacy Solutions monitors FDA shortage and enforcement guidance on an ongoing basis.
The most current, accurate information about what we can prepare for your specific patient in your specific state is available directly from our pharmacists. We will not tell you something is available if it is not, and we will not leave you guessing about the compliance picture for your patient’s situation.
What Pharmacy Solutions Prepares for GLP-1 Prescriptions
Pharmacy Solutions prepares GLP-1 receptor agonist formulations for patient-specific prescriptions as directed by licensed prescribers, subject to applicable regulatory requirements and state availability. All preparations are patient-specific and compounded per a valid provider-issued prescription for an individually identified patient.
Commonly prepared formulations have included:
- Semaglutide injectable preparations at custom concentrations per prescriber direction, subject to current regulatory availability
- Liraglutide and dulaglutide preparations where shortage or regulatory status supports patient-specific compounding
- Combination formulations incorporating GLP-1 active pharmaceutical ingredients with other agents per prescriber specification, subject to applicable requirements
- Alternative delivery forms or concentration ranges not available in commercial products, where patient-specific clinical justification supports compounding under current regulatory guidance
We do not make efficacy or equivalency claims regarding any compounded preparation relative to a commercially manufactured product. Compounded medications are not FDA-approved. The FDA does not review compounded drugs for safety, effectiveness, or quality prior to dispensing. The clinical decision regarding whether a compounded preparation is appropriate for your patient rests entirely with you as the treating provider.
Identifying Patients for Whom Compounding May Be Appropriate
The prescriber-patient-pharmacy conversation about compounded GLP-1 preparations is more specific than it was during the peak shortage period. Prescribers navigating this landscape are generally working with one or more of the following clinical scenarios:
- Patients with documented intolerances or sensitivities to inactive ingredients in commercially available GLP-1 products who require alternative formulations
- Patients requiring a specific strength or titration increment that is not available in any commercial GLP-1 product
- Patients for whom a commercially available GLP-1 product is genuinely inaccessible due to documented supply or access constraints specific to their situation
- Patients for whom an alternative delivery form or formulation modification is clinically indicated based on the prescriber’s assessment of their individual needs
The appropriateness of compounding for each of these scenarios under current regulatory guidance depends on a number of factors specific to the patient, the drug, and the state. Contact our pharmacists to discuss whether compounding is a viable option for your specific patient before prescribing.
Why GLP-1 prescribers choose Pharmacy Solutions Managing GLP-1 prescribing in the current regulatory environment requires a pharmacy partner that compounds accurately, communicates honestly about what is and is not available, and keeps you current as guidance evolves. What you do not need is a pharmacy that tells you something is available when it may not be, or that compounds without the quality verification your patients and your practice depend on.
- PCAB-accredited in both sterile and non-sterile compounding, placing us among fewer than 2% of compounding pharmacies in the United States to hold this independent quality credential.
- All active pharmaceutical ingredients are sourced exclusively from FDA-registered suppliers.
- Sterile preparations are compounded in our ISO-classified cleanroom in compliance with USP standards. Our facility maintains full USP compliance for hazardous drug handling.
- Pharmacists with specific familiarity with GLP-1 regulatory status, compounding requirements, and the weight management protocols in which these preparations are most commonly prescribed.
- Direct pharmacist access for clinical questions before you prescribe, with no queue and no callback from a technician.
What the Partnership Looks Like Day to Day
Working with Pharmacy Solutions on GLP-1 prescribing is designed to keep your clinical workflow intact while giving you accurate, current information at every step. Here is what providers in our network experience:
- Direct pharmacist access for current regulatory availability, formulation options, and patient-specific compounding questions before you prescribe
- Honest, current guidance on what we can and cannot prepare for your patient given today’s regulatory landscape, not yesterday’s
- Injectable preparations compounded under sterile conditions in our ISO-classified cleanroom in compliance with USP <797> standards. Sterile preparations are independently tested for sterility and endotoxins according to current USP guidelines
- Nationwide patient delivery with appropriate cold chain packaging and storage instructions for injectable preparations
- Proactive communication if regulatory status changes in a way that affects your patients’ prescriptions
Accreditation and Quality Standards You Can Stand Behind
GLP-1 receptor agonist compounding involves sterile injectable preparations. The quality standards behind those preparations are not a marketing distinction. They are a patient safety requirement.
Pharmacy Solutions holds PCAB accreditation in both sterile and non-sterile compounding and maintains full compliance with USP <797> standards for sterile preparations. All active pharmaceutical ingredients are sourced exclusively from FDA-registered suppliers. Sterile preparations are independently tested for sterility and endotoxins according to current USP guidelines. These are verifiable credentials available for review, and we are happy to walk your practice through them before you make any commitment.
More Resources for Your Health Journey
What I value most about working with Pharmacy Solutions on GLP-1 prescribing is that they give me a straight answer. When the regulatory picture changed, they called me before I had to call them. When I have a question about a specific patient’s situation, I get an honest answer about what is possible. That kind of transparency is hard to find and it is exactly what I need to prescribe responsibly in this space.
Jennifer, MD
Frequently Asked Questions About GLP-1 Compounding for Providers
Can Pharmacy Solutions still compound semaglutide or tirzepatide?
The FDA removed semaglutide and tirzepatide from its drug shortage list in 2025, which ended the general shortage-based compounding pathway for these APIs. Compounding of these drugs may still be appropriate for specific patients under patient-specific clinical circumstances outside the shortage framework. What is available depends on the specific drug, your patient’s situation, applicable state requirements, and current regulatory guidance. Contact our pharmacists directly for an accurate, current answer before prescribing for a specific patient.
What is the difference between a compounded GLP-1 preparation and a commercial product like Ozempic or Wegovy?
Branded GLP-1 medications such as Ozempic and Wegovy (semaglutide) or Mounjaro and Zepbound (tirzepatide) are FDA-approved commercial products that have undergone review for safety, efficacy, and quality prior to market authorization. Compounded GLP-1 preparations are not FDA-approved. They are prepared by a licensed 503A compounding pharmacy on a patient-specific basis per a valid prescriber order, using active pharmaceutical ingredients sourced from FDA-registered suppliers. Compounded preparations are not equivalent to, interchangeable with, or substitutes for FDA-approved products. The clinical decision regarding appropriateness rests entirely with the treating provider.
Are compounded GLP-1 injectables sterile?
Yes. All injectable GLP-1 preparations compounded by Pharmacy Solutions are sterile. We hold PCAB accreditation in sterile compounding and operate an ISO-classified cleanroom in compliance with USP <797> standards. Sterile preparations are independently tested for sterility and endotoxins according to current USP guidelines.
What other GLP-1 receptor agonists are available for compounding?
Other GLP-1 receptor agonists including liraglutide and dulaglutide are subject to their own regulatory status and availability considerations. Contact our pharmacists directly for current information on specific APIs and whether patient-specific compounding may be appropriate for your patient’s situation.
How do I submit a GLP-1 prescription to Pharmacy Solutions?
Contact our pharmacists first to confirm current availability for your specific patient before prescribing. Once the regulatory and clinical picture is confirmed, prescriptions can be submitted by phone, fax, electronically through your EMR, or through our secure online portal. A valid prescription for an individually identified patient is required for all compounded preparations.
How do I register my practice to begin working with Pharmacy Solutions?
Contact our team using the link below. Tell us about your practice and your GLP-1 prescribing context, and we will walk you through current availability, the compounding process, and any program options relevant to your practice. Most practices begin submitting prescriptions within a short time of making contact.
Ready to Have A Conversation About GLP-1 Compounding for Your Practice?
Whether you are building a medical weight loss program, managing existing GLP-1 patients, or evaluating your options in the current regulatory environment, Pharmacy Solutions is ready to give you accurate, current guidance. PCAB-accredited. USP <797> compliant for sterile preparations. Nationwide dispensing. Pharmacist access when you need it.
