Compounded Medication Policy

Last Updated: March 24, 2026

At StackMD, your health and safety come first. This policy explains what compounded medications are, how we approach quality and clinical oversight, and how recent FDA regulatory changes affect our GLP-1 weight loss program. We are committed to transparency so you can make fully informed decisions about your care.

Our Commitment to Quality

Every care decision at StackMD is guided by these principles:

Personalized care — Treatment plans are tailored to each patient’s individual health needs and goals.
Clinical standards — We follow strict medical and safety protocols and stay current with FDA regulatory guidance.
Compassionate support — Patients are treated with respect, empathy, and professionalism throughout their care.
Transparent communication — We provide clear, timely information about treatments, medications, and applicable regulations.
Ongoing innovation — We continuously evaluate new approaches to improve patient outcomes within appropriate clinical and legal boundaries.

What Are Compounded Medications?

Compounded medications are custom-prepared by licensed pharmacists to meet the specific needs of an individual patient. Compounding has a long history in clinical medicine and remains a legitimate and important option under specific circumstances defined by federal and state law.

Under Section 503A of the Federal Food, Drug, and Cosmetic Act, a licensed pharmacy may compound a medication for an identified patient when:

The patient has a documented clinical need that cannot be met by an FDA-approved formulation — for example, a verified allergy to an inactive ingredient in the commercially available product.
A customized dose, formulation, or delivery method is clinically indicated and not commercially available, and this determination is documented on the prescription by the prescribing provider.
A licensed prescriber has made an individualized clinical judgment that the compounded product produces a clinically significant difference for that specific patient.

Important Notice: Compounded medications are not reviewed or approved by the FDA. They are prescribed based on a licensed provider’s clinical judgment and prepared by qualified compounding pharmacies operating under state and federal law.

GLP-1 Compounding: Current FDA Regulatory Status

The regulatory landscape for compounded GLP-1 medications changed significantly in 2024 and 2025. Patients and providers should be aware of the following:

Tirzepatide (Mounjaro® / Zepbound®)

The FDA declared the national tirzepatide shortage resolved in October 2024.
The enforcement discretion period for 503A compounding pharmacies ended February 18, 2025.
Compounded tirzepatide that is “essentially a copy” of the FDA-approved product is no longer permitted under the shortage exception.

Semaglutide (Ozempic® / Wegovy®)

The FDA declared the national semaglutide shortage resolved February 21, 2025.
The enforcement discretion period for 503A compounding pharmacies ended April 22, 2025.
Compounded semaglutide that is essentially a copy of the FDA-approved product is no longer permitted under the shortage exception.

What Compounding Is Still Permitted

Under Section 503A, compounding of these medications remains lawful in limited circumstances where a patient’s specific, documented medical need cannot be met by an FDA-approved product. Permissible examples include:

A patient with a verified allergy to an inactive ingredient in the commercially available formulation who requires a modified compound.
A clinically indicated dosage strength or route of administration not available in any commercially approved product, with the clinical rationale documented by the prescribing provider on the prescription.

What Is No Longer a Valid Basis for Compounding:

Drug shortage (shortages for both medications are resolved)
Cost or insurance coverage preference
Convenience or patient preference alone
General weight loss without a documented patient-specific clinical need distinguishable from the approved product

Our prescribers document all clinical justifications for compounded medications in accordance with FDA guidance and applicable state law. If you have questions about whether a compounded option is appropriate for you, please speak with your provider.

Our Partner Pharmacies

When compounded medications are clinically appropriate and legally permitted, we work exclusively with licensed, FDA-registered compounding pharmacies that meet or exceed national safety and quality benchmarks. Our pharmacy partners are:

PCAB Accredited — Certified to meet the highest standards in pharmacy compounding.
cGMP Compliant — Aligned with current good manufacturing practices.
503A Certified — Licensed to compound patient-specific medications from individual prescriptions.
Independent Lab Testing — Third-party verification for sterility, potency, and contamination.
USP <800> Compliant — Ensures safe handling of hazardous medications for patients and pharmacy staff.

Frequently Asked Questions

What are compounded GLP-1 medications? Compounded GLP-1 medications are custom formulations of GLP-1 receptor agonists — such as semaglutide or tirzepatide — prepared by licensed compounding pharmacies. They differ from FDA-approved brand-name medications like Wegovy®, Ozempic®, or Zepbound® in that they are made for an individual patient based on a provider’s prescription and clinical judgment.

Can I still get compounded semaglutide or tirzepatide in 2026? In limited cases, yes. The FDA resolved the national shortages of both semaglutide (February 2025) and tirzepatide (October 2024), and the enforcement discretion periods for compounding pharmacies have ended. Compounding of these medications is now legally permissible only when a licensed prescriber documents a specific, individualized clinical need that cannot be met by the FDA-approved product — such as a verified allergy to an inactive ingredient. Your provider will evaluate your clinical situation and advise you accordingly.

Why might my provider prescribe a compounded GLP-1 medication? Your provider may prescribe a compounded GLP-1 if you have a documented medical need that cannot be met by an FDA-approved formulation — for example, an allergy to an inactive ingredient in the commercially available product, or a clinical requirement for a formulation or concentration not commercially available. Drug shortage is no longer a valid basis for compounding semaglutide or tirzepatide, as both shortages have been resolved. Any compounded GLP-1 prescription from StackMD will include documented clinical rationale.

Are compounded GLP-1 medications safe? Compounded medications are not FDA-approved, meaning they have not undergone the FDA’s rigorous review for safety, effectiveness, or manufacturing consistency. When prepared by a licensed, PCAB-accredited compounding pharmacy following USP standards and under proper medical supervision, compounded medications may be appropriate for patients with specific clinical needs. We do not work with gray-market, overseas, or non-FDA-registered sources. If you have concerns about a compounded medication, speak with your provider.

Can HSA or FSA funds be used to pay for compounded medications? In many cases, HSA or FSA funds may be used for compounded medications prescribed by a licensed provider. We recommend confirming with your plan administrator, as eligibility rules vary.

What if I was previously receiving compounded tirzepatide or semaglutide? If you were previously receiving a compounded GLP-1 medication, please schedule a follow-up with your StackMD provider. Your provider will review your clinical situation and discuss whether a compounded option remains appropriate for your specific needs, or whether transition to an FDA-approved product is the right next step.

Transparency and Limitations

We believe in clear communication and patient education. Testimonials and reviews reflect individual experiences and do not guarantee specific results. Outcomes vary from person to person.

Information on this website and in our communications is provided for educational purposes only and does not replace individualized medical advice. Always consult your healthcare provider before starting, adjusting, or discontinuing any treatment.

Disclaimer

The Food and Drug Administration has not evaluated statements on this page. Compounded medications are not FDA-approved and are intended for use only under the supervision of a licensed healthcare provider. Results are not guaranteed.

This policy reflects current FDA regulatory guidance as of March 2026. The regulatory environment for compounded GLP-1 medications continues to evolve. StackMD will update this policy as regulations change.

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Contact: care@stackmdwellness.com | 516-324-2974 | Albertson, NY
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