Effective Date: July 1, 2026
Some medications your Provider may prescribe are compounded — made for you by a licensed pharmacy under an individual prescription. Compounded medications are not FDA-approved, have not gone through the same clinical trials as branded products, and may differ in concentration, ingredients, or dosing. Your Provider will explain when a compounded medication is appropriate and the risks before you start.
1. What compounding is
Compounding is the practice of preparing a medication tailored to an individual patient's prescription by a state-licensed pharmacist at a state-licensed pharmacy (a "503A pharmacy") or, in some cases, by a registered outsourcing facility (a "503B facility") under federal law. Compounded medications are prepared from active pharmaceutical ingredients (APIs) and excipients to meet a specific clinical need that cannot be met by a commercially available FDA-approved drug.
2. Compounded medications are not FDA-approved
Compounded medications are not FDA-approved. This means:
• The FDA has not reviewed compounded medications for safety, efficacy, or quality for each individual prescription.
• Compounded medications do not carry FDA-approved labeling.
• The strength, dosage form, or combination prescribed for you may not match any FDA-approved drug.
The FDA approves drugs at a product level after extensive clinical trials. Compounding is regulated differently: by federal law (sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act), state pharmacy boards, and applicable U.S. Pharmacopeia (USP) chapters that govern compounding standards.
3. Why a clinician may prescribe a compounded medication
A Provider may, in their independent clinical judgment, prescribe a compounded medication when:
• An FDA-approved alternative does not meet your specific clinical need (for example, a different dose, route, combination, or because of a documented allergy to an ingredient in the FDA-approved product); or
• The patient requires a strength or dosage form not commercially available, has a documented intolerance or allergy to a component of the FDA-approved product, or your Provider has documented another individualized clinical justification in the patient record under Section 503A. (Shortage status under section 503A or 503B is no longer a basis for compounded GLP-1 dispensing through the Service; see Section 6(a).)
Your Provider will tell you whether the prescribed medication is FDA-approved or compounded and explain the reason for the recommendation.
4. Risks and benefits
Benefits may include access to a clinically appropriate medication that is not otherwise commercially available in the prescribed strength, combination, or formulation; the ability to address documented intolerances; and access during a shortage of the FDA-approved drug.
Risks include:
• The absence of FDA premarket review for safety, efficacy, and quality at the product level.
• Variability in compounded product quality across pharmacies, despite USP standards and state oversight.
• The same potential for adverse reactions, drug interactions, and side effects as with FDA-approved medications.
• Cold-chain or stability sensitivity that may differ from FDA-approved analogues.
5. Where your medication is compounded
Our compounded medications are dispensed by licensed compounding pharmacies that we have vetted for clinical quality, regulatory compliance, USP-chapter adherence, and reliable cold-chain shipping. Our compounded medications are reviewed for clinical protocol by a regulatory compliance partner.
6. Specific therapy categories
a. Compounded GLP-1 (semaglutide, tirzepatide). GLP-1 medications are available through the Service as branded FDA-approved products (Wegovy, Ozempic, Rybelsus, Zepbound, Mounjaro) and, where your Provider documents an individualized clinical need under Section 503A of the Federal Food, Drug, and Cosmetic Act, as compounded semaglutide or tirzepatide dispensed by a 503A licensed compounding pharmacy on a patient-specific prescription. Compounded GLP-1 products are not FDA-approved, have not undergone the same clinical-trial review, and may differ in concentration, excipients, or dosing schedule from the branded product. FDA declared the tirzepatide shortage resolved on October 2, 2024 and the semaglutide shortage resolved on February 21, 2025, and the enforcement-discretion windows for shortage-based compounding of these molecules closed by mid-2025. As of the Effective Date of this Disclosure, patient-specific 503A compounding remains available only where your Provider documents an individualized clinical need — for example, a documented allergy to an excipient in the FDA-approved product, or a strength not commercially available — that a commercially available FDA-approved product cannot meet for you. Cost, convenience, and prescriber preference are not qualifying reasons. Section 503B outsourcing-facility compounding of these molecules is not available through the Service. Because FDA rulemaking regarding the 503B bulks list for these molecules is ongoing, this Disclosure may be updated as the regulatory framework evolves. Your Provider will explain the differences and the current regulatory status before you start.
b. Compounded testosterone (men). Where an FDA-approved testosterone formulation does not meet your clinical need — for example, a strength, route (cream vs. injection), or carrier-oil tolerance — a compounded testosterone preparation may be prescribed. Your Provider will explain when an FDA-approved option is preferable.
c. Compounded estradiol, progesterone, and women's testosterone. Women's hormone therapy frequently uses compounded preparations to deliver low-dose testosterone (which has no FDA-approved formulation labeled for women in the U.S.), tailored estrogen/progesterone combinations, or specific routes (cream, troche, vaginal). Your Provider will explain the evidence and the rationale for each.
d. Peptides. Peptide availability depends on the applicable FDA bulk-drug lists and current FDA guidance, and on your Provider's individualized clinical judgment. Compounded peptides are not FDA-approved.
• Sermorelin may be compounded by a 503A pharmacy under current guidance.
• NAD+ may be compounded for specific clinical uses; availability and route depend on the pharmacy and your Provider's judgment.
• PT-141 (bremelanotide) is available as the FDA-approved product Vyleesi. Compounded formulations of PT-141 are dispensed only when your Provider documents an individualized clinical need under Section 503A — for example, a documented intolerance to or unavailability of the branded product, or a need for a dosage form or strength not commercially available — and the dispensing pharmacy confirms it is appropriate to compound. Compounded PT-141 is not FDA-approved.
Additional compounded peptides may be prescribed only where your Provider documents an individualized clinical need under Section 503A and the dispensing pharmacy confirms the preparation is appropriate to compound consistent with applicable FDA guidance and state pharmacy law. Your Provider will review the specific options appropriate for you, and the current regulatory status of each, before prescribing.
7. Reporting adverse events
If you experience an adverse event from a compounded medication, contact your care team immediately and, for serious events, seek emergency care or call 911. We report adverse events to FDA MedWatch as required by law. You can also report directly: https://www.fda.gov/safety/medwatch.
8. Acknowledgment
By accepting a prescription for a compounded medication, you confirm that you have read this Disclosure (or had it read to you), have had the opportunity to ask questions, understand the differences between compounded and FDA-approved medications, and consent to receive the compounded medication prescribed by your Provider.
Contact: Clinical questions: care@myleaderhealth.com General questions: support@myleaderhealth.com
9. Drug recalls and safety alerts
If a medication you have received through the Service becomes the subject of a recall or safety alert issued by the U.S. Food and Drug Administration, the dispensing Pharmacy, or the manufacturer, Leader Health will (i) notify you through the email and, where appropriate, the text-message contact methods on file for your account as promptly as practicable after Leader Health becomes aware of the recall, (ii) explain whether the recall is voluntary or mandatory and which lot or formulation is affected, and (iii) coordinate with your Provider so your Provider can give you clinical guidance on whether to stop using the product, return it, or take any other action. Where the recall calls for return or destruction, Leader Health will provide return-shipping instructions and, where the recall covers a medication you paid for and have not used, refund or replace the affected product consistent with the Refunds & Cancellations policy.
