What it means when your prescription is compounded.

Some Mon Élan protocols include medications that are compounded — meaning prepared individually for you by a licensed compounding pharmacy under Section 503A of the Federal Food, Drug, and Cosmetic Act, rather than manufactured by a pharmaceutical company and approved by the FDA. This disclosure explains:

• What 503A compounding is and how it differs from FDA-approved manufacturing.
• When Mon Élan prescribes a compounded preparation versus a branded medication.
• Which substances Mon Élan currently includes in compounded protocols, and which we do not.
• Our relationship with our 503A pharmacy partners, and how billing for compounded medication works.
• Your rights to receive a branded FDA-approved alternative when one is available.

Federal law requires every patient receiving a compounded medication to be informed that the medication is not FDA-approved. This means:

• The FDA has not evaluated the safety or effectiveness of the compounded preparation specifically. Compounding pharmacies operate under FDA inspection and state-board licensure, but the individual compounded prescription is not registered with FDA.
• The compounded preparation has not gone through FDA's drug approval process, which evaluates manufactured drugs for safety, effectiveness, manufacturing quality, and labeling before they reach patients.
• Quality, potency, and stability of compounded preparations depend on the compounding pharmacy's quality systems. Mon Élan partners only with 503A pharmacies that hold valid state licensure and demonstrate USP <797> / <800> compliance during diligence.

By accepting a compounded medication as part of your Mon Élan protocol, you acknowledge that you have read this disclosure and understand the regulatory status of the compounded preparation.

Section 503A of the Federal Food, Drug, and Cosmetic Act allows licensed pharmacies to prepare individualized medications for specific patients pursuant to a valid prescription from a licensed prescriber. 503A compounding is different from 503B "outsourcing facility" production, which prepares larger batches under FDA registration with stricter manufacturing oversight.

Branded FDA-approved medication is the prescribing default at Mon Élan. We prescribe a compounded preparation only when there is a documented patient-specific clinical difference that the branded product does not meet. Examples of valid clinical differences include:

• Documented allergy or intolerance to an inactive ingredient (excipient) in the branded product.
• Need for a non-standard strength or dosage form not available in branded.
• Branded product is on a documented manufacturer-confirmed shortage.
• Substance is not commercially available as a branded product — applies to certain peptide therapies that fall within established 503A clinical practice.

Mon Élan is a medical practice, not a marketplace. We do not publish a peptide product list on our public site by design — whether a compounded therapy is appropriate, and which one, is a clinical decision made by a licensed physician at the documented patient encounter.

Our scope today is limited to peptide therapies that meet all of the following:

• Sufficient peer-reviewed safety and efficacy evidence for the clinical indication.
• Established 503A compounding practice — the substance is on, or consistent with, FDA's recognized bulk-drug-substance framework.
• A documented patient-specific clinical difference that the branded market does not meet (see "When is compounding lawful?" above).
• Mandatory baseline labs and titration requirements per Mon Élan's internal Protocols Master.

Within that scope, the clinical areas a physician may address with peptide therapy include endocrine and HPG-axis support alongside hormone therapy; sleep, recovery, and growth-hormone- axis support; cellular and mitochondrial support; and topical formulations for skin quality and post-procedure recovery. Specific compounds are not listed on the public site for patients who have not yet been evaluated.

Mon Élan does not prescribe, market, SEO-target, or keyword-bid on peptide compounds that fall outside our scope — regardless of market demand, patient request, or competitor practice. Out-of-scope substances include those:

• On FDA's review list for 503A bulk drug substances without favorable reclassification.
• Marketed primarily for research-only use rather than human therapeutic use.
• Lacking sufficient peer-reviewed clinical evidence for the indications being promoted.

Our position will only be reconsidered on formal FDA reclassification of a specific compound — never before, regardless of market pressure or patient demand. If another telehealth practice is advertising substances we don't prescribe, their regulatory posture does not match ours; that's not a comparison we will draw publicly, and it's not a reason to change ours.

We will not name specific out-of-scope compounds on this page because doing so itself creates the appearance of a menu. Your physician can address any specific peptide question directly at your visit.

Branded GLP-1 medication is Mon Élan's default for weight management. We prescribe Wegovy® (semaglutide) and Zepbound® and Mounjaro® (tirzepatide) — dispensed by a separately licensed retail/specialty pharmacy partner. Branded GLP-1 ships at the dispensing pharmacy's published cash price; Mon Élan does not add a markup to medication.

We prescribe compounded GLP-1 only with documented per-patient clinical difference — for example, a documented allergy to an inactive ingredient in the branded preparation. Cost, insurance status, and patient preference for the compounded product are not clinical differences and will not be documented as such.

Compounded GLP-1 dispensed through our 503A pharmacy partner is subject to all the FDA disclosures above: not FDA-approved, quality and potency depend on the compounding pharmacy, and the specific compounded preparation has not been evaluated by FDA. Patients receiving compounded GLP-1 acknowledge the disclosure at the prescription-routing step of intake and checkout.

Mon Élan operates with two separate pharmacy relationships: a licensed 503A compounding pharmacy partner for compounded preparations (peptides and any compounded GLP-1) and a separate licensed retail/specialty pharmacy partner for branded FDA-approved GLP-1 medications. Each partner’s name, license number, and most recent state-board inspection record will be furnished to you in your patient agreement at intake before any prescription is routed.

Mon Élan operates a four-prescription safe harbor posture: we never represent more than 50% of any single partner pharmacy's compounded prescription volume for any essentially-a-copy formulation per month. This is a deliberate volume constraint to keep our compounding posture clearly within 503A scope and to prevent any partner pharmacy from drifting toward de facto bulk manufacturing through Mon Élan demand.

Each compounding partner is a separately licensed pharmacy inspected by their state board. They hold their own malpractice and product-liability coverage. Mon Élan has executed a Business Associate Agreement with each partner where they receive PHI beyond the standard prescriber-pharmacy information exchange.

Mon Élan does not bill you for medication. Your membership covers Mon Élan's clinical services — physician visits, messaging, lab review, protocol design, the patient portal. The medication itself is dispensed and billed by the pharmacy.

• Branded GLP-1 (Wegovy®, Zepbound®, Mounjaro®) is dispensed and billed by our retail/specialty pharmacy partner at the dispensing pharmacy's published cash price. You pay the dispensing pharmacy directly.
• Compounded peptides and any compounded GLP-1 are billed by our 503A compounding pharmacy partner at the pharmacy's published cash price for compounded preparations. The full out-of-pocket figure is shown in your portal before any prescription is routed. You pay the pharmacy directly.
• The full out-of-pocket cost of any prescription is shown in your portal before you authorize routing. There is no hidden markup. There are no surprise bills.

Compounded medications carry the same general risks as branded medications of the same class — for example, a compounded peptide preparation has the same adverse-event profile as the substance itself in published literature. Your physician will discuss specific risks with you at your visit before any prescription is issued.

Additionally, compounded preparations have these regulatory-status risks:

• Quality and stability depend on the compounding pharmacy's processes; FDA has not evaluated the specific preparation for safety, efficacy, or shelf life.
• Lot-to-lot variability can occur in compounded preparations more than in commercially manufactured products. Mon Élan's partner pharmacies use validated USP <797> processes, but no compounding pharmacy can achieve the consistency of large-scale FDA-approved manufacturing.

If you are prescribed a compounded medication and a branded FDA-approved alternative exists for your indication, you have the right to ask your physician for the branded alternative. Examples:

• You can ask for branded Wegovy® or Zepbound® instead of compounded GLP-1 (assuming no clinical contraindication; cost is yours to bear at the dispensing pharmacy's published cash price).
• You can ask for an FDA-approved alternative when one exists for your peptide indication. Some peptide therapies within our scope do not have a branded equivalent — your physician will explain the trade-offs at your visit.

Your physician will review the request, document the clinical-decision rationale either way, and route the prescription accordingly. There is no penalty for asking — and no tier-related restriction on which medications you can receive.