What it means when your prescription is compounded.

Some Vayra 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.
• How your physician chooses between the FDA-approved brand and the Vayra house-brand compounded preparation.
• Which substances Vayra currently includes in compounded protocols, and which we do not.
• Our relationship with our 503A pharmacy partners, and how compounded medication is included in your all-in Vayra price.
• Your ability to choose between the two paths when both are available for your indication.

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. Vayra 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 Vayra 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.

Where both are legally available, Vayra offers two paths for a given condition: the FDA-approved branded medication, or a Vayra house-brand preparation compounded individually for you under Section 503A. Your physician decides which path fits you at your documented visit. Much of what we compound has no commercially available equivalent, for example many peptide formulations and certain custom strengths or dosage forms. Where a compounded preparation would be essentially a copy of a commercially available drug, 503A law permits it only with a documented patient-specific clinical difference that the branded product does not meet. Examples of a valid clinical difference 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.

Vayra is a medical practice, not a marketplace. Physician-prescribed 503A compounded options are part of our programs where they are clinically and legally appropriate, including ED, hair, skin, women's health, and peptide therapy. We do not publish a compounded product list on our public site by design. Whether a compounded preparation is appropriate, and which one, is a clinical decision made by a licensed physician at the documented patient encounter.

For peptide therapy specifically, our scope is limited to compounds 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 Vayra'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.

Vayra 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.

Vayra's GLP-1 weight-management program is brand-only. We prescribe FDA-approved branded GLP-1 medication, Wegovy® (semaglutide) and Zepbound® and Mounjaro® (tirzepatide), dispensed by a separately licensed retail/specialty pharmacy partner. Your branded GLP-1 medication is included in your one all-in monthly Vayra price, so you know what you pay before you start.

Unlike our other programs, the GLP-1 program does not offer a house-brand or compounded version. Vayra does not prescribe compounded semaglutide or tirzepatide. This brand-only stance is specific to GLP-1: because commercially available branded GLP-1 exists, a compounded version would generally be essentially a copy of an approved product, which 503A permits only in narrow, documented clinical circumstances. For clarity and consistency, our GLP-1 program stays on the FDA-approved branded medication.

Vayra does offer physician-prescribed, individualized 503A compounded options in other programs, determined at your visit and never presented as a public menu. Any compounded preparation you receive 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 a compounded medication acknowledge the disclosure at the prescription-routing step of intake and checkout.

Vayra operates with two separate pharmacy relationships: a licensed 503A compounding pharmacy partner for compounded preparations (such as peptides and other individualized formulations) 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.

Vayra 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 Vayra demand.

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

Vayra is one all-in monthly price. That price covers your care and your medication together: physician visits, messaging, lab review, protocol design, the patient portal, and the medication your protocol calls for. Your medication is part of that one price.

• Branded GLP-1 (Wegovy®, Zepbound®, Mounjaro®) is dispensed by our retail/specialty pharmacy partner and is included in your all-in monthly price.
• Compounded preparations, such as peptides are prepared by our 503A compounding pharmacy partner and are included in your all-in monthly price. The figure you pay is shown in your portal before any prescription is routed.
• Your all-in monthly price is shown in your portal before you authorize routing, so you know what you pay before you start.

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. Vayra's partner pharmacies use validated USP <797> processes, but no compounding pharmacy can achieve the consistency of large-scale FDA-approved manufacturing.

Where both a Vayra house-brand compounded preparation and an FDA-approved branded medication are available for your indication, you and your physician choose between them together. Neither path is a lower tier. Examples:

• For GLP-1, the branded medication (Wegovy®, Zepbound®, Mounjaro®) is the only path we offer, and it is included in your all-in monthly price the same as any other medication in your protocol.
• 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.