503A Compounding Disclosure

1. Who is involved in your care

More than one company is involved in an Avellum order, and it matters that you know who does what, because they carry different responsibilities and different licences.

• Avellum Health Co LLC. We operate the Site and provide account, catalog and technology services. We are not a pharmacy, we are not a healthcare provider, and we do not prescribe, compound, dispense or ship any medication. We do not employ the clinicians who treat you and we do not direct their clinical decisions. Patient support is run by the care team rather than by us, which sections 8 and 13 describe.
• Your clinician. Clinical care, including the decision to prescribe a compounded medication and the decision to decline to prescribe one, comes from independent licensed clinicians working through our telehealth partner. That partner runs the medical intake, the telehealth visit, the payment for medication and the care portal you use afterwards. Each clinician exercises independent clinical judgment under their own licensure, training and applicable law. Before a GLP-1 visit we ask a short set of questions on the Site. They apply our telehealth partner’s screening rules, so they decide which of two programs you enter, and they can also tell you before a visit is booked that this treatment is not a match for you. Your answers stay in your browser and are not saved to our records; what leaves the browser is the program you were routed to. Screening is not a clinical evaluation, the rules it applies are the partner’s rather than ours, and whether anything is prescribed to you is a clinician’s decision.
• The dispensing pharmacy. When a clinician issues a prescription, a licensed pharmacy fills it, either by compounding the preparation itself or by dispensing a finished product it obtained from an outsourcing facility. Section 2.2 explains the difference. The pharmacy that fills a prescription is chosen through our telehealth partner once a Provider writes it, and is named on your medication label. Where it is licensed and carries the product, the pharmacy we route to and price against is Precision Pharma Corp, doing business as Precision Pharma, at 555 Heritage Drive, Lab 143, Jupiter, Florida 33458, NPI 1770389629. Precision Pharma holds its own pharmacy license and is a separate company, and it is under common ownership with Avellum Health Co LLC, which you should know when you read the rest of this Disclosure. Everywhere else, and for products it does not carry, your prescription is filled by a partner pharmacy network arranged through our telehealth partner, in which we hold no ownership interest. A dispensing pharmacy is responsible under its own licensure, insurance and applicable law for the pharmacy side of your order, including compounding, dispensing, labeling, packaging, shipping and pharmacy recordkeeping.

Two further companies appear later in this Disclosure. Section 2.2 describes the outsourcing facility that manufactures some finished preparations before a pharmacy dispenses them to you. Section 9 describes the separate company that bills a blood panel, which is not a compounded medication and is outside the rest of this document.

We do not name the members of the partner pharmacy network here. That list belongs to our telehealth partner and it changes, and a document that named a pharmacy which no longer fills your state would be worse than one that describes the arrangement. The pharmacy that filled your order is named on your medication label and on the paperwork in the box.

2. What Section 503A actually means

Section 503A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 353a) governs the traditional pharmacy compounding of human drugs. In broad terms, and not as a full account of the statute:

• A licensed pharmacist or physician compounds a drug product for an individually identified patient, based on a valid prescription for that patient.
• The compounding happens in a state-licensed pharmacy, following applicable USP standards (USP <795> for non-sterile, USP <797> for sterile) and applicable state pharmacy law.
• Compounded drug products are exempt from certain provisions that apply to FDA-approved manufactured drugs. Those include new drug approval, current good manufacturing practice (cGMP), and FDA-approved labeling requirements.

2.1 How Section 503A differs from Section 503B

Section 503B of the same statute created a second pathway, the “outsourcing facility.” The two are not interchangeable and the difference shows up on your label.

• A 503A pharmacy is licensed by a state board of pharmacy. It compounds for an individually identified patient against a valid prescription. It is not required to follow cGMP and is not routinely inspected by the FDA.
• A 503B outsourcing facility registers with the FDA, must follow cGMP, and is subject to FDA inspection. It may compound in batches without a prescription in advance and may sell finished product to pharmacies and healthcare facilities.

Neither pathway produces an FDA-approved drug. Registration and inspection are not approval. A preparation made in a 503B outsourcing facility has not been through the FDA new drug approval process any more than one compounded in a 503A pharmacy has.

2.2 When your pharmacy dispenses a 503B-sourced product

Not every preparation dispensed to an Avellum patient is compounded in the dispensing pharmacy’s own lab. For some products the 503A pharmacy buys a finished, labeled product from an FDA-registered 503B outsourcing facility and dispenses it to you against your prescription. This is lawful and ordinary, and it is worth understanding for two reasons.

• The entity that dispenses to you is the licensed pharmacy named on your label. It holds your prescription, and it is your route for a pharmacy question or a quality complaint. You have no relationship with an outsourcing facility that made a finished preparation, and that facility does not hold your prescription.
• A 503B-sourced product is still not FDA-approved, and the fact that it came from a cGMP facility does not make it a generic, a substitute, or a therapeutic equivalent of any commercially manufactured drug.

Which products are sourced this way changes as pharmacies change what they stock and what they make. Your medication label and the paperwork shipped with it identify what you actually received. If what reaches you is an FDA-approved manufactured drug rather than a compounded preparation, its own FDA-approved labeling governs it and the parts of this Disclosure about compounding do not apply to it.

3. Compounded medications are not FDA-approved

This is the most important point. Compounded medications are not approved by the FDA. The FDA has not evaluated the safety, effectiveness, or quality of any compounded preparation the way it evaluates commercially manufactured drugs. It does not approve compounded preparations, and it does not certify the labeling, the dosing, or any claims made about them.

Compounded medications are also not generic equivalents of commercially manufactured drugs. They are not interchangeable substitutes for FDA-approved products, and they should not be marketed or relied on as such.

4. Patient-specific compounding

Where a preparation is compounded under Section 503A for you, it is prepared for an individually identified patient, based on a valid prescription issued by a licensed clinician after evaluation. It is not compounded for office stock, anticipatory inventory, or wholesale distribution.

Where a preparation is instead a finished product the pharmacy obtained from a 503B outsourcing facility, section 2.2 describes what changes and what does not. It still reaches you against a prescription written in your name, and it is still not an FDA-approved drug.

Prescriptions written through our services are dispensed to the individual patient who will use the medication. Nothing is dispensed to a clinic, a practice or a reseller. Avellum holds and ships no medication inventory, and nothing is dispensed to you without a prescription written in your name by a clinician who evaluated you first. If a clinician declines to prescribe, no medication is compounded for you and none is shipped.

5. Specific categories

5.1 Compounded peptides

The peptide preparations offered through our services are not approved by the FDA as drug products and are not the subject of FDA-approved labeling. The FDA, state regulators and independent pharmacy boards categorize some peptides in ways that affect their compounding eligibility, and those classifications can change. A pharmacy may not lawfully compound a preparation that falls outside what Section 503A permits, and it will decline one it judges it cannot compound. Availability can change without notice, and some products cannot be offered at all in some states because of state law or state licensure rather than anything about you.

5.2 Compounded GLP-1 medications

Compounded versions of GLP-1 receptor agonists (semaglutide, tirzepatide, and the like) are not FDA-approved. They are not therapeutic equivalents of any commercially manufactured GLP-1 product. A compounded GLP-1 preparation may be dispensed only where Section 503A and applicable FDA enforcement positions permit it. That may include, where applicable, the appearance of the active ingredient on the FDA Drug Shortage List, or a determination by your clinician, based on your clinical needs, that there is a clinically significant difference between the compounded preparation and the commercially available product (for example, a different strength, dosage form, or excipient profile required for the patient). The regulatory status of compounded GLP-1 preparations is evolving, and availability can change without notice. Talk to your clinician about the risks, benefits, alternatives, and current regulatory status before starting any compounded GLP-1 medication.

5.3 Other injectables

Other injectables dispensed through our services generally reach you by one of the two routes described in section 2.2. Either the dispensing pharmacy compounds the preparation under Section 503A for an individually identified patient, pursuant to a valid prescription, or it dispenses you a finished product it obtained from an FDA-registered 503B outsourcing facility against that same prescription. Neither is an FDA-approved drug. Your label and the paperwork in the box tell you which one you received, and the same general considerations described in this Disclosure apply to both.

5.4 NAD+ formulations

NAD+ is dispensed in more than one form, and not every form is compounded in the dispensing pharmacy’s own lab. Some are finished products from an FDA-registered 503B outsourcing facility, as section 2.2 describes. No form of it is an FDA-approved drug product. Claims about bioavailability, absorption, or specific health benefits have not been evaluated by the FDA. Discuss the risks, benefits, and alternatives with your clinician before use.

5.5 Nasal preparations

Some preparations are dispensed as a nasal spray rather than an injection. A nasal preparation reaches you by the same routes section 2.2 describes, and it is no more FDA-approved than an injectable one. Route of administration is a clinical decision your clinician makes with you, and it changes the dosing instructions, the handling, and the side effects you should watch for. Follow the instructions on the label you receive rather than instructions you remember from a different form of the same ingredient.

6. Risks

Every medication carries risk, whether it is commercially manufactured or compounded. The risks associated with using compounded medications may include, but are not limited to:

• Allergic or hypersensitivity reactions.
• Injection-site reactions, including pain, redness, swelling, bruising, or infection.
• Systemic side effects, depending on the preparation and on the patient. These may involve the cardiovascular, gastrointestinal, endocrine, neurological, hepatic, or renal systems.
• Sterility failure, including bloodstream infection, despite the application of USP <797> standards.
• Potency variation, since compounded preparations are not subject to the same large-scale stability and uniformity testing as FDA-approved manufactured drugs.
• Drug-drug interactions, contraindications, and underlying conditions that may not be apparent without a thorough medical evaluation.
• Risks associated with off-label use of an active ingredient, including risks that may not be fully understood given the limited clinical data on some compounded ingredients.

Your clinician is responsible for evaluating these risks in the context of your individual health history and discussing them with you before prescribing any compounded medication. Read the labeling from the dispensing pharmacy carefully, follow your clinician’s instructions, and contact your clinician promptly if you experience anything concerning.

7. Sterility, quality, and testing

Each dispensing pharmacy operates as a state-licensed pharmacy and is responsible for following applicable USP standards, including USP <797> for sterile compounding, applicable state pharmacy regulations, and its own internal quality program. For the pharmacies in the partner network, that comes to us through our telehealth partner rather than from any agreement Avellum holds with the pharmacy itself. The dispensing pharmacy is solely responsible for the compounding, sterility assurance, beyond-use dating, labeling, and quality of the compounded preparations it dispenses. Where a preparation is a finished product obtained from a 503B outsourcing facility, that facility is responsible for its manufacture and the dispensing pharmacy remains responsible for its storage, handling and dispensing to you.

Avellum does not compound, test, or release any preparation. We make no independent representation about the sterility, potency, purity, or quality of any compounded medication.

8. Reporting adverse events

If you think you have experienced an adverse event, a side effect, or a quality issue with a compounded medication, do the following:

• If this is a medical emergency, call 911 or go to the nearest emergency room immediately.
• Message your care team in your care portal, the one your welcome email set up. That is where the people who can act on it are.
• Report the event to the dispensing pharmacy using the pharmacy contact details printed on your medication label and on the paperwork shipped with your order.
• Write to support@avellumhealth.com. That mailbox is answered by the care team that runs your care rather than by Avellum, and they are the ones who can take it up with the dispensing pharmacy. Avellum publishes no support telephone number, and the number in section 13 is a compliance and privacy line rather than a route for a medical problem.
• Report to the FDA through the FDA MedWatch program at fda.gov/safety/medwatch, or by calling 1-800-FDA-1088. You can report directly. You do not need anyone’s permission and you do not need to tell us first.

What Avellum can do here is narrow, and it is better said than assumed. We are not a pharmacy, we do not compound or test anything, and outside the states Precision Pharma fills we hold no agreement with the pharmacy that shipped your order. So we cannot investigate a preparation, direct a pharmacy, or decide whether a replacement is sent. Those sit with the dispensing pharmacy and with the clinical team. Your report to the FDA is yours alone and depends on neither of them.

9. Insurance and cost

Compounded medications dispensed through our services are generally not covered by health insurance, Medicare, Medicaid, or other federal or state healthcare programs. We do not bill insurance. You are responsible for the full cost of any consult or compounded medication. We do not warrant or represent that any portion of the cost will be reimbursed by any insurer or program.

Avellum does not charge you for medication. When you finish the medical intake, our telehealth partner charges the card you gave it, on its own payment processor. That charge is taken before a clinician has read your intake, and it is a charge rather than a hold. We never receive, store or see that card. Medication billing then repeats every 28 days on that partner’s schedule, and the consult that authorizes your prescription runs for 12 weeks.

Medication billing, the refill process and the shipment of each cycle are run by our telehealth partner rather than by Avellum. If a charge or a shipment does not look right to you, write to support@avellumhealth.com rather than waiting for the next cycle.

A blood panel is different, and worth separating out. It is not a compounded medication and nothing in this Disclosure applies to it. It is a separate purchase taken at checkout on the Site, and it is billed by a different company from the one that bills your medication. The company charging you for a panel is named on the checkout page before you pay. If you buy a panel and medication in the same visit you will enter a card twice, with two different merchants, and the two charges are taken at different moments.

There is no self-serve way to pause or cancel medication billing today. If you want to stop, or you have a question about a charge, write to support@avellumhealth.com, which is answered by the care team that runs your care rather than by Avellum. The charge for medication is taken by our telehealth partner and its terms govern that charge, including whether any part of it can be returned to you. We are not able to state a refund outcome or a timeline here.

10. No substitution; off-label use

A compounded preparation is not a substitute for, and is not interchangeable with, any FDA-approved drug. Do not substitute a compounded preparation for an FDA-approved medication unless your clinician expressly tells you to. Some compounded preparations contain active ingredients that may be used “off-label”, meaning for indications, in dosages, or in patient populations not described in any FDA-approved labeling. Off-label use is a clinical decision your clinician makes based on your individual situation. If your clinician is recommending off-label use, ask them about the basis for it.

11. Patient acknowledgment

By requesting a consult, completing the medical intake, or accepting a compounded medication dispensed in connection with our services, you acknowledge and agree that:

• You have read and understand this Disclosure.
• You understand that compounded medications are not FDA-approved and are not generic equivalents of FDA-approved drugs.
• You understand that Avellum is not a pharmacy or a healthcare provider, and that clinical and pharmacy services are delivered by separate companies, each responsible under its own licensure, one of which is under common ownership with Avellum as section 1 describes.
• You understand that which pharmacy fills your prescription depends on your state and on the product, and that some preparations are finished products the pharmacy obtains from an FDA-registered 503B outsourcing facility rather than compounding itself.
• You have had, or will have, the chance to discuss the risks, benefits, alternatives, and uncertainties of any compounded medication with your clinician before you use it.
• You agree to report any adverse event or quality concern as described in Section 8.

12. Updates to this Disclosure

Federal and state regulatory positions on compounding, including the compounding of peptides and GLP-1 medications, are evolving. We will update this Disclosure from time to time to reflect changes in law, regulation, FDA enforcement positions, or our own practices. The most current version is posted on the Site. The “Last updated” date at the top tells you when it was last revised.

13. Contact

Questions about this Disclosure go to Avellum itself, at either the email address or the mailing address below. Both reach us rather than the care team, and anything you would rather send on paper can go to the mailing address. A question about your treatment, an order, a shipment or a charge goes to support@avellumhealth.com, answered by the care team that runs your care. Please do not use the number below for either of those, or for an adverse event. It is a compliance and privacy line rather than a clinical one, and section 8 is the route that gets a medical problem to somebody who can act on it.

Mail sent to that address reaches Avellum rather than a pharmacy or the care team, and post is slow. An adverse event, a side effect or a quality complaint should go the way section 8 describes instead.