What Compounded Medications Mean

Compounded Medication Disclosure and Consent

Version 1.0 | Effective October 6, 2026 | Last updated October 6, 2026

1. Who does what

2. What “compounded” means

3. What this means for you

• Not FDA-approved. FDA approves a medicine after it reviews evidence on safety, effectiveness and manufacturing quality. FDA does not do this review for compounded medicines before they are sold.
• Not a generic, and not the same as a brand medicine. Do not assume a compounded medicine is the same as, equivalent to or interchangeable with an FDA-approved medicine, even if it has the same active ingredient.
• It can differ. Strength (concentration), ingredients, form, appearance and beyond-use date can differ between prescriptions, between pharmacies and between batches.
• No FDA-approved labeling. A compounded medicine does not come with FDA-approved labeling or an FDA Medication Guide. Some safety information in WellPeps documents comes from the labeling of approved medicines. That does not mean a compounded medicine is the same.
• Risks may not be fully known. Quality, strength, how your body absorbs the medicine, how well it works and its long-term effects may not be fully known. A compounded injection also carries a risk of contamination or of the wrong strength.

4. FDA-approved medicines may be available

5. Why a clinician may choose a compounded medicine

6. Added ingredients

Some prescriptions include an extra ingredient, such as a vitamin or an amino acid. FDA has not determined that an added ingredient improves safety, effectiveness or how well you tolerate the medicine. An added ingredient can cause its own side effects, interactions or allergic reactions. Check the ingredient list on your label. If it is missing, unclear or not what you expected, do not use the medicine until your pharmacy or clinician explains it.

7. How to read your pharmacy label

Check these things every time you get a new shipment, even if you have received the same medicine before.

Labels differ by pharmacy and by state, and some of this may be on an insert instead of the label. Your pharmacy label and insert list the key details about your medicine. If anything is missing, unclear or does not match what your clinician told you, do not use the medicine until your pharmacy or clinician confirms it. If your label and a WellPeps document disagree, follow your label and ask your clinician or pharmacy.

8. Storage and beyond-use date

9. If something looks wrong

Do not use the medicine, and contact the pharmacy named on your label, if:

• the label is missing or incomplete, or does not match your prescription;
• the seal is broken, the container is leaking or damaged, or the package was exposed to heat;
• a liquid looks cloudy, discolored, frozen or has particles in it, unless the pharmacy told you that is expected;
• the strength, ingredients or look of the medicine changed from your last fill and no one has explained why.

Then message your clinician in the portal at portal.wellpeps.com. Contact WellPeps at [email protected] for shipping or billing problems. Keep the medicine, packaging and label until the pharmacy tells you what to do with them, unless keeping them is unsafe. If you feel seriously ill, call 911. If you may have taken too much or used the wrong dose, call Poison Control at 1-800-222-1222.

Recalls. If a product is recalled, the pharmacy or WellPeps will contact you.

10. Reporting side effects and product problems

Tell your clinician about any side effect in a portal message. Tell the pharmacy about any product problem. You can also report to FDA MedWatch at www.fda.gov/medwatch or 1-800-FDA-1088, even if you are not sure the medicine caused the problem.

11. State rules and availability

Some states limit compounded medicines or how they can be shipped. Laws, FDA positions and pharmacy rules also change. Because of this, a medicine may not be offered in your state, or may become unavailable. If that happens, you will be told, and your clinician can talk with you about other options. Where WellPeps services are offered is listed in States We Serve. This document does not list availability by state.

12. Off-label use (separate consent)

• oral minoxidil for hair loss. FDA-approved oral minoxidil tablets are for severe high blood pressure; the lower doses used for hair loss are not in that labeling;
• a form or dose of a medicine that is not in its FDA-approved labeling, such as a compounded sublingual (under the tongue) form;
• any other use your clinician tells you is off-label.

13. Your choice

You can say no to a compounded medicine, and you can say no to off-label use. If you say no, the clinician may offer another option, or may decide that WellPeps cannot meet your needs. In that case, the Refund, Cancellation and Auto-Renewal Policy explains what happens to your payment. Saying no does not affect your right to get care elsewhere. You can change your mind at any time by telling your clinician in a portal message.

14. How this document fits with others

This is a general document. The safety document for your program has the product details: the GLP-1 Medication Safety Information and Acknowledgment, the Sexual Health Medication Safety Information and Acknowledgment, the Hair Loss Medication Safety Information and Acknowledgment, or the Healthy Aging and Vitality Medication Safety Information and Acknowledgment. Telehealth care in general is covered by the Informed Consent to Telehealth Services and Treatment. Your label and your clinician’s instructions control how you use your medicine. If the law of your state gives you more rights than this document, the law applies. This document may be updated. If a change is important, or the law requires it, you will be asked to read and accept the new version.

Acknowledgment and electronic signature

Please read this document (version 1.0, effective October 6, 2026) before checking each box. Signing does not guarantee a prescription. A licensed clinician decides whether treatment is right for you. You can read this document again at portal.wellpeps.com.

☐ I have read this Compounded Medication Disclosure and Consent and had the chance to ask questions.

☐ I understand that a compounded medicine is made by a pharmacy for me from a prescription, that it is not FDA-approved, and that FDA does not review it for safety, effectiveness or quality.

☐ I understand that a compounded medicine is not a generic of, and is not the same as or equivalent to, any brand medicine, and that its strength, ingredients, form and beyond-use date can differ between pharmacies and batches.

☐ I understand that FDA-approved medicines may be available for me, and that I can ask my clinician about them at any time.

☐ I understand that WellPeps does not prescribe, compound or ship medicine. A clinician of the Practice decides whether to prescribe, a state-licensed pharmacy prepares the medicine, and a prescription is not guaranteed.

☐ I will check my label every time, I will not use a medicine if anything is missing or unclear, and I will store it as the label says and not use it after the beyond-use date.

☐ I know how to report a side effect or product problem to my clinician, the pharmacy and FDA MedWatch.

☐ I understand that state rules may limit what is available to me, and that I can say no to a compounded medicine.

☐ Off-label use (check only if your prescription involves off-label use): I understand what off-label use means, that FDA has not reviewed my medicine for that use, that the risks and benefits may not be fully known, and that I can say no. I agree to off-label use of the medicine my clinician prescribes for me.

Electronic signature

By typing my name, I agree that my electronic signature is the legal equivalent of my handwritten signature, and that I have already agreed to receive and sign documents electronically (see the Electronic Records, Signatures and Communications Consent).