---
title: "What Is a Compounded Medication? Definition and Rules"
description: "A compounded medication is made by a pharmacist or outsourcing facility for a patient's needs and is not FDA-approved. The rules, and how Cuvo Health runs it."
canonical: "https://cuvo.co/glossary/compounded-medication"
last-updated: "Oct 26, 2026"
---
**Definition:** A compounded medication is a drug that a licensed pharmacist, a licensed physician or an outsourcing facility prepares by combining, mixing or altering ingredients to meet a patient's needs. It is not FDA-approved, so FDA does not review its safety, effectiveness or quality before it is marketed.

# What is a compounded medication?

Compounded medications appear in telehealth programs from GLP-1 weight loss to hormone therapy, wherever a provider needs a dose or formulation a manufacturer does not make. They are lawful under conditions, and they are never FDA-approved, which shapes both what a brand can sell and what its ads can say. Cuvo Health runs compounded programs only where a licensed provider finds them clinically appropriate, filled by licensed partner pharmacies.

Published Oct 26, 2026. Facts reviewed Oct 26, 2026.

A compounded medication is a drug prepared by a licensed pharmacist, a licensed physician or, in an outsourcing facility, a person under a licensed pharmacist's supervision, who combines, mixes or alters ingredients to create a medication tailored to a patient's needs. FDA states plainly that compounded drugs are not FDA-approved, which means FDA does not review their safety, effectiveness or quality before they are marketed. They are lawful when the compounder meets the conditions of section 503A or 503B of the Federal Food, Drug, and Cosmetic Act. On Cuvo Health, compounded programs run only where a provider licensed in the patient's state finds them clinically appropriate, and a licensed partner pharmacy fills each prescription with a lot number and beyond-use date.

**At a glance**
- What it is: A drug prepared by combining, mixing or altering ingredients for a patient's needs
- Approval status: Not FDA-approved; no FDA review before marketing
- Who makes it: A 503A pharmacy or physician, or a 503B outsourcing facility
- When FDA says it fits: A need an approved drug cannot meet, or an approved drug that is not commercially available
- Not compounding: Mixing or reconstituting a drug as its approved labeling directs
- On Cuvo: Prescribed by licensed providers where clinically appropriate, filled by licensed partner pharmacies

**Compounded, brand-name and generic drugs compared**

| Question | FDA-approved drug | Generic drug | Compounded medication |
| --- | --- | --- | --- |
| **FDA review before marketing** | Yes | Yes, under section 505(j) | No |
| **Manufacturing standard** | Current good manufacturing practice | Current good manufacturing practice | CGMP in a 503B facility; not required under 503A |
| **Dating on the label** | Expiration date from stability testing (21 CFR 211.137) | Expiration date from stability testing | Beyond-use date set by the compounder, or a 503B expiration date |
| **Can be advertised as FDA-approved** | Yes | Yes | Never |

## 01. Why do telehealth brands offer compounded medication?

Because a patient's need is sometimes one an approved product does not meet: a strength or dose step the manufacturer does not make, a formulation without an ingredient the patient cannot take, or a drug that is not commercially available. FDA says a compounded drug might be appropriate in those cases and should be used only in patients whose medical needs cannot be met by an FDA-approved drug. That judgment belongs to the prescriber, never the brand.

On Cuvo, semaglutide and tirzepatide programs include compounded options where clinically appropriate, and the provider decides dosing, titration and refills. The brand sets the price and the experience.

## 02. Can a brand call a compounded medication FDA approved?

No. Compounded drugs are not FDA-approved, and FDA says prescription drug promotion by or on behalf of compounders must be truthful, non-misleading and accurate. FDA's page on unapproved GLP-1 drugs lists, among its telehealth red flags for consumers, a company that claims a compounded drug is the same as an FDA-approved drug. Ad copy should describe access to a licensed provider, not a product.

## 03. How is a compounded medication different from a generic?

A generic is approved by FDA under section 505(j) after showing therapeutic equivalence to a brand-name drug. A compounded medication goes through no such review, even when it contains the same active ingredient. The two are not interchangeable terms, and a brand should never use one for the other.

## 04. Which rules decide whether a drug can be compounded?

Sections 503A and 503B set the conditions: a valid prescription for an identified patient under 503A, registration and manufacturing standards under 503B, limits on bulk ingredients, and limits on copying commercially available or approved drugs. FDA's shortage list and its bulk substance categories move those limits, and biological products are not eligible for either exemption. Each rule has its own entry in this glossary. This is general information, not legal or medical advice.

## Frequently asked questions

**Q: What is a compounded medication?**

A: It is a drug a licensed pharmacist, physician or outsourcing facility prepares by combining, mixing or altering ingredients for a patient's needs, and it is not FDA-approved. On Cuvo, compounded programs run only where a licensed provider finds them clinically appropriate.

**Q: Are compounded medications FDA approved?**

A: No. FDA states that compounded drugs are not FDA-approved and that it does not review their safety, effectiveness or quality before marketing. On Cuvo, compounded options are prescribed only where a licensed provider finds them clinically appropriate.

**Q: Compounded vs generic medication: what is the difference?**

A: A generic is FDA-approved under section 505(j) and shown to be therapeutically equivalent to a brand-name drug, while a compounded medication is not reviewed or approved by FDA. On Cuvo, the provider chooses between approved and compounded options for each patient.

**Q: Who decides whether a patient gets a compounded medication?**

A: The licensed prescriber, based on the patient's needs; the brand and the platform never make that call. On Cuvo, a provider licensed in the patient's state reviews every intake, with a first review as fast as 15 minutes.

**Q: Does a telehealth brand need a compounding pharmacy?**

A: Only if its programs include compounded preparations, and then the pharmacy must be licensed for every state it ships into. Cuvo Health supplies licensed partner pharmacies verified for each ship-to state, and a brand can bring its own pharmacy at any time.

**Related pages**

- [503A compounding pharmacy](/glossary/503a-pharmacy): Patient-specific compounding under state boards
- [503B outsourcing facility](/glossary/503b-outsourcing-facility): FDA-registered sterile compounding
- [Beyond-use date (BUD)](/glossary/beyond-use-date): How long a compounded preparation may be used
- [503A vs 503B compounding](/blog/compounding-503a-vs-503b): Which compounder fills what
- [GLP-1 weight loss programs](/solutions/glp-1-weight-loss): Semaglutide and tirzepatide on Cuvo
- [Pharmacy and e-prescribing on Cuvo](/pharmacy): Licensed partner pharmacies, cold chain and lot tracking

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