# What is a compounded medication, and is it FDA-approved?

> A compounded medication is a drug a pharmacist or physician mixes or alters to suit one patient, such as leaving out a dye the patient is allergic to. It is not FDA-approved: the agency does not review its safety, effectiveness or quality before sale, and advises using one only when an approved drug can’t meet a patient’s needs.

The journal is published by Rovere, a telehealth service that sells some of the treatments discussed here. Articles are general information, not medical advice. Only a licensed clinician can say whether a treatment is right for you.

- Topic: Regulation
- Web page: https://roverehealth.com/journal/what-is-a-compounded-medication

## Key points

- Compounding can serve patients an approved drug can’t, such as a child who needs a liquid instead of a tablet. The FDA warns poor compounding can contaminate a drug or put the wrong amount of active ingredient in it.
- Pharmacies compounding under section 503A of federal law need a prescription for each patient and answer mainly to state boards of pharmacy. Outsourcing facilities (section 503B) register with the FDA, follow manufacturing quality rules and face FDA inspections.
- Outsourcing facilities, the FDA-registered compounders, must report adverse events (harms after a drug is used) to the FDA. Other pharmacies don’t have to under federal law, so the FDA says adverse events from compounded semaglutide and tirzepatide are likely underreported.
- Federal law limits compounding “essentially copies” of approved drugs, but the FDA says those limits generally lift during a listed shortage. Semaglutide injection was listed from 2022 until February 2025, and tirzepatide injection from 2022 until late 2024.
- Federal law requires a dispensed prescription’s label to name the dispenser, usually the pharmacy that filled it. The FDA has found fake compounded semaglutide and tirzepatide labels naming pharmacies that don’t exist or didn’t make the drug.

## What compounding means

A compounded medication is a drug made to suit one patient by combining, mixing or altering ingredients. Federal law covers compounding by licensed pharmacists and physicians, and by staff under a pharmacist’s supervision at an FDA-registered compounder called an outsourcing facility. In the FDA’s examples, one patient is allergic to a dye in an approved medicine. Another is a child or older adult who cannot swallow a tablet. [1, 2]

## How it differs from FDA-approved medication

Compounded drugs are not FDA-approved and do not go through the FDA’s premarket review. In the agency’s words, it “does not verify the safety, effectiveness or quality of compounded drugs before they are marketed.” [3, 2]

The FDA says compounded drugs should be reserved for patients whose needs an approved drug cannot meet. Unnecessary use may expose patients to risks such as contamination or the wrong amount of active ingredient, which can cause serious injury or death. [2]

Prescribing an FDA-approved drug for a use the FDA has not approved (off-label use) differs from compounding. The FDA says clinicians generally may do this when they judge it medically appropriate. In one FDA example, a drug approved for one type of cancer is used to treat another. Unlike a compounded drug, the product is FDA-approved, but the FDA has not found that its benefits outweigh its risks for that use. [34, 2]

## 503A pharmacies and 503B outsourcing facilities

Federal law sorts compounders into two groups, named after sections of the Federal Food, Drug, and Cosmetic Act. Section 503A covers licensed pharmacists in state-licensed pharmacies or federal facilities, and licensed physicians. Section 503B covers outsourcing facilities, compounders that choose to register with the FDA. Registration is not approval: in the FDA’s words, the agency “does not approve or license any facility.” [6, 4, 5, 9]

The FDA reports that in 2012, contaminated drugs from a Massachusetts compounding pharmacy led to more than 750 infections and more than 60 deaths in 20 states. That fungal meningitis outbreak led Congress to pass the Drug Quality and Security Act, which became law on November 27, 2013, and created outsourcing facilities. [4]

Drugs made under either section’s conditions are exempt from FDA approval and from the legal requirement to give “adequate directions for use” on the label. [4, 5, 3]

How the two kinds of compounder differ. [2, 6, 5, 7, 4, 8]

| What differs | 503A pharmacy | 503B outsourcing facility |
| --- | --- | --- |
| Main overseer | The state board of pharmacy. The FDA also inspects some, to monitor them or over a specific concern. | The FDA, which inspects on a risk-based schedule. Facilities register yearly. |
| Prescription for each patient | Required | Not always. It may fill hospital and clinic orders for stock. |
| Manufacturing quality rules (CGMP) | Not required | Required |
| Reporting harms after use (adverse events) to the FDA | Not required by federal law | Required |
| Label must include, among other details | The dispenser’s name and address (usually the pharmacy that filled it) and the prescriber’s name | The statement “This is a compounded drug.” or a comparable one, and the facility’s name, address and phone number |

Biological products, which have their own licensing process, cannot be compounded under either section. Nor can drugs on the FDA’s list of those withdrawn as unsafe or ineffective. [6, 5, 2]

## Limits on copying approved drugs

Federal law limits compounded drugs that are “essentially copies” of approved ones. In the FDA’s view, the limit spares patients who could use an approved drug from needless risk and protects the drug approval process. Under section 503A, a pharmacy may not compound copies of a drug on the market “regularly or in inordinate amounts.” [10, 6]

Under the FDA’s 503A test, a compounded drug counts as “essentially a copy” of a marketed drug if the two match on active ingredient and route, such as injection. Their strengths must also be the same, similar or easily substituted. This is a legal test, not a finding of equivalence. Copies are not FDA-approved, and the FDA has not reviewed whether they work like the approved drug. [10, 3, 9]

The limit does not apply to a change that produces “a significant difference” for that patient, as the prescriber determines and documents. Leaving out a dye the patient is allergic to is the FDA’s example; a lower price does not count. The agency has said it does not plan to act against a pharmacy that fills four or fewer prescriptions for such a copy in a calendar month. [10, 3]

Outsourcing facilities may not make a drug that is “essentially a copy” of an approved drug, which the law defines to include “identical or nearly identical” versions. They also generally cannot compound from a bulk drug substance, the active ingredient in raw form. Exceptions are substances on the FDA’s list of those with a clinical need (the 503B bulks list) and drugs on its shortage list. [5, 3]

These limits generally lift during a shortage on the FDA’s list. In federal law, a shortage means national demand or projected demand exceeds supply. A listed drug does not count as commercially available, so the 503A limit does not apply. Outsourcing facilities may then make identical or nearly identical versions from bulk. Other conditions still apply, such as a prescription for each patient at a 503A pharmacy. [11, 12, 10, 5]

## Compounded GLP-1 medications

Semaglutide and tirzepatide are called GLP-1 drugs because they act on the receptor for glucagon-like peptide-1 (GLP-1), a hormone the body makes. Tirzepatide also targets the receptor for a second such hormone, GIP. Specific products containing them are FDA-approved for uses such as treating type 2 diabetes and, in certain cases, chronic weight management. Compounded versions are not. [28, 29, 13]

On April 1, 2026, the FDA said neither drug was on the 503B bulks list or the shortage list, so outsourcing facilities cannot compound them from bulk. A 503A pharmacy may compound them only if it meets every condition of section 503A, such as a prescription for each patient and the copy limits. [3]

In the same update, the FDA said semaglutide mixed with another ingredient, such as vitamin B12, may still count as “essentially a copy” of an approved product. That applies if it is given the same way, such as by injection. Each ingredient’s amount must also be within a tenth of the strength of a product already sold. In 2024 it noted that the safety and effectiveness of such mixtures has not been established. [3, 18]

Increased demand put both drugs on the shortage list in 2022. When each shortage ended, the FDA gave compounders a grace period (enforcement discretion). It would not act against copies that relied on the listing, but could still act against substandard products. [11, 14, 3]

When the shortages and grace periods ended. [14, 3, 11, 16, 17]

| Step | Tirzepatide injection | Semaglutide injection |
| --- | --- | --- |
| FDA declared the shortage resolved | October 2, 2024, and again on December 19, 2024, after a review prompted by a lawsuit | February 21, 2025 |
| Grace period ended for 503A pharmacies | March 5, 2025, when a federal court declined to block the decision | April 24, 2025, when a federal court declined to block the decision |
| Grace period ended for 503B outsourcing facilities | March 19, 2025 | May 22, 2025 |
| On the FDA’s shortage list on November 13, 2026 | No | No |

On May 1, 2026, the FDA proposed leaving semaglutide, tirzepatide and liraglutide, another GLP-1 drug, off the 503B bulks list. It tentatively found no basis to conclude that outsourcing facilities have a clinical need to compound them from bulk. That included forms of semaglutide and tirzepatide absorbed under the tongue or through the cheek. Comments closed on July 30, 2026, and no final decision had been published by November 13. [19, 20, 21]

Liraglutide injection, FDA-approved for type 2 diabetes and weight management, has been on the shortage list since July 2023 and still was on November 13, 2026. While it stays listed, the copy limits generally do not apply, and outsourcing facilities may make identical or nearly identical versions from bulk, whatever the bulks-list decision. [32, 33, 16, 17, 12, 5]

Other FDA actions on compounded GLP-1 drugs. [13, 25, 22, 23]

| Date | What the FDA did |
| --- | --- |
| September 5, 2025 | Set up a “green list” import alert: GLP-1 active ingredients can be held at the border unless their maker appears, on FDA inspection or review, to meet its standards. |
| February 6, 2026 | Said it intended to restrict GLP-1 active ingredients for compounded drugs mass-marketed as alternatives to approved drugs. |
| March 3, 2026 | Announced warning letters to 30 telehealth companies over claims about compounded GLP-1 drugs, its second group to telehealth firms since a crackdown on misleading drug ads began in September 2025. Main issues: claims implying sameness with approved drugs, and branding implying the company was the compounder. |
| June 8, 2026 | Sent another group of warning letters to telehealth companies, including some over claims about compounded semaglutide and tirzepatide. Another followed on October 30, 2026. |

The letters cite the federal rule against false or misleading promotion of compounded drugs. [26, 25]

The import alert notes that 503A pharmacies are exempt from manufacturing quality rules, including checks that an active ingredient meets specifications for impurities and strength. That raises the risk that problems with the raw ingredient go unchecked. Of 48 GLP-1 ingredient sites it checked, about one in five were out of compliance. Section 503A does require each bulk ingredient to come from an FDA-registered maker, with a valid certificate of analysis, a report of the supplier’s tests. [15, 6]

The FDA says reports of adverse events associated with compounded semaglutide reached 990 by May 31, 2026, and those for compounded tirzepatide passed 730. Among compounders, only outsourcing facilities must report them, so the agency calls such events likely underreported. Many resemble events seen with the approved drugs, though the FDA cannot always tell whether a drug caused them. [8, 5]

The FDA’s warnings cover dosing errors with multiple-dose vials, doses beyond the approved labels, unapproved salt forms and ingredients, vials used past 28 days and shipments that arrive warm. The journal’s article on checking a compounded injection explains each. [8, 18]

The FDA warns that labels on compounded drugs may lack important information for safe use. The approved drugs’ boxed warning and other risks are covered in the journal’s GLP-1 article. [27]

The trials behind the approvals tested the manufacturers’ products, not compounded versions. A 2025 opinion by pharmacists in the American College of Clinical Pharmacy found only limited outcome data on compounded semaglutide and tirzepatide, from small groups of patients. Of 81,078 reports to the FDA on liraglutide, semaglutide and tirzepatide from 2018 to 2024, a 2025 study found 707 involving compounded versions. These more often described side effects, preparation errors, contamination and hospital stays than reports on approved products, and less often dosing errors. Such reports cannot show cause and effect. [28, 29, 30, 31]

## How to check who made a compounded drug

The FDA warns that the company selling a compounded drug may not be the one that made it. Buyers may not know who did, or whether that compounder is properly licensed. [2, 23]

The FDA says some fraudulent compounded semaglutide and tirzepatide has carried the names of pharmacies that do not exist, or of licensed pharmacies that never made it. Its other warning signs for telehealth purchases, such as prices that seem too good to be true, are listed in the journal’s article on checking a compounded injection. [8]

The FDA’s public list of registered outsourcing facilities shows each one’s latest inspection but leaves out 503A pharmacies, and the journal’s license-checking article explains how to check both. [24, 2]

## Sources

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## Related articles

- [What to check when a compounded injection arrives](https://roverehealth.com/journal/checking-a-compounded-injection.md): Check that the package is intact and cold if required, that the label names the pharmacy, patient, drug, strength and a use-by date, and that you know how to measure the dose. Compounded drugs are not FDA-approved, and these checks cannot show whether one is sterile or as strong as its label says.
- [Which peptides can a pharmacy compound?](https://roverehealth.com/journal/which-peptides-can-be-compounded.md): A pharmacy may compound with a raw peptide only if it meets an official quality standard, is in an FDA-approved drug, or is on an FDA list that names no peptide. Peptides that pass none of these, such as BPC-157, can rely at most on nonbinding FDA or HHS policies of not taking action, which are not approvals.
- [How to check a pharmacy or clinician license](https://roverehealth.com/journal/how-to-check-a-pharmacy-or-clinician-license.md): Check a pharmacy with the board of pharmacy in your state and in its home state, as the FDA advises, and a prescriber with your state’s board for their profession. A license is permission to practice, not FDA approval: compounded drugs are not FDA-approved, and the FDA does not approve or license any pharmacy.
- [What are GLP-1 medications like semaglutide and tirzepatide?](https://roverehealth.com/journal/glp-1-medications.md): GLP-1 medications mimic a gut hormone that helps control blood sugar and appetite; after large trials, the FDA approved semaglutide and tirzepatide products for type 2 diabetes, weight management and other uses. Digestive side effects are common and weight tends to return after stopping; compounded versions are not FDA-approved and were not tested in those trials.