Draft telehealth advertising rules

Draft rule 1

Same active ingredient as a brand

What it says. A page must not say a compounded drug contains the same active ingredient as a named FDA-approved brand.

What FDA said.

Compounded drug products are not FDA-approved. Your claims imply that your products are the same as an FDA-approved product when they are not.

FDA wrote this in a warning letter. Source: FDA telehealth warning letter, 9 Sep 2025 batch.

Statute or regulation. FD&C Act 502(bb), 21 U.S.C. 352(bb)

Example of wording that drops the claim. Compounded semaglutide, prescribed by a licensed clinician when appropriate. Compounded drugs are not FDA-approved and are not the same as any brand-name medicine.

Comment on this rule

Draft rule 2

Generic or compounded version of a brand

What it says. A page must not call a compounded drug a generic, an equivalent or a compounded version of a brand-name drug.

What FDA said.

Your claims imply that your products have been FDA-approved or otherwise evaluated for safety and effectiveness when they have not.

FDA wrote this in a warning letter. Source: FDA telehealth warning letter, 20 Feb 2026 batch.

Statute or regulation. FD&C Act 502(bb), 21 U.S.C. 352(bb)

Example of wording that drops the claim. Compounded tirzepatide (not a generic and not FDA-approved).

Comment on this rule

Draft rule 3

Similar or comparable to a brand

What it says. A page must not liken a compounded drug to a brand with words such as "similar to", "comparable to", "bioidentical" or "from the same family".

What FDA said.

Compounded drug products are not FDA-approved. Your claims imply that your products are the same as an FDA-approved product when they are not.

FDA wrote this in a warning letter. Source: FDA telehealth warning letter, 9 Sep 2025 batch.

Statute or regulation. FD&C Act 502(bb), 21 U.S.C. 352(bb)

Example of the change. Remove the brand comparison. Describe the compounded drug by its own name, dose form and the fact that it is compounded.

Comment on this rule

Draft rule 4

A brand name used for a compounded product

What it says. A page must not use the brand name of an approved drug to name, label or bracket a compounded product, in menus, cart lines, page titles or ads.

What it does not apply to. The title of a blog article or a link to one, or a line saying the service also prescribes the FDA-approved brand drug itself.

What FDA said.

Compounded drug products are not FDA-approved. Your claim implies that your products are the same as an FDA-approved product when they are not.

FDA wrote this in a warning letter. Source: FDA telehealth warning letter, 9 Sep 2025 batch.

Statute or regulation. FD&C Act 502(bb), 21 U.S.C. 352(bb); FD&C Act 502(i)(3), 21 U.S.C. 352(i). FDA’s letters cite section 502(bb). Section 502(i)(3) is our reading of the statute; the letters do not cite it.

Example of wording that drops the claim. Compounded semaglutide injection, 2.5 mg vial.

Comment on this rule

Draft rule 5

A price comparison that implies equal results

What it says. A price comparison with a brand must not state or imply equal results, equal safety or equal quality.

What FDA said.

Compounded drug products are not FDA-approved. Your claims imply that your products are the same as an FDA-approved product when they are not.

FDA wrote this in a warning letter. Source: FDA telehealth warning letter, 9 Sep 2025 batch.

Statute or regulation. FD&C Act 502(bb), 21 U.S.C. 352(bb)

Example of wording that drops the claim. Compounded options can cost less than brand-name medicines. They are not FDA-approved and are not interchangeable with them.

Comment on this rule

Draft rule 6

"FDA-approved" said of a compounded drug

What it says. A page must not describe a compounded drug, its dosing schedule or its active ingredient as FDA-approved or FDA-cleared.

What FDA said.

Compounded drug products are not FDA-approved. Your claims represent that the compounded drug products you offer have been FDA-approved or otherwise evaluated for safety and effectiveness when they have not.

FDA wrote this in a warning letter. Source: FDA telehealth warning letter, 8 Jun 2026 batch.

Statute or regulation. FD&C Act 502(bb), 21 U.S.C. 352(bb)

Example of wording that drops the claim. Compounded drugs are not FDA-approved. Your clinician can explain how a compounded drug differs from an approved one.

Comment on this rule

Draft rule 7

Approval history borrowed from a brand drug

What it says. A page selling a compounded drug must not borrow the approval date, approved uses or prescribing information of a brand drug.

What FDA said.

Compounded drug products are not FDA-approved. Your claims represent that the compounded drug products you offer have been FDA-approved or otherwise evaluated for safety and effectiveness when they have not.

FDA wrote this in a warning letter. Source: FDA telehealth warning letter, 8 Jun 2026 batch.

Statute or regulation. FD&C Act 502(bb), 21 U.S.C. 352(bb)

Example of wording that drops the claim. Semaglutide is the active ingredient in some FDA-approved medicines. The compounded product we prescribe is not one of them and has not been reviewed by FDA.

Comment on this rule

Draft rule 8

"FDA-approved pharmacy"

What it says. A page must not call a compounding pharmacy or outsourcing facility FDA-approved, FDA-licensed or FDA-certified. Registration with FDA may be stated as registration only.

What FDA said.

Compounding facilities, including pharmacies and outsourcing facilities, are not “FDA-approved” or “FDA-licensed” entities.

FDA wrote this in a warning letter. Source: FDA telehealth warning letter, 8 Jun 2026 batch.

Statute or regulation. FD&C Act 502(bb), 21 U.S.C. 352(bb)

Example of wording that drops the claim. Filled by a state-licensed pharmacy. (For a registered outsourcing facility: an outsourcing facility registered with FDA under section 503B. Registration is not FDA approval.)

Comment on this rule

Draft rule 9

FDA inspection or registration used as an endorsement

What it says. A page must not present FDA inspection, monitoring or registration as FDA endorsing the product.

What FDA said.

Compounded drug products are not FDA-approved. Your claims represent that the compounded drug products you offer have been FDA-approved or otherwise evaluated for safety and effectiveness when they have not.

FDA wrote this in a warning letter. Source: FDA telehealth warning letter, 8 Jun 2026 batch.

Statute or regulation. FD&C Act 502(bb), 21 U.S.C. 352(bb)

Example of wording that drops the claim. Filled by a state-licensed pharmacy that follows USP compounding standards. (State only what is documented.)

Comment on this rule

Draft rule 10

"Proven", with nothing to qualify it

What it says. A page must not call a compounded drug or a treatment programme "proven" without qualification.

What FDA said.

Compounded drug products are not FDA-approved. Your claims represent that the compounded drug products you offer have been FDA-approved or otherwise evaluated for safety and effectiveness when they have not.

FDA wrote this in a warning letter. Source: FDA telehealth warning letter, 8 Jun 2026 batch.

Statute or regulation. FD&C Act 502(bb), 21 U.S.C. 352(bb)

Example of wording that drops the claim. Many patients lose weight on GLP-1 treatment with diet and activity. Results vary and are not guaranteed.

Comment on this rule

Draft rule 11

Trial figures from brand-drug studies

What it says. Outcome figures from trials of a brand drug must not appear beside a compounded product, and any figure shown must name its study and the people studied.

What FDA said.

Overstatements of efficacy or minimization of risk are of particular concern and may constitute misbranding.

FDA wrote this in a warning letter. Source: FDA telehealth warning letter, 9 Sep 2025 batch.

Statute or regulation. FD&C Act 502(bb), 21 U.S.C. 352(bb)

Example of the change. Remove the figure. If a figure stays, state the study, the drug studied, the population and that it was not a compounded product.

Comment on this rule

Draft rule 12

The seller’s name on the pictured drug label

What it says. A product image must not show the platform’s brand on a vial, pen or box unless the platform compounded the drug.

What FDA said.

The appearance on a drug product label of a person's name without qualification is a representation that the named person is the sole manufacturer of the product.

FDA quoted its own regulation, 21 CFR 201.1(h)(2), in a footnote. Source: FDA telehealth warning letter, 20 Feb 2026 batch.

Statute or regulation. FD&C Act 502(bb), 21 U.S.C. 352(bb); 21 CFR 201.1(h)(2)

Example of the change. Show a generic vial with no brand, or the dispensing pharmacy's actual label. Caption: Compounded and dispensed by [pharmacy name], a state-licensed pharmacy.

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