Compounded is not approved

A compounded drug is mixed for an individual patient by a pharmacy. It is legal, it is prescribed under federal law, and it is exempt from the premarket review that approved medicines undergo. It has not been assessed for safety, for effectiveness, or for manufacturing quality by the FDA — not because anyone judged it and found it wanting, but because that assessment does not apply to it.

That is not a scandal. Compounding exists for good reasons and serves real needs, particularly where no approved product covers a combination a clinician wants. It is, however, a material fact about what a buyer is purchasing, and it is the fact this category is least willing to state.

Four answers to one question

Ro prints six words directly beneath its price, above the first call to action: compounded medication, not FDA-approved. Follow the link and the explanation does not soften — compounded drugs are permitted under federal law but are not FDA-approved and do not undergo safety, effectiveness or manufacturing review. That sentence appears three times across its safety pages.

Obagi says nothing. Its hydroquinone cream is a marketed unapproved drug — legal, prescribed for decades, carrying a National Drug Code, never taken through a New Drug Application. The FDA's own listing for it states that the drug has not been found by FDA to be safe and effective and that the labeling has not been approved. The product page carries an RX ONLY marking and a full prescribing insert, which together read as an approved medicine to anyone who has not checked.

Alloy uses the word selectively. Its navigation sells Compounded Semaglutide, Compounded Tirzepatide and Compounded Liraglutide; the word appears seven times on its tretinoin page. It appears on none of its three estriol pages — and estriol has no FDA-approved form in the United States at all, so those preparations are compounded by definition.

Dermatica gives the wrong answer. A scrolling badge strip runs across its treatment pages: alcohol free, fragrance free, 100% vegan, cruelty free, easily recyclable packaging, formulated by experts, science backed, developed with dermatologists, FDA regulated.

Eight of those are cosmetic marketing attributes. The ninth is a regulatory status, and in that company it will be read as approved.

A 503A pharmacy is subject to FDA oversight, so the two words are defensible in isolation. Placed ninth in a list that begins with vegan and cruelty-free, on a compounded product, they are doing different work.

The alternative nobody advertises

Two products in this register avoid the question entirely by not compounding. Obagi manufactures a defined drug with a National Drug Code and a printed excipient list. Sesame sells no product at all — the prescription goes to the patient's own pharmacy, and what arrives is an ordinary labelled generic with its concentration, fill weight, excipients and patient leaflet in the box.

That second route deserves more attention than it gets. Every complaint we have made about unpublished formulas — no concentration, no fill size, no ingredient list, no insert — is structurally impossible when a pharmacy dispenses an approved medicine, and it is frequently cheaper than the compounded alternative.

We are not against compounding. We are against a buyer being unable to tell which of the two they have bought, on a page that had room for eight other badges.