# L-05 — Compounded is not approved

Most of the prescription skincare sold online is compounded, which means it has never been through FDA review. Four companies in this register give four different answers to that fact, and one of them gives the wrong one.

- **Canonical:** https://www.30plusskin.care/ledger/compounded-is-not-approved
- **Site:** 30+/SKIN — Skincare, published as a spec sheet.
- **Issue:** ISSUE NO. 13 / REV. 2026.10
- **Standing terms:** INDEPENDENT · AFFILIATE-FUNDED · NOT MEDICAL ADVICE

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- **Published:** 2026-07-26
- **Reading time:** 6 min
- **Tags:** REGULATION, DISCLOSURE, REGISTER

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 REGULATORY FILE**

- [R-25 Ro Custom Rx Treatment](/reviews/ro-custom-rx-treatment-review) — CONDITIONAL 68/100 — States it at the point of sale, and explains what it means.
- [R-21 Honeydew Low Dose Accutane](/reviews/honeydew-low-dose-accutane-review) — CONDITIONAL 82/100 — Volunteers that its own regimen is off-label and unapproved at that dose.
- [R-26 Obagi Nu-Derm Clear](/reviews/obagi-nu-derm-clear-review) — CONDITIONAL 74/100 — An unapproved marketed drug whose page never says so.
- [R-28 Alloy M4 Face Cream Rx](/reviews/alloy-m4-face-cream-review) — CAUTION 59/100 — Compounded estriol, with no approved US form, and the word never used.
- [R-19 Dermatica Anti-Ageing Treatment](/reviews/dermatica-anti-ageing-review) — CONDITIONAL 71/100 — 'FDA REGULATED' on a compounded formula, ninth in a list after cruelty-free.

## 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.

| Field | Value |
| --- | --- |
| COMPOUNDED, PERSONALISED | NO PREMARKET REVIEW |
| TYPICAL CONCENTRATION DISCLOSURE | ABSENT OR PARTIAL |
| TYPICAL FILL SIZE DISCLOSURE | ABSENT |
| PHARMACY-DISPENSED GENERIC | APPROVED, LABELLED, LEAFLETED |
| WHO STATES THE DIFFERENCE | 1 OF 4 BRANDS ASSESSED |

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.

## Related records

- [L-07 Where the warning lives](/ledger/where-the-warning-lives)
- [L-06 A course is not a subscription](/ledger/a-course-is-not-a-subscription)
- [R-27 Sesame Skincare Rx](/reviews/sesame-skincare-rx-review) — CONDITIONAL
- [R-18 Curology DayPrime Rx](/reviews/curology-day-prime-review) — CONDITIONAL
- [PROFILE Ro](/brands/ro)
- [PROFILE Obagi](/brands/obagi)
- [L-14 Tretinoin online: a pharmacy prescription or a custom subscription?](/ledger/tretinoin-online-visit-vs-subscription)
- [L-12 Rosacea prescriptions: persistent redness and bumps are different targets](/ledger/rosacea-prescriptions-redness-vs-bumps)
- [L-11 Before a compounded melasma prescription: five questions to ask](/ledger/compounded-melasma-questions)

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[About promotional placements](/disclosure)

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## Elsewhere in the register

- [Review register](/reviews)
- [Active monographs](/actives)
- [Brand register](/brands)
- [Evidence register](/evidence)
- [The ledger](/ledger)
- [How we test](/how-we-test)
- [Agent guide](/llms.txt)
- [Sitemap](/sitemap.xml)

_SOURCE-BASED ASSESSMENTS. PUBLISHER PREFERENCES ARE IDENTIFIED SEPARATELY._