Compounded Medication Disclosures

This is the most important thing on this page. A drug compounded under section 503A has not been approved by the FDA, and the FDA does not review it for safety, efficacy or manufacturing quality before it reaches a patient.

That is not an oversight or a gap in enforcement — it is the exemption itself. Section 503A exempts a qualifying compounded drug from three things at once: new-drug approval, the requirement to bear adequate directions for use, and current good manufacturing practice requirements. The exemption is the absence of approval.

Compounded drugs are lawful and often clinically necessary — a patient may need a strength that is not manufactured, a formulation without an allergen, or a route a commercial product does not offer. But a prescriber choosing a compounded preparation is choosing a product that has not been through the approval pathway, and should be able to say why.

Section 503A conditions the exemption on the drug being compounded for an identified individual patient based on receipt of a valid prescription order. There is no general-inventory pathway under 503A.

This is why trellOS requires a named patient on every prescription, and why Office Use (503B) — compounding for administration in a clinic without a patient-specific prescription — appears in the product as a separate, distinct surface rather than an option inside the ordinary flow. 503A and 503B are different statutory regimes with different registration, inspection and quality obligations. Software that blurred them would invite practices that blur them.

trellOS does not exercise clinical judgement and has no view on whether a preparation is appropriate for a patient. The prescriber remains solely responsible for:

• The clinical appropriateness of the preparation, its strength, route and quantity.
• A valid prescriber–patient relationship meeting the requirements of the state the patient is in — including any telehealth-specific rules, which vary and which trellOS does not interpret for you.
• Their own licensure in the state the medication is being shipped to.
• Informing the patient that the preparation is compounded and not FDA-approved, where their judgement or their state requires it.

The dispensing pharmacy is an independent business, licensed and regulated in its own right. It — not trellOS — is responsible for compounding, for USP <795> and <797> conformance where applicable, beyond-use dating, labelling, quality testing, storage, shipping and its own state and federal registrations. Pharmacies visible in the platform’s network are those a clinic holds a relationship with; their inclusion is not an endorsement or a warranty by trellOS of their practices.

trellOS does not currently support prescribing controlled substances of any schedule. The platform rejects them at the database level, not merely in the interface. Electronic prescribing of controlled substances has prerequisites — identity proofing, two-factor authentication at signing, and an audited signing credential — that we have not completed, and we would rather refuse than half-support them.

Section 503A limits the quantity of compounded drugs a pharmacy may distribute out of its home state, in coordination with a memorandum of understanding between the state and the FDA. Compliance rests with the dispensing pharmacy. trellOS surfaces each pharmacy’s stated licensure by jurisdiction in the network view so a clinic can see where a pharmacy says it is licensed, but that display reflects what the pharmacy has told us and is not independent verification.

Nothing here or anywhere in trellOS is medical, pharmaceutical or legal advice, and no part of the platform creates a prescriber–patient relationship between trellOS and anyone. Patients should raise questions about a compounded medication with the prescriber or pharmacist who is treating them.

Report a suspected problem with a compounded medication to the dispensing pharmacy, to the prescriber, and to the FDA through MedWatch.