Compounded medicines: what they are and why they are not FDA-approved

Creator: Reserve Meds
Published: 2026-10-17

A plain explanation for patients, families and doctors, checked against the regulator's own pages on 17 October 2026.

Reviewed by the Reserve Meds clinical operations team on 17 October 2026. Sources accessed 17 October 2026.

The short answer

Compounding is when a licensed pharmacist or physician, or an outsourcing facility, combines or alters ingredients to make a medicine for a patient whose needs an approved drug cannot meet. Compounded drugs are not FDA-approved, so FDA does not check their safety, effectiveness or quality before they are sold. Reserve Meds coordinates FDA-approved medicines only, not compounded products.

What it is: A medicine prepared for a patient's specific need.
FDA status: Compounded drugs are not FDA-approved.
Two US settings: Section 503A compounders and section 503B outsourcing facilities.
Our scope: FDA-approved medicines only.

When compounding is used

A drug may be compounded for a patient who cannot be treated with an FDA-approved medication, for example someone allergic to a dye who needs it made without that dye, or an older adult or child who cannot swallow a tablet and needs a liquid. Hospitals and clinics sometimes use compounded drugs when an approved drug is not medically appropriate.^[1]

Why compounded drugs are not FDA-approved

Compounded drugs are not FDA-approved: FDA does not verify their safety, effectiveness or quality before they are marketed. A compounded drug is also not a generic, because generics are approved under section 505(j) and must show therapeutic equivalence to a brand-name drug.^[1]

FDA says compounded drugs should only be used for patients whose medical needs cannot be met by an FDA-approved drug. Poor compounding practices can cause contamination or the wrong amount of active ingredient, which can lead to serious injury and death.^[1]

503A compounders and 503B outsourcing facilities

US law covers compounding by a licensed pharmacist in a state-licensed pharmacy or a federal facility, or by a physician, under section 503A, and compounding in outsourcing facilities under section 503B. Outsourcing facilities were created in 2013 by the Drug Quality and Security Act.^[1]

Section 503B outsourcing facilities are overseen and inspected by FDA on a risk-based schedule and must follow current good manufacturing practice. Section 503A compounders are mainly overseen by state boards of pharmacy and are not subject to those manufacturing requirements, although FDA conducts surveillance and for-cause inspections.^[1]

What this means for patients abroad

Regulators abroad generally treat a medicine's approval in its country of origin as the starting point for any special import. A compounded product has no such approval, which makes it a poor candidate for named-patient import.

Reserve Meds coordinates access to FDA-approved medicines through a US-licensed pharmaceutical wholesale partner. If your doctor is considering a compounded product, ask whether an FDA-approved alternative exists; FDA's Drugs@FDA lists approved products.^[2]

Questions to ask if a compounded product is suggested

Is there an FDA-approved medicine, strength or dosage form that would meet the need?
Why is the approved product not suitable: an allergy, a swallowing problem, a needed strength?
Where will the product be compounded, and is that facility licensed or registered?
How will it be stored and shipped, and what is its beyond-use date?

FDA advises that compounded drugs be used only when an FDA-approved drug cannot meet the patient's needs, because they are not reviewed for safety, effectiveness or quality before marketing.^[1]

How Reserve Meds helps

Reserve Meds is a digital health company. Medicines are supplied through a US-licensed pharmaceutical wholesale partner. We help families and treating doctors understand the route, prepare the documents the regulator or hospital asks for, arrange supply from the US once approval is in place, and keep everyone updated. We do not diagnose, prescribe or decide what a regulator approves.

We coordinate access to FDA-approved medicines only. Investigational medicines are only available through a manufacturer's expanded-access program requested by the treating physician; we can explain that route, but we do not supply them. Your coordination fee is quoted in writing for your case before you commit. No hidden charges. We give you a written timeline estimate for your case before you commit.

Ask us whether a medicine can reach your patient

Tell us the medicine, your country and a WhatsApp or phone number. We reply within one business day. On WhatsApp we usually reply the same day.

Frequently asked questions

Are compounded drugs FDA-approved?

No. FDA does not verify the safety, effectiveness or quality of compounded drugs before they are marketed.

What is the difference between 503A and 503B?

Section 503A covers compounding by licensed pharmacists or physicians, mainly overseen by states. Section 503B covers outsourcing facilities, which FDA inspects and which must follow current good manufacturing practice.

When is a compounded drug appropriate?

FDA says only when a patient's medical needs cannot be met by an FDA-approved drug, for example a needed dye-free or liquid form.

Can Reserve Meds supply a compounded medicine?

No. We coordinate FDA-approved medicines only.

Sources for these answers: ^{[1, 3]}

Sources

All sources were opened and checked on 17 October 2026. Rules and labels change, so the treating hospital or regulator confirms the current position before anything is filed.

US FDA: Compounding and the FDA, Questions and Answers (accessed 17 October 2026)
US FDA: How do I find out if a drug is approved? (accessed 17 October 2026)
US FDA: Human Drug Compounding (accessed 17 October 2026)

This page is general information, not medical or legal advice. It does not replace advice from your own doctor or the regulator.