01 / Direct answer
The default rule and the limited exception are different things
The most important distinction is between what the law generally requires and when FDA personnel may exercise enforcement discretion. FDA’s public guidance says products purchased abroad often have not been approved for U.S. use and sale, and that personal importation is generally not permitted. The agency then lists limited circumstances it may consider for a product intended for a serious condition when effective treatment may not be available domestically.
That discretion is case-specific. It does not turn a foreign product into an FDA-approved product, pre-clear a shipment, or create a guaranteed delivery route. The Congressional Research Service likewise explains that the policy is not intended simply as a lower-price import channel.
02 / Factors
Factors FDA publicly identifies
Shipment admissibility remains an agency determination and other rules may apply.
- The product is for a serious condition and effective treatment may not be available domestically through commercial or clinical means.
- There is no known commercialization or promotion of the product to U.S. residents.
- The product does not appear to present an unreasonable risk.
- The consumer affirms in writing that the product is for personal use.
- The quantity is generally no more than a three-month supply.
- The request includes the U.S.-licensed treating physician’s name and address or evidence that treatment began abroad.
03 / Limits
What the policy does not promise
| Misconception | More accurate interpretation |
|---|---|
| “A 90-day supply is always allowed.” | Quantity is one factor in a narrow, case-specific review; it is not automatic permission. |
| “A U.S. prescription guarantees release.” | Physician documentation may be relevant, but it does not by itself determine admissibility. |
| “FDA-approved molecule means every foreign version is approved.” | Approval is product-specific and includes manufacturing, labeling, listing, and other requirements. |
| “The policy exists mainly for cheaper medicine.” | CRS describes the policy as focused on serious conditions and treatments not effectively available in the United States, not a general lower-price route. |
| “Controlled substances follow the same process.” | DEA requirements also apply, and controlled-substance import questions require separate review. |
04 / Documentation
Information commonly needed for a meaningful review
A case can only be evaluated when the product and intended use are clear. Useful non-sensitive intake information includes the brand and active ingredient, strength, dosage form, package quantity, manufacturer, country of dispensing, intended recipient category, destination, and treating physician contact where appropriate.
Do not send diagnoses, prescriptions, patient names, or other protected health information through a general website form. Sensitive records should only be exchanged through an appropriate process after the responsible licensed and regulated parties are identified.
05 / Next step
Treat every product and route as its own case
Start with the FDA source pages, confirm whether the product is approved and available in the United States, and identify every party in the proposed route. A legitimate review should be willing to say “not suitable” when approval status, product risk, controlled-substance rules, promotion, documentation, or supply-chain integrity makes a pathway inappropriate.
US Med Access can organize package and source information for review, but it does not make FDA decisions and cannot guarantee importation. Review the broader process and compliance framework before submitting a request.
Frequently asked questions
Clear answers for the next decision.
01Can a U.S. resident legally import any prescription drug for personal use?
No. FDA states that personal importation is generally not permitted, with limited case-specific enforcement discretion described in its guidance.
02Does the three-month quantity create an automatic exemption?
No. A quantity generally not exceeding three months is one of several factors FDA may consider. It does not guarantee admissibility.
03Does a prescription guarantee that Customs or FDA will release a shipment?
No. A prescription or physician letter may support a review, but FDA and other authorities determine admissibility under the facts of the case.
04Can controlled substances be handled under the same policy?
Controlled substances involve DEA as well as FDA requirements and require separate, product-specific review.
Primary and authoritative sources
Sources used for this guide
- FDA: Personal Importation
- FDA: Importing Prescription Drugs
- Congressional Research Service: Prescription Drug Importation
- FDA: Human Drug Imports
This page is general information, not medical or legal advice. Requirements and source pages can change; verify the current rule for the specific product and route.