FDA import rules for medicines and health products

This guide covers what can and can't be shipped into the United States by mail or courier (USPS, FedEx, UPS, DHL) when it comes to medicines and health products. It covers five product types with meaningfully different rules: vitamins and supplements, over-the-counter (OTC) medicines, prescription medicines ordered by US citizens and residents, prescription medicines mailed to visitors from other countries, and veterinary medicines. A sixth category — DEA-controlled drugs — overrides all five, no matter which category the product would otherwise fall into.

Vitamins and supplements 

Supplements are treated as food, not medicine, so makers don't need government approval before selling one — but every shipment still has to follow FDA's rules.

Red flags that get shipments stopped:

• New ingredients without a safety filing. If an ingredient wasn't sold in the US before October 1994, the maker must file a safety notice with FDA first. Many foreign herbal ingredients skip this, making them illegal to import even where they're legal at home.
• Banned ingredients. Ephedra has been banned since 2004. Kratom is treated as unlawful; "strong" kratom means more than 0.05% 7-hydroxymitragynine (7-OH), or a processed/synthetic product with more than 1 mg of 7-OH.
• Hidden real drugs, especially in weight-loss, sexual-health, and bodybuilding supplements — one of the most common reasons shipments get stopped.
• Banned muscle-building ingredients — SARMs, DMAA, and anabolic steroids sold as "testosterone boosters," even when labeled as supplements.
• A factory with a bad history. Repeated FDA problems can put a factory or product on an Import Alert, triggering automatic detention.
• Disease-cure claims. Claiming a product treats, cures, or prevents a disease turns it into an unapproved drug in FDA's eyes.
• Missing Prior Notice. Most supplements require Prior Notice to FDA before shipping, even for personal-use quantities — the confirmation number must travel with the package.
• Unregistered manufacturer. Because supplements count as food, the foreign factory generally needs an active FDA food-facility registration.

Label must show: a Supplement Facts box with ingredients and serving amounts, in English. General wellness claims ("supports immune health") are fine; disease-cure claims are not.

Over-the-counter (OTC) medicines 

OTC medicines must meet US drug requirements before they can be sold or imported — either specific FDA approval, or coverage under an FDA "OTC monograph." A foreign version of a familiar medicine (like foreign-made ibuprofen) usually doesn't qualify if it was made only for another country's market: the manufacturer must be FDA-registered, the product FDA-listed, and the formulation/label must meet US rules. An NDC (drug-listing number) is a good sign but not proof of FDA approval; missing one is a strong sign the product was never listed for US sale.

For ordinary, low-risk OTC medicines, FDA may choose to allow a personal-use shipment even if it doesn't meet all US requirements — but this is discretionary, not guaranteed.

Watch closely:

• Pseudoephedrine and ephedrine — common cold-medicine ingredients, watched because they can be used to make illegal drugs.
• Codeine — controlled in the US even at strengths sold over the counter elsewhere. A foreign codeine product is treated as a controlled-drug import, not an ordinary OTC issue (see Controlled drugs, below).

Label must show: a Drug Facts box with active ingredients, dosage, and warnings, in English.

Prescription medicines — for US citizens and residents 

Bringing in an unapproved drug for personal use is technically against the law, but FDA's Personal Importation Policy sometimes allows it — a discretionary, case-by-case choice, not a right. All four of these usually need to be true:

• The medicine treats a serious illness with no good US treatment available.
• No one in the supply chain is advertising or promoting the product to US customers.
• The product isn't considered unreasonably risky.
• The receiver signs a note confirming personal use (usually a 90-day supply or less), and either names a US doctor overseeing their care or shows treatment already started abroad.

The first two of these can be documented (a doctor's letter; the prescription plus a signed personal-use note). The other two depend on the seller and the product, not the buyer — no amount of paperwork fixes a pharmacy that markets to US customers, and "unreasonably risky" is FDA's call alone.

Most foreign pharmacy websites built to attract US shoppers — US-dollar pricing, US-targeted advertising — fail the marketing condition by design, which means the most common real-world case often doesn't qualify at all, before the controlled-drug question even comes up.

If a shipment doesn't qualify: FDA holds it and gives the receiver a short window to respond through its ITACS system. If unresolved, FDA refuses the shipment — and since these shipments are $2,500 or less, FDA can order it destroyed rather than returned, usually without charging the individual buyer for destruction. Bigger or repeated cases can lead to seizure and legal action.

Prescription medicines — for visitors from other countries 

This follows almost the same rules as above — a Canadian "snowbird" mailed medicine from their home pharmacy, for example. FDA's guidance doesn't depend on citizenship, and specifically expects this situation: a visitor may receive up to a 90-day supply, with more shipments allowed for longer stays.

One of the four conditions above — naming a US doctor, or showing treatment already started abroad — is satisfied here by the foreign prescription and doctor. Canada Post's own guidance agrees. (A separate DEA rule allows travelers to carry limited controlled medicine across the border in person — generally 50 doses for US residents bringing medicine from abroad — but that only applies to carrying it in person, not mailing it.)

Pet and animal medicines 

Regular animal medicines (flea/tick treatment, heartworm prevention, antibiotics, pain relievers) need FDA approval; animal vaccines are handled separately by USDA. Most pet medicine ordered by individual owners falls under FDA's rules, since USDA import permits are mainly for businesses.

FDA's personal-use policy also covers pet medicine, using a veterinarian's letter instead of a doctor's letter — but current FDA import-enforcement guidance says unapproved animal drugs aren't eligible for personal importation. In practice, a vet's letter helps with documentation but doesn't make an unapproved foreign animal drug admissible — and many of the specific products people try to order (cheaper flea, tick, and heartworm medicine from abroad) come from factories already subject to FDA Import Alerts.

Label must show which animal (species) the medicine is for, with clear directions — missing this makes the label illegal even if the medicine itself is fine.

Sedatives: ketamine and tramadol are controlled drugs — never mail these (see below). Xylazine and medetomidine aren't officially controlled yet, but FDA has flagged both for misuse alongside illegal opioids — treat them the same way.

Controlled drugs — never mail these 

Every category above is an FDA rule, where FDA sometimes chooses to allow a personal shipment. Controlled drugs are different: DEA has said there is no personal-use exception at all for mail or courier shipments — no matter which category the product would otherwise fall into, and no matter who is receiving it.

Commonly seen here: strong pain medicine (opioids), anxiety medicine (benzodiazepines), ADHD medicine (stimulants), codeine at any strength, testosterone and other steroids, and — for pets — ketamine and tramadol.

DEA allows travelers to carry certain lawfully obtained controlled medicines across the border in person (generally 50 doses for US residents), but that rule is only for carrying it in person. DEA has said plainly that it is illegal to have controlled substances shipped to the US from another country unless the receiver is DEA-registered — regardless of a valid prescription. Ordinary foreign pharmacies are almost never DEA-registered.

This overrides the other sections: a valid prescription doesn't help (prescription medicines); codeine cough syrup sold OTC abroad is still controlled here (OTC medicines); anabolic steroids and SARMs fall here too regardless of label (supplements — SARMs specifically are unlawful under FDA's unapproved-drug rules, not DEA's controlled-substance rules); ketamine and tramadol are controlled, and xylazine/medetomidine should be treated the same way (pet medicines).

The penalty is also more severe: an ordinary unapproved-but-harmless product usually just gets held, refused, or destroyed. Controlled-drug shipments can be seized permanently and referred for criminal charges.

Quick answers 

Terms to know 

• FDA: Decides whether medicines, supplements, and devices can be sold or brought into the US.
• DEA: Handles controlled drugs — separate from, and stricter than, FDA.
• NDC: A drug's official US listing number. Not having one is a strong sign a product isn't listed for US sale; having one doesn't mean FDA approved it.
• Personal Importation Policy: FDA's name for its case-by-case discretion to sometimes allow a small, personal shipment of an otherwise unapproved drug.
• Import Alert: A public FDA list of factories, products, or countries whose shipments can be detained automatically, without inspection or testing, because of past problems.
• Importer of record (IOR): The company or person legally responsible for a shipment following the rules — can be fined or face legal trouble if it doesn't.
• PGA data: Extra information partner government agencies like FDA require before a shipment can clear, now required for every shipment in this guide regardless of value.