FDA import rules for medicines and health products
What you can and can't mail into the US under FDA rules — vitamins, OTC medicines, prescription drugs, pet medicine, and controlled substances.
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.
A big change is coming — October 22, 2026
Starting October 22, 2026, FDA-regulated mail shipments can no longer use the simplified postal entry process, even for very small, low-value packages. They must move through an ACE entry process that supports the required FDA data (PGA data). Zonos (or a Zonos partner) often acts as the importer of record on these shipments — the party customs holds legally responsible for the shipment clearing correctly.
Vitamins and supplements are treated the same way: FDA regulates both under the food category rather than as medicine.
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. Supplements count as food, so FDA Prior Notice is required before the parcel is mailed, even for personal-use quantities — see FDA Prior Notice below.
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.
Bottom line
Supplements get stopped often — almost always for a hidden ingredient or an illegal health claim. Check for banned ingredients, check the factory isn't blocked, and never allow disease-cure claims on the label.
Prior Notice is a filing made to FDA before a shipment arrives. It is separate from the customs entry, and filing the entry does not satisfy it.
Does it apply?
Type of good↕
Prior Notice required?↕
Dietary supplements
Yes
Food and beverages
Yes
Pet food and animal feed
Yes
OTC medicines
No
Prescription medicines
No
Pet and animal medicines
No
Food a traveler carries into the US for their own use
No
Homemade food mailed by the individual who made it, as a personal gift
No
Store-bought food mailed by an individual as a personal gift
No
Medicines are not food, which is why the three medicine categories are out of scope. Ordering food or supplements from a foreign seller is not covered by any of the No rows.
The two gift rows get there differently. Homemade food sent by the person who made it is exempt under the regulation. Store-bought food sent as a gift relies on FDA policy instead: FDA and CBP typically take no action over a missing Prior Notice when an individual — not a business — bought the food and mailed it to another individual for non-business reasons. Neither covers a business shipping to a customer.
What has to be done, in order
Mail runs on a different clock from other transport. Air, ocean, road, and rail file a set number of hours before arrival. A mailed parcel has to be filed for before it is sent to the United States.
Create the shipping label. From October 1, 2026, the filing has to include the mail service name and the mail tracking number, so the tracking number has to exist before the filing can be made.
File the Prior Notice with FDA, before the parcel is mailed. FDA responds with a PN Confirmation Number.
Put the PN Confirmation Number on the customs declaration. It has to appear on the CN22 or CN23 travelling with the package.
Give the number to whoever files the customs entry. From October 22, 2026, it is part of the FDA data filed electronically with the entry. A number that exists only on the paper declaration does not reach FDA through that filing.
Step 1 is the new part. Until October 1, 2026, the filing needs only the anticipated date of mailing, which is why a Prior Notice can currently be obtained before a label exists.
If the information changes after filing
What has to happen depends on the status of the Prior Notice.
In progress — amend it in place. It has not gone to FDA yet.
Submitted — it can no longer be edited. It has to be cancelled and refiled, and who can do that depends on how it was filed:
Filed in FDA's Prior Notice System Interface — cancel it there, then submit a new one.
Filed through ACE — a customs broker filed it, and only a customs broker can go back and submit a correction or cancel it. The change has to go through them.
If a parcel arrives without it
CBP holds the parcel for 72 hours so FDA can inspect it and decide. From there:
FDA refuses it and there is a return address — the parcel may be returned to the sender marked "No Prior Notice—FDA Refused."
There is no return address, or FDA judges the food a hazard — FDA may destroy it.
FDA does not respond within the 72 hours — CBP may return the parcel to the sender, or destroy it if there is no return address.
If a refused parcel is not exported, Prior Notice has to be filed within 10 calendar days of the refusal notice.
Bottom line
File the Prior Notice before the parcel is mailed, and put the confirmation number on the customs declaration. The order of operations changes on October 1, 2026: the tracking number has to be in the filing, so the label has to be created first.
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 (National Drug Code) 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.
What FDA looks for in a personal-use OTC shipment:
The individual importing the drug verifies in writing that it is for their own use.
The product is not for treatment of a serious condition, and there is no known significant health risk.
Not more than a 3-month supply.
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.
Bottom line
Ordinary foreign pain relievers and allergy pills don't get stopped nearly as often as prescription drugs, but that's not a guarantee. Treat any codeine or pseudoephedrine product as high risk no matter how it's sold abroad.
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.
There is no commercialization or promotion of the drug to US residents.
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.
If effective treatment is already available in the US, the exemption does not apply. That is what the serious-illness condition means in practice: the medicine has to be for something that cannot be effectively treated here, either by a product sold commercially or through a clinical trial.
Documentation covers the illness and the personal-use conditions — a doctor's letter, and the prescription plus a signed personal-use note. The commercialization and risk conditions depend on the seller and the product, not the buyer: no amount of paperwork fixes a pharmacy that markets to US residents, and "unreasonably risky" is FDA's call alone.
What to include with the shipment:
A list of the medications, with the manufacturer's name and address for each drug.
Suggested: a copy of the prescription, or a letter from the physician overseeing the treatment.
Most foreign pharmacy websites built to attract US shoppers — US-dollar pricing, US-targeted advertising — fail the commercialization 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.
Bottom line
Treat FDA's personal-use policy as a narrow exception that can be revoked, not a green light. A shipment from a pharmacy that advertises to US customers, lacks doctor documentation, or exceeds a 90-day supply is very likely outside this policy.
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.)
What to include with the shipment:
Documentation showing the medication is for the recipient's own use while visiting the US. This can include:
A copy of the visa or passport.
A letter from the doctor.
A copy of the prescription, in English.
Not more than a 90-day supply per shipment.
Bottom line
A visitor receiving ordinary, non-controlled medicine mailed from their home country, on the same terms as the citizen/resident case above, is one of the safer cases in this guide. Controlled drugs are not allowed either way — citizenship doesn't change that.
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.
FDA's personal-use conditions for pet medicine:
The drug is for a serious condition for which effective treatment is not available in the United States.
There is no commercialization or promotion of the drug to US residents.
The drug is considered not to represent an unreasonable risk.
The individual importing the drug verifies in writing that it is for their own use for their pet, and either provides the name and address of the US veterinarian responsible for the pet's treatment with the drug, or shows the product is for the continuation of treatment begun in a foreign country.
Not more than a 3-month supply.
What to include with the shipment:
A list of the medications, with the manufacturer's name and address for each drug.
Suggested: a copy of the prescription, or a letter from the veterinarian overseeing the treatment.
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.
Bottom line
Pet medicine is a mixed case: FDA recognizes personal importation with veterinary documentation, but enforcement guidance is stricter for unapproved animal drugs. A vet's letter doesn't overcome an unapproved product, an Import Alert, or a controlled ingredient.
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.
Bottom line
If it's a controlled drug, treat it as a hard no for mail or courier — full stop. This overrides FDA's personal-use policy, a valid prescription, and the receiver's citizenship. Build this in as an automatic screening rule, not a case-by-case judgment call.
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: National Drug Code, FDA's unique identifier for a drug product marketed in the US. 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.
Prior Notice (PN): An FDA filing that tells FDA a food shipment is on its way, separate from the customs entry. Required for food, supplements, and beverages — not for medicines.
PN Confirmation Number: The number FDA issues once it accepts a Prior Notice for review. For mail it has to appear on the customs declaration.
Disclaimer
This guide is for general informational purposes and does not constitute legal or customs advice. Rules in this area are changing quickly — confirm current requirements with FDA, CBP, or a licensed customs professional before shipping or filing.
FDA import rules for medicines and health products
FDA import rules for medicines and health products
What you can and can't mail into the US under FDA rules — vitamins, OTC medicines, prescription drugs, pet medicine, and controlled substances.
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.
Starting October 22, 2026, FDA-regulated mail shipments can no longer use the simplified postal entry process, even for very small, low-value packages. They must move through an ACE entry process that supports the required FDA data (PGA data). Zonos (or a Zonos partner) often acts as the importer of record on these shipments — the party customs holds legally responsible for the shipment clearing correctly.
Vitamins and supplements
Vitamins and supplements are treated the same way: FDA regulates both under the food category rather than as medicine.
Red flags that get shipments stopped:
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.
Supplements get stopped often — almost always for a hidden ingredient or an illegal health claim. Check for banned ingredients, check the factory isn't blocked, and never allow disease-cure claims on the label.
FDA Prior Notice
Prior Notice is a filing made to FDA before a shipment arrives. It is separate from the customs entry, and filing the entry does not satisfy it.
Does it apply?
Medicines are not food, which is why the three medicine categories are out of scope. Ordering food or supplements from a foreign seller is not covered by any of the No rows.
The two gift rows get there differently. Homemade food sent by the person who made it is exempt under the regulation. Store-bought food sent as a gift relies on FDA policy instead: FDA and CBP typically take no action over a missing Prior Notice when an individual — not a business — bought the food and mailed it to another individual for non-business reasons. Neither covers a business shipping to a customer.
What has to be done, in order
Mail runs on a different clock from other transport. Air, ocean, road, and rail file a set number of hours before arrival. A mailed parcel has to be filed for before it is sent to the United States.
Step 1 is the new part. Until October 1, 2026, the filing needs only the anticipated date of mailing, which is why a Prior Notice can currently be obtained before a label exists.
If the information changes after filing
What has to happen depends on the status of the Prior Notice.
If a parcel arrives without it
CBP holds the parcel for 72 hours so FDA can inspect it and decide. From there:
If a refused parcel is not exported, Prior Notice has to be filed within 10 calendar days of the refusal notice.
File the Prior Notice before the parcel is mailed, and put the confirmation number on the customs declaration. The order of operations changes on October 1, 2026: the tracking number has to be in the filing, so the label has to be created first.
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 (National Drug Code) 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.
What FDA looks for in a personal-use OTC shipment:
Watch closely:
Label must show: a Drug Facts box with active ingredients, dosage, and warnings, in English.
Ordinary foreign pain relievers and allergy pills don't get stopped nearly as often as prescription drugs, but that's not a guarantee. Treat any codeine or pseudoephedrine product as high risk no matter how it's sold abroad.
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:
If effective treatment is already available in the US, the exemption does not apply. That is what the serious-illness condition means in practice: the medicine has to be for something that cannot be effectively treated here, either by a product sold commercially or through a clinical trial.
Documentation covers the illness and the personal-use conditions — a doctor's letter, and the prescription plus a signed personal-use note. The commercialization and risk conditions depend on the seller and the product, not the buyer: no amount of paperwork fixes a pharmacy that markets to US residents, and "unreasonably risky" is FDA's call alone.
What to include with the shipment:
Most foreign pharmacy websites built to attract US shoppers — US-dollar pricing, US-targeted advertising — fail the commercialization 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.
Treat FDA's personal-use policy as a narrow exception that can be revoked, not a green light. A shipment from a pharmacy that advertises to US customers, lacks doctor documentation, or exceeds a 90-day supply is very likely outside this policy.
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.)
What to include with the shipment:
A visitor receiving ordinary, non-controlled medicine mailed from their home country, on the same terms as the citizen/resident case above, is one of the safer cases in this guide. Controlled drugs are not allowed either way — citizenship doesn't change that.
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.
FDA's personal-use conditions for pet medicine:
What to include with the shipment:
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.
Pet medicine is a mixed case: FDA recognizes personal importation with veterinary documentation, but enforcement guidance is stricter for unapproved animal drugs. A vet's letter doesn't overcome an unapproved product, an Import Alert, or a controlled ingredient.
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.
If it's a controlled drug, treat it as a hard no for mail or courier — full stop. This overrides FDA's personal-use policy, a valid prescription, and the receiver's citizenship. Build this in as an automatic screening rule, not a case-by-case judgment call.
Quick answers
Terms to know
This guide is for general informational purposes and does not constitute legal or customs advice. Rules in this area are changing quickly — confirm current requirements with FDA, CBP, or a licensed customs professional before shipping or filing.
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