Can You Import Medication During a Drug Shortage? The FDA's Answer
Your drug is on the FDA shortage list, the pharmacy cannot get it, and a friend says Canadian pharmacies will ship it. Can you import medication during a drug shortage? The short answer: the FDA's personal importation policy is discretion, not permission, and it was never designed for shortage drugs that are approved and marketed in the US.
Read this first. I am not a pharmacist or a lawyer. Importing prescription drugs is illegal in most cases under the Federal Food, Drug, and Cosmetic Act, and this article explains the policy landscape, not a loophole. Talk to your prescriber and pharmacist about legal options first.
The Personal Importation Policy, in plain English
The FDA's Personal Importation Policy (PIP) is a guidance document that tells agency staff when to look the other way on small personal drug shipments. The key word is guidance. It sets out the factors the FDA considers before exercising enforcement discretion:
- The drug treats a serious condition for which there is no effective treatment available in the US.
- There is no commercialization or promotion of the drug to US residents.
- The product does not represent an unreasonable health risk.
- The shipment is for the patient's own use, generally no more than a 90-day supply, with a written affirmation.
- The request names a US-licensed physician responsible for the patient's treatment.
The FDA says plainly that this policy does not give anyone a license to import, does not change the law, and creates no legally enforceable rights. And notice the first factor: no effective treatment available domestically. A drug that is FDA-approved and simply in shortage usually has some domestic channel, a therapeutic alternative, or a compounded version, so it fits the policy poorly even before 2026.
What changed in October 2026
New Customs and Border Protection rules that took effect October 22, 2026, ended the old informal customs entry for low-value mail shipments and routed them through a new electronic informal entry process (Entry Type 13). The practical effect: personal-use drug parcels that used to pass through with minimal scrutiny now face upfront review against the FDA's criteria. Shipments that would have quietly arrived in September are now refused or seized when they do not meet every PIP factor. If you were counting on the old informal-mail route, the enforcement gap you were using has closed.
Can you import medication during a drug shortage? Do these first
If the import route is as narrow as it sounds, it is. Here is the order I would try things in, because every one of these has a better success rate than a cross-border parcel.
First, ask your prescriber about a therapeutic alternative or a different dosage form. During shortages, manufacturers sometimes still ship one strength while another is out; your doctor can adjust the prescription, and pharmacists can often substitute with authorization.
Second, ask the pharmacy about a partial fill. Many states allow pharmacists to dispense part of a prescription now and the rest when supply returns, so you do not lose the full fill to someone else's queue.
Third, ask whether a compounding pharmacy can prepare the drug. For some shortages this is the most practical answer; it is legal, domestic, and regulated by state boards of pharmacy.
Fourth, report the shortage to the FDA. The agency tracks shortage reports and has, in some cases, worked with manufacturers to resolve supply problems or allowed temporary import of specific drugs under regulatory supervision. That is the legal version of importing: the FDA arranging it, not you.
If you are still considering a personal import after all of that, bring the full PIP criteria to a lawyer, not a forum. The policy is a decision tree for border agents, and you want to know where you fall in it before the package is in the mail.
Frequently asked questions
Can you import medication during a drug shortage?
The FDA's Personal Importation Policy lets the agency exercise enforcement discretion over small personal shipments in narrow circumstances, but it is not a legal right to import. Importing a drug that is approved and marketed in the US, even one in shortage, generally falls outside that discretion.
What is the FDA Personal Importation Policy?
A guidance the FDA uses to decide when not to enforce the law against personal drug imports. It considers whether the drug treats a serious condition with no effective domestic treatment, is not promoted in the US, poses no unreasonable risk, is for personal use in a 90-day supply or less, and is tied to a named US-licensed physician.
How much medication can you bring into the US for personal use?
The FDA generally considers shipments of a 90-day supply or less when exercising discretion under the Personal Importation Policy. Amounts above that look commercial and are more likely to be refused or seized.
What changed about importing prescription drugs in 2026?
New Customs and Border Protection rules effective October 22, 2026 ended the old informal entry process for low-value mail shipments and moved them through a new electronic informal entry system, subjecting more personal-use drug parcels to upfront FDA review.
Is it legal to buy prescription drugs from a Canadian pharmacy?
In most cases, no. Importing prescription drugs from abroad remains illegal under the Federal Food, Drug, and Cosmetic Act even with a valid prescription. The FDA has historically exercised discretion on some small personal shipments, but that discretion grants no legal right.
Related reading: How to Check the FDA Drug Shortage List · Can Your Pharmacist Give a Partial Fill? · Can a Compounding Pharmacy Help During a Shortage? · The Questions to Ask Your Doctor About a Shortage