Shipping prescription drugs to U.S. patients from a foreign pharmacy after October 22, 2026

What changes on October 22, 2026?

The interim final rule of June 24, 2026 (FR 2026-12669) amended 19 CFR 145.12. From October 22, 2026, mail of $2,500 or less needs formal entry if it is subject to the requirements of another government agency, or to duties in HTSUS chapter 98 or 99. A prescription drug is always subject to FDA. A patented drug can also be subject to a Section 232 duty in chapter 99.

• Route: a formal entry (type 01), or an entry type 13 (Informal Mail Entry) while the CBP test runs.
• Bond: a basic importation and entry bond, single transaction or continuous (19 CFR 113.62).
• Filer: the owner or purchaser of the goods, or a licensed customs broker that the owner, purchaser or consignee designates.

The de minimis exemption is suspended for all countries, including mail, since August 29, 2025. CBP can also require formal entry of any mail shipment at any value (19 CFR 145.12(a)(1)).

Who can be the importer of record?

Under 19 U.S.C. 1484(a)(2)(B), the importer of record is the owner or purchaser of the goods, or a licensed customs broker that the owner, purchaser or consignee designates. The importer of record answers to CBP for the entry, the duty and the data.

• The U.S. patient, when the patient is the purchaser of the drug at the time of import.
• The pharmacy, only when it still owns the drug when the parcel enters the United States.
• A licensed customs broker, when a party with that right designates it. Under entry type 13, the broker acts as importer of record for a consignee that is not the owner or purchaser, and the broker's bond is obligated.

A postal operator, a carrier or a fulfillment partner that does not own the drug cannot be the importer of record itself. A broker does not lend its name: it signs for an entry only with complete data and a written appointment. Your sale terms decide who owns the drug at import, so settle them before the first parcel. Every importer of record needs an IOR number, with accurate CBP Form 5106 data.

Does FDA allow a patient to import a prescription by mail?

Not as a right. FDA states that in most cases it is illegal for individuals to import drugs for personal use, because drugs bought abroad are often not approved by FDA. FDA can use enforcement discretion for a personal import. For a serious condition, its personal importation policy lists these conditions:

• Effective treatment may not be available in the United States.
• There is no known commercialization or promotion of the product to persons who live in the United States.
• The product does not represent an unreasonable risk.
• The patient affirms in writing that the product is for personal use.
• The quantity is generally not more than a three-month supply, with the name and address of the U.S.-licensed doctor who treats the patient, or evidence that the treatment began abroad.

What FDA data goes in the entry for a drug?

Each drug line carries the FDA product code, the country of production, an intended use code and, for some codes, affirmations of compliance. The intended use code must describe the real product and the real use.

Canadian-labelled stock carries a Drug Identification Number (DIN), not a U.S. National Drug Code (NDC). It is not the U.S.-approved product, so code 080.012 does not describe it. For a parcel dispensed to a named patient, the true code is usually 100.000. Do not declare 080.012 with the application number of a U.S. product that is not in the parcel.

FDA drug lines use affirmation codes. They do not use a license or permit record (LPCO). In the entry, LPCO data for a drug is a DEA item only: a DEA-357 import permit (code 911) or a DEA-236 import declaration (code 921).

What Section 232 duty applies to a patented drug?

Proclamation 11020 put a Section 232 duty on patented drugs and their ingredients. It applies to the products of all companies entered from 12:01 a.m. Eastern on September 29, 2026 (CSMS #70054007). The rate depends on the country where the drug was made, not on where the pharmacy is.

• U.S. note 40(c) defines a patented drug as one subject to a valid, unexpired U.S. patent and listed in the FDA Orange Book or Purple Book. A generic is an FDA-approved drug that is off patent and off exclusivity, approved under a qualifying application such as an ANDA.
• Canada has no reduced rate. USMCA does not remove the duty: CBP collects it in addition to any special rate.
• 9903.04.66 (0%) is only for listed specialty drugs, for example orphan drugs and cell or gene therapies, from the jurisdictions listed in 91 FR 60360. Canada is not on the list.
• Every covered line must report its chapter 99 number, also at 0%. Settle the heading for each product before you ship it.

What happens if FDA refuses a parcel?

FDA sends the owner or consignee a notice with the reasons and a period to present evidence (21 CFR 1.94). If the refusal stands, the drug must be exported or destroyed, generally within 90 days. FDA can destroy a refused drug valued at $2,500 or less without the opportunity to export it (21 U.S.C. 381(a)). Most prescription parcels are under that value.

When CBP needs a formal entry for a held parcel, it sends the addressee a CBP Form 3509. The addressee has 30 days from the date of the notice to act.

Can a foreign pharmacy mail controlled drugs?

No. Only a DEA registrant with a DEA import permit or declaration can import a controlled substance (21 U.S.C. 952 and 957, 21 CFR part 1312). The personal exemption in 21 CFR 1301.26 covers only a person who carries the drug when entering the United States. It does not cover mail. Remove every controlled drug from a U.S. program.

Can a pharmacy use Section 804 importation?

Not on its own. Section 804 of the FD&C Act (21 U.S.C. 384) and 21 CFR part 251 allow importation programs that a State or an Indian Tribe sponsors. A Canadian wholesaler with a Health Canada licence sells to a U.S.-licensed pharmacist or wholesaler, which owns the drugs at entry. It is a wholesale channel, not a route to mail parcels to patients.

What data must a pharmacy send for each parcel?

Send the data before the mail arrives, by API or by file. For each parcel:

• Foreign postal tracking number, sender name and address, and patient name and address.
• The importer of record for the parcel, under your sale terms.
• For each drug: name, strength, dosage form, quantity and value in USD.
• DIN or NDC, and the U.S. application number if the product is the U.S.-approved version.
• Country where the drug was made, the manufacturer name and address, and the FEI or DUNS if known.
• Patent status: patented brand or generic.
• Prescription data: the name and address of the U.S.-licensed prescriber, and the patient's written personal-use affirmation.
• A statement that the parcel contains no controlled substance.

How can Allied help?

• Entry type 13 program: we file as a licensed customs broker, CBP filer code 9AJ, and agree the importer of record and the bond with you.
• Data feed: we take your parcel data by API or by file and map it to the ACE data.
• Review of each parcel: classification, the Section 232 heading, the intended use code, and a stop on any controlled drug.
• Held parcels: we file the formal entry when CBP sends a CBP Form 3509.

We control the accuracy of the entry. We do not control FDA's decision, and we cannot promise that FDA releases a parcel.