FDA's personal importation policy and the 90-day supply rule

In 2022, FDA inspectors at the country's international mail facilities examined nearly 53,000 drug shipments. Thirty-three contained opioids and none contained fentanyl, the agency told KFF Health News in 2023³. FDA officials told the outlet that more than 90 percent of the drugs found at those facilities are destroyed or denied entry.

Whether a parcel like that gets through is governed less by a statute than by a few pages of an internal FDA manual. Subchapter 9-2 of the agency's Regulatory Procedures Manual, "Coverage of Personal Importations," is where the often-repeated "90-day supply" comes from.

That figure is widely read as a right to bring in three months of any medicine. FDA's own text describes something narrower: a set of conditions under which staff may use discretion not to refuse a shipment, aimed mostly at treatments people cannot get in the United States. Below: what the manual says, who inspects what, what FDA says about the risks, and a 2003 waiver authority that has never been put to wide use.

What federal law says about bringing medicine in

Section 801(a) of the Federal Food, Drug, and Cosmetic Act says an imported drug "shall be refused admission" if it appears to be adulterated, misbranded or unapproved, according to the text at 21 U.S.C. 381⁵. A separate clause, section 801(d)(1), bars anyone but the manufacturer from bringing back a prescription drug that was made in the United States and exported.

Congress added that reimportation ban in 1988 to keep a "closed system" for prescription drugs, the Congressional Research Service wrote in its March 2026 summary of importation law⁴. The same report notes FDA's view that even a foreign version of an approved drug, with the same active ingredient from the same company, is "highly unlikely" to meet every US requirement.

FDA states the general rule plainly on its personal importation page²: "In most circumstances, it is illegal for individuals to import drugs or devices into the U.S. for personal use."

Where the 90-day figure comes from

Subchapter 9-2's background section explains why the policy exists. Personal shipments are "normally small, both in size and value," so "comprehensive coverage of these imports is normally not justified," according to Chapter 9 of the Regulatory Procedures Manual¹, in the version dated March 2024. Enforcement focuses more on commercial shipments, including small mail-order ones, than on medicine a traveler carries in.

For prescription drugs, the manual lists the situations in which staff "may consider a more permissive decision." Both are reproduced on FDA's public page².

Sources: FDA Regulatory Procedures Manual, Chapter 9¹ and FDA's personal importation page², updated Aug. 18, 2025.

FDA's manual adds a caution of its own. Although FDA "may use discretion to allow admission of certain violative items, this should not be interpreted as a license to individuals to bring in such shipments." CRS put it another way: the policy "has normally not been intended as a way for consumers to bring lower-priced prescription drugs into the United States," its report says⁴, but to give access to treatments not otherwise available here.

Who opens the package

FDA staff do not search luggage. "FDA personnel are not to examine personal baggage. This responsibility rests with the CBP," the manual says¹, referring to US Customs and Border Protection, which is expected to alert FDA when it finds something that looks commercial, fraudulent or risky.

Mail works differently. Parcels arriving through the international mail facilities are examined first by CBP officers, who set aside anything that appears to contain a drug. FDA then reviews those parcels, usually relying on a "documentary sample" such as labels and inserts. Staff can release a parcel "with comment," warning that the drug appears unapproved and future shipments may be detained. Drugs that fall under Drug Enforcement Administration jurisdiction are returned to CBP for handling.

Since 2012, FDA has also had the power to destroy refused drugs valued at $2,500 or less without giving the owner the option of sending them back abroad. That clause was added by section 708 of the FDA Safety and Innovation Act, according to the statutory notes to section 801⁵. Before destruction, the owner gets a written notice and a chance to present testimony, under 21 CFR 1.94⁷. FDA also refuses shipments of products on an import alert, the subject of GxRadar's explainer on how FDA import alerts work.

What FDA says about the risks

FDA's stated concern is that it cannot vouch for what is inside. "The FDA cannot ensure the safety and effectiveness of medicine purchased over the Internet from foreign sources, storefront businesses that offer to buy foreign medicine for you, or during trips outside the U.S.," its personal importation page says².

Counterfeit drugs, FDA says, "may contain the wrong ingredients, contain too much, too little or no active ingredient at all or contain other harmful ingredients," and many "are made abroad and arrive in the U.S. through the mail," according to its counterfeit medicine page⁸. The manual itself notes that some exporting countries do not regulate what leaves, so buyers "may not be afforded the protection of either foreign or U.S. laws." CBP data obtained by KFF Health News³ showed 365 counterfeits among the more than 30,000 drugs CBP inspected at mail facilities in 2022. The domestic system for tracing packages is covered in GxRadar's pieces on counterfeit drugs and the Drug Supply Chain Security Act.

For online sellers, FDA's BeSafeRx campaign⁹ lists warning signs. A site may be unsafe, the agency says¹⁰, if it does not require a prescription, is not licensed by a state board of pharmacy, or offers "prices that seem too good to be true." Readers with questions about a specific product, or about whether a medicine bought abroad matches the version sold here, can take them to a pharmacist; GxRadar's pharmacy finder lists licensed pharmacies by ZIP code.

Why generics rarely fit the savings story

Most of the price argument for importation concerns brand-name drugs. For generics, the numbers point the other way. A 2021 RAND analysis prepared for HHS found that in 2018, US prices for unbranded generics were 84 percent of prices in 32 comparison countries combined, according to the Office of the Assistant Secretary for Planning and Evaluation¹¹. Against Canada alone, the index for unbranded generics was 56.7, meaning US prices were roughly 57 percent of Canadian ones, in Table C.1 of the full report¹².

US generic prices have kept falling since. The GxRadar generic price index, built from federal NADAC survey data, stood at 47.4 in October 2026 (January 2014 = 100), about 53 percent below its starting point. Current pharmacy acquisition costs for 47 common generics are on the GxRadar prices page.

The waiver Congress wrote in 2003

Congress addressed personal importation directly in section 804(j) of the act, added by the Medicare Modernization Act of 2003. It declares that the HHS secretary "should" focus enforcement on imports that pose "a significant threat to public health" and exercise discretion to permit imports that are "clearly for personal use," according to 21 U.S.C. 384(j)⁶.

Two more paragraphs of the subsection go further. Paragraph (j)(2) lets the secretary grant waivers by regulation or case by case and requires published guidance "so that individuals may know with the greatest practicable degree of certainty whether a particular importation for personal use will be permitted." Paragraph (j)(3) directs a regulation allowing individuals to import up to a 90-day supply of an FDA-approved drug from a licensed Canadian pharmacy, with a copy of a valid prescription. The whole section takes effect only if the secretary certifies to Congress that it poses "no additional risk" and will cut costs significantly.

That certification came only in 2020, and it was made alongside the final rule for state bulk-importation programs¹³, the pathway covered in GxRadar's explainers on section 804 and on state importation programs. An executive order that July, reprinted in the notes to section 384⁶, directed HHS to facilitate individual waivers under (j)(2).

A second order, Executive Order 14297 of May 12, 2025, told the secretary to "consider certification" that importation under section 804(j) will pose no added risk and save money. If the secretary so certifies, FDA is to describe "circumstances under which waivers will be consistently granted" for drugs from "developed nations with low-cost prescription drugs," the order says¹⁴.

Neither FDA's personal importation page, last updated in August 2025, nor the Congressional Research Service's March 2026 summary describes a certification or waiver guidance issued under that order. Until one appears, the governing text remains the March 2024 version of RPM subchapter 9-2.