How FDA uses temporary importation during drug shortages

On May 24, 2023, hospitals were sent a letter about cisplatin, a platinum chemotherapy drug then in national shortage. The vials about to arrive had labels printed only in Chinese. They did not carry the words "Rx only." Their barcodes might not scan. The product, the letter posted by FDA¹ said, was "marketed and manufactured in China and is not FDA-approved." FDA had agreed to let it in anyway.

FDA calls this temporary importation. In its annual reports to Congress, the agency describes it as something it does with "FDA-registered foreign sources, in rare instances when all alternative approaches were exhausted," in the words of the report for 2025¹¹. Since 2023 it has been used for at least three widely watched shortages: cisplatin, the long-acting antibiotic penicillin G benzathine, and the IV and dialysis fluids lost when Hurricane Helene damaged a North Carolina plant in September 2024.

This piece explains the legal gap temporary importation fills, how FDA says it picks a foreign source, what changes for the hospitals and pharmacies that receive the product, and how each of the three cases ended or did not. It is a separate mechanism from state programs under section 804 and from FDA's personal importation policy.

The legal problem it works around

A foreign version of a US drug is, in US law, a different and unapproved product, even when the active ingredient and strength match. Its label, packaging and sometimes its formulation were approved by another country's regulator. Under 21 U.S.C. 381(a)⁵, FDA refuses admission to an imported drug that appears to be "in violation of section 355 of this title," the section that requires approval before a new drug is sold.

Temporary importation does not change that rule. FDA chooses, for a period, not to enforce it. When FDA allowed in a France-marketed penicillin product, the CDC told clinicians in a Jan. 16, 2024 letter⁶ that FDA "has exercised enforcement discretion for a temporary importation and use of this treatment." FDA's report for 2024¹⁰ used the same phrase about IV fluids: the agency "exercised enforcement discretion for temporary importation to provide treatment options for patients in critical need during the shortage."

How FDA says it picks a source

FDA's shortage FAQ⁴ lays out the sequence. When US manufacturers cannot resolve a shortage quickly and the drug is medically necessary, FDA "may look for an FDA-registered foreign manufacturer that is willing and able to redirect foreign-approved product into the U.S. market." It asks that firm for information about the formulation and other attributes of the drug and about the quality of the plant. FDA's Drug Shortages Staff then monitors the shortage and decides when the foreign product is no longer needed.

A December 2024 FDA presentation to clinicians gave more detail. Importation, the slides⁷ said, is explored when US-approved makers cannot meet demand and "there are no adequate substitutes," and it is a "last resort to meet critical patient need." FDA first asks companies that already sell in the US whether they make the drug for other markets, then contacts regulators in countries with strong regulatory systems, naming the European Union, the United Kingdom, Canada and Australia as examples. The last step on the slide is to "confirm import will not cause shortage in other countries."

FDA's FAQ adds an exception. After a declared public health emergency or a natural disaster, several firms may approach FDA at once with foreign products, and FDA says it generally considers those offers as they arrive while seeking the same formulation and manufacturing information.

FDA's reports to Congress do not give a separate yearly count of temporary importations. They give a broader figure, the number of times it used "regulatory flexibility and discretion" to prevent or ease a shortage, which also covers steps such as supplying filters with a product that has particulate problems or requiring extra testing before release.

One instance can cover several products, the reports note, and the totals include products FDA carved out of import alerts. Temporary importation is one category inside these numbers.

What arrives at the hospital

The importations described here each came with a "Dear Healthcare Provider" letter, written by the importing firm and posted by FDA. The letters list the lots allowed in and flag the ways the product departs from what US staff expect. They also name the authorized importer and its distributors, and say no other entity is authorized by FDA to import or distribute that product.

The cisplatin letter is typical. The foreign cartons lacked two warnings that appear on the US product, so a sticker with the warnings, product name, strength, US National Drug Code and a US-readable barcode was applied to each vial and carton. A second sticker added "Rx only." Hospitals were told to enter the product into their systems by hand. The carton also lacked the product identifier the Drug Supply Chain Security Act requires: the NDC, a serial number, lot and expiration date in both human-readable form and a two-dimensional barcode. A June 26, 2023 update² added more lots under the same terms.

A June 2024 penicillin G benzathine letter¹³ carried the same barcode caution and said the Portuguese manufacturer did not meet DSCSA requirements for interoperable exchange of tracing information. For the France-marketed version, the CDC letter noted that "preparation and administration" and the contraindications differ from the US product, details that belong to clinicians and pharmacists.

Three recent cases

Sources: FDA roundups of June 28, 2024³ and Oct. 18, 2024¹⁶; FDA-posted letters of May 24, 2023¹, Nov. 21, 2023¹² and June 11, 2024¹³; GxRadar's shortage tracker.

Cisplatin. When FDA declared the shortage over, its June 28, 2024 roundup³ listed temporary importation among its steps and added that the foreign manufacturer "has since received FDA approval for cisplatin, bringing the total number of approved manufacturers to seven." The foreign source became an approved one. Our history of the 2023 cancer drug shortage covers the plant closure behind it.

Penicillin G benzathine. Only one FDA-approved version of the injection was on the market, and FDA's slides said most other countries reported relying on the same source. The first import was marketed in France and made in Italy, under an FDA-posted letter dated Nov. 21, 2023¹². A second came from Portugal in June 2024 and was renewed for new lots in a June 17, 2026 letter¹⁴. That import was still listed as available in September 2026, while the approved product's syringes were not expected to recover until late 2027. The full timeline is in our history of the shortage.

IV fluids. By Oct. 11, 2024, FDA had added dextrose 70%, lactated Ringer's and peritoneal dialysis solution to its shortage list, according to the Oct. 11, 2024 roundup¹⁵. A week later, the agency said it had helped facilitate "the temporary importation of 23 different IV and PD fluids from five" of the manufacturer's facilities around the world. The 2024 report to Congress described "millions of units of product from at least four different international facilities." The shortage of 0.9% sodium chloride ended on Aug. 8, 2025, when FDA's commissioner said in a statement¹⁷ that temporary importation had been one of the tools used. Our account of the 2024 IV fluid shortage has the details.

How an importation winds down

FDA's statement on saline included a line that applies to all of these cases: "We generally recommend hospitals, health systems, and clinics use the FDA-approved drug when available." Once approved supply covers demand, the foreign lots stop being needed, and FDA's shortage staff makes that call. Imported lots carry their own expiration dates; the Portuguese penicillin lots listed in the June 2026 letter are labeled to expire in early 2030.

Some of what the 2024 storm took off the market is still short. On Nov. 3, 2026, GxRadar's tracker showed dextrose 70% injection, added to FDA's list in October 2024, still in current shortage, alongside dextrose 5%, 10% and 50% solutions that were short before the storm. Penicillin G benzathine has been on the list since April 2023. Broader federal efforts to keep supply from depending on one plant are covered in how FDA works to prevent shortages and in our piece on compounding during shortages.