Where Your Drug Is Made Depends On Who You Ask

Federal Law and Drug Labeling: Differing Definitions of An Imported Drug

Your medication is – most likely – not made in the United States. 

We reviewed the Food, Drug and Cosmetic Act (FDCA), the Tariff Act, and the Federal Trade Commission (FTC) Act because they each can affect how a drug manufacturer labels a drug product in terms of its country of origin. The interplay of the various requirements can prove difficult for consumers and policymakers to readily ascertain where a drug was made.

The FDA, which is responsible for enforcing the FDCA, and U.S. Customs and Border Protection, an agency with the Department of Homeland Security, play prominent roles in the importation of prescription drugs[i]:

❖      The FDA regulates which drugs can be imported.

❖      CBP, along with the FDA, regulates the physical importation of drugs.

The FDA and CBP have different definitions for assigning a country of origin to a drug. To the FDA, the country where the final drug formulation (FDF) of a drug occurs, including where it’s packaged, is the drug’s country of manufacture.[ii] The FDCA does not require manufacturers to publish the countries of manufacture on prescription drug labels or otherwise make the information public.^[iii]

To CBP, the country in which the active pharmaceutical ingredient (API) is made is the country of origin.[iv] Therefore, to the CBP, under most circumstances, an imported drug is one where the API was manufactured outside the United States.[v] There are exceptions to CBP’s definition: if a drug is substantially transformed during the manufacturing process regardless of where the ingredients came from, and/or when two APIs are combined into one drug formulation.[vi]

Consider the drug Eliquis (apixaban). According to its label, the API of Eliquis, apixaban, is made in Switzerland, but it becomes an FDF in the United States. To the FDA, Eliquis is manufactured in the United States. To the CBP, Eliquis is an imported drug.

While the FDCA does not require drug companies to publish the countries of manufacture on prescription drug labels, the Tariff Act and the FTC Act add requirements and constraints on drug labels of imported products. ^{[vii] [viii]}

❖      The Tariff Act mandates that the country of a product’s origin is printed on the labels of all imported products and is enforced by CBP.[ix]

❖      The FTC Act prohibits false or misleading “Made in America” claims.[x]

In understanding the requirements of the FDCA, the Tariff Act, and the FTC Act, and how they work together, with access to the manufacturer’s label, it usually becomes clear where a drug was made, both the FDF and the API.

The Manufacturing Origin of the Top Expenditure Medicare Drugs in 2018, According to the FDA and CBP Differing Definitions

Data originally published by PharmacyChecker Research in the 2022 report Not Made in the USA: The Global Pharmaceutical Supply Chain and Prospects for Safe Drug Importation.

[i] Import basics. (2020, February 27). U.S. Food and Drug Administration. https://www.fda.gov/industry/import-program-food-and-drug-administration-fda/import-basics

[ii] Customs and FDA at odds on pharmaceutical labeling. (2016, September 15). Benjamin L. England & Associates. https://benjaminlengland.com/customs-fda-odds-pharmaceutical-labeling/

[iii] Federal food, drug, and cosmetic act (FD&C act) (Title 21). (2018, March 29). United States Code. https://www.fda.gov/regulatory-information/laws-enforced-fda/federal-food-drug-and-cosmetic-act-fdc-act

[iv] Trade agreements Act of 1979, 19 U.S. code § 2518 – Definitions (1979). ^{https://uscode.house.gov/view.xhtml?path=/prelim@title19/chapter13&edition=prelim}

[v] Customs, supra note 23.

[vi] Import Basics, supra note 22.

[vii] Tariff act of 1930, 19 U.S. code §2571 —Customs duties (1930). https://uscode.house.gov/view.xhtml?path=/prelim@title19/chapter4&edition=prelim

[viii] Federal Trade Commission Act. (2018, December 14). Federal Trade Commission. https://www.ftc.gov/enforcement/statutes/federal-trade-commission-act

[ix] Tariff act of 1930, supra note 28.

[x] Federal Trade Commission Act, supra note 29.