Where Your Drug Is Made Depends On Who You Ask

Written by Lucia Mueller | Posted March 30, 2022 | Updated December 12, 2023

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

Brand Name Medicare Spending 2018 FDA MADE IN CBP MADE IN Marketing Drug Company
Eliquis $4,992,184,164.40 USA SWITZERLAND Bristol-Myers Squibb & Pfizer
Revlimid $4,065,088,800.50 SWITZERLAND SWITZERLAND Celgene Corporation
Xarelto $3,358,810,708.00 USA GERMANY Janssen Pharmaceuticals, Inc.
Januvia $3,228,917,720.20 UK ITALY Merck Sharp & Dohme Corp.
Lyrica $2,950,257,660.50 SINGAPORE SINGAPORE Pfizer
Advair Diskus $2,394,014,929.40 UK ENGLAND GlaxoSmithKline LLC
Humira Pen $2,388,794,496.60 USA USA AbbVie Inc.
Lantus Solostar $2,370,490,821.50 GERMANY GERMANY sanofi-aventis U.S. LLC
Imbruvica $1,867,207,012.50 USA CHINA Pharmacyclics LLC; Janssen Biotech, Inc.
Symbicort $1,751,221,155.50 FRANCE FRANCE AstraZeneca
Harvoni $1,726,263,039.20 IRELAND IRELAND Gilead
Novolog Flexpen $1,712,623,585.10 DENMARK DENMARK Novo Nordisk
Levemir Flextouch $1,584,105,949.80 DENMARK DENMARK Novo Nordisk
Ibrance $1,507,730,890.00 IRELAND IRELAND Pfizer Laboratories
Zytiga $1,475,649,550.90 FRANCE BELGIUM Janssen
Spiriva $1,425,533,898.50 GERMANY GERMANY Boehringer Ingelheim Pharmaceuticals, Inc.
Trulicity $1,360,642,452.00 IRELAND IRELAND Eli Lilly and Company
Victoza 3-Pak $1,341,681,067.80 DENMARK DENMARK Novo Nordisk
Lantus $1,253,375,347.20 GERMANY GERMANY sanofi-aventis U.S. LLC
Enbrel Sureclick $1,247,769,463.30 USA USA Amgen
Copaxone $1,208,097,769.30 USA ISRAEL Teva Neuroscience, Inc.
Humalog Kwikpen U-100 $1,199,656,303.70 USA USA Lilly
Xtandi $1,182,615,333.30 USA USA Astellas Pharma US
Latuda $1,172,672,481.00 JAPAN JAPAN Sunovion
Breo Ellipta $1,159,269,757.70 USA USA GlaxoSmithKline LLC
Invega Sustenna $1,066,610,505.70 BELGIUM IRELAND Janssen
Myrbetriq $1,063,585,890.00 JAPAN; IRELAND JAPAN; IRELAND Astellas Pharma US, Inc.
Restasis $1,058,506,137.70 USA USA Allergan
Tradjenta $1,043,195,403.10 GERMANY GERMANY Boehringer Ingelheim Pharmaceuticals, Inc.
Tecfidera $1,019,481,294.40 USA SWITZERLAND Biogen
Jakafi $925,013,339.45 USA USA Incyte Corporation
Pomalyst $911,338,941.04 SWITZERLAND SWITZERLAND Celgene Corporation
Epclusa $896,454,302.85 IRELAND IRELAND Gilead Sciences, Inc.
Atorvastatin Calcium $881,065,067.26 IRELAND IRELAND Pfizer
Genvoya $871,858,538.09 CANADA CANADA Gilead Sciences, Inc.
Levothyroxine Sodium* $828,162,512.18 USA, IRELAND USA, FRANCE, ITALY, JAPAN, MEXICO, GERMANY Abbot Laboratories
Triumeq $764,629,132.10 USA USA ViiV Healthcare Company
Linzess $761,658,895.28 IRELAND; UK IRELAND; UK AbbVie and Ironwood Pharmaceuticals, Inc.
H.P. Acthar $724,638,118.93 USA USA Questcor Pharmaceuticals
Oxycontin $711,006,196.30 USA USA Purdue Pharma LP
Metoprolol Succinate $705,396,295.30 USA SPAIN Validus Pharmaceuticals
Novolog $694,913,262.07 DENMARK DENMARK Novo Nordisk
Janumet $692,159,591.60 UK UK Merck Sharp & Dohme Corp.
Vesicare $691,720,521.79 USA IRELAND Astellas Pharma US
Invokana $671,727,313.53 ITALY; PUERTO RICO BELGIUM Janssen Pharmaceuticals, Inc.
Creon $668,508,828.37 GERMANY GERMANY AbbVie Inc.
Jardiance $668,459,355.87 ITALY ITALY Boehringer Ingelheim Pharmaceuticals, Inc.
Anoro Ellipta $666,541,776.00 USA USA GlaxoSmithKline LLC
Ranexa $658,259,298.44 GLOBALLY GLOBALLY Gilead
Renvela $654,147,390.98 UK UK SANOFI Genzyme Corporation
Tivicay $642,056,270.21 JAPAN JAPAN ViiV Healthcare Company
Pradaxa $637,564,815.62 GERMANY GERMANY Boehringer Ingelheim
Xifaxan $633,453,580.70 CANADA CANADA Salix Pharmaceuticals, Inc.
Tresiba Flextouch U-200 $627,964,946.53 DENMARK DENMARK Novo Nordisk
Aubagio $627,062,230.08 GERMANY GERMANY SANOFI Genzyme Corporation
Ofev $618,635,441.84 GERMANY GERMANY Boehringer Ingelheim Pharmaceuticals, Inc.
Enbrel $611,605,535.46 USA USA Amgen
Letairis $608,195,650.13 CANADA CANADA Gilead
Dexilant $601,789,192.16 JAPAN/GERMANY JAPAN/GERMANY Takeda
Forteo $599,576,421.55 FRANCE AUSTRIA Lilly USA, LLC
Humira $596,366,042.85 USA; ITALY USA (PUERTO RICO); SINGAPORE; GERMANY AbbVie Inc.
Toujeo Solostar $596,026,240.76 GERMANY GERMANY Sanofi-Aventis U.S. LLC
Humalog $589,288,819.45 USA USA Lilly
Stelara* $582,683,696.71 USA; SWITZERLAND USA; SWITZERLAND Janssen Biotech, Inc.
Gabapentin $579,940,201.97 INDIA INDIA Pfizer
Ventolin HFA $574,608,767.94 UK UK GlaxoSmithKline LLC
Esbriet $571,407,727.59 USA USA Genentech, Inc.
Descovy $568,751,710.66 CANADA CANADA Gilead Sciences, Inc.
Lumigan $548,708,659.54 USA USA Allergan
Vimpat* $545,362,956.28 USA USA UCB, Inc.
Imatinib Mesylate $539,684,275.87 GERMANY IRELAND Novartis
Levemir $538,215,607.69 DENMARK DENMARK Novo Nordisk
Spiriva Respimat $529,512,525.92 GERMANY GERMANY Boehringer Ingelheim Pharmaceuticals, Inc.
Hydrocodone-Acetaminophen $529,426,439.49 USA USA Mayne Pharma
Rosuvastatin Calcium $527,275,103.59 USA UK AstraZeneca
Incruse Ellipta $517,467,101.90 USA USA GlaxoSmithKline LLC
Aripiprazole $507,896,142.19 JAPAN JAPAN Otsuka America Pharmaceutical, Inc.
Combivent Respimat $507,498,092.26 GERMANY GERMANY Boehringer Ingelheim
Esomeprazole Magnesium $506,138,795.93 SWEDEN FRANCE AstraZeneca
Potassium Chloride* $500,342,391.44 USA USA Upsher Smith
Entresto $476,575,743.08 SINGAPORE SINGAPORE Novartis Pharmaceuticals Corporation
Duloxetine HCl $471,161,117.21 USA USA Eli Lilly
Shingrix $470,758,395.75 BELGIUM BELGIUM GlaxoSmithKline
Gilenya $470,215,655.42 SWITZERLAND SWITZERLAND Novartis Pharmaceuticals Corporation
Opsumit $468,822,598.28 SWITZERLAND SWITZERLAND Actelion Pharmaceuticals US, Inc.
Novolog Mix 70-30 Flexpen $465,998,078.48 DENMARK DENMARK Novo Nordisk
Basaglar Kwikpen U-100 $465,157,479.09 USA USA Eli Lilly and Company
Mavyret $461,337,390.85 IRELAND IRELAND AbbVie Inc.
Brilinta $424,147,174.95 SWEDEN BELGIUM AstraZeneca Pharmaceutical
Bystolic $406,228,393.84 IRELAND IRELAND Allergan
Flovent HFA $400,675,877.63 FRANCE FRANCE GlaxoSmithKline LLC
Travatan Z $393,794,154.41 USA USA Alcon Laborities Inc
Ezetimibe $392,719,405.97 USA SINGAPORE Merck Sharp & Dohme Corp.
Omeprazole $389,696,704.42 USA IRELAND AstraZeneca
Tagrisso $387,940,689.67 SWEDEN SWITZERLAND AstraZeneca
Afinitor $386,491,662.51 SWITZERLAND SWITZERLAND Novartis Pharmaceuticals Corporation
Proair HFA $377,179,823.13 IRELAND IRELAND Teva Respiratory
Sevelamer Carbonate $374,445,195.52 UK UK Genzyme Corporation
Sprycel $372,249,027.07 SWITZERLAND SWITZERLAND Bristol-Myers Squibb
Farxiga $356,573,700.23 IRELAND IRELAND AstraZeneca Pharmaceuticals LP

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.

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