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NBC Nightly News (1/22/19) carried a story about people purchasing insulin (which may or may not require a prescription) in Mexico because the same drug costs approximately 10% of the US price.

One person said they were purchasing a one-years supply for 104 USD versus 1400, had it been purchased in the US.

It would appear that this "might" be a federal crime FDA Basics, however the FDA link does not specify if this misdemeanor applies only for prescription drugs.

So, is insulin covered? Does it make a difference if it is obtained in Mexico without a prescription?

If it is not illegal, and a prescription is not required, is there anything to prevent a person from purchasing (in Mexico) say, five years worth and then "giving" the insulin to their US friends for a donation of 104$ to cover expenses.

Lastly, how would a person declare such purchases at the border? (based on US market price or actual price paid)?

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Importation of drugs is not per se illegal, but in specific cases could be. 21 USC 331(d) prohibits "the introduction or delivery for introduction into interstate commerce of any article in violation of section 344, 350d, 355, or 360bbb–3 of this title". §355 refers to and forbids importing any "new drug" which are not approved. "New drug" is a technical term referring to drugs that are not generally recognized among scientific experts as safe and effective for the labeled use, or are not so used "to a material extent or for a material time". Additionally, it is illegal to import adulterated or misbranded drugs. Lantus is one of many approved brands of insulin, so the law does not prohibit its importation. It is not sufficient that a drug be made by the company that makes an approved drug, it also has to be made in an approved way. In addition, it is illegal under 21 USC 381(d)(1) to re-import US-manufactured approved drugs (if you are not the manufacturer). The misdemeanor penalty for violation of the law is 1 year in prison and $100,000 fine. There is no requirement that you know that importation would be illegal (that the drug is unapproved). The maximum penalty for reimportation is a decade in prison and a quarter of a million dollars.

The prescription status of a drug in a foreign country is not relevant. There is some indication that the FDA has approved certain forms of insulin for OTC sale (this article names names).

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  • "The penalty for reimportation is a decade in prison and a quarter of a million dollars." Are you sure that should not be "The maximum penalty...". Ten years seems a bit extreme for accidentally bringing back a couple of vials of insulin you bought on holiday because your original supply was stolen.
    – Martin Bonner supports Monica
    Commented Jan 23, 2019 at 17:09
  • Does your answer square up with the FDA's web page that states that on of the conditions that they would not object to importation is : "The drug is for use for a serious condition for which effective treatment is not available in the United States;" and "Generally, not more than a 3-month supply of the drug is imported." ?
    – BobE
    Commented Jan 23, 2019 at 17:25
  • FYI: Have you seen <prnewswire.com/news-releases/…>
    – BobE
    Commented Jan 23, 2019 at 17:38
  • @BobE, it does because effective treatment is available in the US (effective and affordable are not the same). Whether or not the FDA actually cares is a political policy question, not a legal one.
    – user6726
    Commented Jan 23, 2019 at 20:45
  • Perhaps you misunderstood the FDA guidance. It says it is not contrary to FDA regs if there is no treatment available in the US. FDA regs are law and those laws are enforced under the FDCA. Generally speaking, CBP will confiscate drugs at the border.
    – BobE
    Commented Jan 24, 2019 at 3:57

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