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user6726
user6726
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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).

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 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).

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).

Source Link
user6726
user6726
  • 216.6k
  • 11
  • 351
  • 583

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 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).