Can We Buy Imported Drugs?

Last week, while vacationing in Belize, Central America, I saw advertisements for the sale of  U.S. equivalent pharmaceutical products without a prescription.  The ads touted the convenience, discounts, and legality of the drugs and for a split second I was tempted to stock up on levaquin, tamaflu, and Zpack.  Then I pulled myself back on my high horse and resisted the temptation.

Many of our members receive fax or email price lists from questionable companies (without traveling outside the United States!) for too-good-to-be-true-pricing on oncology products imported from the UK or elsewhere. Well, you know the saying…”if it seems to good to be true then it probably is!”

As a result of the many, many inquiries into these imported drugs and the legality of practices purchasing these products, I asked an attorney to review the importation discussion and the response is cut and paste below for your review.

Dear Lesli,


This letter responds to your request for information regarding the importation of drugs from the U.K. As we understand it, a member physician has asked if importing drugs from the U.K. is legal. The drugs are less expensive than their U.S. equivalents and are functionally identical.


In general, the importation of drugs from outside the country is not legal. The Federal Food, Drug, and Cosmetic Act explicitly prohibits the sale of food, drug, devices, or cosmetics that are misbranded. (21 USCA 331(a)). It is also explicitly prohibited to import a drug when that drug is misbranded. (21 USCA 331(t)). In general, drugs or devices will be deemed "misbranded" if they are manufactured, prepared, propagated, compounded or processed in a location not duly registered with the FDA. (21 USCA 352(o)).
Based on the above information, the question, therefore, is whether the drugs to be imported are registered for distribution in the U.S. By your physician's own statement, this is not the case. Therefore, importing the drugs for sale will be a violation of the Act. Initial violations of the act will result in imprisonment for not more than one (1) year or a fine of not more than $1,000 or both. Subsequent violations or violations with the intent to defraud or mislead will result in three (3) years imprisonment, a fine of not more than $10,000, or both. (21 USC 333(a)).


The FDA further explains on its website that drugs from outside the country are often not approved by the FDA for distribution in the U.S.. Even though the active components may be identical, because the foreign-made drugs are not formally approved by the FDA, it is illegal to import them. As part of the FDA's approval process, a drug manufacturer may be permitted to make a particular drug only at a specific facility in the U.S. even though the drug is functionally identical to one made in a foreign facility. The FDA explains that drugs produced overseas may not have been packaged or stored under approved conditions to prevent degradation, and may not have been manufactured in accordance with current good manufacturing practice standards.
 We hope this letter is useful to you. Because the FDA position preludes the importing of foreign drugs, there is no reason to look at Medicare or counterfeiting issues. To have and sell these drugs will almost surely violate the law, subject to extreme narrow exceptions. In the meantime, if you or your members have additional questions or concerns, please do not hesitate to get in touch.