Congress has the power to determine which articles may be permitted importation into the United States from a foreign source and the terms upon which the importation will occur. An article subject to the Federal Food, Drug, and Cosmetic Act is still in "interstate commerce" even if it is purchased before being shipped across state lines. This is true even if the article is intended solely for personal consumption. Therefore, the Act properly regulates personal articles imported into the United States for personal consumption. The Act also prohibits the importation into the United States of any unapproved new drug.
We appreciate that there is a significant cost differential between drugs available here and those in other countries/areas. However, many drugs sold in foreign countries/areas as "foreign versions" of approved prescription drugs sold in the United States are often of unknown quality with inadequate directions for use and may pose a risk to the patient's health. FDA approves a drug on the basis of scientific data proving it to be safe and effective. FDA approved labeling provides information on how and when the drug can be used to maximize effectiveness and minimize any harmful side effects. The manufacturing facilities and procedures for approved products are also carefully regulated by FDA to ensure product integrity. Since FDA cannot assure the consumer that the drug purchased in the foreign country/area would be the same product his or her physician's prescription is written for, we recommend the product covered by the prescription be acquired in the United States.
It is legal to buy Botox as long as it is manufactured at an FDA approved facility. The lot number originates from the facility it is manufactured, not from where it is distributed. All Botox is manufactured at the same plant in Ireland. Allergan uses scare tactics because they do not receive sales credit when it is not purchased from the sales rep. Reputable Canadian pharmacies will supply Botox with the same lot number as Botox purchased directly from Allergan and physicians will receive it the next day on ice. Physicians can call Allergan, give them the lot number, and Allergan will confirm the product as being authentic. The FDA "recommends" that these products are bought directly from Allergan, but it is not illegal.
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Posted to Is It Illegal for Doctors to Purchase "Botox" from Canada? on 27 Aug 2012
http://www.fda.gov/ForIndustry/ImportProgram/ucm173751.htm
Congress has the power to determine which articles may be permitted importation into the United States from a foreign source and the terms upon which the importation will occur. An article subject to the Federal Food, Drug, and Cosmetic Act is still in "interstate commerce" even if it is purchased before being shipped across state lines. This is true even if the article is intended solely for personal consumption. Therefore, the Act properly regulates personal articles imported into the United States for personal consumption. The Act also prohibits the importation into the United States of any unapproved new drug.
We appreciate that there is a significant cost differential between drugs available here and those in other countries/areas. However, many drugs sold in foreign countries/areas as "foreign versions" of approved prescription drugs sold in the United States are often of unknown quality with inadequate directions for use and may pose a risk to the patient's health. FDA approves a drug on the basis of scientific data proving it to be safe and effective. FDA approved labeling provides information on how and when the drug can be used to maximize effectiveness and minimize any harmful side effects. The manufacturing facilities and procedures for approved products are also carefully regulated by FDA to ensure product integrity. Since FDA cannot assure the consumer that the drug purchased in the foreign country/area would be the same product his or her physician's prescription is written for, we recommend the product covered by the prescription be acquired in the United States.
Posted to Is It Illegal for Doctors to Purchase "Botox" from Canada? on 27 Aug 2012