Tequila A Estados Unidos

Information on Importation of Drugs
Prepared by the Division of Import Operations and Policy, FDA
The United States Federal Food, Drug, and Cosmetic Act (Act) (21 U.S.C. section 331) prohibits the interstate shipment (which includes importation) of unapproved new drugs. Thus, the importation of drugs that lack FDA approval, whether for personal use or otherwise, violates the Act. Unapproved newdrugs are any drugs, including foreign-made versions of U.S. approved drugs, that have not been manufactured in accordance with and pursuant to an FDA approval. Under the Act, FDA may refuse admission to any drug that "appears" to be unapproved, placing the burden on the importer to prove that the drug sought to be imported is in fact approved by FDA. Absent evidence that the specific drugssought to be imported from a foreign country/area have been manufactured pursuant to an approved new drug application, in the manufacturing facility permitted under the application, such drugs would appear to be unapproved new drugs subject to FDA enforcement action.

The use of FDA resources to provide comprehensive coverage of unapproved new drugs imported for personal use is generally notjustified, however, the agency developed guidance in its Regulation Procedures Manual (RPM)1 2entitled "Coverage of Personal Importations" (copy enclosed). This guidance sets forth the agency's enforcement priorities related to the personal importation of unapproved new drugs, with enforcement being focused on products apparently intended for the commercial market and on fraudulent products and those thatpose an unreasonable health risk. The guidance recognizes that circumstances may exist where, for example, a person has begun treatment with an unapproved drug in a foreign country/area or suffers from a condition for which there exists no FDA approved treatment. If such circumstances can be substantiated, as the text of the guidance quoted below notes, the guidance suggests that refraining fromtaking action against the illegal importation, in the exercise of enforcement discretion, may be appropriate. The guidance document is not, however, a license for individuals to import unapproved (and therefore illegal) drugs for personal use into the U.S., and even if all the factors noted in the guidance are present, the drugs remain illegal and FDA may decide that such drugs should be refusedentry or seized. Similarly, the factors noted in the guidance, and documentation that should be obtained from individuals importing the drugs, are not mandatory requirements. They are intended to guide FDA enforcement discretion and should not be represented as binding requirements. The statements in the RPM are intended only to provide operating guidance for FDA personnel and are not intended tocreate or confer any rights, privileges, or benefits on or for any private person.

That said, FDA's guidance for coverage of personal importations of unapproved drugs identifies several factors that should be considered by FDA personnel when determining whether to exercise enforcement discretion and refrain from taking action against the importation of unapproved drugs. The General GuidanceSection states that FDA should consider not taking enforcement actions against such importation:

"when 1) the intended use [of the drug] is unapproved and for a serious condition for which effective treatment may not be available domestically either through commercial or clinical means; 2) there is no known commercialization or promotion to persons residing in the U.S. by those involved in thedistribution of the product at issue; 3) the product is considered not to represent an unreasonable risk; and 4) the individual seeking to import the product affirms in writing that it is for the patient's own use (generally not more than 3 month supply) and provides the name and address of the doctor licensed in the U.S. responsible for his or her treatment with the product or provides evidence...