Would 9 vials of 10mL and 500 tabs be considered more then personal use?
That may be more than personal use. Read FDA policy:
FDA STATEMENT REGARDING THE IMPORTATION OF FOREIGN DRUGS FOR PERSONAL USE
In general, the FDA permits its field offices to use discretion in allowing entry of small, "personal use" quantities (
generally not more than a three-month supply) of foreign drugs not approved in the United States. This applies in cases in which satisfactory treatment for the condition is not available in this country, the drugs pose no unreasonable safety risk, and their use is not promoted in the United States.
The most accurate statement of the law pertaining to the Importation of Foreign Drugs for Personal Use and the FDA policy regarding field agent discretionary enforcement (or non-enforcement), entitled "Information on Importation of Drugs Prepared by the Division of Import Operations and Policy, FDA", was drafted by a representative of the FDA in 1998 and is reproduced here in its entirety. This statement still represents the FDA's position on this issue, and most questions regarding the Importation Policy for Personal Use are answered by reading and studying this statement.
Read this as well:
FDA Policy Statement
"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 new drugs 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 drugs sought to be imported from a foreign country 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 not justified, however, the agency developed guidance in its Regulation Procedures Manual (RPM) entitled "Coverage of Personal Importations". 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 that pose 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 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 from taking 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 refused entry 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 to create or confer any rights, privileges, or benefits on or for any private person.
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