The US Food and Drug Administration (FDA) permits importation of unapproved drugs into the United States if certain specific criteria are met. Failure to meet these criteria makes the importation of the drug illegal.


Criteria for importation of unapproved drugs:

(1) the patient has a serious or life-threatening condition

(2) the drug is not available in the United States

(3) a licensed physician writes a prescription for the drug

(4) a declaration from the physician that he or she understands the following about the drug:

(4a) its indications

(4b) its contraindications and precautions

(4c) dosage and administration

(4d) drug interactions

(4e) possible side effects

(5) a waiver releasing the pharmacy from liability


NOTE: The FDA monitors imports to make sure that foreign companies and individuals do not use this as a means to bypass regulations intended to protect the public.


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