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Overview :
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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