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The FDA: International Prescriptions Trade
It is illegal for anyone, including a foreign pharmacy, to ship prescription drugs that are not approved by FDA into the U.S.
even though the drug may be legal to sell in that pharmacy's country. Under the scheme that Congress established to ensure that
drugs are safe and effective, drugs are tested and test results are thoroughly reviewed by FDA scientists. U.S. law also requires
that products approved for sale in the United States have their formulation approved by FDA, be made in a plant registered with
FDA, and be produced under quality standards enforced by FDA.
Prescription drugs available from a foreign pharmacy that are products that FDA has not approved; products with similar,
but not identical formulations as FDA-approved products; products not made under the quality standards required by U.S. law
or labeled according to U.S. requirements; or products not stored or distributed under the quality conditions required in the U.S.
cannot be legally sold in the U.S.
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A Caution from the FDA about Pharmacy Websites
1. Why is FDA concerned about unlawful drug sales on the Internet?
Patients who buy prescription drugs from Websites operating outside the law are at increased risk of suffering life-threatening
adverse events, such as side effects from inappropriately prescribed medications, dangerous drug interactions, contaminated drugs,
and impure or unknown ingredients found in unapproved drugs.
The current system of federal and state safeguards for protecting patients from the use of inappropriate or unsafe drugs has generally
served the country well. These laws require that certain drugs be dispensed only with a valid prescription because they are not safe
for use without the supervision of a licensed health care practitioner. Generally, before the practitioner issues a prescription for
a drug the patient has never taken before, he or she must first examine the patient to determine the appropriate treatment.
Subsequently, the patient receives the drug from a registered pharmacist working in a licensed pharmacy that meets state practice
standards.
The Internet makes it easy for unscrupulous people to sell drugs to patients without these safeguards in place.
A Website may appear to be associated with a legitimate pharmacy when in fact it is not. Websites that sell prescription drugs without
a valid prescription deny consumers the protection provided by an examination conducted by a licensed practitioner.
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