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  FDA Guidelines on importation/foreign pharmacies

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Author Topic:   FDA Guidelines on importation/foreign pharmacies
Sittin' On Diesel

Pro Bodybuilder

Posts: 488
From:5th ward
Registered: Jan 2000

posted October 20, 2000 02:59 PM

Staff Use Only: IP: Logged


I know there are a lot of rumors going around that you can import this and that under the "Personal Importation Policy" enacted by the FDA. This info is copy and pasted from the FDA website, so it is legit.

Bottom line is that it goes to the inspector's descretion whether or not you can take bring this into the good ol USA.

webpage if you're interested: http://www.fda.gov/oc/buyonline/faqs.html

Here's the text:
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12. Can an American patient get a medication not approved in the U.S. from a foreign dispenser?

As a general matter, it is illegal to import an unapproved drug into the U.S. However, under FDA's personal importation policy, FDA has authorized its inspectors to use their enforcement discretion to allow U.S. residents to import certain products under certain limited conditions. Under this policy, FDA may allow a U.S. resident to bring into this country an unapproved drug for their personal use for a serious condition, if there has been no commercialization or promotion of the drug to U.S. residents.

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13. Is it illegal for a foreign pharmacy to ship prescription medicines into the U.S.?

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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Got this from: http://www.fda.gov/bbs/topics/ANSWERS/ANS00052.html

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For many years FDA has permitted individuals to bring into the country
small "personal-use" quantities of drugs sold abroad but not approved in the
U.S. -- provided that the drugs do not pose unreasonable or significant
safety risks, that their use will not be commercialized, and that they are
for a serious condition for which there is no satisfactory treatment
available in this country. The policy was designed to allow people to
import through their personal baggage small quantities of medicines they may
have been treated with while traveling abroad, and to allow individuals with
serious conditions the ability to import through the mail personal-use
quantities of unapproved drugs that they feel might be helpful in treating
their conditions.

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Also bros, you might want to check out the FDA's import alerts. They list sources where they have been known to send unapproved prescription drugs to the US. More than likely people getting stuff from these sources will get tagged IMO.

Here's a sample link: http://www.fda.gov/ora/fiars/ora_import_ia6657.html


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Damn, I got more info.. this is alarming. Check this:

In a third case, OCI was advised by a State Board of Pharmacy that an Internet site was offering prescription drugs to U.S. customers from foreign manufacturers, by acting as an authorized "buyers club" using the "personal importation policy" of FDA. OCI notified the U.S. Customs Service (USCS) at a particular U.S. international mail facility to watch for suspicious shipments bound for the operator of this Internet site. As a result, USCS intercepted what appeared to be steroid shipments to the web site's address. Search warrants were obtained and over a period of approximately four weeks, nine incoming shipments of steroids were searched and control delivered by USCS and OCI agents. Deliveries coordinated with surveillance of the suspect revealed a sophisticated operation centered out of an apartment building. OCI and USCS arrested the suspect and simultaneously served a search warrant at the business location. The primary suspect was sentenced in Federal court.

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This is a long ass post, but just wanted to shed some light on some things here.

PEACE!


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