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Re: FDA Warning to Overseas Pharmacies...Feb 2000 from www.fda.gov website

Re: FDA Warning to Overseas Pharmacies...Feb 2000 from www.fda.gov website

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Posted by Manila Kid on May 29, 2000 at 14:40:30:

In Reply to: FDA Warning to Overseas Pharmacies...Feb 2000 from www.fda.gov website posted by MLWhitworth, MD on May 29, 2000 at 00:47:54:

: T00-8 Print Media: 301-827-6242
: February 2, 2000 Broadcast Media: 301-827-3434
: Consumer Inquiries: 301-827-3434

:
: FDA LAUNCHES "CYBER" LETTERS AGAINST POTENTIALLY ILLEGAL, FOREIGN-BASED
: ONLINE DRUG SITES

: In recent weeks FDA has issued "cyber" letters -- letters sent electronically via the Internet -- to a dozen operators of foreign-based internet sites that offer to sell
: online prescription drugs that may be illegal. The letters warn these website operators that they may be engaged in illegal activities, and informs them of the laws that
: govern prescription drug sales in the United States. This is the first time the FDA has used the Internet as a means for reaching those who are potentially violating
: the Federal Food, Drug, and Cosmetic Act, and it represents a new stage in the agency's efforts to protect the public against illegal and potentially dangerous products
: sold through websites.

: In each of these internet cases, FDA sent letters electronically to the domain holders for sites it had determined may be engaged in illegal activity such as offering to
: sell prescription drugs to U.S. citizens without valid (or in some cases without any) prescriptions. Through various means, the agency has gained the ability to identify
: and monitor these sites. These drugs could pose a serious risk to patients, particularly if used without proper medical supervision.

: The "cyber" letters sent are electronic versions that are similar to traditional "warning" or "untitled" letters, which the agency has long sent to organizations or
: individuals it believes are engaged in violative activities. These letters usually outline the nature of the alleged violation and request a formal response.

: The "cyber" letters also provided these foreign operators with an explanation of the statutory provisions that govern interstate commerce of drugs in the United
: States, as well as a warning that future shipments of their products to this country may be automatically detained and subject to refusal of entry.

: Hard copies of each "cyber" letter are sent to the website operator, the U.S. Customs Service and to regulatory officials in the country in which the operator is based.

: To date, FDA has already received one response from a "cyber" letter recipient indicating that it will cease its illegal activities.

: FDA may also use this approach in its ongoing efforts to prevent illegal sales of prescription drugs by domestic websites.

: Consumers who want information about online pharmacies, or who wish to report websites that they believe may be acting illegally, can contact the FDA through its
: Website at www.fda.gov/oc/buyonline/.

: "Cyber" Letters 2000 Homepage

Then we get into the difficult area of international law in these matters. Many of these foreign pharmaceutical sales are perfectly legal in their own country, even to U.S. recipients. Plus different countries have widely varying laws as to what is a "prescription" drug. For example, here in the Philippines, antibiotics are over-the-counter; no prescription necessary. Likewise, last time I was in Thailand, Tylenol 3 was over-the-counter. Finally, most countries would resent any heavy-handed American pronouncements on this matter. The way to go is probably through mutual treaty negotiations, maybe many of which are already in place. Besides, isn't it the U.S.'s own problem for their own customs inspectors to monitor what gets mailed into the U.S.? I don't believe the rest of the world has to observe internal U.S. medications laws. Sorry, Doc, not trying to be argumentative; just trying to give a little international perspective on the situation. But whoever orders such items in the U.S. should be forewarned of the legal consequences. It's not the foreign sellers at fault if they are breaking no laws in their own countries. It's the U.S. customer at fault for trying to circumvent the U.S. laws.


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