181 lines
9.2 KiB
Plaintext
181 lines
9.2 KiB
Plaintext
I'm afraid I won't type in the whole thing, but at least I'll give you
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a reference. The FDA bulletin that details the importation "loop-hole" can
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be found in its entirety in appendix G of _Smart Drugs and Nutrients_. The
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bulletin's date is July 20th, 1988, from "Director, Office of Regional
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Operations (HFC-100)", and its subject heading is "Pilot Guidance for
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Release of Mail Importations".
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Hope that helps... and good luck. I got my order from In-Home with no
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problem; perhaps I was lucky...
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=============================================================================
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From a tip on alt.drugs, I got an order form from Inhome Health
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Services in Delemont, Switzerland. The form requires the purchaser to
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sign a statement saying that the products are not for commercial resale,
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all use is with the consent of a physician, etc. I ordered $11 of
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vasopressin and $16.75 of piracetam. That was in september. Nothing
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happened for months. I sent them a letter complaining in december, but
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all I got back was another order form.
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Then on January 28th, I got a letter from the Food and Drug
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Administration, a "Notice of Detention and Hearing". "Article is subject
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to refusal of admission pursuant to section 505(a) in that it appears to
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be an unapproved new drug.; and 503(b)(2) in that it appears to be misbranded
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in that it needs a prescription; and 502(c) in that it appears not to be in
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English per 21 CFR 201.15(c).
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There doesn't appear to be anything I can do about this. (I called a lawyer
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who does customs work -- he said it would cost a lot to try to get it back.)
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Has anyone else had similar problems? How do the rest o' you get your
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piracetam and vasopressin? Isn't it legal to import for personal use?
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=============================================================================
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> Subject: FDA stops smart drug importation?
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>
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> I just logged onto the Toll-Free FDA BBS and saw that the FDA just issued
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> an import alert against all products from Interlab and several other
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> foreign companies. I have appended the full text below.
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>
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>
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> P92-3 Food and Drug Administration
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> FOR IMMEDIATE RELEASE
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>
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> The Food and Drug Administration announced today it has issued an import
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> alert against unapproved mail-order drugs promoted by six overseas companies.
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> Many of these drugs are illegally advertised in periodicals and through
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> direct mail, as foreign versions of approved prescription drugs. The
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> promotion and distribution of unapproved drug products within the United
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> States is illegal.
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> "In some cases, the drugs are counterfeit -- lacking any real similarity
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> to the approved drug. The uncertain character and quality of these drugs
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> constitute an unreasonable risk to the public health," FDA Commissioner
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> David A. Kessler, M.D., said.
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>
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> The import alert instructs FDA field offices to automatically detain all
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> imported unapproved prescription products manufactured by six overseas
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> companies which have promoted their products in this country. The companies
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> cited are Interpharm, Inc., of Nassau, Bahamas; Northam Medication Service
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> International Pharmacy of Nassau, Bahamas; Inhome Services of Delemont,
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> Switzerland; International Products of Hannover, Germany; Azteca Trio
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> Internacional, S.A. de C.V., of Zona Rio Tijuana, Mexico; and Interlab of
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> London, England.
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> These companies have been promoting a wide variety of products purported
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> to treat various conditions, including depression, high blood pressure,
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> fungal infections, fatigue, chronic bronchitis and hair loss.
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> -MORE-
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>
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>
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> Page 2, P92-3, Import Alert
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> Many of the ads for these unapproved drugs claim that people can save
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> money on the costs of prescription drugs, but in reality the drugs may pose
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> a risk to the patient's health. Dr. Kessler said so-called "foreign
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> versions" of prescription drugs are often of unknown quality with inadequate
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> directions for use.
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> For many years FDA has permitted -- and will continue to permit -- its
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> field offices to exercise discretion regarding the release for entry into
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> the United States of small "personal-use" quantities of drugs sold abroad
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> but not approved in the United States -- provided that the drugs do not pose
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> unreasonable safety risks, that their use is not promoted in the United
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> States and that they are for a serious condition for which there is no
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> satisfactory treatment available in this country. The policy was designed
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> to give FDA field offices discretion to release small quantities of
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> medicines with which individuals returning to the United States may have
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> been treated while traveling abroad and to allow individuals with serious
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> conditions the ability to import, under certain limited conditions,
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> personal-use quantities of unapproved drugs that they believe might be
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> helpful in treating their conditions.
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> Personal-use quantities are generally considered to be amounts for a
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> patient's treatment for three months or less. Imports involving larger
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> quantities are not permitted as they lend themselves to commercialization.
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> FDA approves drugs on the basis of scientific data proving them to be
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> safe and effective. FDA-approved labeling provides information on how and
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> when the drugs can be used to maximize their effectiveness and minimize
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> their harmful side effects. The manufacturing facilities and procedures for
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> approved products are also carefully regulated by FDA to ensure product
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> integrity.
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> -MORE-
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>
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>
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> Page 3, P92-3, Import Alert
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> The unapproved drugs promoted by these overseas operations lack these
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> safeguards and quality assurance standards.
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> Consumers should also be aware that the acquisition and use of
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> prescription drugs without the valid prescription of a physician or other
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> licensed health professional may violate state or local laws. FDA warns
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> that severe adverse reactions, including death, can result from the improper
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> use of prescription drugs.
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> Persons with questions about importation of drugs for personal use
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> should consult with their local FDA district office or the FDA Imports
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> Operations Branch in Rockville, Md., at (301) 443-6553.
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> The Food and Drug Administration is one of the eight Public Health
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> Service agencies within HHS.
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>
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I called the Rockville MD (no bad pun intended) phone number and ask
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about my recent order from Inhome. Boy, the guy sounded really defensive.
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Not only giving me the scoop, but justifying everything the FDA does.
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The scoop is that they are cracking down on the services that
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advertise in the US. They are not going after the drugs themselves.
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They claim that you can not really be sure what your getting (as if
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I am supposed to trust a bottle from Lilly more than a bottle from
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Santoz)
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I asked if my shipment had been stopped, and he said (of course) that
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he couldn't tell me, but if the custom officials did detain a package,
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I should receive a letter informing me why. He also said that if I
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could justify my need for the drug, and if it was not available as a
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prescription in the US, and my doctor approved, and ... and ... and ...
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then they might let it through just this once.
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=============================================================================
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the FDA has started to seize shipments of drugs from overseas, including
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some drugs which are used as unapproved therapies for AIDS. The FDA had
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not previously been halting importation of the drugs.
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The drugs have not been approved in the United States but are legal in some
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foreign countries - and can sometimes be obtained without a prescription.
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The drugs affected by the crackdown include:
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EL-10 (DHEA), available in Japan and Italy for the treatment of depression,
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and also used as an AIDS drug.
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Dextran sulfate, an AIDS drug available in Europe. It has not done well in
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studies.
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Fluconzole, a drug used in the treatment of meningitis. It's approved in
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the US, but cheaper overseas.
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Several drugs which are claimed to improve mental performace also fall
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under the ban: piracetam, vasopressin, dihydroergotixine, phenytoin, and
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tacrine.
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It will still be possible to import small quantities of the drugs for
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personal use (enough for three months or less of treatment), but large
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quantities will be detained. Products from Interlab in London, Inhome
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Services in Switzerland, Interpharm in Nassau, and other wholesale pharmacies
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will be detained automatically.
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The FDA claims that "the uncertain character and quality of these drugs
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constitute an unreasonable risk to the public health." The law allowing
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the seizures was already on the books, but had not been aggressively
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enforced.
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=============================================================================
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There's been a few postings here about the FDA confiscating imported drugs.
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Well, I ordered a few things from InHome and YES they have arrived today!
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They came in a small box from Belgium, with a sticker on the outside
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declaring that this was medication for personal use.
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I ordered Piracetam, Vasopressin, and Lucidril. I havn't taken anything
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yet; I'm going to talk with my doctor first. I'll let you know my
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experiences. But antway, at least in NYC, this stuff gets thru
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with no hassle.
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