Hallarian said:
The drugs are made by an American Company (Uusually Phizer the biggest) most right here in the US then bought by Canada or other countries. I have a number of meds in my stock room approved by the FDA made in India purchased through my wholesaler. My VA patients often bring in the meds they got from the VA and peeling off the VA sticker it says bought in Canada but made here. Don't be brainwashed!
Actually, some importation IS allowed:
http://www.fda.gov/ora/import/pipinfo.htm
To whit:
The General Guidance Section states that FDA should consider
not taking enforcement actions against such importation:
"when 1) the intended use [of the drug] is unapproved and for a serious condition for which effective treatment may not be available domestically either through commercial or clinical means; 2) there is no known commercialization or promotion to persons residing in the U.S. by those involved in the distribution of the product at issue; 3) the product is considered not to represent an unreasonable risk; and 4) the individual seeking to import the product affirms in writing that it is for the patient's own use (generally not more than 3 month supply) and provides the name and address of the doctor licensed in the U.S. responsible for his or her treatment with the product or provides evidence that the product is for the continuation of a treatment begun in a foreign country." (Emphasis added)
The above guidance does not specify that a U.S. citizen may import an unapproved drug only with a prescription from a U.S. licensed physician, or that a foreign citizen may import an unapproved new drug only with a foreign prescription. Rather, to ensure that the importation is for personal use only (and not for resale), and to ensure that the use of the unapproved new drug sought to be imported into the U.S. is supervised and does not represent an unreasonable risk, the guidance provides that the individual affirm in writing that the drug is for his or her personal use, and provide either the name and address of the U.S. licensed physician who will supervise its use or some evidence that the treatment was begun in a foreign country and that the drugs are being imported to continue/conclude the already begun treatment. Thus, while not the only documentation, either a U.S. or foreign prescription, along with an affirmation of personal use, could be supplied as evidence that this factor exists.
The guidance also provides that the importation should generally not represent more than a 3 month supply of the unapproved products. The purpose for this provision is in keeping with the intent that the guidance relate to only drugs for personal use, not commercial distribution. As the document sets forth only guidance, the 3 month limitation is not a "requirement" or a "restriction." If an individual presents evidence that he or she requires more than a 3 month supply for the full treatment of his or her illness, and it appears that the reordering of a one or two month additional amount may be inappropriate, FDA may consider the release of the full amount. Similarly, if a foreign traveler to the U.S. seeks to import unapproved drugs during his or her stay in the U.S., the amount sought to be imported should represent the amount needed for personal use during the U.S. visit. Where the evidence appears to indicate that the drugs may be imported for commercial distribution, the guidance provides that FDA should refuse admission of such drugs.
It must be emphasized that the intent of the personal use importation guidance is to save FDA resources and to generally permit, through the exercise of enforcement discretion, medical treatments sought by individuals that are not otherwise available in the United States (where such treatments are not promoted/commercialized in the U.S.). Thus, foreign-made chemical versions of drugs available in the U.S. are not intended to be covered by the policy. For example, a person may decide that his or her FDA approved heart medication is cheaper in Mexico, and attempt to import the unapproved version of the drug from Mexico. FDA cannot assure that such products have been properly manufactured and are effective; therefore, given that such products are available in the U.S., their use would present an unreasonable risk and the guidance would not apply (unless the person seeking their importation could establish that the drugs were needed to refill a prescription while traveling or were otherwise needed while traveling).
AND:
We appreciate that there is a significant cost differential between drugs available here and those in other countries. However, many drugs sold in foreign countries as "foreign versions" of approved prescription drugs sold in the United States are often of unknown quality with inadequate directions for use and may pose a risk to the patient's health. FDA approves a drug on the basis of scientific data proving it to be safe and effective. FDA approved labeling provides information on how and when the drug can be used to maximize effectiveness and minimize any harmful side effects. The manufacturing facilities and procedures for approved products are also carefully regulated by FDA to ensure product integrity. Since FDA cannot assure the consumer that the drug purchased in the foreign country would be the same product his or her physician's prescription is written for, we recommend the product covered by the prescription be acquired in the United States.
SO, SOME IMPORTATION IS ALLOWED, BUT IF YOU WANT TO TRY UNTESTED DRUGS ON YOUR BODY, FEEL FREE. I AM ONE THAT'LL STAY AWAY. TOO MANY UNAPPROVED DRUGS IN THOSE. THEY DID A STUDY OF UNAPPROVED IMPORTS COMING IN AND FOUND OVER 80% OF THOSE, THE SO CALLED "GENERIC" BRANDS OF WHAT WE HAVE IN THE US DID, IN FACT, HAVE UNAPPROVED INGREDIENTS THAT WERE
NOT IN THE US BRAND. SO GOOD LUCK WITH THAT....
Who is not seeing or hearing here?
That was not a wink. I got some food in my eye. arrg!!