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Date: Fri, 06 Feb 2004 16:54:00 -0800
This is what I've found on the FDA website:
---snip----
That said, FDA's guidance for coverage of personal importations of
unapproved drugs identifies several factors that should be considered by
FDA personnel when determining whether to exercise enforcement
discretion and refrain from taking action against the importation of
unapproved drugs. 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)
---snip----
So, I guess, it means, that really it is illegal to import drugs which
are not manufactured in the USA, but the specific officers should close
both eyes under certain circumstances - like, if the drugs are for
personal use only, there is no effective treatment in the USA, it's only
a 3 months supply, etc..
Sounds very similar to the visa issue: you can be fortunate or
misfortunate, depending on the officer...
Here's the full text about drug imports:
Information on Importation of Drugs
Prepared by the Division of Import Operations and Policy, FDA
The United States Federal Food, Drug, and Cosmetic Act (Act) (21 U.S.C.
section 331) prohibits the interstate shipment (which includes
importation) of unapproved new drugs. Thus, the importation of drugs
that lack FDA approval, whether for personal use or otherwise, violates
the Act. Unapproved new drugs are any drugs, including foreign-made
versions of U.S. approved drugs, that have not been manufactured in
accordance with and pursuant to an FDA approval. Under the Act, FDA may
refuse admission to any drug that "appears" to be unapproved, placing
the burden on the importer to prove that the drug sought to be imported
is in fact approved by FDA. Absent evidence that the specific drugs
sought to be imported from a foreign country have been manufactured
pursuant to an approved new drug application, in the manufacturing
facility permitted under the application, such drugs would appear to be
unapproved new drugs subject to FDA enforcement action.
The use of FDA resources to provide comprehensive coverage of unapproved
new drugs imported for personal use is generally not justified, however,
the agency developed guidance in its Regulation Procedures Manual (RPM)
entitled "Coverage of Personal Importations" (copy enclosed). This
guidance sets forth the agency's enforcement priorities related to the
personal importation of unapproved new drugs, with enforcement being
focused on products apparently intended for the commercial market and on
fraudulent products and those that pose an unreasonable health risk. The
guidance recognizes that circumstances may exist where, for example, a
person has begun treatment with an unapproved drug in a foreign country
or suffers from a condition for which there exists no FDA approved
treatment. If such circumstances can be substantiated, as the text of
the guidance quoted below notes, the guidance suggests that refraining
from taking action against the illegal importation, in the exercise of
enforcement discretion, may be appropriate. The guidance document is
not, however, a license for individuals to import unapproved (and
therefore illegal) drugs for personal use into the U.S., and even if all
the factors noted in the guidance are present, the drugs remain illegal
and FDA may decide that such drugs should be refused entry or seized.
Similarly, the factors noted in the guidance, and documentation that
should be obtained from individuals importing the drugs, are not
mandatory requirements. They are intended to guide FDA enforcement
discretion and should not be represented as binding requirements. The
statements in the RPM are intended only to provide operating guidance
for FDA personnel and are not intended to create or confer any rights,
privileges, or benefits on or for any private person.
That said, FDA's guidance for coverage of personal importations of
unapproved drugs identifies several factors that should be considered by
FDA personnel when determining whether to exercise enforcement
discretion and refrain from taking action against the importation of
unapproved drugs. 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).
Likewise, a drug such as Valium is available in the U.S. and, as such, a
foreign-made version of the U.S. approved drug would not generally be
considered a candidate to be permitted entry under the guidance.
However, because the United States Drug Enforcement Administration (DEA)
may have specific requirements that apply to the importation of
controlled substances such as Valium, FDA's guidance on personal
importations specifically provides that controlled substances should be
returned to Customs for handling.
FDA will not approve a particular form or format for information to
accompany personal use shipments, or approve any scheme proposed to
facilitate the importation of an unapproved new drug, because to do so
would be to imply that such importation meets FDA's personal importation
guidance and is legally permitted.
Congress has the power to determine which articles may be permitted
importation into the United States from a foreign source and the terms
upon which the importation will occur. An article subject to the Federal
Food, Drug, and Cosmetic Act is still in "interstate commerce" even if
it is purchased before being shipped across state lines. This is true
even if the article is intended solely for personal consumption.
Therefore, the Act properly regulates personal articles imported into
the United States for personal consumption. The Act also prohibits the
importation into the United States of any unapproved new drug.
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.
drafted: Marvin A. Blumberg, HFC-170, 4/3/98
-- -------------------------------------------------------- Nicole Hillbrecht headwire 25006 crystal circle lake forest ca 92630, usa ++1 949 595 4365 http://www.headwire.com headwire - connect your brain we make the future come true -------------------------------------------------------- _______________________________________________ Swiss-list mailing list Swiss-list_at_swiss-list.com http://www.swiss-list.com/mailman/listinfo/swiss-listReceived on Sat Feb 07 2004 - 04:19:08 PST
