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The first lines of the text are so clear that you wonder what is all the talk about buying pharmaceuticals abroad.

What is an approved drug? What is an unapproved drug? What is an unapproved new drug?
Can approved old drugs be imported or shipped interstate?

Which foreing pharmacies sell FDA approved drugs?
How can I get unapproved drugs?
How can I get the drugs I use now for less?

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