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 |
