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Importation
of Prescription Medicines/Drugs
Traveler Alert
The U.S. Customs Service enforces Federal laws and regulations, including those of the
Drug Enforcement Administration (DEA) and the Food and Drug Administration (FDA).
The United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. sections 331(d), and
355(a)), which is administered by FDA, prohibits the interstate shipment (which includes
importation) of unapproved new drugs. Unapproved new drugs are any drugs,
including foreign-made versions of U.S. approved drugs, that have not received FDA
approval to demonstrate they meet the federal requirements for safety and effectiveness.
It is the importer's obligation to demonstrate to FDA that any drugs offered for
importation have been approved by FDA.
FDA has developed guidance entitled "Coverage of Personal
Importations" which sets forth that agency's enforcement priorities with respect
to the personal importation of unapproved new drugs by individuals for their personal use.
The guidance identifies circumstances in which FDA may consider exercising enforcement
discretion and refrain from taking legal action against illegally imported drugs. Those
circumstances are as follows:
"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 a 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)
FDA's guidance is not, however, a license for individuals to import unapproved (and
therefore illegal) drugs for personal use into the U.S. Even if all of 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. The guidance represents FDA's current thinking
regarding the issues of personal importation and is intended only to provide operating
guidance for FDA personnel. The guidance does not create any legally enforceable rights
for the public; nor does it operate to bind FDA or the public.
To avoid travel delays and to prevent possible harm from taking unsafe or ineffective
medications, residents and visitors upon arrival to or departure from the U.S. should keep
in mind the following precautions:
- Do not assume that medications which are legal in foreign countries are also approved
for use in the United States. These products may be illegal and may include addictive and
dangerous substances;
- Be aware that the labeled uses (conditions for which the product is represented to be
effective) for a product purchased outside the U.S. may not be approved in the United
States;
- It can be dangerous to take some medications without medical supervision. The reason why
some medications are limited to prescription use in the United States is that either they
are unsafe without medical supervision or a medical diagnosis is required to ensure that
the medication is appropriate for your condition;
- Avoid purchasing any drug products that are not approved for sale in the U.S. (including
foreign-manufactured versions of U.S. approved drugs). FDA cannot assure that these
products conform to the manufacturing and quality assurance procedures mandated by U.S.
laws and regulations and, therefore, these products may be unsafe. In addition, such
products are illegal in the U.S. and, therefore, may be subject to entry refusal;
- Some medications which may appear to be U.S. approved drug products may in fact be
counterfeit versions of such products. (The term "counterfeit drug" is defined
as "a drug which, or the container or labeling of which, without authorization, bears
the trademark, trade name, or other identifying mark, imprint, or device, or any likeness
thereof, of a drug manufacturer, processor, packer, or distributor other than the person
or persons who in fact manufactured, processed, packed, or distributed such drug and which
thereby falsely purports or is represented to be the product of, or to have been packed or
distributed by, such other drug manufacturer, processor, packer, or distributor." See
21 U.S.C. 321(g)(2));
- In the event you develop complications from using a medication which require medical
attention, your treatment could be delayed or made more difficult unless there is
sufficient information available about the product, such as the generic name of the
product, dosage form and strength, and how often you need to take the product.
- Possession of certain medications without a prescription from a physician licensed in
the United States may violate Federal, State, and/or local laws;
- It is important to have medications in the originally-dispensed container;
- FDA's personal importation guidance provides that when bringing unapproved drugs into
the U.S. for use in treating serious or life threatening illnesses, such products should
be used under the care and supervision of a U.S. licensed physician. It is advisable to
make available for examination by U.S. Customs Inspectors or other appropriate government
authorities appropriate documentation of such monitoring;
- It is against the law not to properly declare imported medications to U.S. Customs.
- When the type of drug, the quantity, or the combination of various drugs arouse
suspicions, U.S. Customs Inspectors will ordinarily contact the nearest FDA or DEA office
for advice and will then make a final determination about whether to release or detain the
article. (See 19 U.S.C. 1499).
In addition to federal requirements, individual States may have additional requirements
covering prescription (Rx) or controlled medications. Travelers should check with State
authorities, where they reside or are traveling, to verify that a particular prescription
does in fact comply with State regulations. In many areas, the local police department and
pharmacies can provide additional information.
For more detailed information on FDA's personal importation guidance, contact your
local FDA office, or check out FDA's Internet website at:
http://www.fda.gov/ora/compliance_ref/rpm_new2/ch9pers.html
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