Guide to

importing medicine
into the USA

A step by step guide on how

to import a medicine into the
United States.
You shouldn’t have to wait to
access newly approved
medicines
Importing medicine that is unapproved by the Food and Drug Administration (FDA) is still possible
under a policy named Personal Importation Policy (PIP).

FDA recognizes there are circumstances under

which a United States citizen may wish to seek
treatment with an unapproved drug that is not
domestically available [...].

The Personal Importation Policy (PIP) was

developed to address such circumstances and gives
FDA instructions on exercising its enforcement
discretion to permit importation of drugs otherwise
considered illegal in the United States.

Is it legal for me to personally import drugs into the

United States?
The FDA stipulates that yes, but only under very limited circumstances:

The drug is for use for a There is no The drug is considered

serious condition for commercialization or not to represent an
which effective treatment promotion of the drug to unreasonable risk
is not available in the US United States residents

The individual importing the drug verifies in writing that Generally, not more
it is for his or her own use, and provides contact than a 3-month supply
information for the doctor providing treatment or of the drug is imported
shows the product is for the continuation of treatment
begun in a foreign country

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Requirements for importing medicine

into the United States:

A prescription from the patient’s treating doctor in the United

1 States.

The prescription should include:

The treating doctor’s details and official letterhead

The date on which the prescription was written

The patient’s name and date of birth

The name of medicine, its strength and quantity

The doctor’s signature and official stamp

Go to page 3 to see what a valid prescription should look like.

An import letter written by the patient’s treating doctor in the

2 United States.

The import letter should include:

The intended use of the medicine

The name and address of the United States–licensed treating doctor responsible for

the patient’s treatment

Name of the medicine

An affirmation that the medicine will be used only for the individual patient and not

distributed to others.

Go to page 4 to see what the import letter should look like.

3 A detailed description of the treatment plan.

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Prescription Guideline
If you need help with your prescription, send a message with your questions at

support@everyone.org.

Patient name:

Date of birth:

Date:

Name of medicine:

Strength:

Quantity:

Do
cto
rs
Sta
mp

Doctor signature:

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Import letter Sample
If you need help with your import letter, send a message with your questions at
support@everyone.org.

[letter head if available] [city and date]

To Whom it may concern

By writing this letter, I confirm that my patient [name of the patient], born on [date of
birth of the patient] who is suffering from [disease], needs to be treated with
[medicine]. The dosage would be:

[dosage]

[quantity required]

[treatment duration]

I understand medicine has not been approved for indication however I believe that
this treatment is appropriate for my patient and a key component to ensure
maximal quality of life.

This treatment will be used by [name of patient] only.

I am reachable on [phone number] should you have any queries.

I would like the medication to be sent to [the clinic/the patient] as soon as possible at
the following address:

[address]

Thank you in advance for giving priority to this request.

Best regards,

[name of doctor including qualifications]

[signature of doctor]

[practice number/md number/registration at the board number]

Download editable letter by clicking here.

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 Help with accessing and importing a
medicine into the United States
Our Patient Support Team can also assist you when the medicine you are trying to access is
approved by the FDA but not yet available.

support@everyone.org +31 20 808 4414 +31 615 535 558

everyone.org is registered with the Dutch Ministry of Health in The Hague as an independent medicines intermediary, registration
number 6730 BEM and as a pharmaceutical wholesale distributor, registration number 16258 G.