Some logical connection exists between
the medical complaint, the medical history, the physical examination
and the drug prescribed.
A patient completing a questionnaire that is then reviewed by a
physician hired by or working on behalf of an Internet pharmacy does
not establish a doctor/patient relationship. A consumer can more
easily provide false information in a questionnaire than in a
face-to-face meeting with the physician. It is illegal to receive a
prescription for a controlled substance without the establishment of a
legitimate doctor/patient relationship, and it is unlikely for such a
relationship to be formed through Internet correspondence alone.
However, this is not intended to limit the ability of practitioners to
engage in telemedicine. For purposes of this guidance document,
telemedicine refers to the provision of health care using
telecommunication networks to transmit and receive information
including voice communications, images and patient records.
Some Internet sites recommend to the patient that they not take a
new drug before they have a complete physical performed by a doctor.
These sites then ask the patient to waive the requirement for a
physical and to agree to have a physical before taking the drug they
purchase via the Internet. An after the fact physical does not take
the place of establishing a doctor/patient relationship. The physical
exam should take place before the prescription is written. These types
of activities by Internet pharmacies can subject the operators of the
Internet site and any pharmacies or doctors who participate in the
activity to criminal, civil, or administrative actions. For DEA
registrants, administrative action may include the loss of their DEA
registration. Additionally, providing false material information to
obtain controlled substances could be considered obtaining a
controlled substance by fraud and deceit, which is subject to Federal
and State penalties.
What are the types of risks taken by individuals
when ordering drugs via the Internet? How can those risks be minimized?
Persons considering purchasing drugs via an Internet pharmacy
should exercise good common sense and scrutiny in selecting an
Internet pharmacy. An "Internet pharmacy" site should
provide a physical address for the pharmacy, in addition to the
Internet address and a telephone number for the pharmacy. Some common
indicators that the "Internet Pharmacy" site may not be
legitimate and should not be used as a source for controlled
substances include the following:
The site does not require that you
provide a bona fide prescription issued by your personal physician
or mid-level practitioner.
Can underage individuals acquire drugs on the
Internet? How can this be prevented from happening?
Underage individuals can acquire drugs on the Internet in the same
manner as an adult. The only way to prevent this is to restrict
Internet access. In many instances, the young person will need a
credit card to pay for the drugs. In these instances, parents can
prevent drug purchases by withholding access to a credit card.
As previously stated, a prescription not issued in the usual course
of professional practice or not for legitimate medical/research
purposes is not considered valid. Both the practitioner and the
pharmacy have a responsibility to ensure that only legitimate
prescriptions are written and filled.
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General Information
What are the basic requirements for prescribing, dispensing, and
importing controlled substances?
Only practitioners acting in the usual course of their professional
practice may prescribe controlled substances. These practitioners must
be registered with DEA and licensed to prescribe controlled substances
by the State(s) in which they operate. Pharmacies filling
prescriptions for controlled substances must also be registered with
DEA and licensed to dispense controlled substances by the State(s) in
which they operate. A prescription not issued in the usual course of
professional practice or not for legitimate and authorized research is
not considered valid. Both the practitioner and the pharmacy have a
responsibility to ensure that only legitimate prescriptions are
written and filled.
Pharmacists must receive written and manually signed prescriptions
for Schedule II substances. They may receive oral or faxed
prescriptions for Schedule III-V substances provided they confirm the
legitimacy of the prescription and the practitioner. Prescriptions for
Schedule II controlled substances may not be refilled. Prescriptions
for Schedule III-V controlled substances may be authorized to be
refilled five times, but no prescription may be filled or refilled
more than six months after the date on which the prescription was
issued. Only those people who are registered with DEA as importers and
who are in compliance with DEA requirements may have controlled
substances shipped into the customs territory or jurisdiction of the
U.S. from a foreign country.
DEA regulations covering prescriptions can be found in Title 21 of
the Code of Federal Regulations, part
1306; rules on importers are found in 21
CFR 1312.
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DEA Registrant Questions about Internet Pharmacies
Is it legal for Internet pharmacies to approach a
physician to write prescriptions based on on-line consultations with
customers/consumer?
A physician may use the Internet to provide information and to
communicate with the patient, but it cannot be the sole basis for
authorizing prescriptions. If a doctor/patient relationship exists, a
doctor can use the Internet to communicate with patients. Where a
doctor/patient relationship exists, the doctor may use the Internet to
receive requests for treatment. DEA cautions, however, that such
requests for treatment should be logical based upon a doctor’s
knowledge of the patient’s medical history and the medical
complaint. The doctor may also use the Internet to receive requests
for refills of prescriptions from patients.
Can an independent pharmacy purchase supplies on
the Internet? What procedures must be followed?
Pharmacies can use the Internet to facilitate their purchases;
however, the basic regulations regarding registration and
recordkeeping apply. The pharmacy can only purchase from a registered
supplier and the pharmacy must maintain complete and accurate records
describing the name, address and registration number of the supplier,
a description of the drugs purchased and the date the drugs are
received. For Schedule II controlled substances, official DEA Order
Forms must be used. Recordkeeping requirements for dispensers can be
found in Section 1304 of the Code of Federal Regulations (see 21
CFR 1304.22(c) for continuing recordkeeping requirements).
Recordkeeping requirements pertaining to the use of official Order
Forms can be found in Section 1305
of the Code of Federal Regulations.
Does the label on a prescription filled via the
Internet indicate the Internet pharmacy or the registered location that
filled the prescription?
The label must list the name and registered location of the
pharmacy that dispensed the controlled substance.
Does being an Internet pharmacy change a pharmacy’s
responsibilities under DEA regulations?
No, Internet pharmacies are still authorized to sell controlled
substances only when there is a valid prescription from a DEA-registered
practitioner who issued the prescription in the usual course of his or
her professional practice.
Is it possible for an Internet pharmacy to fill
prescriptions for Schedule II controlled substances?
An Internet pharmacy may fill valid prescriptions for Schedule II
substances if the patient or prescriber provides the pharmacy with the
manually signed original prescriptions prior to dispensing.
Practically, it is unlikely that most patients will want to wait the
time required for such a transaction to be completed.
Is it possible for an Internet pharmacy to fill
prescriptions for Schedule III-V controlled substances?
Internet pharmacies may receive an original signed prescription or
a facsimile of the original signed prescription, or an oral
prescription, where allowed, which must be verified and immediately
reduced to writing. Internet pharmacies have the responsibility to
ensure the legitimacy of the prescription and the prescriber. At this
time, DEA does not permit a prescription received via the Internet to
be filled. If prescription information is transmitted via the
Internet, the receiving pharmacy must contact the prescriber via
telephone and receive an oral prescription for the controlled
substance, including the full name and address of the patient, the
drug name, strength, dosage form, quantity prescribed, directions for
use and the name, address and registration number of the practitioner
(21 CFR 1306.05(a)). The
pharmacy must immediately reduce this oral prescription to writing (21
CFR 1306.21(a)).
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Is it legal to buy controlled substances from
foreign Internet sites and have them shipped to the U.S.?
No, having controlled substances shipped to the U.S. is illegal
unless the purchaser is registered with DEA as an importer and is in
compliance with 21 U.S.C. 952, 953
and 954 and 21
CFR part 1312. Some foreign Internet sites claim they can legally
sell these controlled substances; other sites, knowing that such
shipments are illegal, advise consumers of ways to avoid having the
packages seized by U.S. Customs. The Controlled Substances Act
prohibits any person from importing into the customs territory of the
U.S. any controlled substance or List I chemical (21
U.S.C 971) and (21 CFR part
1313) unless that person maintains a valid, current authorization
to import such substances or chemicals (21
U.S.C. 957(a)).
Illegal importation of controlled substances is a felony that may
result in imprisonment and fines (21
U.S.C. 960).
Does it make a difference if an individual has a
prescription from a U.S. doctor for controlled substances and buys from
a foreign Internet site?
No, the law remains the same. The only condition in which
controlled substances may be shipped to a purchaser in the U.S. from
another country is if the purchaser is registered with DEA as an
importer and is in compliance with DEA's requirements.
Are the rules different for "life
style" drugs?
Some people have applied the phrase "life style drugs" to
certain medications, such as Viagra®, weight control medications and
tranquilizers. Many of the so-called life style drugs, such as
Viagra®, are not controlled substances. If a "life style"
drug is a controlled substance, however, it is still subject to all
regulations for controlled substances. In order to have a prescription
filled for a "life style" drug that is a controlled
substance, DEA requires a prescription from a DEA registered
prescriber and the prescription must be filled by a DEA registered
pharmacy.
What does the VIPPS Seal seen on some Internet
pharmacy sites mean?
The National Association of Boards of Pharmacy (NABP) has developed
a voluntary program called the Verified Internet Pharmacy Practice
Sites (VIPPS). The NABP issues a "seal of approval" to
Internet pharmacies that meet standards regarding State licensing and
DEA registration. To be VIPPS certified, a pharmacy must comply with
the licensing and inspection requirements of their State and each
State to which they dispense pharmaceuticals. In addition, pharmacies
displaying the VIPPS seal have demonstrated to NABP compliance with
VIPPS criteria including patient rights to privacy, authentication and
security of prescription orders, adherence to a recognized quality
assurance policy and provision of meaningful consultation between
patients and pharmacists. The NABP also provides information on
whether a pharmacy is licensed and in good standing (http://www.nabp.net).
Where should complaints regarding an
"Internet Pharmacy" site on the Internet that appears to be
illegally selling drug be directed?
If the complaint involves a pharmaceutical controlled substance,
you may file
a report on-line, or contact the DEA, Office of Diversion Control, Drug Operations Section,
Washington, DC 20537, telephone (202) 307-7194 or contact your local DEA
office .
If the complaint involves any pharmaceutical drug other than a
controlled substance, contact the U.S. Food and Drug Administration,
HFC-230, 5600 Fishers Lane, Rockville, MD 20857, or file a report on
the FDA's web site at http://www.fda.gov/oc/buyonline/buyonlineform.htm.
If the complaint involves a pharmacist or a physician, the
respective State Board of Pharmacy or the State Board of Medicine
where the pharmacist or doctor is located should be contacted.
Persons wishing to file complaints may wish to view other sites on
the Internet such as the NABP (http://www.nabp.net).
In the event further websites are identified which advertise the
sale of controlled pharmaceutical substances, the nearest DEA
Diversion Group office should be contacted and provided that
information. A list of DEA offices and telephone numbers can be found
at the DEA Office of Diversion website.
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