[Federal Register Volume 66, Number 82 (Friday, April 27, 2001)]
[Notices]
[Pages 21181-21184]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-10255]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[DEA-191N]
Dispensing and Purchasing Controlled Substances over the Internet
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Guidance.
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SUMMARY: This notice is intended to provide guidance to prescribers,
pharmacists, law enforcement authorities, regulatory authorities, and
the public concerning the application of current laws and regulations
as they relate to the use of the Internet for dispensing, purchasing,
or importing controlled substances. This guidance document explains
when controlled substances can be legally purchased from U.S.-based
Internet sites. This notice clarifies that consumers must have valid
prescriptions to obtain controlled substances legally and that
consumers cannot legally purchase controlled substances from foreign
supplier Internet sites and have them shipped to the U.S, unless the
consumers are registered with DEA as controlled substances importers
and are in compliance with all DEA requirements.
FOR FURTHER INFORMATION CONTACT: Patricia M. Good, Chief, Liaison and
Policy Section, Office of Diversion Control, Drug Enforcement
Administration, Washington, DC 20537. Telephone (202) 307-7297.
SUPPLEMENTARY INFORMATION:
Why is This Notice Necessary?
With the advent of Internet pharmacies, DEA registrants and the
public have asked how these Internet pharmacies fit into the
requirements that currently exist for the prescribing and dispensing of
controlled substances. DEA is issuing this notice to provide guidance
to prescribers, pharmacists, law enforcement authorities, regulatory
authorities, and the public about the application of current laws and
regulations to the use of the Internet for prescribing, dispensing,
purchasing, or importing controlled substances.
This document is in the format of questions and answers. The first
section provides the context for this notice. The next two sections
address issues that apply to DEA registrants and consumers.
General Questions
What are Controlled Substances?
Most drugs that require a prescription from a doctor are not
controlled substances. The Controlled Substances Act and its
implementing regulations, however, assign certain substances to one of
five ``schedules.'' These substances are placed in a schedule based on
their potential for abuse, which may lead to physical or psychological
dependency. Schedule I substances have no accepted medical use for
treatment in the United States and are not available by prescription.
Schedule II through V substances have accepted medical use and varying
potentials for abuse and dependency. Practitioners (e.g., doctors,
dentists, veterinarians, physician assistants, advance practice nurses)
who are licensed by a State and registered with DEA may prescribe these
substances. Controlled substances include narcotics (pain relievers),
stimulants, depressants, hallucinogens, and anabolic steroids. A
complete list of controlled substances can be found in Title 21 of the
Code of Federal Regulations (CFR) part 1308. Examples of controlled
substances are shown below.
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Schedule Example of controlled substances
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Schedule I................... Heroin, marijuana, mescaline,
methcathinone,
Schedule II.................. Amphetamine, codeine, fentanyl,
Hydromorphone, meperidine, methadone,
Methylphenidate (Ritalin), morphine,
oxycodone, pentobarbital, phencyclidine
(PCP), secobarbital
Schedule III................. Anabolic steroids, phendimetrazine, and
products that contain small quantities
of certain schedule II controlled
substances, such as codeine, in
combination with noncontrolled
ingredients, such as aspirin.
Schedule IV.................. Alprazolam (Xanax), chlordiazepoxide
(Librium), diazepam (Valium), lorazepam
(Ativan), phenobarbital, phentermine
Schedule V................... Buprenorphine and many cough Preparations
that contain a limited amount of codeine
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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 Schedules III-V substances provided they confirm the
legitimacy of the prescription and the practitioner. Prescriptions for
Schedule II substances may not be refilled. Prescriptions for Schedules
III-V controlled substances may 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 importation are
found in 21 CFR 1312.
[[Page 21182]]
Why are Internet Sales an Issue?
The Internet is primarily a communications tool that can be used to
facilitate any type of business. On-line pharmacies are currently
providing access to a full range of pharmaceuticals, including
prescription drugs and controlled substances. Many people view the
Internet as changing the way in which business is conducted. For
controlled substances, however, the Controlled Substances Act and DEA's
regulations continue to determine when and how these substances may be
obtained. Internet sales must be in accordance with these requirements.
DEA rules affect how controlled substances may be ordered from an
Internet pharmacy and the conditions under which such orders are legal.
DEA is currently working on a revision to its regulations that will
define the conditions under which prescribers may electronically sign
and transmit to any pharmacy (retail, mail order, or Internet)
prescriptions for controlled substances. Until these revisions are
complete, however, use of the Internet for dispensing controlled
substances is governed by existing DEA rules, described above.
DEA is issuing this notice to answer questions that legitimate
pharmacies and practitioners have about using the Internet as part of
their business. DEA is also aware that some Internet sites are engaged
in the illegal sale of controlled substances. Consumers may be
illegally purchasing controlled substances from these Internet sites
without realizing that they are committing a crime. This notice
provides information for consumers to help them understand when they
may legally purchase controlled substances.
DEA Registrant Questions About Internet Pharmacies
Must my Internet Pharmacy be Registered with DEA?
The actual physical location of the pharmacy which purchases,
stores and dispenses controlled substances pursuant to prescription
orders processed by the Internet site must be registered with DEA. The
web site itself would not require a separate registration unless it is
the same physical location, since the web site does not store or
dispense controlled substances. For example, some Internet pharmacies
maintain a central pharmacy warehouse site and offices where
prescriptions are verified and substances shipped; this location must
be registered with DEA as a retail pharmacy. Other Internet sites allow
patients to pick up their prescriptions for controlled substances from
a local pharmacy; these local pharmacies must be registered with DEA.
In this case, the Internet ``pharmacy'' has no obligations under DEA
regulations because the responsibility for assuring compliance with DEA
regulations rests with the actual pharmacy where the controlled
substances are dispensed.
Your pharmacy must have a license from the State in which the
controlled substances are stored and dispensed and, in most instances,
from any state in which you plan to conduct business with customers.
You should also be aware that many States require licenses for the web
site itself since these sites often provide services like patient
counseling.
Does the Label on a Prescription I Fill Indicate the Internet Pharmacy
or the Registered Location that Filled the Prescription?
The label must list the registered location that dispensed the
controlled substance.
Does Being an Internet Pharmacy Change my Responsibilities Under DEA
Regulations?
No, you 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 my Internet Pharmacy to Fill Prescriptions for
Schedule II Substances?
You may fill valid prescriptions for Schedule II substances if the
patient or prescriber provides you with the signed original
prescriptions prior to dispensing. Practically, it is unlikely that
most patients will want to wait the time required for such a
transaction.
Is it Possible for my Internet Pharmacy to Fill Prescriptions for
Schedule III-V Substances?
You may receive an original signed prescription or a facsimile of
the original signed prescription, or an oral prescription, where
allowed, which you verify and immediately reduce to writing. You 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 you receive prescription information
transmitted via the Internet, you 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)). You must immediately reduce this oral prescription to
writing (21 CFR 1306.21(a)).
Does DEA Intend to Allow Electronic Transmission of Prescriptions in
the Future?
DEA is currently engaged in a project to determine the requirements
for secure electronic transmission of all controlled substance
prescriptions between the practitioner and the pharmacy. When
completed, these requirements will automatically certify the
authenticity of the prescriber, protect the content of the prescription
from alteration, and bind the digital signature on the prescription to
the actual prescriber and no one else. These requirements will be
subject to rulemaking, and you will have an opportunity to comment on
them before they are finalized. You can find more information on this
project on the DEA web site at http://www.deadiversion.usdoj.gov/ecomm/index.html.
Can Patients Request a Refill of a Controlled Substance Prescription
From my Pharmacy by Sending me an email Instead of Calling me on the
Telephone?
Yes, the Internet can be used to facilitate communication between
you and your patient when your patient is requesting a permissible
refill of an existing Schedule III-V controlled substance prescription.
Some Internet Pharmacies have Doctors who Prescribe Substances Based on
an on-line Questionnaire. Is this Legal?
Federal law requires that ``A prescription for a controlled
substance to be effective must be issued for a legitimate medical
purpose by an individual practitioner acting in the usual course of his
professional practice'' (21 CFR 1306.04(a)). Every state separately
imposes the same requirement under its laws. Under Federal and state
law, for a doctor to be acting in the usual course of professional
practice, there must be a bona fide doctor/patient relationship.
For purposes of state law, many state authorities, with the
endorsement of medical societies, consider the existence of the
following four elements as an indication that a legitimate doctor/
patient relationship has been established:
A patient has a medical complaint;
A medical history has been taken;
A physical examination has been performed; and
[[Page 21183]]
Some logical connection exists between the medical
complaint, the medical history, the physical examination, and the drug
prescribed.
Completing a questionnaire that is then reviewed by a doctor hired
by the Internet pharmacy could not be considered the basis for a
doctor/patient relationship. A consumer can more easily provide false
information in a questionnaire than in a face-to-face meeting with a
doctor. 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, as discussed later in
this document, this circumstance 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 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.
I am a Practitioner who is Considering Starting an Internet Practice.
Can I use the Internet to Facilitate the Prescribing of Controlled
Substances?
You 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, you can use the
Internet to communicate with patients. Where a doctor/patient
relationship exists, you may use the Internet to receive requests for
treatment. DEA cautions, however, that such requests for treatment
should be logical based on your knowledge of the patient's medical
history and the medical complaint. You may also use the Internet to
receive requests for refills of prescriptions from patients.
I am a Physician. Does the need for a Physical Exam Mean that I Cannot
Engage in Telemedicine and Prescribe Controlled Substances?
No, DEA does not intend to limit the ability of doctors to engage
in telemedicine. If the patient cannot travel to your office, but you
supervise an exam given by a nurse or other professional, you can then
prescribe the needed medications based on the results, to the extent
that State law allows. In this case, your decision on the
appropriateness of the medication is based on facts (symptoms, blood
pressure, etc.) that have been verified by a qualified third party and
observed by you electronically.
I have Read in the Controlled Substances Act (CSA) that it is a
Violation of the law to use a Communications Facility to Facilitate the
Illegal sale of a Controlled Substance. Does this Apply to the use of
the Internet to Obtain Pharmaceutical Controlled Substances?
Yes, Title 21, United States Code, section 843(b) defines a
communication facility as ``any and all public and private
instrumentalities used or useful in the transmission of writing, signs,
signals, pictures or sounds of all kinds and includes mail, telephone,
wire, radio, and all other means of communication.'' Anyone who uses
the Internet to facilitate the illegal sale of a controlled substance
would be in violation of 21 U.S.C. 843(b), which is punishable by a
term of imprisonment of not more than four years and a fine of not more
than $30,000. This provision could apply to owners of Internet sites,
prescribers, pharmacists, and patients.
Questions for Consumers
Are Internet Pharmacy Sites Legitimate?
Many Internet pharmacy sites are legitimate. These Internet
pharmacy sites may vary in the services they provide, but they may fill
a prescription for a controlled substance which was issued to you by an
authorized practitioner for a legitimate medical purpose. They should
confirm the legitimacy of the prescription for a Schedule III-V
controlled substance before filling it by contacting the prescriber.
They are not authorized to fill a prescription for a Schedule II
controlled substance unless they have first received the original
signed prescription.
Some Internet sites for pharmacies advertise local pharmacies and
usually list the name, address, and telephone number of the local
pharmacy closest to you. Many of these sites provide a great deal of
information concerning specific diseases or medical conditions, and
drug information. Many Internet sites operated by local pharmacies or
mail order pharmacies serve as a communication link so that you can
request refills of prescriptions, check the status of your
prescription, or ask the pharmacist a question. These are appropriate
uses of the Internet by pharmacies.
Some sites simply provide information about specific drugs and
medical conditions. After obtaining some general information from you,
this type of ``Internet Pharmacy'' will refer you to a specific local
pharmacy or a mail order pharmacy to have the prescription that you
obtained from your physician filled. These are appropriate uses of the
Internet by pharmacies.
Are There Internet Pharmacy Sites That are Not Legitimate?
Some Internet pharmacy sites do not require that you have a
prescription from your doctor. These ``Internet Pharmacies'' require
the customer to complete a medical questionnaire. This type of site
advises that the information will be reviewed by a doctor, and the drug
will be prescribed and sent to you, if appropriate. The medical
questionnaire often has most of the questions set so that if the
default answers are not changed, the questions are answered in an
appropriate manner to obtain the desired drug. Questionnaire sites
often require that the customer waive certain rights. This type of
pharmacy usually does not name the doctor who will be reviewing the
medical questionnaire or provide any information about the
qualifications of the doctor. These sites operate in a manner that is
not consistent with state laws regarding standards of medical practice
and may be engaging in illegal sales of controlled substances (see
discussion above).
Some Internet Pharmacy sites are operating in a foreign country and
often do not require any prescription before sending controlled
substances to you. These sites often advise that there have been
changes to the U.S. law that authorize the customer to import a
controlled substance into the United States without benefit of a
prescription. These types of sites may be engaging in
[[Page 21184]]
illegal sales of controlled substances (see discussion below).
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 you are registered with DEA as an importer and you are 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)). DEA regulations
further state:
``No person shall import or cause to be imported any controlled
substance * * * unless and until such person is properly registered
under the Act (or exempt from registration) and the Administrator has
issued him a permit to do so pursuant to Sec. 1312.13. * * *'' (21 CFR
1312.11(a))
Illegal importation of controlled substances is a felony that may
result in imprisonment and fines (21 U.S.C. 960).
The CSA Provides a Personal Use Exemption for Controlled Substances
Purchased Abroad. Does the Exemption Apply to Controlled Substances
Bought from a Foreign Internet Site?
The Controlled Substances Act and DEA regulations allow you a
personal use exemption to bring a limited quantity of controlled
substances into the U.S. for your use only when you bring the
controlled substances across the U.S. border in your possession (21
U.S.C. 956, 21 CFR 1301.26). It does not apply to controlled substances
being shipped into the U.S. Purchasing controlled substances on the
Internet and having them shipped to you in the U.S. is not permitted by
the personal use exemption. Such purchases and shipments would be
considered ``imports'' of the controlled substance even if the
substance is for your personal use. Unless you are registered as an
importer and in compliance with the requirements, such shipments are
illegal and subject to seizure.
Does it Make a Difference if I Have a Prescription from a U.S. Doctor
for Controlled Substances That I Buy From a Foreign Internet Site?
No, the law remains the same. Unless you are registered with DEA as
an importer and are in compliance with DEA's requirements, you may not
have controlled substances shipped to you in the U.S. from another
country.
What are the Things to Consider 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 indicators that the ``Internet Pharmacy'' may not be
legitimate and should not be used as a source for controlled substances
are the following:
The site is not a participant in any insurance plan and
requires that all payments be made with a credit card.
The site requires that you waive some rights before they
send you the drugs.
The site advises you about the law and why it is
permissible for you to obtain pharmaceutical controlled substances from
foreign countries via the Internet.
The site does not ask the name, address, or phone number
of your current physician.
The site advises you to have the drugs sent to post office
boxes or other locations to avoid detection by U.S. authorities.
I Have Seen a VIPPS Seal on Some Internet Pharmacy Sites. What Does
This Mean?
The National Association of Boards of Pharmacy (NABP) has developed
a voluntary program called the Verified Internet Pharmacy Practice
Sites (VIPPS). The NABP has begun issuing 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 (see http://www.nabp.net).
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 are not
controlled substances. If a ``life style'' drug is a controlled
substance, however, it is still subject to all regulations for
controlled substances. You must obtain a prescription from a DEA
registered prescriber and have it filled by a DEA registered pharmacy.
I Have a Complaint About an ``Internet Pharmacy'' Site on the Internet
That Appears to be Illegally Selling Drugs. Where Should I Send the
Complaint?
If the complaint involves a pharmaceutical controlled substance,
contact the DEA, Office of Diversion Control, Drug Operations Section,
Washington, DC 20537, telephone (202) 307-7194 or your local DEA office
(for a list of contacts, see http://www.dea.gov/agency/domestic.htm.)
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, you may
contact the State Board of Pharmacy or the State Board of Medicine
where the doctor or pharmacist is located.
Additionally, you may wish to view other sites on the Internet that
are for registering complaints such as the NABP (http://www.nabp.net).
Dated: March 19, 2001.
Laura M. Nagel,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. 01-10255 Filed 4-26-01; 8:45 am]
BILLING CODE 4410-09-P