[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]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[DEA-191N]


Dispensing and Purchasing Controlled Substances over the Internet

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Guidance.

-----------------------------------------------------------------------

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.

------------------------------------------------------------------------
           Schedule                 Example of controlled substances
------------------------------------------------------------------------
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
------------------------------------------------------------------------

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