Federal Register / Vol. 66, No. 82 / Friday, April 27, 2001 / Notices 21181

business on June 13, 2001. All

submissions should be addressed to the

Secretary, United States International

Trade Commission, 500 E Street SW.,

Washington, DC 20436.

Persons with mobility impairments

who will need special assistance in

gaining access to the Commission

should contact the Office of the

Secretary at 202–205–2000.

LIST OF SUBJECTS: Chile, tariffs, and

imports.

By order of the Commission.

Issued: April 24, 2001.

Donna R. Koehnke,

Secretary.

[FR Doc. 01–10527 Filed 4–26–01; 8:45 am]

BILLING CODE 7020–02–P

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.

21182 Federal Register / Vol. 66, No. 82 / Friday, April 27, 2001 / Notices

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 DEAregistered 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

Federal Register / Vol. 66, No. 82 / Friday, April 27, 2001 / Notices 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-thefact 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

21184 Federal Register / Vol. 66, No. 82 / Friday, April 27, 2001 / Notices

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 § 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

DEPARTMENT OF LABOR

Employment Standards Administration

Wage and Hour Division

Minimum Wages for Federal and

Federally Assisted Construction;

General Wage Determination Decisions

General wage determination decisions

of the Secretary of Labor are issued in

accordance with applicable law and are

based on the information obtained by

the Department of Labor from its study