U.S. Department of Justice
Federal Bureau of Prisons

OPI: HSD
NUMBER: 6080.01
DATE: May 27, 1994
SUBJECT: Autopsies

1. PURPOSE AND SCOPE. To prescribe the decision-making
authority of Bureau personnel to order autopsies.
An autopsy examination is ordinarily done in the interest of
practicing a high standard of medicine. For example, the Joint
Commission on Accreditation of Healthcare Organizations requires
all-approved hospitals to secure as high a percentage of
autopsies as possible. Title 18, United States Code, section
4045, authorizes the Bureau of Prisons to order an autopsy in two
specific situations as outlined in Sections 4.a. and 4.b. of this
Program Statement.
2.

DIRECTIVES AFFECTED
a. Directive Referenced
P.S. 6000.03 Health Services Manual (03/15/90)

b. Rules cited in this Program Statement are contained in
28 ยง CFR 549.80.
3.

STANDARDS REFERENCED

a. American Correctional Association Foundation/Core Standards
for Adult Correctional Institutions: C2-4160;
b. American Correctional Association 3rd Edition Standards for
Adult Correctional Institutions: 3-4375;
c. American Correctional Association Foundation/Core Standards
for Adult Local Detention Facilities: C2-5191;
[Bracketed Bold - Rules]
Regular Type - Implementing Information

P.S. 6080.01
May 27, 1994
Page 2
d. American Correctional Association 3rd Edition Standards for
Local Detention Facilities: 3-ALDF-4E-45;
e. Joint Commission On Accreditation of Healthcare
Organizations, 1994 Accreditation Manual For Hospitals, Volume I:
MS.5.1.8.3.
4.

[AUTHORITY TO CONDUCT AUTOPSIES ยง549.80

a. The Warden may order an autopsy and related scientific or
medical tests to be performed on the body of a deceased inmate of
the facility in the event of homicide, suicide, fatal illness or
accident, or unexplained death. The autopsy or tests may be
ordered in one of these situations only when the Warden
determines that the autopsy or test is necessary to detect a
crime, maintain discipline, protect the health or safety of other
inmates, remedy official misconduct, or defend the United States
or its employees from civil liability arising from the
administration of the facility.
(1) The authority of the Warden under this section may not
be delegated below the level of Acting Warden.
(2) Where the Warden has the authority to order an autopsy
under this provision, no non-Bureau of Prisons authorization
(e.g., from either the coroner or from the inmate's
next-of-kin) is required. A decision on whether to order an
autopsy is ordinarily made after consultation with the attending
physician, and a determination by the Warden that the autopsy is
in accordance with the statutory provision. Once it is
determined that an autopsy is appropriate, the Warden shall
prepare a written statement authorizing this procedure. The
written statement is to include the basis for approval.]
While next-of-kin permission is not required in these
circumstances, an attempt should always be made to obtain. If a
decision is made to obtain the autopsy but the next-of-kin does
not desire one, the Warden's statement so shall note that the
attempt was made.
[b. In any situation other than as described in paragraph (a)
of this section, the Warden may order an autopsy or post-mortem
operation, including removal of tissue for transplanting, to be
performed on the body of a deceased inmate of the facility with
the written consent of a person (e.g., coroner, or next-of-kin,
or the decedent's consent in the case of tissue removed for
transplanting) authorized to permit the autopsy or post-mortem
operation under the law of the State in which the facility is
located.

P.S. 6080.01
May 27, 1994
Page 3
(1) The authority of the Warden under this section may not
be delegated below the level of Acting Warden.
(2) When the conducting of an autopsy requires permission
of the family or next-of-kin, the following message is to be
included in the telegram notifying the family or next-of-kin of
the death: "Permission is requested to perform a complete
autopsy". Also inform the family or next-of-kin that they may
telegraph the institution collect with their response. Where
permission is not received from the person (e.g., coroner or
next-of-kin) authorized to permit the autopsy or post-mortem
operation, an autopsy or post mortem operation may not be
performed under the conditions of this paragraph (b).]
In addition to telegram notification, any dated method of
communication, such as telefax or written electronics, would be
acceptable for next-of-kin notification or their response.
[c. In addition to the provisions of paragraphs (a) and (b) of
this section, each institution also is expected to abide by the
following procedures.
(1) Staff shall ensure that the state laws regarding the
reporting of deaths are followed.]
The staff member referred to above is the Health Services
Administrator.
[(2) Time is a critical factor in arranging for an autopsy,
as this ordinarily must be performed within 48 hours. While a
decision on an autopsy is pending, no action should be taken that
will affect the validity of the autopsy results. Therefore,
while the body may be released to a funeral home, this should be
done only with the written understanding from the funeral home
that no preparation for burial, including embalming, should be
performed until a final decision is made on the need for an
autopsy.]
The Warden shall determine the best method for disposition
of the body prior to an autopsy.
[(3) Medical staff shall arrange for the approved autopsy
to be performed.
(4) To the extent consistent with the needs of the autopsy
or of specific scientific or medical tests, provisions of state
and local laws protecting religious beliefs with respect to such
autopsies are to be observed.]

P.S. 6080.01
May 27, 1994
Page 4
Due to the sensitive nature of autopsies within certain
religions, the institution Chaplain, prior to an autopsy being
performed, shall be consulted to apprise the Warden of any
religious issues or concerns which might arise.
5. RECORDKEEPING. All documentation, including autopsy results,
shall be filed in section 6 of the inmate's medical record.

\s\
Kathleen M. Hawk
Director


url: https://www.ojp.gov/about/ocr/pdfs/Civil Rights Compliance Checklist.pdf

text:
Sample Federal Civil Rights Compliance Checklist for Use by Recipients
1. Has the subrecipient submitted a Certification Form to the OCR certifying compliance with
the Equal Employment Opportunity Program (EEOP) requirements?
Yes

No

If yes, on what date did the subrecipient submit the Certification Form?
2. If the subrecipient is required to prepare a written EEO Plan in accordance with 28 C.F.R. pt.
42, subpt. E, does the subrecipient have an EEO Plan on file for review? (If a subrecipient is
unsure as to whether they are required to prepare a written EEO Plan, they can find out at
https://ojp.gov/about/ocr/eeop.htm, where they can also prepare and file their EEOP
electronically).
Yes

No

If yes, on what date did the subrecipient complete the EEOP?
3. If the subrecipient is required to submit an EEOP Utilization Report to the Office for Civil
Rights (OCR), Office of Justice Programs (OJP), U.S. Department of Justice (DOJ) in
accordance with 28 C.F.R. pt. 42, subpt. E, has the subrecipient done so? (If a subrecipient is
unsure as to whether they are required to prepare a written EEO Plan, they can find out at
https://ojp.gov/about/ocr/eeop.htm, where they can also prepare and file their EEOP
electronically).
Yes

No

If yes, on what date did the subrecipient submit the EEOP Utilization Report?
If yes, what is the date of the subrecipient’ts most recent EEOP Utilization Report
Approval Letter?
4. How does the subrecipient notify program participants and beneficiaries (e.g., through
brochures, postings, or policy statements) that it does not discriminate in the delivery of
services or benefits based on race, color, national origin, religion, sex, disability, and age (as
well as sexual orientation and gender identity if the subrecipient receives funding from the
Office on Violence Against Women (OVW) or under the Violence Against Women Act
(VAWA) of 1994, as amended)?
Comments:

5. How does the subrecipient notify employees and prospective employees (e.g., through
advertisements, recruitment materials, postings, dissemination of orders or policies) that it
does not discriminate on the basis of race, color, national origin, religion, sex, and disability
(as well as sexual orientation and gender identity if the subrecipient receives funding from
OVW or under VAWA)?
Comments:
6. Does the subrecipient have written policies or procedures for notifying employees and
applicants on how to file complaints alleging discrimination by the subrecipient?
Yes

No

If yes, explain these policies and procedures.
7. Does the subrecipient have written policies or procedures for notifying program participants
and beneficiaries on how to file complaints alleging discrimination by the subrecipient,
including how to file complaints with the [State Administering Agency] and the OCR?
Yes

No

If yes, explain these policies and procedures.
8. If the subrecipient has fifty or more employees and receives DOJ funding of $25,000 or
more, has the subrecipient taken the following actions:
a. Adopted grievance procedures that incorporate due process standards and provide for
the prompt and equitable resolution of complaints alleging a violation of the DOJ
regulations implementing Section 504 of the Rehabilitation Act of 1973, found at 28
C.F.R. pt. 42, subpt. G, which prohibit discrimination on the basis of disability in
employment practices and the delivery of services?
Yes

No

b. Designated a person to coordinate compliance with the prohibitions against disability
discrimination contained in 28 C.F.R. pt. 42, subpt. G?
Yes

No

c. Notified program participants, beneficiaries, employees, applicants, and others that
the subrecipient does not discriminate on the basis of disability?
Yes

No

Comments:
9. If the subrecipient operates an educational program or activity, has the subrecipient taken the
following actions:
a. Adopted grievance procedures that provide for the prompt and equitable resolution of
complaints alleging a violation of the DOJ regulations implementing Title IX of the
Education Amendments of 1972, found at 28 C.F.R. pt. 54, which prohibit
discrimination on the basis of sex?
Yes

No

b. Designated a person to coordinate compliance with the prohibitions against sex
discrimination contained in 28 C.F.R. pt. 54?
Yes

No

c. Notified applicants for admission and employment, employees, students, parents, and
others that the subrecipient does not discriminate on the basis of sex in its educational
programs or activities?
Yes

No

Comments:
10. Has the subrecipient complied with the requirement to submit to the OCR any adverse
findings of discrimination against the subrecipient based on race, color, national origin,
religion or sex that are the result of a due process hearing conducted by a federal or state
court or a federal or state administrative agency?
Yes

No

Comments:
11. What steps has the subrecipient taken to provide meaningful access to its programs and
activities to persons who have limited English proficiency (LEP)?
Comments:

12. Does the subrecipient have a written language-access policy on providing services to LEP
persons?
Yes

No

13. Does the subrecipient conduct any training for its employees on the requirements of
applicable federal civil rights laws?
Yes

No

Comments
14. Does the subrecipient provide federally funded services to eligible beneficiaries regardless of
religion, a religious belief, a refusal to hold a religious belief, or a refusal to attend or
participate in a religious practice?
Yes

No

15. If the subrecipient engages in explicitly religious activities, does the subrecipient:
a. Separate the explicitly religious activities in either time or location from the federally
funded activities?
Yes

No

b. Ensure that participation in the explicitly religious activities is voluntary for
participants in the federally funded program?
Yes

No

Comments:
16. If the subrecipient is a religious institution or a faith-based organization, does the
subrecipient:
a. Provide appropriate notice to program beneficiaries or prospective beneficiaries that
the subrecipient does not discriminate on the basis of religion in the delivery of
services or benefits?
Yes

No

b. Provide appropriate notice to program beneficiaries or prospective beneficiaries that
if they object to the “religious character” of the subrecipient, the subrecipient will
make a reasonable effort to find an acceptable alternative provider in close
geographic proximity that offers comparable services?
Yes

No

c. Keep a record of the requests for an alternative provider from beneficiaries or
prospective beneficiaries who object to the subrecipient’s “religious character,”
noting the subrecipient’s efforts to find an appropriate alternative provider and to
follow up with the beneficiary or prospective beneficiary?
Yes

No

Comments:
17. If the subrecipient receives funding under VAWA or from OVW, does the subrecipient serve
male victims of domestic violence, dating violence, sexual assault, and stalking?
Yes

No

Comments:
18. If the subrecipient receives funding under VAWA or from OVW, does the subrecipient
provide sex- segregated or sex-specific services?
Yes

No

If yes, describe how the services are sex-segregated or sex-specific.
If yes, has the subrecipient determined that providing services that are sexsegregated or sex specific is necessary to the essential operation of the program?
Yes

No

If yes, describe how the subrecipient determined that providing sex-segregated or
sex-specific services is necessary to the essential operation of the program.

Revised May 2020


url: https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-2) A Pharmacist Guide to Prescription Fraud.pdf


url: https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-3) Recognizing the Drug Abuser.pdf

text:
• Wants an appointment toward end of of
fice hours;

• Perform a thorough examination appro
priate to the condition.

• Calls or comes in after regular business
hours;

• Document examination results and ques
tions you asked the patient.

• Traveling through town, visiting friends
or relatives (not a permanent resident);

• Request picture I.D. or other I.D. and
Social Security number. Photocopy these docu
ments and include in the patient’s record.

• Feigning physical problems, such as
abdominal or back pain, kidney stone, or mi
graine headache in an effort to obtain narcotic
drugs;
• Feigning psychological problems, such as
anxiety, insomnia, fatigue or depression in an
effort to obtain stimulants or depressants;
• States that specific non-narcotic analge
sics do not work or that he/she is allergic to
them;
• Contends to be a patient of a practitioner
who is currently unavailable or will not give
the name of a primary or reference physician;
• States that a prescription has been lost or
stolen and needs replacing;

U

gE

m

ru

i ni

s t ra

t ion

.

DO:

U.S. Department of Justice
Drug Enforcement Administration

par tment o
f

n f or c e m e n t

• Confirm a telephone number, if provided
by the patient.
• Confirm the current address at each visit.
• Write prescriptions for limited quantities.

DON’T:
• “Take their word for it” when you are
suspicious.
• Dispense drugs just to get rid of drugseeking patients.
• Prescribe, dispense or administer con
trolled substances outside the scope of your
professional practice or in the absence of a
formal practitioner-patient relationship.

Pressures the practitioner by eliciting
sympathy or guilt or by direct threats;

___________

Utilizes a child or an elderly person when
seeking methylphenidate or pain medication.

Sections of this document were adapted from A Guide to
Prescribing, Administering and Dispensing Controlled
Substances in Missouri, January 1999. Printed with
permission. All rights reserved.

Ad

Recognizing
the
Drug Abuser

• Call a previous practitioner, pharmacist
or hospital to confirm the patient’s story,

• Deceives the practitioner, such as by
requesting refills more often than originally
prescribed;

ce
st i
Ju

• Must be seen right away;

What You Should Do
When Confronted by a
Suspected Drug Abuser

D

Modus Operandi Often Used
by the Drug-Abusing Patient
Include:

De
.S.

Office of Diversion Control
Liaison and Policy Section
Additional information on DEA’s Diversion Control Program
is available at: www.DEAdiversion.usdoj.gov

Your Responsibilities

T

he purpose of this guide is

to inform and educate you, the
healthcare practitioner, to
ensure that controlled sub

The abuse of prescription drugs–especially
controlled substances–is a serious social and
health problem in the United States today. As a
healthcare professional, you share responsibil
ity for solving the prescription drug abuse and
diversion problem.
• You have a legal and ethical responsibil
ity to uphold the law and to help protect society
from drug abuse.

stances continue to be avail

• You have a professional responsibility to
prescribe controlled substances appropriately,
guarding against abuse while ensuring that
your patients have medication available when
they need it.
• You have a personal responsibility to
protect your practice from becoming an easy
target for drug diversion. You must become
aware of the potential situations where drug
diversion can occur and safeguards that can be
enacted to prevent this diversion.
This guide will help you meet these
responsibilities.

able for legitimate medical

Recognizing the Drug Abuser

and scientific purposes while

Telling the difference between a legitimate pa
tient and a drug abuser isn’t easy. The drug-seeking
individual may be unfamiliar to you. They could
be a person who claims to be from out-of-town and
has lost or forgotten a prescription or medication.
Or the drug seeker may actually be familiar to you
such as another practitioner, co-worker, friend or
relative. Drug abusers or “doctor shoppers” often
possess similar traits and modus operandi. Recog
nizing these characteristics and modus operandi is
the first step to identifying the drug-seeking patient
who may be attempting to manipulate you in order
to obtain desired medications.

preventing their diversion
into the illicit market. It is
not the intent of this publica
tions to reduce or deny the use
of controlled substances where
medically indicated. Nothing
in this guide should be

Common Characteristics of the Drug
Abuser:

construed as authorizing

• Unusual behavior in the waiting room;

or permitting any person to

• Assertive personality, often demanding
immediate action;

conduct any act that is not
authorized or permitted
under federal or state laws.

• Unusual appearance–extremes of either
slovenliness or being over-dressed.
• May show unusual knowledge of controlled substances and/or gives medical
history with textbook symptoms OR gives

evasive or vague answers to questions regarding medical history;
• Reluctant or unwilling to provide reference information. Usually has no regular doctor
and often no health insurance;
• Will often request a specific controlled
drug and is reluctant to try a different drug;
• Generally has no interest in diagnosis;
fails to keep appointments for further diagnostic tests or refuses to see another practitioner for consultation;
• May exaggerate medical problems and/or
simulate symptoms;
• May exhibit mood disturbances, suicidal
thoughts, lack of impulse control, thought
disorders, and/or sexual dysfunction;
• Cutaneous signs of drug abuse–skin
tracks and related scars on the neck, axilla,
forearm, wrist, foot and ankle. Such marks
are usually multiple, hyper-pigmented and
linear. New lesions may be inflamed. Shows
signs of “pop scars” from subcutaneous
injections.


url: https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-1) Drug Addiction in Health Care Professionals.pdf

text:
Should I Become Involved?
Health care professionals often avoid dealing
with drug impairment in their colleagues.
There is a natural reluctance to approach a
co-worker suspected of drug addiction. There
is the fear that speaking out could anger the
co-worker, resulting in retribution, or could
result in a colleague's loss of professional
practice.
Many employers or co-workers end up being
"enablers" of health care practitioners whose
professional competence has been impaired
by drug abuse. Addicted colleagues are often
given lighter work schedules, and excuses are
made for their poor job performance. Exces
sive absences from the work site are often
overlooked. Drug impaired co-workers are
protected from the consequences of their
behavior. This allows them to rationalize
their addictive behavior or continue their
denial that a problem even exists.
If you recognize the aforementioned signs or

symptoms in a co-worker, it's time to demon
strate concern. You may jeopardize a person's
future if you cover up or don't report your
concerns. Many well-educated, highly
trained, and experienced health care practi
tioners lose their families, careers, and fu
tures to substance abuse. Tragically, some
health care workers have even lost their lives
to their drug addiction because the people
who saw the signs and symptoms of their
drug use refused to get involved.
By becoming involved, you can not only help
someone who may be doing something illegal,
but more importantly, your action could affect
the safety and welfare of your addicted em
ployee or coworker AND those patients or the
public who may come in contact with him or
her.

What If I Know That Drugs
Are Being Sold or Stolen?

U.S. Department of Justice
Drug Enforcement Administration

Drug abuse and drug dealing are serious
problems that should be handled by qualified
professionals. If you suspect that a drug deal
is in progress, do not intervene on your own.
Contact security or notify the police.
If you are a DEA registrant and become aware

of a theft or significant loss involving control
led substances, you must immediately report
the theft or loss to the nearest DEA office as
well as your local police department.

What Can I Do to Help?
For some employees, the mere fact that their
supervisor talks to them about their poor
work performance is enough to help them
change. For others, however, the problem
may be more severe and require more drastic
measures. The threat of losing a job may have
more influence on a drug abuser than a
spouse's threat to leave or a friend's decision
to end a relationship. Many drug abusers will
seek help for their problem if they believe
their job is at stake, even though they have
ignored such pleas from other people impor
tant in their life.
Drug addicts can recover, and effective help
is available. Encourage your co-worker or
employee to seek drug treatment assistance.
Treatment programs range from self-help to
formal recovery programs. A number of state
licensing boards, employee assistance pro
grams, state diversion programs and peer
assistance organizations will refer individuals
and their families to appropriate counseling
and treatment services. These services will
maintain the confidentiality of those seeking
assistance to the greatest extent possible.
It is not the intent of this publication to reduce or deny the
use ofcontrolled substances where medically indicated.
Nothing in this guide should be construed as authorizing
or permitting any person to do any act that is not autho
rized or permitted under federal or state laws.

Department of Justice
Drug Enforcement Administration
Office of Diversion Control
Liaison and Policy Section
Washington, D.C. 20537
Additional information on DEA's Diversion Control Program
is available at: www.deadiversion.usdoj.gov

What Are My Responsibilities?
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• You have a legal and ethical responsibil
ity to uphold the law and to help protect
society from drug abuse.
• You have a professional responsibility to
prescribe and dispense controlled substances
appropriately, guarding against abuse while
ensuring that patients have medication
available when they need it.

• You have a personal responsibility to
protect your practice from becoming an easy
target for drug diversion. You must become
aware of the potential situations where drug
diversion can occur and safeguards that can
be enacted to prevent this diversion.

d'Jf.~ ~ddiction o.r,~~ o/J~~th care

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ibith ·our ~~~f;~el_nj.- .. Yet.~~f!l~h, ca;.e···.

How Do I Recognize a Drug Impaired Co-Worker?
• Interpersonal relations with colleagues,
staff and patients suffer. Rarely admits errors
or accepts blame for errors or oversights;

~~ii" though the vast majority of

Drug abusers often exhibit similar aberrant
behavior. Certain signs and symptoms may
indicate a drug addiction problem in a health
care professional. Have you observed some of
the following signs?
• Work absenteeism -absences without
notification and an excessive number of sick
days used;

• Sloppy recordkeeping, suspect ledger
entries and drug shortages;

~~~~-~~J:
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with the controlled substances law
··· "''5 :."q,nd regulations in a responsible
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"impaired health professionals are
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".·:~:~~~(liversion. Many have easy access to
r::~::.,.;"~:t~'·.::. 'controlled substance me~~Jions;
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• Frequent disappearances from the work
site, having long unexplained absences, mak
ing improbable excuses and taking frequent
or long trips to the bathroom or to the stock
room where drugs are kept;
• Excessive amounts of time spent near a
drug supply. They volunteer for overtime and
are at work when not scheduled to be there;

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· tlie.-: ~:i~stlt~tmay i~dic~tt!'~~ii:~ ·q,<:' · . ..... ::'·;,:;·.
c(J~~,~gue or co-ll)O~~t?r; ~8 .d iverting ;::

Cf1nft:olled substances to support a
substance abuse ]Jroblein.

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• Unreliability in keeping appointments
and meeting deadlines;
• Work performance which altemates
between periods of high and low productivity
and may suffer from mistakes made due to
inattention, poor judgment and bad decisions;
• Confusion, memory loss, and difficulty
concentrating or recalling details and instruc
tions. Ordinary tasks require greater effort
and consume more time;

• Heavy "wastage" of drugs;

• Inappropriate prescriptions for large
narcotic doses;
• Insistence on personal administration of
injected narcotics to patients;
• Progressive deterioration in personal
appearance and hygiene;
• Uncharacteristic deterioration of hand
writing and charting;
• Wearing long sleeves when inappropriate;
• Personality change - mood swings, anxiety,
depression, lack of impulse control, suicidal
thoughts or gestures;
• Patient and staff complaints about health
care provider's changing attitude/behavior;
• Increasing personal and professional
isolation.


Potential Diversion: Patients
Possible Red Flags


Patient demands immediate attention



Patient recites textbook symptoms



Patient gives very vague medical history



Patient exaggerates medical condition



Patient wants appointments towards the end of office hours or
arrives after regular business hours



Patient is not interested in an examination or undergoing diagnostic tests



Patient is unwilling to give permission to obtain past medical
records



Patient claims they failed to pack medication, lost it, or that it
was stolen



Patient claims that hospital or clinic, with past medical records, is out of business or burned down



Patient deceives doctors or seeks alternate doctors while normal doctor is out of the office



Patient solicits Medicaid recipients to use Medicaid cards as
payment method



Patient offers to buy other patient’s pills



Patient alters prescriptions

WWW. DEADIVERSION. USDOJ. GOV

Report forged, altered, or
counterfeit prescriptions to
local police.
Report drug diversion:
DEA Tip Line: https://
www.dea.gov/ops/
submit.php

Possible Signs of Drug-Seeking


Fictitious records

Diversion Hotline:
1-877-792-2873



Wounds inflicted to self, family members, and pets



Requests specific medication due to allergies



Vacationing in area, no local address



Requests pain medications for a pet

DISCLAIMER: This list is not all-inclusive. It is not the intent of this publication to reduce or deny the use of controlled
substances where medically indicated.

Potential Diversion: Practitioners
Questions to Consider


Does the practitioner follow state laws when prescribing controlled substances?



Does the practitioner conduct cursory medical exams or any medical exam at all?



Does the doctor do diagnostic testing or refer patients out for diagnostic testing?



Is the practitioner referring patients to other specialists (surgery, physical therapy, etc.)?



Are the initial office visits or follow-up visits brief?



Does the practitioner prescribe multiple drugs within the same drug category?



Does the practitioner prescribe excessive quantities of controlled substances relative to the medical condition
the prescription is purported to treat?



Do patients travel a great distance to see the practitioner?



Does the practitioner ignore signs of abuse?


Patient appears to be under the influence



Patient asks for the controlled substances he wants



Patient is doctor shopping in PDMP



Practitioner is warned by family members that the patient is abusing or selling his controlled
substances



Does the practitioner ignore toxicology reports?



Does the practitioner only treat patients with narcotic controlled substances?



Does the practitioner start on a low-dose or low-level controlled substance and then over time work up to
higher levels, or does the practitioner just start patients on a high-dose narcotic?



Does the practitioner continue to prescribe controlled substances to patients even though it would be
ineffective for treatment purposes?



Does the practitioner allow the non-medical staff to determine the narcotic to be prescribed, the practitioner
just signs the prescription?



Does the practitioner coach patients on what to say so that patients can get the narcotics that they want?



Does the practitioner violate his own pain management policies and guidelines?



Does the practitioner ignore warnings from insurance companies, law enforcement, other practitioners, family
members, etc.?



Does the practitioner receive other compensation for narcotic prescriptions (sex, guns, drugs, etc.)?



Does the doctor still charge patients for visits if the patients do not receive narcotic prescriptions?



Are patient deaths attributed to drug abuse or overdose?



Does the practitioner use inventory for personal use?

DISCLAIMER: Doing one or more of these does not make prescribing illegal. It is the totality of the circumstances. This
list is not all-inclusive.


url: https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-6) Clarification of TItle 21 CFR - Employee Screening - Non Practitioners.pdf

text:
U. S. Department of Justice
Drug Enforcement Administration
8701 Morrisette Drive
Springfield, VA 22152

www.dea.gov
Dear Registrant:
The Attorney General has encouraged Department of Justice agencies to carefully review their regulations and
identify those that may create unintended collateral consequences for a formerly incarcerated person to successfully
reenter society. As part of this review, the following Drug Enforcement Administration (DEA) was identified: Section
1301.90 of Title 21, Code of Federal Regulations (CFR), which sets forth the DEA’s position on employee screening by
non-practitioners. The DEA believes that a limited clarification regarding the scope of section 1301.90 may remove an
impediment to successful reentry, without harming controlled substances security or frustrating any other public safety
goal.
DEA would like to clarify that section 1301.90, the complete text of which is set forth below, applies only to
screening procedures for prospective employees at a non-practitioner’s DEA-registered location where controlled
substances are stored, distributed, manufactured, or otherwise handled. This regulation does not apply to prospective
employees who will be employed at non-registered locations, such as corporate headquarters or sales offices.
Thank you for your attention to this matter.
Title 21 CFR § 1301.90 - EMPLOYEE SCREENING -- NON- PRACTITIONERS
Employee screening procedures
It is the position of DEA that the obtaining of certain information by non-practitioners is vital to
fairly assess the likelihood of an employee committing a drug security breach. The need to know
this information is a matter of business necessity, essential to overall controlled substances security.
In this regard, it is believed that conviction of crimes and unauthorized use of controlled substances
are activities that are proper subjects for inquiry. It is, therefore, assumed that the following
questions will become a part of an employer's comprehensive employee screening program:
Question: Within the past five years, have you been convicted of a felony, or within the past two
years, of any misdemeanor or are you presently formally charged with committing a criminal
offense? (Do not include any traffic violations, juvenile offenses or military convictions, except by
general court-martial.) If the answer is yes, furnish details of conviction, offense, location, date and
sentence.
Question: In the past three years, have you ever knowingly used any narcotics, amphetamines or
barbiturates, other than those prescribed to you by a physician? If the answer is yes, furnish details.
Advice: An authorization, in writing, that allows inquiries to be made of courts and law
enforcement agencies for possible pending charges or convictions must be executed by a person
who is allowed to work in an area where access to controlled substances clearly exists. A person
must be advised that any false information or omission of information will jeopardize his or her
position with respect to employment. The application for employment should inform a person that
information furnished or recovered as a result of any inquiry will not necessarily preclude
employment, but will be considered as part of an overall evaluation of the person's qualifications.
The maintaining of fair employment practices, the protection of the person's right of privacy, and the
assurance that the results of such inquiries will be treated by the employer in confidence will be
explained to the employee.


url: https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-9) Questions and Answers for Prescribing Practitioners (EPCS).pdf

text:
EPCS Questions and Answers for Prescribing Practitioners

Page 1 of 6

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Electronic Prescriptions for Controlled Substances (EPCS)

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Interim Final Rule with Request for Comment
Questions and Answers for Prescribing Practitioners
[as of 03/31/2010]

Cases Against Doctors

The questions and answers below are intended to summarize and provide information for prescribing practitioners regarding
the Drug Enforcement Administration (DEA) Interim Final Rule with Request for Comment “Electronic Prescriptions for
Controlled Substances” (75 FR 16236, March 31, 2010) [Docket No. DEA-218, RIN 1117-AA61]. The information in this
section is not intended to convey specific information about every aspect of the rule, nor is it a substitute for the regulations
themselves.

Controlled Substance Schedules

Introduction

Chemical Control Program
CMEA (Combat Meth Epidemic
Act)

DATA Waived Physicians
Drug Disposal Information
Drug and Chemical Information
E-commerce Initiatives
Federal Agencies & Related Links

General

Federal Register Notices

Individual Practitioners: Getting Started

National Prescription Drug Take
Back Day

Institutional Practitioners: Getting Started

NFLIS
Publications & Manuals

Accessing the Electronic Prescription Application or Electronic Health Record Application to Sign Controlled
Substances Prescriptions

Questions & Answers

Creating and Signing Prescriptions

Synthetic Drugs

Other Issues

Title 21 Code of Federal
Regulations

Transmitting Prescriptions to the Pharmacy and Printing Prescriptions

Title 21 USC Codified CSA

Significant Guidance Documents

Reporting Security Incidents

Introduction
Q. What is DEA's rule “Electronic Prescriptions for Controlled Substances?”
A. DEA's rule, “Electronic Prescriptions for Controlled Substances” revises DEA's regulations to provide practitioners with
the option of writing prescriptions for controlled substances electronically. The regulations will also permit pharmacies to receive, dispense, and archive
these electronic prescriptions. The rule was published in the Federal Register Wednesday, March 31, 2010 and becomes effective on June 1, 2010.
Q. Is the use of electronic prescriptions for controlled substances mandatory?
A. No, the new regulations do not mandate that practitioners prescribe controlled substances using only electronic prescriptions. Nor do they require
pharmacies to accept electronic prescriptions for controlled substances for dispensing. Whether a practitioner or pharmacy uses electronic prescriptions
for controlled substances is voluntary from DEA's perspective. Prescribing practitioners are still able to write, and manually sign, prescriptions for
schedule II, III, IV, and V controlled substances and pharmacies are still able to dispense controlled substances based on those written prescriptions.
Oral prescriptions remain valid for schedule III, IV, and V controlled substances. Electronic prescriptions for controlled substances are only permissible if
the electronic prescription and the pharmacy application meet DEA's requirements. In addition, electronic prescriptions for controlled substances may be
subject to state laws and regulations. If state requirements are more stringent than DEA's regulations, the state requirements would supersede any less
stringent DEA provision.
Q. Did DEA consider public comment in the development of this rule?
A. DEA considered almost 200 separate comments received from the public to the “Electronic Prescriptions for Controlled Substances” Notice of
Proposed Rulemaking (73 FR 36722, June 27, 2008) in the development of this rule.
Q. Did DEA work with other Federal agencies in the development of this rule?

A. DEA worked closely with a number of components within the Department of Health and Human Services. DEA's discussions with the Office of the
National Coordinator for Health Information Technology (ONC), Centers for Medicare and Medicaid Services (CMS), and Agency for Healthcare Research
and Quality (AHRQ) were instrumental in the development of this rule. DEA also worked closely with the National Institute of Standards and Technology
and the General Services Administration.

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General
Q. When can a practitioner start issuing electronic prescriptions for controlled substances?
A. A practitioner will be able to issue electronic controlled substance prescriptions only when the electronic prescription or electronic health record (EHR)
application the practitioner is using complies with the requirements in the interim final rule.
Q. How will a practitioner be able to determine that an application complies with DEA's rule?
A. The application provider must either hire a qualified third party to audit the application or have the application reviewed and certified by an approved
certification body. The auditor or certification body will issue a report that states whether the application complies with DEA's requirements and whether
there are any limitations on its use for controlled substance prescriptions. (A limited set of prescriptions require information that may need revision of
the basic prescription standard before they can be reliably accommodated, such as hospital prescriptions issued to staff members with an identifying
suffix.) The application provider must provide a copy of the report to practitioners who use or are considering use of the electronic prescription
application to allow them to determine whether the application is compliant with DEA's requirements.
Q. Until a practitioner has received an audit/certification report from the application provider indicating that the application meets DEA's
requirements, how can the electronic prescription application or electronic health record application be used to write controlled substances
prescriptions?
A. Nothing in this rule prevents a practitioner or a practitioner's agent from using an existing electronic prescription or EHR application that does not
comply with the interim final rule to prepare and print a controlled substance prescription, so that EHR and other electronic prescribing functionality may
be used. Until the application is compliant with the final rule,however, the practitioner will have to print the prescription for manual signature. Such
prescriptions are paper prescriptions and subject to the existing requirements for paper prescriptions.

Individual Practitioners: Getting Started
Note: The questions and responses below assume that the practitioner is an individual practitioner (e.g., physician, dentist, veterinarian, nurse practitioner) and is a
DEA registrant lawfully permitted to prescribe controlled substances. The practitioner may be a member of a group practice. They further assume that the practitioner
has received an audit or certification report from the application provider of the practitioner's software used to create prescriptions for controlled substances that
indicates the application meets DEA's requirements.)
Q. Is identity proofing of individual prescribing practitioners required. If so, who will conduct it?
A. Yes, identity proofing is critical to the security of electronic prescribing of controlled substances. Authentication credentials used to sign controlled
substance prescriptions may be issued only to individuals whose identity has been confirmed. Individual practitioners will be required to apply to certain
Federally approved credential service providers (CSPs) or certification authorities (CAs) to obtain their two-factor authentication credential or digital
certificate. The CSP or CA will be required to conduct identity proofing that meets National Institute of Standards and Technology Special
Publication 800-63-1 Assurance Level 3. Both in person and remote identity proofing will be acceptable.
Q. If a practitioner wants to undergo identity proofing to prescribe controlled substances, how is this accomplished?
A. DEA expects application providers will work with CSPs or CAs to direct practitioners to one or more sources of two-factor authentication credentials
that will be interoperable with their applications. Prescribing practitioners may wish to contact their application provider to determine which CSP or CA
the provider recommends the practitioner use. The specifics of each application will determine what kind of two-factor credential will be needed.
Q. Is remote identity proofing permissible?
A. Yes, the rule permits both in-person and remote identity proofing. DEA believes that the ability to conduct remote identity proofing allowed for in
National Institute of Standards and Technology Special Publication 800-63-1 Level 3 will ensure that practitioners in rural areas will be able to obtain an
authentication credential without the need for travel.
Q. Once a practitioner has undergone identity proofing, will the practitioner receive something?
A. The CSP or CA that conducted the identity proofing of the practitioner may issue a new hard token or register and provide credentials for an existing
token. Regardless of whether a new token is provided and activated, an existing token is registered, or a biometric is used for the signing of controlled
substance prescriptions, communications between the CSP or CA and practitioner applicant must occur through two channels (e.g., mail, telephone,
e-mail).
Q. Why is DEA requiring the use of two-factor authentication credentials?
A. Two-factor authentication (two of the following – something you know, something you have, something you are) protects the practitioner from
misuse of his/her credential by insiders as well as protecting him/her from external threats because the practitioner can retain control of a biometric or
hard token. Authentication based only on knowledge factors is easily subverted because they can be observed, guessed, or hacked and used without the
practitioner's knowledge.
Q. What two-factor credentials will be acceptable?
A. Under the interim final rule, DEA is allowing the use of two of the following – something you know (a knowledge factor), something you have (a hard
token stored separately from the computer being accessed), and something you are (biometric information). The hard token, if used, must be a
cryptographic device or a one-time password device that meets Federal Information Processing Standard 140-2 Security Level 1.
Q. What is a hard token?
A. A hard token is a cryptographic key stored on a hardware device (e.g., a PDA, cell phone, smart card, USB drive, one-time password device) rather
than on a general purpose computer. A hard token is a tangible, physical object possessed by an individual practitioner.
Q. Is it permissible for an individual practitioner to have the office manager or other staff maintain custody of the individual practitioner's hard
token?
A. No, the practitioner must retain sole possession of the hard token, where applicable, and must not share the password or other knowledge factor with
any other person. The practitioner must not allow any other person to use the token or enter the knowledge factor or other identification means to sign
prescriptions for controlled substances. Failure by the practitioner to secure the hard token or knowledge factor may provide a basis for revocation or
suspension of the practitioner's DEA registration.
Q. If an individual practitioner wants to use a biometric as one factor of the two-factor authentication credential, does DEA have any special
requirements?
A. DEA is establishing several standards for the use of biometrics and for the testing of the software used to read the biometrics. DEA wishes to
emphasize that these standards do not specify the types of biometrics that may be acceptable. Any biometric that meets the criteria DEA has specified
may be used as the biometric factor in a two-factor authentication credential used to indicate that prescriptions are ready to be signed and sign

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controlled substance prescriptions. The use of biometrics as one factor in the two-factor authentication protocol is strictly voluntary, as is all electronic
prescribing of controlled substances.
Q. Does an individual practitioner need separate authentication credentials if the practitioner has more than one DEA registration?
A. No, a single authentication credential can be used. The practitioner or the practitioner's agent must, however, select the appropriate DEA registration
number when the prescription is created.
Q. If an individual practitioner uses more than one application to create and sign controlled substance prescriptions, will the practitioner need to
undergo identity proofing for each and obtain separate credentials for each?
A. Whether the individual practitioner needs to undergo identity proofing and obtain separate credentials for separate applications will depend on the
requirements of the applications. It is likely that if a practitioner has privileges at one or more hospitals, the hospitals will require separate credentials to
use their applications.
Q. Once a practitioner possesses the two-factor credential, is the practitioner ready to sign controlled substance prescriptions?
A. No, there is another step that must be taken. Any application that meets DEA's requirements will require the practice to set access controls so that
only individuals legally authorized to sign controlled substance prescriptions are allowed to do so. The application will determine whether access control
is set by name or by role. If the logical access controls are role-based, one or more roles will have to be limited to individuals authorized to prescribe
controlled substances. This role may be labeled “DEA registrant” or physician, dentist, nurse practitioner, etc.
Q. How are access controls set?
A. Setting access controls requires two people. One person must determine which individuals are authorized to sign controlled substance prescriptions
and enter those names or assign those names to a role that is allowed to sign controlled substance prescriptions. A DEA registrant must then use
his/her two-factor credential to execute the access control list. The access control list will need to be updated when registrants join or leave a practice.
Q. Who has to determine whether a prescribing practitioner's DEA registration is current and in good standing?
A. A person at the practice who is setting access control has to check to be sure that each practitioner being granted authorization to sign controlled
substances prescriptions has a DEA registration, state authorization to practice and, where applicable, state authorization to dispense controlled
substances that are still current and in good standing. DEA expects this will be done simply by checking the latest certificates.

Institutional Practitioners: Getting Started
(Note: The questions and responses below assume that the practitioner is an institutional practitioner (e.g., a hospital or clinic) and is a DEA registrant lawfully
permitted to prescribe controlled substances. They further assume that the practitioner has received an audit or certification report from the application provider of the
practitioner's software used to create prescriptions for controlled substances that indicates the application meets DEA's requirements.)
Q. Is identity proofing required for any individual practitioner whom the institutional practitioner is granting access to issue prescriptions using the
institution's electronic prescribing application? If so, who will conduct it?
A. Yes, as identity proofing is critical to the security of electronic prescribing of controlled substances. Authentication credentials used to sign controlled
substance prescriptions are issued only to individuals whose identity has been confirmed. DEA is allowing institutional practitioners, who are DEA
registrants, to conduct the identity proofing for any individual practitioner whom the institutional practitioner is granting access to issue prescriptions
using the institution's electronic prescribing application. Because institutional practitioners have credentialing offices, those offices may conduct inperson identity proofing as part of the credentialing process. DEA is not requiring institutional practitioners to meet the requirements of National
Institute of Standards and Technology Special Publication 800-63-1 for identity proofing. Before the institutional practitioner issues the authentication
credential, a person designated by the institutional practitioner must check the individual practitioner's government-issued photographic identification
against the person presenting it. The institutional practitioner must also check State licensure and DEA registrations, where applicable.
Q. Is an institutional practitioner required to conduct identity proofing in this manner?
A. No, institutional practitioners are allowed, but not required, to conduct identity proofing. If an institutional practitioner decides to have each
practitioner obtain identity proofing and the two-factor authentication credential on his own, as other individual practitioners do, that is permissible
under the rule.
Q. For an institutional practitioner, is remote identity proofing permissible?
A. The rule only allows institutional practitioners to conduct in-person identity proofing. Remote identity proofing is not permissible for institutional
practitioners.
Q. For an institutional practitioner, how is the two-factor authentication credential issued?
A. Under the rule, the institutional practitioner may issue the two-factor authentication credentials or obtain them from a third party which will have to
be a CSP or CA that meets the criteria DEA has specified. In the latter case, the institutional practitioner could have each practitioner apply for the twofactor credential himself, which would entail undergoing identity proofing by the CSP or CA. Alternatively, the institutional practitioner can serve as a
trusted agent for the third party. Trusted agents conduct part of the identity proofing on behalf of the CSP or CA and submit the information for each
person along with a signed agreement that specifies the trusted agent's responsibilities.
Q. Why is DEA requiring the use of two-factor authentication credentials?
A. Two-factor authentication (two of the following – something you know, something you have, something you are) protects the practitioner from
misuse of his/her credential by insiders as well as protecting him/her from external threats because the practitioner can retain control of a biometric or
hard token. Authentication based only on knowledge factors is easily subverted because they can be observed, guessed, or hacked and used without the
practitioner's knowledge.
Q. What two-factor credentials will be acceptable?
A. Under the interim final rule, DEA is allowing the use of two of the following – something you know (a knowledge factor), something you have (a hard
token stored separately from the computer being accessed), and something you are (biometric information). The hard token, if used, must be a
cryptographic device or a one-time-password device that meets Federal Information Processing Standard 140-2 Security Level 1.
Q. What is a hard token?
A. A hard token is a cryptographic key stored on a hardware device (e.g., a PDA, cell phone, smart card, USB drive, one-time password device) rather
than on a general purpose computer. A hard token is a tangible, physical object possessed by an individual practitioner.
Q. Is it permissible for a practitioner to have another staff person at the institutional practitioner maintain custody of the hard token?

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A. No, the practitioner must retain sole possession of the hard token, where applicable, and must not share the password or other knowledge factor with
any other person. The practitioner must not allow any other person to use the token or enter the knowledge factor or other identification means to sign
prescriptions for controlled substances.
Q. If an institutional practitioner wants to use a biometric as one factor of the two-factor authentication credential issued to persons prescribing
controlled substances, does DEA have any special requirements?
A. DEA is establishing several standards for the use of biometrics and for the testing of the software used to read the biometrics. DEA wishes to
emphasize that these standards do not specify the types of biometrics that may be acceptable. Any biometric that meets the criteria DEA has specified
may be used as the biometric factor in a two-factor authentication credential used to indicate that prescriptions are ready to be signed and sign
controlled substance prescriptions. The use of biometrics as one factor in the two-factor authentication protocol is strictly voluntary, as is all electronic
prescribing of controlled substances.
Q. Are any additional steps needed to give practitioners the ability to sign controlled substance prescriptions?
A. Yes, once a person's identity has been confirmed by the credentialing office and a two-factor credential has been issued, another office must set
access controls. The application must have the ability to assign permissions by name or role so that only authorized practitioners are allowed to sign
controlled substance prescriptions. Two individuals must be involved in setting the access controls; one will enter the data based on information from
the credentialing office and the second will approve the entry.

Accessing the Electronic Prescription Application or Electronic Health Record Application to Sign Controlled Substance Prescriptions
Q. When must a practitioner's permission to indicate that controlled substance prescriptions are ready to be signed and sign controlled substance
prescriptions be revoked?
A. A practitioner's permission to indicate that controlled substance prescriptions are ready to be signed and to sign controlled substance prescriptions
must be revoked whenever any of the following occurs, on the date it is discovered:
• If a hard token or any other authentication factor required by the two-factor authentication protocol is lost, stolen, or compromised. Such
access must be terminated immediately upon receiving notification from the individual practitioner.
• The individual practitioner's DEA registration expires, unless the registration has been renewed.
• For individual practitioners prescribing controlled substances under the registration of an institutional practitioner, when the institutional
practitioner's DEA registration expires, unless the registration has been renewed.
• The individual practitioner's DEA registration is terminated, revoked, or surrendered.
• For individual practitioners prescribing controlled substances under the registration of an institutional practitioner, when the institutional
practitioner's DEA registration is terminated, revoked, or surrendered.
• The individual practitioner is no longer authorized to use the electronic prescription application (e.g., when the individual practitioner leaves the
practice).
• When an individual practitioner is no longer authorized to use the institutional practitioner's electronic prescription application (e.g., when the
individual practitioner is no longer associated with the institutional practitioner).

Creating and Signing Prescriptions
Q. What information is an electronic prescription for a controlled substance required to contain?
A. As with paper prescriptions, all electronic prescriptions for controlled substances are required to contain the full name and address of the patient,
drug name, strength, dosage form, quantity prescribed, directions for use, and the name, address and registration number of the practitioner. The
prescription shall be dated as of the day when signed and shall be signed by the practitioner using his/her two-factor authentication credential. Where
applicable, refill information must also be included, as well as any other information required by DEA regulations.
Q. Is a practitioner required to review a prescription before signing it?
A. All controlled substances must be reviewed by the prescribing practitioner. The practitioner must affirmatively indicate those prescriptions that are
ready to be signed. A practitioner has the same responsibility when issuing an electronic prescription as when issuing a paper prescription to ensure that
the prescription conforms in all respects with the requirements of the Controlled Substances Act and DEA regulations. This responsibility applies with
equal force regardless of whether the prescription information is entered by the practitioner or a member of his staff.
Q. When a practitioner reviews a prescription, what information must be displayed?
A. All information required of any controlled substance prescription must be displayed, except for the patient's address. However, the patient's address
must be part of the elements of the prescription that are digitally signed by the practitioner or the application and transmitted to the pharmacy.
Q. Must a practitioner separately attest to each prescription?
A. No, the application must include, on the prescription review screen, the following statement or its substantial equivalent: “By completing the twofactor authentication protocol at this time, you are legally signing the prescription(s) and authorizing the transmission of the above information to the
pharmacy for dispensing. The two-factor authentication protocol may only be completed by the practitioner whose name and DEA registration number
appear above.” However, no keystroke is required to acknowledge the statement.
Q. Is it permissible to have a staff person in the practitioner's office complete all of the required information for a controlled substance prescription
and then have the practitioner review, sign, and authorize the transmission of the prescription?
A. Yes, however, if an agent of the practitioner enters information at the practitioner's direction prior to the practitioner reviewing and approving the
information, the practitioner is responsible in the event the prescription does not conform in all essential respects to the law and regulations.
Q. How will the two-factor credential be used?
A. The practitioner will use the two-factor credential to sign the prescription; that is, using the two-factor credential will constitute the legal signature of
the DEA-registered prescribing practitioner. When the credential is used, the application must digitally sign and archive at least the DEA-required
information contained in the prescription.
Q. May a practitioner use his/her own digital certificate to sign an electronic controlled substance prescription?
A. Yes, the interim final rule allows any practitioner to use his/her own digital certificate to sign electronic prescriptions for controlled substances. If the
practitioner and his/her application provider wish to do so, the two-factor authentication credential can be a digital certificate specific to the practitioner

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that the practitioner obtains from a certification authority that is cross-certified with the Federal Bridge Certification Authority at the basic assurance
level.
Q. How is an electronic controlled substance prescription signed?
A. The prescribing practitioner whose name and DEA registration number appear on the prescription must indicate those controlled substance
prescriptions that are ready to be signed. When the registrant indicates that one or more prescriptions are to be signed, the application must prompt
him/her to begin a two-factor authentication protocol. Completion of the two-factor authentication protocol legally signs the prescription(s).
Q. Will a practitioner be allowed to simultaneously issue multiple prescriptions for multiple patients with a single signature?
A. A practitioner is not permitted to issue prescriptions for multiple patients with a single signature.
Q. If a practitioner is signing more than one controlled substance prescription for a single patient, how many executions of the two-factor
authentication protocol are required?
A. Each controlled substance prescription will have to be indicated as ready for signing, but execution of a single two-factor authentication protocol can
then sign all prescriptions for a given patient.
Q. Once an electronic controlled substance prescription is signed, must it be transmitted to the pharmacy immediately?
A. No, signing and transmitting an electronic controlled substance prescription are two distinct actions. Electronic prescriptions for controlled substances
should be transmitted as soon as possible after signing, however, it is understood that practitioners may prefer to sign prescriptions before office staff
add pharmacy or insurance information. Therefore, DEA is not requiring that transmission of the prescription occur simultaneously with signing the
prescription.

Other Issues
Q. If a mid-level practitioner practices in a state that requires the controlled substance prescription to contain the mid-level practitioner's
supervisor's DEA number as well as the mid-level practitioner's DEA number, is this possible with electronic controlled substance prescriptions?
A. Multiple DEA numbers can appear on a single prescription, if required by state law or regulations, provided that the electronic prescription application
clearly identifies which practitioner is the prescriber and which is the supervisor.
Q. Practitioners who work in a group practice with multiple practitioners may have all of the practitioners' names printed on the practice's
prescription pads. Can all of the practitioners' names appear on the practice's electronic controlled substance prescriptions?
A. No, for electronic prescriptions, only one prescribing practitioner's name and DEA number will appear. If a practitioner needs to sign a prescription
originally created and indicated as ready for signing by another practitioner in a practice, he/she must change the practitioner name and DEA number to
his/her own. The only exception to this rule is if required by state law or regulations, multiple DEA numbers can appear on a single prescription provided
that the electronic prescription application clearly identifies which practitioner is the prescriber and which is the supervisor.
Q. Can a qualified practitioner who prescribes schedules III, IV, and V narcotic controlled drugs approved by the Food and Drug Administration
specifically for use in maintenance or detoxification treatment use electronic prescriptions for controlled substances for this purpose?
A. Yes, a qualified practitioner may use electronic prescriptions for controlled substances to prescribe schedules III, IV, and V narcotic controlled drugs
approved by the Food and Drug Administration specifically for use in maintenance or detoxification treatment if the audit or certification report the
practitioner receives from the application provider specifically states that the application meets DEA's requirements for those prescriptions.
Q. How can a practitioner obtain his/her prescribing history?
A. DEA is requiring that the electronic prescription application be able to generate a log, upon request by the practitioner, of all electronic prescriptions
for controlled substances the practitioner issued using the application over at least the preceding two years. This log is required to be sortable at least
by patient name, drug name, and date of issuance.

Transmitting Prescriptions to the Pharmacy and Printing Prescriptions
Q. What is an intermediary?
A. An intermediary means any technology system that receives and transmits an electronic prescription between the practitioner and the pharmacy.
Q. If transmission of an electronic prescription fails, may the intermediary convert the electronic prescription to another form (e.g. facsimile) for
transmission?
A. No, an electronic prescription must be transmitted from the practitioner to the pharmacy in its electronic form. If an intermediary cannot complete a
transmission of a controlled substance prescription, the intermediary must notify the practitioner. Under such circumstances, if the prescription is for a
schedule III, IV, or V controlled substance, the practitioner can print the prescription, manually sign it, and fax the prescription directly to the
pharmacy. This prescription must indicate that it was originally transmitted to, and provide the name of, a specific pharmacy, the date and time of
transmission, and the fact that the electronic transmission failed.
Q. What are the DEA requirements regarding the storage of electronic prescription records?
A. Once a prescription is created electronically, all records of the prescription must be retained electronically. As is the case with paper prescription
records, electronic controlled substance prescription records must be kept for a minimum period of two years.

Reporting Security Incidents
Q. Is a person who administers logical access controls required to report security incidents?
A. Yes, the application is required to run an internal audit for potential security incidents daily and generate a report of any such incidents. If the
application generates a report and, upon investigation, the person(s) designated to administer logical access controls for the practice or institutional
practitioner determines that the issuance or records of controlled substance prescriptions has been compromised or could have been compromised, it
must be reported to the application provider and DEA within one business day. In general, the security incidents that should be reported are those that
represent successful attacks on the application or other incidents in which someone gains unauthorized access.

https://www.deadiversion.usdoj.gov/ecomm/e_rx/faq/practitioners.htm

12/29/2019

EPCS Questions and Answers for Prescribing Practitioners

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