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[Federal Register: October 6, 2010 (Volume 75, Number 193)]
[Rules and Regulations]               
[Page 61613-61617]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06oc10-10]                         

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1306

[Docket No. DEA-339S]

 
Role of Authorized Agents in Communicating Controlled Substance 
Prescriptions to Pharmacies

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Statement of policy.

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SUMMARY: The Drug Enforcement Administration (DEA) is issuing this 
statement of policy to provide guidance under existing law regarding 
the proper role of a duly authorized agent of a DEA-registered 
individual practitioner in connection with the communication of a 
controlled substance prescription to a pharmacy.

FOR FURTHER INFORMATION CONTACT: Mark W. Caverly, Chief, Liaison and 
Policy Section, Office of Diversion Control, Drug Enforcement 
Administration, 8701 Morrissette Drive, Springfield, VA 22152; 
telephone (202) 307-7297.

SUPPLEMENTARY INFORMATION:

Legal Authority

    DEA implements and enforces Titles II and III of the Comprehensive 
Drug Abuse Prevention and Control Act of 1970, often referred to as the 
Controlled Substances Act (CSA) and the Controlled Substances Import 
and Export Act (CSIEA) (21 U.S.C. 801-971), as amended. DEA publishes 
the implementing regulations for these statutes in title 21 of the Code 
of Federal Regulations (CFR), parts 1300 through 1321. These 
regulations are designed to ensure that there is a sufficient supply of 
controlled substances for legitimate medical, scientific, research, and 
industrial purposes and to deter the diversion of controlled substances 
to illegal purposes. Controlled substances are drugs that have a 
potential for abuse and dependence; these include substances classified 
as opioids, stimulants, depressants, hallucinogens, anabolic steroids, 
and drugs that are immediate precursors of these classes of substances. 
The CSA mandates that DEA establish a closed system of control for 
manufacturing, distributing, and dispensing controlled substances. Any 
person who manufactures, distributes, dispenses, imports, exports, or 
conducts research or chemical analysis with controlled substances must 
register with DEA (unless exempt) and comply with the applicable 
requirements for the activity.

Background

    Under longstanding Federal law, controlled substances are strictly 
regulated to ensure a sufficient supply for legitimate medical, 
scientific, research, and industrial purposes and to deter diversion of 
controlled substances to illegal purposes. The substances are regulated 
because of their potential for abuse and likelihood to cause dependence 
when abused and because of their serious and potentially unsafe nature 
if not used under proper circumstances. To minimize the likelihood that 
pharmaceutical controlled substances would be diverted into illicit 
channels, Congress established under the CSA a closed system of drug 
distribution for legitimate handlers of controlled substances. The 
foundation of this system is the concept of registration. The only 
persons who may lawfully manufacture, distribute and dispense 
controlled substances under the CSA are those who have obtained a DEA 
registration authorizing them to do so. 21 U.S.C. 822. Thus, the 
prescribing of controlled substances may be carried out only by those 
practitioners who have obtained a DEA registration authorizing such 
activity.
    To be eligible for a DEA registration as a practitioner under the 
CSA, one must be a physician, dentist, veterinarian, hospital, or other 
person licensed, registered, or otherwise permitted by the United 
States or the State in which he or she practices to dispense controlled 
substances in the course of professional practice. 21 U.S.C. 802(21), 
823(f). Thus, State licensure to prescribe controlled substances is 
generally a prerequisite to obtaining a DEA registration to do so. The 
term ``individual practitioner'' excludes institutions such as 
hospitals, which are themselves DEA registrants and are permitted to 
administer and dispense, but not prescribe, controlled substances under 
their registration. 21 CFR 1300.01(b)(17).
    By longstanding statutory requirement, a valid prescription issued 
by a DEA-registered practitioner is required for dispensing a 
controlled substance. To be effective (i.e., valid), a prescription for 
a controlled substance must be issued for a legitimate medical purpose 
by a practitioner acting in the usual course of professional practice. 
United States v. Moore, 423 U.S. 122 (1975); 21 CFR 1306.04(a). Thus, 
the practitioner must determine that a prescription for a controlled 
substance is for a legitimate medical purpose. While the core 
responsibilities pertaining to prescribing controlled substances may 
not be delegated to anyone else, an individual practitioner may 
authorize an agent to perform a limited role in communicating such 
prescriptions to a pharmacy in order to make the prescription process 
more efficient. Nonetheless, it is important to understand that any 
agency relationship must also preserve the requirement that medical 
determinations to prescribe controlled substances be made by a 
practitioner only, not by an agent. Accordingly, this statement of 
policy outlines DEA's existing statutory and regulatory requirements as 
to the proper role of duly authorized agents of individual 
practitioners. DEA anticipates the utilization of electronic 
prescribing by practitioners for

[[Page 61614]]

controlled substance prescriptions will reduce the role of agents over 
time.

Medical Determination of Need for a Controlled Substance Prescription 
Cannot Be Delegated

    DEA regulations state: ``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. The responsibility for the proper prescribing and dispensing 
of controlled substances is upon the prescribing practitioner, but a 
corresponding responsibility rests with the pharmacist who fills the 
prescription.'' 21 CFR 1306.04(a). Accordingly, the practitioner must 
determine that a prescription for a controlled substance is for a 
legitimate medical purpose. This determination is the sole 
responsibility of the practitioner and may not be delegated.

Elements of a Valid Prescription Must be Specified by the Practitioner 
and Cannot be Delegated

    Controlled substance prescriptions are orders for medication to be 
dispensed to an ultimate user and are required to contain specific 
information including: Patient name, address, drug name and strength, 
quantity prescribed, directions for use, and the name, address and DEA 
number of the issuing practitioner. 21 CFR 1306.05(a). All 
prescriptions for controlled substances must be dated as of, and signed 
on, the day when issued. Paper prescriptions must be manually signed by 
the issuing practitioner in the same manner that the practitioner would 
sign a check or other legal document (21 CFR 1306.05(d)); electronic 
prescriptions for controlled substances must be signed in accordance 
with DEA regulations (21 CFR 1306.05(e), 21 CFR 1311.140).
    The regulations provide that ``[a] prescription may be prepared by 
the secretary or agent for the signature of a practitioner, but the 
prescribing practitioner is responsible in case the prescription does 
not conform in all essential respects to the law and regulations.'' 21 
CFR 1306.05(f). Accordingly, an authorized agent may prepare a 
controlled substance prescription only based on the instructions of the 
prescribing practitioner as to the required elements of a valid 
prescription and then provide the prescription to the practitioner to 
review. The authorized agent does not have the authority to make 
medical determinations. The practitioner must personally sign the 
prescription, whether manually or electronically. The prescribing 
practitioner cannot delegate his or her signature authority.

Role of Agent Under the CSA

    As discussed above, the CSA does not permit a prescribing 
practitioner to delegate to an agent or any other person the 
practitioner's authority to issue a prescription for a controlled 
substance. A practitioner acting in the usual course of his or her 
professional practice must determine that there is a legitimate medical 
purpose for a controlled substance prescription; an agent may not make 
this determination. Even though the CSA established a closed system in 
which all persons in the distribution chain are required to be 
registered and are held accountable for every controlled substance 
transaction, Congress recognized a role for agents under the Act. The 
CSA exempts agents of registrants, including practitioners, from the 
requirement of registration. 21 U.S.C. 822(c)(1). The statute defines 
an ``agent'' as ``an authorized person who acts on behalf of or at the 
direction of a manufacturer, distributor, or dispenser. * * *.'' 21 
U.S.C. 802(3). Likewise, DEA regulations implementing the CSA 
specifically permit a practitioner to use an authorized agent to 
perform certain ministerial acts in connection with communicating 
prescription information to a pharmacy. The common means to communicate 
a prescription to a pharmacy include hand delivery, facsimile, phone 
call, or an electronic transmission. As explained below, the proper 
role of an agent depends upon the schedule of the controlled substance 
prescribed, the circumstances of the ultimate user, and the method of 
communication.

Communication by Facsimile or Oral Communication of a Valid 
Prescription for a Schedule III, IV, or V Controlled Substance May be 
Delegated to an Authorized Agent

    The CSA provides that a pharmacy may dispense Schedule III and IV 
controlled substances pursuant to a ``written or oral prescription.'' 
21 U.S.C. 829(b). DEA regulations further specify that a pharmacist may 
dispense a Schedule III, IV, or V controlled substance pursuant to 
``either a paper prescription signed by a practitioner [or] a facsimile 
of a signed paper prescription transmitted by the practitioner or the 
practitioner's agent to the pharmacy, * * *.'' 21 CFR 1306.21(a). 
Accordingly, an authorized agent may transmit such a practitioner-
signed paper prescription via facsimile to the pharmacy on behalf of 
the practitioner.
    Controlled substances in Schedules III, IV and V may also be 
dispensed by a pharmacy pursuant to ``an oral prescription made by an 
individual practitioner and promptly reduced to writing by the 
pharmacist containing all information required [for a valid 
prescription], except for the signature of the practitioner.'' 21 CFR 
1306.21(a). Under DEA regulations, an authorized agent may orally 
communicate such a prescription to a pharmacist. 21 CFR 1306.03(b). 
Where the pharmacist has reason to believe that a prescription has been 
communicated by an agent, the pharmacist, in accordance with his or her 
responsibility for proper dispensing of controlled substances, may have 
a duty to inquire into the legitimacy of the prescription. The 
particular circumstances will dictate the appropriate level of inquiry 
by the pharmacist. As noted above, the practitioner remains responsible 
for ensuring that the prescription conforms to the law and regulations, 
and the practitioner cannot delegate to an agent the authority to make 
a medical determination of need for a controlled substance 
prescription.

Generally, a Valid Schedule II Controlled Substance Prescription May 
Not be Communicated by Facsimile

    Because Schedule II controlled substances have the highest 
potential for abuse and the greatest likelihood of dependence among the 
pharmaceutical controlled substances (those in Schedules II-V), the CSA 
controls on Schedule II drugs are the most restrictive. The CSA 
requires that a Schedule II controlled substance be dispensed by a 
pharmacy only pursuant to a written prescription, except in emergency 
situations, and prohibits Schedule II prescriptions from being 
refilled. 21 U.S.C. 829(a). Thus, in most cases, a pharmacist must 
receive the original, manually signed paper prescription or an 
electronic prescription prior to dispensing a Schedule II controlled 
substance. 21 CFR 1306.11(a).

A Valid Schedule II Controlled Substance Prescription For a Person in a 
Hospice or Long Term Care Facility (LTCF) May be Communicated by 
Facsimile and That Communication May be Delegated to an Authorized 
Agent

    DEA regulations specify two exceptions whereby a Schedule II 
controlled substance prescription sent by facsimile may serve as the 
original written prescription. A practitioner or a practitioner's 
authorized agent may transmit a valid Schedule II controlled

[[Page 61615]]

substance prescription to a pharmacy via facsimile for: (1) Patients 
enrolled in a hospice care program certified and/or paid for by 
Medicare under Title XVIII or hospice programs which are licensed by 
the State (21 CFR 1306.11(g)); and (2) residents of LTCFs (21 CFR 
1306.11(f)). The facsimile serves as the original written prescription 
and must be maintained by the pharmacy as such. An authorized agent of 
the prescribing practitioner may transmit the practitioner-signed 
prescription by facsimile on behalf of the practitioner.

Emergency Oral Communication of a Valid Schedule II Controlled 
Substance Prescription May Not be Delegated to an Authorized Agent

    The CSA contains an exception that allows a practitioner to issue 
oral prescriptions for Schedule II controlled substances in an 
emergency. 21 U.S.C. 829(a). An emergency for this purpose is defined 
by the Food and Drug Administration in 21 CFR 290.10. DEA regulations 
limit such an emergency oral prescription to the quantity necessary to 
treat the patient during the emergency period and require that it be 
followed up within 7 days by a practitioner-signed, written 
prescription to the dispensing pharmacy. 21 CFR 1306.11(d). Moreover, 
oral emergency prescriptions must immediately be reduced to writing by 
the pharmacist and must contain all the information ordinarily required 
in a prescription, except for the signature of the prescribing 
individual practitioner. If the prescribing individual practitioner is 
not known to the pharmacist, the pharmacist must make a reasonable 
effort to determine that the oral authorization came from a registered 
individual practitioner, which may include a call back to the 
prescribing individual practitioner and/or other good faith efforts to 
ensure the practitioner's identity. 21 CFR 1306.11(d). Because the more 
specific requirement that the emergency Schedule II oral authorization 
must be from a registered individual practitioner (21 CFR 1306.11(d)) 
supersedes the general rule that an employee or agent of the individual 
practitioner may communicate prescriptions to a pharmacist (21 CFR 
1306.03(b)), the prescribing individual practitioner must personally 
communicate the emergency oral prescription to the pharmacist. An agent 
may not call in an oral prescription for a Schedule II controlled 
substance on behalf of a practitioner even in an emergency 
circumstance.

Pharmacist Dispensing a Controlled Substance Prescription Has a Duty To 
Fill Only Valid Prescriptions

    Regardless of the method of transmission of a controlled substance 
prescription--by hand delivery, facsimile, phone call or 
electronically--DEA regulations make it clear that the legal 
responsibility for issuing a valid prescription that ``conform[s] in 
all essential respects to the law and regulations'' rests upon the 
prescribing practitioner. As noted, however, a pharmacist has a 
corresponding responsibility for the proper prescribing and dispensing 
of controlled substances. 21 CFR 1306.04(a). Further, ``A corresponding 
liability rests upon the pharmacist, including a pharmacist employed by 
a central fill pharmacy, who fills a prescription not prepared in the 
form prescribed by DEA regulations.'' 21 CFR 1306.05(f). A pharmacist 
must carefully review all purported controlled substance prescriptions 
to ensure that the prescription meets all of the legal requirements for 
a valid prescription. The pharmacist has a duty to inquire further as 
to any question surrounding the satisfaction of any or all of the legal 
requirements for a valid prescription depending upon the particular 
circumstances, including the requirement that the prescription be 
issued for a legitimate medical purpose by a practitioner acting in the 
usual course of professional practice. The pharmacist must be satisfied 
that the prescription is consistent with the CSA and DEA regulations 
before dispensing a controlled substance to the ultimate user.

Summary of the Acts That an Agent May Take in Connection With 
Controlled Substance Prescriptions

    1. An authorized agent of an individual practitioner may prepare a 
written prescription for the signature of the practitioner, provided 
that the practitioner, in the usual course of professional practice, 
has determined that there is a legitimate medical purpose for the 
prescription and has specified to the agent the required elements of 
the prescription. 21 CFR 1306.04(a); 1306.05(a), (f).
    2. Where a DEA-registered individual practitioner has made a valid 
oral prescription for a controlled substance in Schedules III-V by 
conveying all the required prescription information to the 
practitioner's authorized agent, that agent may telephone the pharmacy 
and convey that prescription information to the pharmacist. 21 CFR 
1306.03(b), 1306.21(a).
    3. In those situations in which an individual practitioner has 
issued a valid written prescription for a controlled substance, and the 
regulations permit the prescription to be transmitted by facsimile to a 
pharmacy (as set forth in 21 CFR 1306.11(a), 1306.11(f), 1306.11(g), 
and 1306.21(a)), the practitioner's agent may transmit the 
practitioner-signed prescription to the pharmacy by facsimile.

Who Is an Agent of an Individual Practitioner for the Purpose of 
Communicating a Prescription for a Controlled Substance

    The CSA defines an ``agent'' as ``an authorized person who acts on 
behalf of or at the direction of a manufacturer, distributor, or 
dispenser. * * *'' 21 U.S.C. 802(3). Under the CSA, the term 
``dispense'' includes ``prescribing.'' 21 U.S.C. 802(10). Establishment 
of an agency relationship, consistent with the CSA, is guided by 
general precepts of the common law of agency. For the purposes of 
explaining the law of agency as it relates to the CSA, it is 
appropriate to refer to and consider as generally applicable the 
Restatement of Agency (Restatement) which provides:

    Agency is the fiduciary relationship that arises when one person 
(a ``principal'') manifests assent to another person (an ``agent'') 
that the agent shall act on the principal's behalf and subject to 
the principal's control, and the agent manifests assent or otherwise 
consents so to act.
    Restatement (Third) of Agency Sec.  1.01 (2006).

    The Restatement is useful in evaluating whether, for CSA purposes, 
a valid agency relationship exists between a prescribing practitioner 
and another person for the purpose of communicating a prescription for 
a controlled substance to a pharmacy. The Restatement requires that the 
principal (in this context, the DEA-registered individual practitioner) 
``manifests assent'' for a certain person to act on his or her behalf. 
This is consistent with the CSA and its registration-based system of 
accountability. Where non-DEA registrants communicate a prescription 
for a controlled substance on behalf of a registrant, it is important 
that such persons be clearly identified and their activities be subject 
to evaluation to ensure they do not exceed the bounds of the agency 
relationship and the legal limits of an agent's role under the CSA. 
Because the individual practitioner remains responsible for ensuring 
that all prescriptions issued pursuant to his or her DEA registration 
comply in all respects with the CSA and DEA regulations, it is 
important that the practitioner decide who may act as his

[[Page 61616]]

or her agent. This is also consistent with the CSA definition that an 
agent is ``an authorized person who acts on behalf of or at the 
direction of'' the prescribing individual practitioner. 21 U.S.C. 
802(3).
    In addition to requiring that the principal (i.e., individual 
prescribing practitioner) ``manifests assent'' to having a particular 
person act as his or her agent, and that the agent reciprocate by 
manifesting assent to serve as such, the Restatement also requires that 
the agent acts ``subject to the principal's control.'' In an employment 
situation, an individual practitioner may establish the duties of his 
or her employees and is responsible for monitoring their activities. 
Absent an employer-employee relationship, a practitioner will generally 
have less control over other persons that he or she may designate as 
his or her agent(s). Prior to designating an agent, a practitioner may 
wish to consider the degree of control that the registrant may exercise 
over the proposed agent, the proposed agent's licensure, level of 
training and experience, and other such factors to determine whether 
the person would be an appropriate agent and to ensure that the agent 
will not engage in activities that exceed the scope of the agency 
relationship. Absent affirmative actions by the practitioner and the 
proposed agent, a valid agency relationship generally will not exist 
outside an employer-employee relationship.
    By requiring that an agency relationship is created when (1) the 
principal manifests assent that a particular person shall act (i) on 
his or her behalf and (ii) subject to his or her control, and (2) the 
agent manifests assent so to act, the Restatement definition of 
``agency'' is consistent with the CSA's definition of ``agent'' as ``an 
authorized person who acts on behalf of or at the direction of'' the 
prescribing practitioner. 21 U.S.C. 802(3). An agent may not legally 
perform duties that must be personally performed by the individual 
practitioner. The practitioner may assign only those duties which may 
be carried out by an agent.
    DEA notes that in a 2001 notice and solicitation of information on 
the potential use of automated dispensing systems to prevent the 
accumulation of surplus controlled substances at LTCFs, DEA briefly 
discussed the role of nurses in the narrow setting of LTCFs outside of 
an employer-employee relationship and where no affirmative actions 
established an agency relationship between the individual practitioner 
and the LTCF nurse. 66 FR 20833, 20834 (April 25, 2001). This 
incidental example and other informal discussions have resulted in the 
need for this published articulation of what existing law allows and 
what affirmative actions may be required to establish a valid agency 
relationship for purposes of an authorized agent to communicate 
controlled substance prescriptions to pharmacies, particularly in 
settings where there is no employer-employee relationship. DEA 
regulations on the role of authorized agents in communicating 
controlled substance prescriptions to pharmacies generally have not 
changed.
    This policy statement outlines the proper role of agents in those 
situations where an individual practitioner and an individual agent 
(including but not limited to an LTCF nurse) have taken affirmative 
steps to establish a valid agency relationship for those aspects of the 
CSA that may be appropriately executed by an authorized agent under 
Federal law. As such, DEA is hereby outlining a suggested mechanism to 
establish a valid agency relationship as well as explaining the 
appropriate roles an authorized agent may play regardless of the 
setting. This statement of policy is intended to provide general 
guidance on establishment of a valid agency relationship between an 
individual practitioner and an identified individual. DEA wishes to 
emphasize that, regardless of the setting, it is the practitioner's 
sole decision as to whether or not to designate an agent to act on his 
or her behalf and subject to his or her control. To be consistent with 
the purpose of the CSA to implement a ``closed system'' of distribution 
and for DEA to enforce this framework, an agency relationship between a 
registered individual practitioner and an identified agent for the 
purposes of communicating controlled substance prescriptions must be 
explicit and transparent. DEA believes its existing regulations are 
adequate in addressing the role of an authorized agent but will analyze 
whether additional federal rulemaking or guidance is needed beyond this 
statement to establish the necessary explicit and transparent nature of 
an authorized agency relationship, particularly when outside an 
employer-employee relationship.

Written Authorization of an Agent Recommended--Sample Agency Agreement

    Due to the legal responsibilities of practitioners and pharmacists 
under the CSA and the potential harm to the public from inappropriate 
and unlawful prescribing and dispensing of controlled substances, 
violations of the law are subject to criminal, civil, and 
administrative sanctions. DEA believes it is in the best interests of 
the practitioner, the agent, and the dispensing pharmacist that the 
designation of those persons authorized to act on behalf of the 
practitioner and the scope of any such authorization be reduced to 
writing.
    DEA provides below an example of a written agreement that would 
properly confer authority to an agent to act on behalf of an individual 
practitioner with regard to controlled substance prescriptions. 
Individual practitioners may choose to designate and authorize one or 
more persons at one or more locations within or outside their practice 
to act as their agent. Likewise, an individual may act as an authorized 
agent for multiple individual practitioners depending upon the 
circumstances. A practitioner may or may not wish to delegate all of 
these types of authorized communications to a particular agent and may 
tailor the agreement accordingly. The agreement should be clear that 
the agent may not further delegate the outlined responsibilities.
Designating Agent of Practitioner For Communicating Controlled 
Substance Prescriptions to Pharmacies
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(Name of registered individual practitioner)

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(Address as it appears on certificate of registration)-----------------

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(DEA registration number)

I, ---------------- (name of registrant), the undersigned, who is 
authorized to dispense (including prescribe) controlled substances in 
Schedules II, III, IV, and V under the Controlled Substances Act, 
hereby authorize---------------- (name of agent), to act as my agent 
only for the following limited purposes:
    1. To prepare, for my signature, written prescriptions for 
controlled substances in those instances where I have expressly 
directed the agent to do so and where I have specified to the agent the 
required elements of the prescription (set forth in 21 CFR 1306.05).
    2. To convey to a pharmacist by telephone oral prescriptions for 
controlled substances in Schedules III, IV, and V in those instances 
where I have expressly directed the agent to do so and where I have 
specified to the agent the required elements of the prescription (set 
forth in 21 CFR 1306.05).
    3. To transmit by facsimile to a pharmacy prescriptions for 
controlled

[[Page 61617]]

substances in those instances where I have expressly directed the agent 
to do so and where I have specified to the agent the required elements 
of the prescription (set forth in 21 CFR 1306.05) and I have signed the 
prescription.

This authorization is not subject to further delegation to other 
persons. Both the undersigned DEA-registered individual practitioner 
and the undersigned agent understand and agree that the practitioner is 
solely responsible for making all medical determinations relating to 
prescriptions for controlled substances communicated by the agent 
pursuant to this agreement, and for ensuring that all such 
prescriptions conform in all other essential respects to the law and 
regulations.

The undersigned agent understands he or she does not have authority to 
make any medical determinations. The undersigned DEA-registered 
prescribing practitioner further understands that the prescribing 
practitioner must personally communicate all Schedule II emergency oral 
prescriptions to the pharmacist. Both the undersigned practitioner and 
agent understand that the agent may not call in an emergency oral 
prescription for a Schedule II controlled substance on behalf of the 
practitioner.

This agency agreement shall be terminated immediately if and when any 
of the following occur:
    1. The undersigned practitioner no longer possesses the active DEA 
registration specified in this agreement.
    2. The undersigned agent is no longer employed in the manner 
described in this agreement.
    3. The practitioner or the agent revokes this agency agreement by 
completing the revocation section at the end of this document or by 
executing a written document that is substantially similar to the 
revocation section at the end of this document.
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(Signature of practitioner)

I, ---------------- (name of agent), hereby affirm that I am the person 
named herein as agent and that the signature affixed hereto is my 
signature. I further affirm that I am a -------------- (title), 
licensed in the State of ------, (where applicable) and (if applicable) 
am employed by/under contract with ---------------- (name of employer 
or contracting entity). I agree to abide by all the terms of this 
agreement and to comply with all applicable laws and regulations 
relating to controlled substances.

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(Signature of agent)

-----------------------------------------------------------------------
(State license number of agent where applicable)

-----------------------------------------------------------------------
(Name of employer/contracting entity where applicable)

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(Address of employer/contracting entity where applicable)

Witnesses:

    1.--------------------

    2.--------------------
Signed and dated on the -------- day of ------------ (month) ----------
--, (year), at ----------------.
Revocation
The foregoing agency agreement is hereby revoked by the undersigned. 
The agent is no longer authorized to communicate Schedule II, III, IV 
and V controlled substance prescriptions to a pharmacy on my behalf. A 
copy of this revocation has been given to the agent this same day.
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(Signature of registered practitioner revoking power)

Witnesses:

    1. --------------------

    2. --------------------

Signed and dated on the --------day of ------------(month)--------, 
(year), at ----------------.

    DEA recommends that the original signed agency agreement be kept by 
the practitioner during the term of the agency relationship and for a 
reasonable period after termination or revocation. DEA requires that 
inventory and other records be kept for at least two years (21 U.S.C. 
827(b), 21 U.S.C. 828(c), 21 CFR 1304.04). This is simply a suggested 
time period for retention of agency agreements and is not required by 
DEA. A signed copy should also be provided to the practitioner's 
designated agent, the agent's employer (if other than the 
practitioner), and any pharmacies that regularly receive communications 
from the agent pursuant to the agreement. Providing a copy to 
pharmacies likely to receive prescriptions from the agent on the 
practitioner's behalf may assist those pharmacies with their 
corresponding responsibility regarding the dispensing of controlled 
substances. It is important to reiterate that a pharmacist always has a 
corresponding responsibility to ensure that a controlled substance 
prescription conforms with the law and regulations, including the 
requirement that the prescription be issued for a legitimate medical 
purpose by a practitioner acting in the usual course of professional 
practice, and a corresponding liability if a prescription is not 
prepared or dispensed in a manner consistent with the CSA or DEA 
regulations. Even where the pharmacist has a copy of an agency 
agreement, the pharmacist may also have a duty to inquire further 
depending upon the particular circumstances. Because the agency 
agreement may be revoked at any time by the practitioner or by the 
agent, the party terminating the agreement should notify the other 
party immediately upon termination. The practitioner should notify 
those pharmacies that were originally made aware of the agency 
agreement of the termination of that agreement. In most circumstances 
where an agent changes employment, the agreement should be revoked.

    Dated: October 1, 2010.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. 2010-25136 Filed 10-5-10; 8:45 am]
BILLING CODE 4410-09-P
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