Federal Register / Vol. 75, No. 193 / Wednesday, October 6, 2010 / Rules and Regulations 61613 

this rule effective within less than 30 

days. 

List of Subjects in 14 CFR Part 91 

Air traffic control, Aircraft, Airmen, 

Airports, Aviation safety. 

The Amendment 

■ In consideration of the foregoing, the 

Federal Aviation Administration 

amends Chapter I of Title 14, Code of 

Federal Regulations, as follows: 

PART 91—GENERAL OPERATING AND 

FLIGHT RULES 

■ 1. The authority citation for part 91 

continues to read as follows: 

Authority: 49 U.S.C. 106(g), 1155, 40103, 

40113, 40120, 44101, 44111, 44701, 44704, 

44709, 44711, 44712, 44715, 44716, 44717, 

44722, 46306, 46315, 46316, 46504, 46506– 

46507, 47122, 47508, 47528–47531, articles 

12 and 29 of the Convention on International 

Civil Aviation (61 Stat. 1180). 

■ 2. Amend Appendix D to Part 91 by 

revising section 1 introductory text to 

read as follows: 

Appendix D to Part 91—Airports/ 

Locations: Special Operating 

Restrictions 

Section 1. Locations at which the 

requirements of § 91.215(b)(2) and 

§ 91.225(d)(2) apply. The requirements of 

§§ 91.215(b)(2) and 91.225(d)(2) apply below 

10,000 feet MSL within a 30-nautical-mile 

radius of each location in the following list. 

* * * * * 

Issued in Washington, DC, on October 1, 

2010. 

Pamela Hamilton-Powell, 

Director, Office of Rulemaking. 

[FR Doc. 2010–25102 Filed 10–5–10; 8:45 am] 

BILLING CODE 4910–13–P 

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. 

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 

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61614 Federal Register / Vol. 75, No. 193 / Wednesday, October 6, 2010 / Rules and Regulations 

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 practitionersigned 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 

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Federal Register / Vol. 75, No. 193 / Wednesday, October 6, 2010 / Rules and Regulations 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 § 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 

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61616 Federal Register / Vol. 75, No. 193 / Wednesday, October 6, 2010 / Rules and Regulations 

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 employeremployee 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 

lllllllllllllllllll

(Name of registered individual 

practitioner) 

lllllllllllllllllll

(Address as it appears on certificate of 

registration) llllllllllll

lllllllllllllllllll

(DEA registration number) 

I, llllllll (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 

authorizellllllll (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 

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Federal Register / Vol. 75, No. 193 / Wednesday, October 6, 2010 / Rules and Regulations 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. 

lllllllllllllllllll

(Signature of practitioner) 

I, llllllll (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 lll____ 

(title), licensed in the State of lll, 

(where applicable) and (if applicable) 

am employed by/under contract with 

llllllll (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. 

lllllllllllllllllll

(Signature of agent) 

lllllllllllllllllll

(State license number of agent where 

applicable) 

lllllllllllllllllll

(Name of employer/contracting entity 

where applicable) 

lllllllllllllllllll

(Address of employer/contracting entity 

where applicable) 

Witnesses: 

1.llllllllll 

2.llllllllll 

Signed and dated on the llll day 

of llllll (month) llllll, 

(year), at llllllll. 

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. 

lllllllllllllllllll

(Signature of registered practitioner 

revoking power) 

Witnesses: 

1. llllllllll 

2. llllllllll 

Signed and dated on the llllday of 

llllll(month)llll, (year), at 

llllllll. 

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 

DEPARTMENT OF DEFENSE 

Office of the Secretary 

32 CFR Part 323 

[Docket ID DOD–2010–OS–0139] 

Privacy Act of 1974; Implementation 

AGENCY: Defense Logistics Agency; DoD. 

ACTION: Final rule; request for 

comments. 

SUMMARY: The Defense Logistics Agency 

is revising two exemption rules. The 

exemption rule for S100.10 entitled 

‘‘Whistleblower Complaint and 

Investigative Files’’ is being deleted in 

its entirety and the exemption rule 

system identifier for the ‘‘Incident 

Investigation/Police Inquiry Files’’ 

system of records is being revised. 

DATES: The rule will be effective on 

December 6, 2010, unless comments are 

received that would result in a contrary 

determination. 

Comments will be accepted on or 

before December 6, 2010. 

ADDRESSES: You may submit comments, 

identified by docket number and title, 

by any of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: Federal Docket Management 

System Office, 1160 Defense Pentagon, 

Room 3C843, Washington, DC 20301– 

1160. 

Instructions: All submissions received 

must include the agency name, docket 

number and title for this Federal 

Register document. The general policy 

WReier-Aviles on DSKGBLS3C1PROD with RULES