[Federal Register Volume 66, Number 173 (Thursday, September 6, 2001)]
[Proposed Rules]
[Pages 46567-46571]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-22322]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Parts 1300, 1301, 1304, 1305 and 1306

[DEA-208P]
RIN 1117-AA58


Allowing Central Fill Pharmacies To Fill Prescriptions for 
Controlled Substances on Behalf of Retail Pharmacies

AGENCY: Drug Enforcement Administration (DEA), Justice

ACTION: Notice of proposed rulemaking

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SUMMARY: DEA is proposing to amend its regulations to provide for the 
use of central fill pharmacies, also known as refill pharmacies, 
fulfillment centers, or call centers. Unlike retail pharmacies which 
dispense controlled substances directly to the patient, central fill 
pharmacies provide a service to retail pharmacies by preparing and 
packaging prescriptions for retail pharmacies to dispense to the 
patient. Prescription information is transmitted from a retail pharmacy 
to a central fill pharmacy where the prescription is filled or 
refilled. The filled prescription is delivered to the retail pharmacy 
for pick up by the patient. Industry has expressed interest in 
utilizing central fill pharmacy operations to allow for more efficient 
delivery of prescriptions to patients. With this rulemaking, DEA is 
proposing to expand the definition of ``dispense'' to include the 
activities of central fill pharmacies. Mail order and Internet 
pharmacies, which currently obtain prescriptions from and dispense 
directly to a patient, are not affected by this regulation. They will 
continue to be registered as retail pharmacies.

DATES: Written comments must be submitted on or before November 5, 
2001.

ADDRESSES: Comments should be submitted in triplicate to the Deputy 
Assistant Administrator, Office of Diversion Control, Drug Enforcement 
Administration, Washington, DC 20537, Attention: DEA Federal Register 
Representative/CCR.

FOR FURTHER INFORMATION CONTACT: Patricia M. Good, Chief, Liaison and 
Policy Section, Office of Diversion Control, Drug Enforcement 
Administration, Washington, DC 20537. Telephone (202) 307-7297.

SUPPLEMENTARY INFORMATION:

What Is the Purpose of the Proposed Rule?

    DEA is proposing these amendments in response to significant 
changes taking place in the pharmacy industry. Increased demands are 
being placed on traditional pharmacy systems by the rapid growth in the 
number of prescriptions written and dispensed. The National Association 
of Chain Drugstores recently estimated that in 2005, pharmacists in the 
United States will fill over 4 billion prescriptions. While the number 
of prescriptions dispensed is growing dramatically, the United States 
is facing a severe pharmacist shortage. Between 1999-2004, the volume 
of prescriptions dispensed in retail pharmacies is expected to increase 
35%, while during the same period the number of available pharmacists 
is projected to increase only 6%. These factors have forced the 
pharmacy industry to seek new ways to increase efficiency while 
maintaining quality patient care. By transferring some of the time-
consuming, non-clinical duties such as prescription filling to central 
fill pharmacies, traditional retail pharmacies can dedicate more time 
to assisting patients.
    In response to industry's interest in improving efficiency by 
implementing the concept of central fill pharmacies, DEA contacted a 
variety of relevant trade associations and professional organizations 
to obtain more information on the issue. Several segments of the 
industry submitted written comments to DEA's solicitation; two others, 
including one trade association and one company, requested to meet with 
DEA to provide additional information. After considering the issues 
raised by industry, DEA determined that changes to the regulations 
would be appropriate and would give industry needed flexibility to 
accommodate the tremendous growth in the number of prescriptions 
presented for dispensing.
    DEA's current regulations do not permit the utilization of central 
fill pharmacies for the dispensing of controlled substances. With this 
rulemaking, DEA is proposing several amendments to its regulations to 
allow for the use of central fill pharmacies, subject to certain 
restrictions, in states where such activities are permitted. While DEA 
is committed to responding to emerging industry practices, such as 
central fill pharmacies, which will

[[Page 46568]]

allow for more efficient delivery of prescription drugs, its primary 
responsibility is to prevent the diversion of controlled substances. 
Therefore, some restrictions on the use of central fill pharmacies are 
necessary.

What Do the Regulations Currently Permit?

    At present, there is no provision in DEA's regulations for central 
fill pharmacy operations. Retail pharmacies, including those which 
utilize the mail service and the Internet, are registered by DEA to 
dispense prescriptions for controlled substances directly to the 
patient. ``Dispensing'' is defined in the Controlled Substances Act as 
delivering a controlled substance ``to an ultimate user'' (21 U.S.C. 
802(10)). DEA regulations do not currently provide for central fill 
pharmacy operations which fill prescriptions for delivery to a 
traditional retail pharmacy. Allowing central fill pharmacies to fill 
prescriptions on behalf of retail pharmacies for subsequent dispensing 
to the ultimate user is a legitimate extension of current practice.

What Would the Proposed Regulations Allow?

    This notice proposes to allow central fill pharmacies to become 
registered as practitioners under 21 CFR 1301.13(e)(1)(iii) so long as 
and to the extent that their activities are authorized by the state in 
which they are located. At present, the business activities under 21 
CFR 1301.13(e)(1)(iii) include practitioners, hospitals/clinics, retail 
pharmacies, and teaching institutions. DEA is proposing to create a new 
business activity to be known as ``central fill pharmacies.'' This 
would allow the central fill pharmacy to prepare prescriptions for 
controlled substances in Schedules II-V for dispensing to a patient by 
a registered traditional retail pharmacy pursuant to a prescription 
issued by an authorized practitioner and communicated to the central 
fill pharmacy by the retail pharmacy.
    DEA has determined that central fill pharmacy activities are better 
characterized as ``dispensing'' activities as opposed to 
``distributing'' activities. Therefore, central fill pharmacies will 
not be limited by the restrictions on ``distributions'' from one 
practitioner to another set forth in 21 CFR 1307.11, in particular the 
5% limitation which limits the amount of controlled substances that can 
be distributed by one practitioner to another. Similarly, no official 
order forms (DEA Form 222) will be required for transfer of Schedule II 
controlled substances from a central fill pharmacy to a retail pharmacy 
since DEA considers this activity to be a form of dispensing, not 
distribution. 21 CFR 1305.03 is proposed to be amended to clarify that 
the order form requirement does not apply to such transfers.
    Central fill pharmacies would be permitted to prepare both initial 
and refill prescriptions, subject to all applicable state and federal 
regulations. Only a licensed pharmacist may fill such prescriptions (21 
CFR 1306.06). By definition, the filled prescriptions must be 
transported to a retail pharmacy for delivery to the patient. Both the 
pharmacist employed by the central fill pharmacy and the pharmacist who 
dispenses the prescription to the patient will be responsible for 
insuring that the prescription was issued for a legitimate medical 
purpose by an individual practitioner acting in the usual course of 
professional practice and otherwise in the manner specified by DEA 
regulations (21 CFR 1306.04(a), 1306.05(a)).
    This notice proposes to allow a central fill pharmacy to prepare 
prescriptions on behalf of retail pharmacies with which it has a 
contractual agreement to provide such services or with which it shares 
a common owner. The central fill pharmacy would be required to keep a 
list of retail pharmacies for which it has agreed to provide such 
services. The central fill pharmacy would also be required to keep 
current copies of the Certificates of Registration for each retail 
pharmacy for which it is authorized to fill prescriptions. Similarly, 
retail pharmacies would be required to keep a list of those central 
fill pharmacies, along with current copies of their DEA Certificates of 
Registration, permitted to prepare prescriptions on their behalf. This 
information must be made available for inspection upon request by DEA.
    A central fill pharmacy will not be permitted to prepare 
prescriptions provided directly by a patient or individual practitioner 
or to mail or otherwise deliver a filled prescription directly to a 
patient or individual practitioner. If a retail pharmacy and a central 
fill pharmacy are operated from the same location, each must be 
separately registered with DEA and maintain separate stock, 
inventories, and records.
    Retail pharmacies would be permitted to transmit prescription 
information to a central fill pharmacy in two ways. First, a facsimile 
of a prescription for a controlled substance in Schedule II, III, IV or 
V may be provided by the retail pharmacy to the central fill pharmacy. 
The retail pharmacy must maintain the original hard copy of the 
prescription and the central fill pharmacy must maintain the facsimile 
of the prescription. Alternatively, DEA is proposing to allow the 
prescription information to be communicated electronically by the 
retail pharmacy to the central fill pharmacy. Since there appears to be 
little risk that an outside party will divert such prescription 
information, DEA is not proposing specific security standards with 
respect to electronic transmission in this particular situation. DEA 
will soon propose standards for electronic transmission of prescription 
information in a separate rulemaking. When setting up the transmission 
system, the participating pharmacies must be mindful of all federal and 
state requirements regarding patient confidentiality, network security, 
and use of shared databases. Both pharmacies must maintain the 
prescription information in a readily retrievable manner and comply 
with all applicable federal and state recordkeeping requirements.
    With respect to security, central fill pharmacies would be required 
to comply with the same security requirements applicable to other 
practitioners (21 CFR 1301.71, 1301.75, 1301.76). While not 
specifically required by DEA regulations, central fill pharmacies may 
choose to implement additional security measures based on the volume of 
controlled substances handled, number of employees in the facility, or 
other unique factors. Such additional security measures may be needed 
in order to comply with the general requirement to maintain effective 
controls and procedures to guard against theft and diversion of 
controlled substances (21 CFR 1301.71). As indicated above, since 
pharmacists at central fill pharmacies will be preparing prescriptions 
for controlled substances, they shall bear a corresponding 
responsibility, along with the pharmacist at the retail pharmacy, for 
the proper dispensing of the prescription (21 CFR 1306.04(a), 
1306.05(a)). Additionally, central fill pharmacies must be vigilant in 
their choice of carriers to transport filled prescriptions to retail 
pharmacies and be aware of their responsibilities for reporting in-
transit losses (21 CFR 1301.74(e)).

Regulatory Certifications

Regulatory Flexibility Act

    The Deputy Assistant Administrator, Office of Diversion Control, 
hereby certifies that this rulemaking has been

[[Page 46569]]

drafted in accordance with the Regulatory Flexibility Act (5 U.S.C. 
605(b)), has reviewed this regulation, and by approving it certifies 
that this regulation will not have a significant economic impact on a 
substantial number of small entities. In fact, it is anticipated that 
this rule, by affording additional flexibility to pharmacies in the 
dispensing of prescriptions, will help lower total health care costs.

Executive Order 12866

    The Deputy Assistant Administrator, Office of Diversion Control, 
further certifies that this rulemaking has been drafted in accordance 
with the principles in Executive Order 12866 Section 1(b). DEA has 
determined that this is not a significant rulemaking action. Therefore, 
this action has not been reviewed by the Office of Management and 
Budget.

Executive Order 12988

    This regulation meets the applicable standards set forth in 
Sections 3(a) and 3(b)(2) of Executive Order 12988.

Executive Order 13132

    This rulemaking does not preempt or modify any provision of state 
law; nor does it impose enforcement responsibilities on any state; nor 
does it diminish the power of any state to enforce its own laws. 
Accordingly, this rulemaking does not have federalism implications 
warranting the application of Executive Order 13132.

Unfunded Mandates Reform Act of 1995

    This rule will not result in the expenditure by state, local, and 
tribal governments, in the aggregate, or by the private sector, of 
$100,000,000 or more in any one year, and will not significantly or 
uniquely affect small governments. Therefore, no actions were deemed 
necessary under the provisions of the Unfunded Mandates Reform Act of 
1995.

Small Business Regulatory Enforcement Fairness Act of 1996

    This rule is not a major rule as defined by Section 804 of the 
Small Business Regulatory Enforcement Fairness Act of 1996. This rule 
will not result in an annual effect on the economy of $100,000,000 or 
more, a major increase in costs or prices, or significant adverse 
effects on competition, employment, investment, productivity, 
innovation, or on the ability of United States-based companies to 
compete with foreign-based companies in domestic and export markets.

Plain Language Instructions

    The Drug Enforcement Administration makes every effort to write 
clearly. If you have suggestions as to how to improve the clarity of 
these regulations, call or write Patricia M. Good, Chief, Liaison and 
Policy Section, Office of Diversion Control, Drug Enforcement 
Administration, Washington, DC 20537. Telephone (202) 307-7297.

List of Subjects

21 CFR Part 1300

    Definitions, Drug traffic control

21 CFR Part 1301

    Administrative practice and procedure, Drug traffic control, 
Security measures

21 CFR Part 1304

    Drug traffic control, Reporting requirements

21 CFR Part 1305

    Drug traffic control, Reporting requirements

21 CFR Part 1306

    Drug traffic control, prescription drugs

    For the reasons set out above, Title 21, Code of Federal 
Regulations, Parts 1300, 1301, 1304, 1305, and 1306 are proposed to be 
amended to read as follows:

PART 1300--[AMENDED]

    1. The authority citation for part 1300 continues to read as 
follows:

    Authority: 21 U.S.C. 802, 871(b), 951, 958(f).

    2. Section 1300.01 is proposed to be amended by redesignating the 
existing paragraphs (b)(6) through (42) as (b)(7) through (43) and by 
adding a new paragraph (b)(6) to read as follows:


Sec. 1300.01  Definitions relating to controlled substances.

* * * * *
    (b) * * *
    (6) The term central fill pharmacy means a pharmacy which is 
authorized by the state in which it is located to prepare controlled 
substances orders for dispensing pursuant to a valid prescription 
transmitted to it by a registered retail pharmacy and to return the 
labeled and filled prescriptions to the retail pharmacy for delivery to 
the ultimate user. A pharmacist employed by a central fill pharmacy may 
only fill controlled substance prescriptions pursuant to a written or 
electronic prescription provided by a retail pharmacy.
* * * * *

PART 1301--[AMENDED]

    1. The authority citation for part 1301 continues to read as 
follows:

    Authority: 21 U.S.C. 821, 822, 823, 824, 871(b), 875, 877.

    2. Section 1301.13(e)(1)(iii) is proposed to be revised to read as 
follows:


Sec. 1301.13  Application for registration; time for application, 
expiration date, registration for independent activities; application 
forms, fees, contents and signature; coincident activities.

* * * * *
    (e) * * *
    (1) * * *

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(iii) Dispensing or             Schedules II-V...  New--224........        210          3  May conduct research
 Instructing (Includes                             Renewal--224a...        210              and instructional
 Practitioner, Hospital/                                                                    activities with
 Clinic, Retail Pharmacy,                                                                   those substances for
 Central Fill Pharmacy,                                                                     which registration
 Teaching Institution).                                                                     was granted, except
                                                                                            that a mid-level
                                                                                            practitioner may
                                                                                            conduct such
                                                                                            research only to the
                                                                                            extent expressly
                                                                                            authorized under
                                                                                            state statute. A
                                                                                            pharmacist may
                                                                                            manufacture an
                                                                                            aqueous or
                                                                                            oleaginous solution
                                                                                            or solid dosage form
                                                                                            containing a
                                                                                            narcotic controlled
                                                                                            substance in
                                                                                            Schedule II-V in a
                                                                                            proportion not
                                                                                            exceeding 20% of the
                                                                                            complete solution,
                                                                                            compound or mixture.
----------------------------------------------------------------------------------------------------------------


[[Page 46570]]

* * * * *
    3. Section 1301.76 is proposed to be amended by adding new 
paragraph
    (d) to read as follows:


Sec. 1301.76  Other security measures for practitioners.

* * * * *
    (d) Central fill pharmacies must comply with Sec. 1301.74(e) when 
selecting private, common or contract carriers to transport filled 
prescriptions to a retail pharmacy for delivery to the ultimate user. 
When central fill pharmacies contract with private, common or contract 
carriers to transport filled prescriptions to a retail pharmacy, the 
central fill pharmacy is responsible for reporting in-transit losses 
upon discovery of such loss by use of a DEA Form 106. Retail pharmacies 
must comply with Sec. 1301.74(e) when selecting private, common or 
contract carriers to retrieve filled prescriptions from a central fill 
pharmacy. When retail pharmacies contract with private, common or 
contract carriers to retrieve filled prescriptions from a central fill 
pharmacy, the retail pharmacy is responsible for reporting in-transit 
losses upon discovery of such loss by use of a DEA Form 106.

PART 1304--[AMENDED]

    1. The authority citation for Part 1304 continues to read as 
follows:

    Authority: 21 U.S.C. 821, 827, 871(b), 958(e), 965, unless 
otherwise noted.

    2. Section 1304.04 is proposed to be amended by adding the new 
paragraph (i) to read as follows:


Sec. 1304.04  Maintenance of records and inventories.

* * * * *
    (i) If a central fill and retail pharmacy are located at the same 
premises, each must maintain separate inventories of controlled 
substances, as well as separate records.
    3. New Sec. 1304.05 is proposed to be added to read as follows:


Sec. 1304.05  Records of authorized central fill pharmacies and retail 
pharmacies.

    (a) Every retail pharmacy that utilizes the services of a central 
fill pharmacy must keep a record of all central fill pharmacies, 
including name, address and DEA number, that are authorized to fill 
prescriptions on its behalf. The retail pharmacy must also maintain a 
current copy of the Certificate of Registration for each central fill 
pharmacy authorized to fill prescriptions on its behalf. These records 
must be made available upon request for inspection by DEA 
investigators.
    (b) Every central fill pharmacy must keep a record of all retail 
pharmacies, including name, address and DEA number, for which it is 
authorized to fill prescriptions. The central fill pharmacy must also 
maintain a current copy of the Certificate of Registration for all 
retail pharmacies for which it is authorized to fill prescriptions. 
These records must be made available upon request for inspection by DEA 
investigators.

PART 1305--[AMENDED]

    1. The authority citation for part 1305 continues to read as 
follows:

    Authority: 21 U.S.C. 821, 828, 871(b), unless otherwise noted.

    2. Section 1305.03 is proposed to be revised to read as follows:


Sec. 1305.03  Distributions requiring order forms.

    An order form (DEA Form 222) is required for each distribution of a 
Schedule I or II controlled substance except to persons exempted from 
registration under part 1301 of this chapter; which are exported from 
the United States in conformity with the Act; for delivery to a 
registered analytical laboratory, or its agent approved by DEA; or for 
transfer from a central fill pharmacy as defined in 21 CFR 
1300.01(b)(6) to a retail pharmacy.

PART 1306--[AMENDED]

    1. The authority citation for Part 1306 continues to read as 
follows:

    Authority: 21 U.S.C. 821, 829, 871(b), unless otherwise noted.

    2. Section 1306.05(a) is proposed to be revised to read as follows:


Sec. 1306.05  Manner of issuance of prescriptions.

    (a) All prescriptions for controlled substances shall be dated as 
of, and signed on, the day when issued and shall bear the full name and 
address of the patient, the drug name, strength, dosage form, quantity 
prescribed, directions for use and the name, address and registration 
number of the practitioner. A practitioner may sign a prescription in 
the same manner as he would sign a check or legal document (e.g., J.H. 
Smith or John H. Smith). Where an oral order is not permitted, 
prescriptions shall be written with ink or indelible pencil or 
typewriter and shall be manually signed by the practitioner. The 
prescriptions 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. 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 these regulations.
* * * * *
    3. Section 1306.06 is proposed to be revised to read as follows:


Sec. 1306.06  Persons entitled to fill prescriptions.

    A prescription for a controlled substance may only be filled by a 
pharmacist, acting in the usual course of his professional practice and 
either registered individually or employed in a registered pharmacy, a 
registered central fill pharmacy, or registered institutional 
practitioner.
    4. Section 1306.11 is proposed to be amended by adding a new 
paragraph (d)(5)to read as follows:


Sec. 1306.11  Requirement of prescription.

* * * * *
    (d) * * *
    (5) Central fill pharmacies shall not be authorized under this 
paragraph to prepare prescriptions for a controlled substance listed in 
Schedule II upon receiving an oral authorization from a retail 
pharmacist or an individual practitioner.
* * * * *
    5. Section 1306.14 is proposed to be amended by redesignating 
existing paragraphs (b) and (c) as paragraphs (c) and (d), and by 
adding a new paragraph (b) to read as follows:


Sec. 1306.14  Labeling of substances and filling of prescriptions.

* * * * *
    (b) If the prescription is filled at a central fill pharmacy, the 
central fill pharmacy shall affix to the package a label showing the 
retail pharmacy name and address and a unique identifier, (i.e. the 
central fill pharmacy's DEA registration number) indicating that the 
prescription was filled at the central fill pharmacy, in addition to 
the information required under paragraph (a) of this section.
* * * * *
    6. A new Sec. 1306.15 is proposed to be added to read as follows:


Sec. 1306.15  Transfer of prescription information between retail 
pharmacies and central fill pharmacies for prescriptions of Schedule II 
controlled substances.

    Prescription information may be transferred between a retail 
pharmacy and a central fill pharmacy for dispensing purposes only if 
permitted under state law and only if the retail pharmacy and central 
fill pharmacy

[[Page 46571]]

have a contractual relationship providing for such activities or share 
a common owner. The following requirements shall also apply:
    (a) Prescriptions for controlled substances listed in Schedule II 
may be transmitted from a retail pharmacy to a central fill pharmacy 
via facsimile or a common, real-time electronic database. The retail 
pharmacy transmitting the prescription information must:
    (1) Write the word ``CENTRAL FILL'' on the face of the original 
transmitted prescription, if sent via facsimile;
    (2) Record and transmit to the central fill pharmacy (on the 
reverse side of the transmitted prescription, if sent via facsimile) 
the name, address, and DEA registration number of the central fill 
pharmacy to which the prescription has been transmitted and the retail 
pharmacy from which transmitted, the name of the retail pharmacy 
pharmacist transmitting the prescription, and the date of transmittal;
    (3) Ensure that all information required to be on a prescription 
pursuant to Sec. 1306.05 of this part is transmitted to the central 
fill pharmacy (either on the face of the prescription or in the 
electronic transmission of information);
    (4) Maintain the original prescription for a period of two years 
from the date the prescription was filled;
    (5) Keep a record of receipt of the filled prescription, including 
the method of delivery (private, common or contract carrier) and the 
name of the retail pharmacy employee accepting delivery.
    (b) The central fill pharmacy receiving the transmitted 
prescription must:
    (1) Keep a copy of the prescription (if sent via facsimile) or an 
electronic record of all the information transmitted by the retail 
pharmacy, including the name, address, and DEA registration number of 
the retail pharmacy transmitting the prescription;
    (2) Keep a record of the date of receipt of the transmitted 
prescription, the name of the licensed pharmacist filling the 
prescription, and the date of filling of the prescription;
    (3) Keep a record of the date the filled prescription was delivered 
to the retail pharmacy and the method of delivery (i.e. private, common 
or contract carrier).
    7. Section 1306.24 is proposed to be amended by redesignating the 
existing paragraphs (b) and (c) as paragraphs (c) and (d), and by 
adding a new paragraph (b) to read as follows:


Sec. 1306.24  Labeling of substances and filling of prescriptions.

* * * * *
    (b) If the prescription is filled at a central fill pharmacy, the 
central fill pharmacy shall affix to the package a label showing the 
retail pharmacy name and address and a unique identifier, (i.e. the 
central fill pharmacy's DEA registration number) indicating that the 
prescription was filled at the central fill pharmacy, in addition to 
the information required under paragraph (a) of this section.
* * * * *
    8. Section 1306.26 is proposed to be amended by adding a new 
paragraph (g) to read as follows:


Sec. 1306.26  Dispensing without prescription.

* * * * *
    (g) Central fill pharmacies shall not be permitted to dispense 
controlled substances to a purchaser at retail pursuant to this 
section.
    9. A new Sec. 1306.27 is proposed to be added to read as follows:


Sec. 1306.27  Transfer of prescription information between retail 
pharmacies and central fill pharmacies for initial and refill 
prescriptions of Schedule III, IV, or V controlled substances.

    Prescription information may be transferred between a retail 
pharmacy and a central fill pharmacy for dispensing purposes only if 
permitted under state law and only if the retail pharmacy and central 
fill pharmacy have a contractual relationship providing for such 
activities or share a common owner. The following requirements shall 
also apply:
    (a) Prescriptions for controlled substances listed in Schedule III, 
IV or V may be transmitted from a retail pharmacy to a central fill 
pharmacy via facsimile or a common, real-time electronic database. The 
retail pharmacy transmitting the prescription information must:
    (1) Write the word ``CENTRAL FILL'' on the face of the original 
transmitted prescription, if sent via facsimile;
    (2) Record and transmit to the central fill pharmacy (on the 
reverse side of the transmitted prescription, if sent via facsimile) 
the name, address, and DEA registration number of the central fill 
pharmacy to which the prescription has been transmitted and the retail 
pharmacy from which transmitted, the name of the retail pharmacy 
pharmacist transmitting the prescription, and the date of transmittal;
    (3) Ensure that all information required to be on a prescription 
pursuant to Section 1306.05 of this part is transmitted to the central 
fill pharmacy (either on the face of the prescription or in the 
electronic transmission of information);
    (4) Indicate in the information transmitted the number of refills 
already dispensed and the number of refills remaining;
    (5) Maintain the original prescription for a period of two years 
from the date the prescription was last refilled;
    (6) Keep a record of receipt of the filled prescription, including 
the method of delivery (private, common or contract carrier) and the 
name of the retail pharmacy employee accepting delivery.
    (b) The central fill pharmacy receiving the transmitted 
prescription must:
    (1) Keep a copy of the prescription (if sent via facsimile) or an 
electronic record of all the information transmitted by the retail 
pharmacy, including the name, address, and DEA registration number of 
the retail pharmacy transmitting the prescription;
    (2) Keep a record of the date of receipt of the transmitted 
prescription, the name of the licensed pharmacist filling the 
prescription, and dates of filling or refilling of the prescription;
    (3) Keep a record of the date the filled prescription was delivered 
to the retail pharmacy and the method of delivery (i.e. private, common 
or contract carrier).

    Dated: August 27, 2001.
Laura M. Nagel,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. 01-22322 Filed 9-5-01; 8:45 am]
BILLING CODE 4410-09-P