[Federal Register Volume 68, Number 121 (Tuesday, June 24, 2003)]
[Rules and Regulations]
[Pages 37405-37411]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-15912]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

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

[Docket No. DEA-208F]
RIN 1117-AA58


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

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: DEA is finalizing a Notice of Proposed Rulemaking (NPRM) 
defining central fill pharmacy activities and permitting central fill 
pharmacies to prepare controlled substances prescriptions on behalf of 
retail pharmacies with which the central fill pharmacies have a 
contractual agreement to provide such services or with which the 
pharmacies share a common owner. When one retail pharmacy receives a 
prescription and a second pharmacy prepares and subsequently delivers 
the controlled substance medication to the first retail pharmacy for 
dispensing to the patient, the second pharmacy is engaging in a 
``central fill activity''. Records must be maintained by both the 
central fill pharmacy and the retail pharmacy that completely and 
accurately reflect the disposition of all controlled substance 
prescriptions dispensed. With respect to security, central fill 
pharmacies would be required to comply with the same security 
requirements applicable to retail pharmacies including the general 
requirement to maintain effective controls and procedures to guard 
against theft and diversion of controlled substances. DEA is creating 
an allowance for retail pharmacies that also perform central fill 
activities to do so without separate DEA registration, separate 
inventories, or separate records. This rulemaking is sought by the 
regulated industry and will allow for more efficient delivery of 
controlled substance prescriptions to patients.

EFFECTIVE DATE: July 24, 2003.

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:

Background

    On September 6, 2001, DEA published a Notice of Proposed Rulemaking 
(NPRM) in the Federal Register (66 FR 46567) proposing to allow central 
fill pharmacies to fill prescriptions for controlled substances on 
behalf of retail pharmacies. The NPRM was published 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.
    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. Current DEA regulations do not permit a 
prescription for controlled substances to be brought to one pharmacy, 
filled at a second pharmacy, and then returned to the first pharmacy 
for dispensing to the patient. 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.
    Therefore, the regulations are being amended to allow for central 
fill pharmacies to fill prescriptions on behalf of retail pharmacies 
and to allow retail pharmacies to perform central fill activities 
without separate DEA registration and separate inventories.

[[Page 37406]]

Benefits of This Rulemaking

    Regulations finalized in this rulemaking have been developed in 
conjunction with the regulated industry. Industry indicates that 
central fill pharmacy activities focus on removing the most time 
intensive, and, therefore, most costly administrative tasks, from a 
retail setting and centralizing them in an automated non-retail 
setting. Currently, many states permit central fill activities for 
noncontrolled substances, so long as they are otherwise permitted. This 
final rule is not requiring states to promulgate new regulations to 
permit central fill activities for controlled substances. The regulated 
industry has noted that it has realized cost savings from these 
activities, as the filling of prescriptions is a very labor intensive 
activity. Further, industry believes that permitting central fill 
pharmacy activities provides the following benefits:
    [sbull] Reduces the potential for dispensing errors, resulting in 
improved patient safety and effective drug utilization.
    [sbull] Improves pharmacist accessibility, pharmacists will have 
more time to spend on patient care.
    [sbull] Patients encounter less ``wait'' time at pharmacy.

Requirements Proposed in the NPRM

    The NPRM proposed to allow central fill pharmacies to become 
registered as pharmacies 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. Central fill pharmacies would prepare 
prescriptions for controlled substances in Schedules II-V for 
dispensing to a patient by a registered retail pharmacy pursuant to a 
prescription issued by an authorized practitioner and communicated to 
the central fill pharmacy by the retail pharmacy. Central fill 
pharmacies would be permitted to prepare both initial and refill 
prescriptions, subject to all applicable state and federal regulations. 
The central fill pharmacy would be allowed to fill 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 
NPRM proposed requiring central fill pharmacies to keep current copies 
of the DEA Certificates of Registration for each retail pharmacy for 
which it is authorized to fill prescriptions. Similarly, it was 
proposed that 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.
    The NPRM did not allow for a retail pharmacy and a central fill 
pharmacy to be operated under the same DEA registration, therefore 
requiring separate inventories and separate records.
    The NPRM proposed to permit retail pharmacies to transmit a written 
prescription via facsimile or communicate prescription information 
electronically to a central fill pharmacy. The prescription information 
would be required to be maintained by the retail pharmacy and the 
central fill pharmacy in a readily retrievable manner and comply with 
all applicable federal and state recordkeeping requirements.
    The NPRM also recognized that pharmacists at central fill 
pharmacies would be preparing prescriptions for controlled substances 
and, therefore, must bear a corresponding responsibility, along with 
the pharmacist at the retail pharmacy, for the proper dispensing of the 
prescription.

Comments Received in Response to the NPRM

    Six comments were received in response to the NPRM: four from trade 
associations representing the affected industries, one from a DEA 
registrant and one from a pharmacy software provider. While the 
comments expressed general support for the changes, concerns were 
raised regarding specific facets of the proposed rule. Where possible, 
DEA has adopted changes suggested by the commenters to make the rule 
more flexible and less burdensome for DEA registrants.

1. Retail Pharmacies Performing Central Fill Functions Without Separate 
Registration

    Three commenters discussed DEA's provisions in the proposed rule 
that would require separate registration for each facility that 
performs central fill activities. Commenters stated that registered 
retail pharmacies should be allowed to perform central fill activities 
without separate registration. Commenters indicated that retail 
pharmacies currently perform all activities associated with dispensing 
controlled substances directly to the patient. Commenters argued that 
it is not necessary for a retail pharmacy to maintain a separate 
registration, separate inventory and separate recordkeeping when the 
same retail pharmacy engages in central fill activities on behalf of 
another retail pharmacy. By allowing retail pharmacies to perform 
central fill activities without separate registration, commenters 
argued, a single stock/inventory of controlled substances can be 
maintained.
    DEA agrees that retail pharmacies may also act in the capacity of a 
central fill pharmacy as long as complete and accurate records are 
maintained to indicate which registrant prepared the prescription and 
which registrant dispensed the prescription. The records must include 
the name, address, and DEA number of the pharmacies involved. Shipping 
and receiving records regarding the ``centrally filled'' prescription 
must be maintained by each pharmacy involved in the transaction.
    The original prescription record must be maintained at the pharmacy 
which dispenses the medication to the patient (end user). If records 
are maintained electronically, they must be readily retrievable and 
identifiable as to which records pertain to the retail pharmacy 
activities and which pertain to the central fill pharmacy activities.
    When one retail pharmacy receives a prescription and a second 
pharmacy prepares and subsequently delivers the controlled substance 
medication to the first retail pharmacy for dispensing to the patient, 
the second pharmacy is engaging in a ``central fill activity''. 
Pharmacies engaging in central fill activities must have a contractual 
agreement with the retail pharmacy to provide such services, or share a 
common owner.

2. Transferring Prescriptions for Controlled Substances

    One commenter suggested that not allowing a central fill pharmacy 
to deliver prescription medication directly to the patient would 
require that the prescription record be transferred. The commenter 
further stated that this potentially would disrupt patients' continuity 
of care and could prohibit patients from obtaining proper 
pharmaceutical care from the pharmacist of their choice. DEA 
acknowledges that if one retail pharmacy receives and dispenses an 
initial prescription and a second retail pharmacy prepares and 
subsequently dispenses/delivers any remaining refills of the controlled 
substance medication to the patient, this is a ``transfer'' of the 
prescription. The second retail pharmacy's records must indicate that 
the prescription record was obtained by transfer. It is not the intent 
of this rulemaking to change current regulations regarding the 
``transfer'' of controlled substance prescriptions records. However, 
controlled substance prescriptions that are prepared by a

[[Page 37407]]

central fill pharmacy are not considered ``transferred'' prescriptions.

3. Requirement To Maintain Copies of Each Pharmacy's DEA Registration 
Certificate

    Three commenters stated that pharmacies participating in central 
fill activities should not be required to maintain copies of each 
pharmacy's DEA registration certificate. Commenters indicated that such 
a requirement would be burdensome, requiring them to maintain large 
quantities of paper. Commenters suggested that DEA permit registrants 
to verify the registration of the affiliated retail pharmacies, noting 
that such a requirement would be similar to what is required of 
suppliers when registrants are purchasing controlled substances.
    Upon further review, DEA agrees that requiring retail pharmacies 
and central fill pharmacies to maintain copies of the DEA registration 
certificates for their partner pharmacies is unnecessary. However, DEA 
is requiring that the participating registrants verify that they are 
doing business with DEA registrants prior to sending and receiving 
controlled substances prescriptions. Therefore, DEA is amending this 
final rule to require that central fill pharmacies verify the 
registration of each affiliated retail pharmacy. Further, retail 
pharmacies contracting with other pharmacies performing central fill 
activities must verify the registration of each affiliated registrant. 
Such a requirement is less burdensome than the one initially proposed 
by DEA, but will still permit DEA, and registered pharmacies, to ensure 
that the persons they are conducting business with are, indeed, DEA 
registrants permitted to handle controlled substances.

4. Miscellaneous Comments

    One commenter requested that DEA allow controlled substance 
prescriptions that are prepared and packaged at a central fill pharmacy 
to be delivered through DEA registered distribution facilities. The 
filled prescriptions, placed in a sealed container, would be delivered 
from the central fill pharmacy to a DEA registered distribution 
facility. At the distribution facility the sealed containers would be 
sorted for subsequent delivery to the retail pharmacy. The commenter 
further stated that registered distribution facilities have much better 
security than common or contract carrier locations and the employees at 
the registered distribution facilities have experience in handling 
controlled substances. There are no provisions in the current 
regulations to allow for patient specific controlled substances 
prescriptions to be delivered from one registered pharmacy location, 
through a registered distribution facility, to another registered 
pharmacy location for dispensing to the patient. Therefore, no change 
is being made from the language of the proposed rule.
    One commenter suggested that DEA allow for hospitals to engage in 
central fill activities. While DEA does not disagree that hospitals may 
benefit from ``central fill activities,'' the pharmacy activities of a 
hospital are significantly different than those of a retail pharmacy. 
Hospitals generally maintain stocks of non-patient specific controlled 
substances in a variety of locations throughout the hospital. The 
controlled substances are often dispensed and administered on an urgent 
and frequently changing basis. Controlled substances that are prepared 
by a central fill pharmacy, as defined in this rulemaking, are issued 
pursuant to a patient specific prescription and generally requested and 
subsequently delivered within 24 hours. When non-patient specific 
controlled substances are transferred from one DEA registrant to 
another DEA registrant, this constitutes distribution and not 
dispensing. With this rulemaking, DEA is allowing only retail 
pharmacies to utilize the services of a central fill pharmacy.
    One commenter suggested that DEA's proposed requirement that both 
the retail pharmacist and central fill pharmacist have a corresponding 
liability regarding the manner of issuance of a prescription is 
considered a dual verification and, therefore, unnecessary. DEA is not 
suggesting that each centrally filled controlled substance prescription 
be independently verified by a retail pharmacist and a central fill 
pharmacist. Rather, the intent is to confirm that if either the retail 
pharmacist or the central fill pharmacist believes that the 
prescription is not issued in a manner that is in compliance with 
federal regulations, then the prescription should not be dispensed.
    One commenter suggested that DEA indicate what course of action 
should be taken if a patient does not pick up a controlled substance 
prescription that has been ``centrally filled.'' The retail pharmacy's 
records should indicate that the prescription was ``filled'' at the 
central fill pharmacy and subsequently delivered to the retail 
pharmacy. Therefore, the retail pharmacy in possession of the 
controlled substance prescription is responsible for the proper 
disposition of the controlled substance if the patient fails to pick up 
the prescription, as would be the case with any prescription dispensed 
by the pharmacy.
    One commenter suggested that DEA clarify section 1306.05(a), which 
was not proposed to be changed in the NPRM and states that written 
prescriptions must be written with ink or indelible pencil or by 
typewriter and shall be manually signed by the practitioner. While this 
amendment is not within the scope of this regulation, DEA wishes to 
clarify and reiterate that a prescription that is generated by a 
computer software application and subsequently printed is acceptable so 
long as it is manually signed by the practitioner and contains all 
required elements of a prescription.
    One commenter suggested that DEA require pharmacies engaged in 
central fill activities to establish a mechanism to ensure that printed 
literature developed by the pharmaceutical manufacturer accompanies 
every prescription. While DEA does not have any objection to central 
fill pharmacies or retail pharmacies providing printed drug information 
to patients, requiring pharmacies to provide such information is not 
within the purview of the DEA's regulatory authority regarding 
controlled substance prescriptions.

Further Clarifications

    In this final rule DEA has changed the titles of Sections 1306.15 
and 1306.27 due to the perceived confusion with using the word 
``transfer'' to describe the action of a retail pharmacy providing 
prescription information to a central fill pharmacy.

Conclusion

    This final rule permits central fill pharmacies to become 
registered as pharmacies 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 creating a new business 
activity to be known as ``central fill pharmacy.'' This allows 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.

[[Page 37408]]

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 has deemed 
this activity to be a form of dispensing, not a distribution. Title 21, 
CFR 1305.03 is amended to clarify that the order form requirement does 
not apply to such transfers.
    Central fill pharmacies are 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 the retail pharmacy from which the prescription 
information was received for delivery to the patient. Both the 
pharmacist employed by the central fill pharmacy and the pharmacist who 
dispenses the prescription to the patient have a corresponding 
responsibility to ensure 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)).
    DEA is creating an allowance for 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 is required to keep a list of 
retail pharmacies for which it has agreed to provide such services. The 
central fill pharmacy is also required to verify the DEA registration 
of any retail pharmacy they are doing business with prior to sending or 
receiving controlled substance prescriptions. Similarly, retail 
pharmacies are required to keep a list of those central fill pharmacies 
permitted to prepare prescriptions on their behalf and verify that they 
are DEA registrants. 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.
    DEA regulations do not prohibit central fill pharmacies in one 
state which have a contractual relationship or common ownership with a 
retail pharmacy located in another state from filling prescriptions 
transmitted by the retail pharmacy to the central fill pharmacy. 
However, each state involved in the transaction must permit this cross-
state activity.
    If authorized by the state in which they are located, a retail 
pharmacy may engage in central fill pharmacy activities as a 
coincidental activity associated with their retail pharmacy DEA 
registration. Therefore, a retail pharmacy may operate as both a retail 
pharmacy and a central fill pharmacy at the same location without 
maintaining separate registration, inventories, or records.
    Retail pharmacies are 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 allowing for 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 requiring specific security standards with 
respect to electronic transmission in this particular situation. 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 are required to 
comply with the same security requirements applicable to other 
pharmacies (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 are 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)). 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)).

Application for Registration for Central Fill Pharmacies

    As have been previously noted in this rulemaking, persons wishing 
to conduct central fill pharmacy activities must register with DEA to 
do so. To apply for registration, persons must complete a DEA Form 224, 
Application for Registration. As DEA has not yet issued updated forms 
specifically referencing the central file pharmacy business activity, 
persons wishing to register as central fill pharmacies must choose the 
retail pharmacy business activity on the form and then must attach a 
written statement signed by the person signing the registration 
application acknowledging that the pharmacy wishes to register as a 
central fill pharmacy.

Regulatory Certifications

Regulatory Flexibility Act

    The Deputy Assistant Administrator, Office of Diversion Control, 
hereby certifies that this rulemaking has been 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.
    As has been discussed elsewhere in this rulemaking, permitting 
controlled substance prescriptions to be processed through the use of 
central fill pharmacies will provide benefits to the regulated 
industry. The filling of prescriptions is a labor intensive process. 
There are significant cost reductions associated with the cost of 
filling a prescription through the use of central fill pharmacies. The 
regulated industry has indicated that labor costs are significantly 
reduced. For example, industry has indicated that, depending on the 
number of prescriptions

[[Page 37409]]

dispensed per day, the cost savings can be between $1.00 and $5.00 per 
prescription dispensed.

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 regulatory action. Therefore, 
this action has not been reviewed by the Office of Management and 
Budget. As previously noted, this rule will provide a number of 
benefits to the regulated industry as efficiencies are gained in the 
processing of controlled substance prescriptions.

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.

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.


0
For the reasons set out above, title 21, Code of Federal Regulations, 
parts 1300, 1301, 1304, 1305, and 1306 are amended to read as follows:

PART 1300--[AMENDED]

0
1. The authority citation for part 1300 continues to read as follows:

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


0
2. Section 1300.01 is amended by adding a new paragraph (b)(43) to read 
as follows:


Sec.  1300.01  Definitions relating to controlled substances.

* * * * *
    (b) * * *
    (43) The term central fill pharmacy means a pharmacy which is 
permitted 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. Such central fill pharmacy shall be deemed 
``authorized'' to fill prescriptions on behalf of a retail pharmacy 
only if the retail pharmacy and central fill pharmacy have a 
contractual relationship providing for such activities or share a 
common owner.

PART 1301--[AMENDED]

0
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.


0
2. Section 1301.13 is amended by revising paragraph (e)(1)(iii) 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) * * *

----------------------------------------------------------------------------------------------------------------
 
----------------------------------------------------------------------------------------------------------------
(iii) Dispensing or Instructing    Schedules II-V..........  New--224...............    210   3  May conduct
 (Includes Practitioner, Hospital/                           Renewal--224a..........    210       research and
 Clinic, Retail Pharmacy, Central                                                                 instructional
 Fill Pharmacy, Teaching                                                                          activities
 Institution).                                                                                    with those
                                                                                                  substances for
                                                                                                  which
                                                                                                  registration
                                                                                                  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. A
                                                                                                  retail
                                                                                                  pharmacy may
                                                                                                  perform
                                                                                                  central fill
                                                                                                  pharmacy
                                                                                                  activities.
----------------------------------------------------------------------------------------------------------------

* * * * *

0
3. Section 1301.76 is 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,

[[Page 37410]]

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]

0
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.


0
2. Section 1304.05 is 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 verify the 
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.
    (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 
verify the 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.

PART 1305--[AMENDED]

0
1. The authority citation for part 1305 continues to read as follows:

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


0
2. Section 1305.03 is 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 
delivery from a central fill pharmacy, as defined in Sec.  
1300.01(b)(43), to a retail pharmacy.

PART 1306--[AMENDED]

0
1. The authority citation for part 1306 continues to read as follows:

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


0
2. Section 1306.05 is amended by revising paragraph (a) 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.
* * * * *

0
3. Section 1306.06 is 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.

0
4. Section 1306.11 is 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.
* * * * *

0
5. Section 1306.14 is 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.
* * * * *

0
6. Section 1306.15 is added to read as follows:


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

    Prescription information may be provided to an authorized central 
fill pharmacy by a retail pharmacy for dispensing purposes. The 
following requirements shall also apply:
    (a) Prescriptions for controlled substances listed in Schedule II 
may be transmitted electronically from a retail pharmacy to a central 
fill pharmacy including via facsimile. The retail pharmacy transmitting 
the prescription information must:
    (1) Write the word ``CENTRAL FILL'' on the face of the original 
prescription and record the name, address, and DEA registration number 
of the central fill pharmacy to which the prescription has been 
transmitted and, the name of the retail pharmacy pharmacist 
transmitting the prescription, and the date of transmittal;
    (2) 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);
    (3) Maintain the original prescription for a period of two years 
from the date the prescription was filled;
    (4) Keep a record of receipt of the filled prescription, including 
the date of receipt, 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

[[Page 37411]]

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 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).

0
7. Section 1306.24 is 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.
* * * * *

0
8. Section 1306.26 is amended by adding a new paragraph (g) to read as 
follows:


Sec.  1306.26  Dispensing without prescription.

* * * * *
    (g) Central fill pharmacies may not dispense controlled substances 
to a purchaser at retail pursuant to this section.

0
9. Section 1306.27 is added to read as follows:


Sec.  1306.27  Provision 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 provided to an authorized central 
fill pharmacy by a retail pharmacy for dispensing purposes. The 
following requirements shall also apply:
    (a) Prescriptions for controlled substances listed in Schedule III, 
IV or V may be transmitted electronically from a retail pharmacy to a 
central fill pharmacy including via facsimile. The retail pharmacy 
transmitting the prescription information must:
    (1) Write the word ``CENTRAL FILL'' on the face of the original 
prescription and record the name, address, and DEA registration number 
of the central fill pharmacy to which the prescription has been 
transmitted and the name of the retail pharmacy pharmacist transmitting 
the prescription, and the date of transmittal;
    (2) 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);
    (3) Indicate in the information transmitted the number of refills 
already dispensed and the number of refills remaining;
    (4) Maintain the original prescription for a period of two years 
from the date the prescription was last refilled;
    (5) Keep a record of receipt of the filled prescription, including 
the date of receipt, 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: June 17, 2003.
Laura M. Nagel,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. 03-15912 Filed 6-23-03; 8:45 am]
BILLING CODE 4410-09-P