[Federal Register Volume 68, Number 212 (Monday, November 3, 2003)]
[Proposed Rules]
[Pages 62255-62259]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-27511]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 68, No. 212 / Monday, November 3, 2003 /
Proposed Rules
[[Page 62255]]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Parts 1300, 1301, 1304, and 1307
[Docket No. DEA-240P]
RIN 1117-AA75
Preventing the Accumulation of Surplus Controlled Substances at
Long Term Care Facilities
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of proposed rulemaking.
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SUMMARY: Because long term care facilities (LTCFs) generally do not
have pharmacies on site and are not registered with DEA, they typically
receive controlled substances prescribed for specific patients in 30
day supplies, although smaller supplies are sometimes used. As patients
leave or their medication needs to be changed, the LTCFs accumulate
stocks of excess controlled substances. The excess stocks can result in
significant problems with waste and disposal and present opportunities
for diversion of controlled substances. DEA is proposing changes to its
existing regulations to allow, where State laws permit, for pharmacy
installation of automated dispensing systems (ADSs) at LTCFs. Automated
dispensing systems would allow dispensing of single dosage units and
mitigate the problem of excess stocks and disposal.
DATES: Written comments must be postmarked on or before January 2,
2004.
ADDRESSES: Comments should be submitted to the Deputy Assistant
Administrator, Office of Diversion Control, Drug Enforcement
Administration, Washington, DC 20537, Attention: 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:
I. Background
Legal Authority
DEA enforces the Controlled Substances Act (CSA) (21 U.S.C. 801 et
seq.), as amended. DEA regulations implementing this statute are
published in Title 21 of the Code of Federal Regulations (CFR), Part
1300 to end. These regulations are designed to establish a framework
for the legal distribution of controlled substances to deter their
diversion to illegal purposes and to ensure that there is a sufficient
supply of these drugs for legitimate medical purposes. Controlled
substances are those substances listed in the schedules of the CSA and
21 CFR 1308.11-1308.15, and generally include narcotics, stimulants,
depressants, hallucinogens, and anabolic steroids that have a high
potential for abuse and dependency. DEA's regulations require that
persons involved in the manufacture, distribution, research,
dispensing, import, and export of controlled substances register with
DEA, keep track of all stocks of controlled substances, and maintain
records to account for all controlled substances received, distributed,
or otherwise disposed of.
Controlled Substances at Long Term Care Facilities (LTCFs)
Patients at LTCFs receive numerous medications, including
controlled substances. Unlike hospitals, LTCFs are rarely DEA
registrants. Patients at these facilities are usually seen by their
personal physicians, who prescribe any necessary medication. These
prescriptions are filled by retail pharmacies and delivered to the
LTCFs for patients' use. Because LTCFs are not registrants and
generally do not have physicians or pharmacists on staff, they may not
order and maintain stocks of controlled substances to be dispensed
under the order of a practitioner as occurs in hospitals. Instead, the
LTCF holds the controlled substance medications that are dispensed by
prescription to the specific patients by a provider pharmacy in a
custodial manner for administration to the patient. Any controlled
substance medications that are not ultimately administered to the
individual specific patient are waste that must be disposed of.
Although DEA permits pharmacies to dispense a prescription for a LTCF
patient on a daily or dosage unit basis rather than dispense the entire
quantity prescribed, reimbursement rules under Medicare and Medicaid
and other third party payors make daily dispensing financially
unattractive for pharmacies; pharmacies are allowed a limited number of
dispensing fees plus the calculated cost of the medication per month.
As a consequence, pharmacies routinely dispense the entire prescription
to the patient at once.
A result of this dispensing practice is that when patients leave
the facility or their medications change, the LTCF is left with excess
controlled substances, which must be disposed of to avoid diversion.
Because they are not registrants, the LTCFs may not transfer the
substances to either the pharmacy that supplied them or to a reverse
distributor for disposal. The LTCF must dispose of the excess
controlled substances directly.
Previous DEA Actions
DEA has frequently been asked to assist in resolving this matter.
The principal concern has been to prevent the accumulation of
controlled substances that are dispensed but not administered to the
patient. DEA has attempted to address this problem through the
establishment of partial dispensing provisions for Schedules II-V
prescriptions (including unit-dose dispensing, if desired), to limit
the quantity of controlled substances dispensed at one time and avoid
waste if the treatment was changed or discontinued. According to the
pharmacy industry, however, dispensing fees, reimbursement practices,
and difficulties in educating practitioners regarding the need to
prescribe controlled substances in anticipation of a patient's actual
need for the controlled substance have, for the most part, precluded
using that approach.
Current DEA Regulations
Although most LTCFs are not registered with DEA, DEA regulations
allow a LTCF to register, if licensed by its State to handle controlled
substances. DEA issues a registration in one of the following
categories based upon the type of license/permit issued
[[Page 62256]]
by a State and the authorized activities associated with the license/
permit:
[sbull] Retail pharmacy--A pharmacy located on-site at the LTCF
maintains stocks of controlled substances and a pharmacist dispenses
patient-specific controlled substances to residents of the LTCF who
have prescriptions for the substances.
[sbull] Hospital/clinic--The LTCF maintains institutional stocks of
controlled substances for dispensing by a pharmacist for administration
to residents under medication orders from a practitioner.
[sbull] Mid-Level Practitioner--Controlled substance activities are
limited to those authorized by the individual State.
[sbull] Practitioner--An individual practitioner, such as the
Medical Director of the LTCF, registers at the site of the LTCF and is
responsible for the handling of controlled substances utilized at the
LTCF.
Request for Information
On April 25, 2001, DEA published a notice in the Federal Register
(66 FR 20833) soliciting comments and suggestions on the problem of
excess controlled substances at LTCFs. Almost two dozen comments were
received from a range of organizations and individuals, including State
agencies, automated dispensing system (ADS) manufacturers, trade
associations, and pharmaceutical providers. Information received in
response to that notice is discussed below.
II. Discussion of the Proposed Rule
DEA's Proposal
To further address the issue of excess controlled substances in
LTCFs, DEA is proposing to allow a provider pharmacy to register at the
site of the LTCF and store controlled substances in an ADS. An ADS is
conceptually similar to a vending machine. A pharmacy stores bulk drugs
in the ADS in separate bins or containers and programs and controls the
ADS remotely. Only authorized staff at the LTCF would have access to
its contents, which are dispensed on a single-dose basis at the time of
administration pursuant to a prescription. The ADS electronically
records each dispensing, thus maintaining dispensing records for the
pharmacy. Because the drugs would not be considered dispensed until the
system provided them, drugs in the ADS would be pharmacy stock, not
waste.
Specifically, DEA is proposing the definition of ``automated
dispensing system'' as follows: ``a mechanical system that performs
operations or activities, other than compounding or administration,
relative to the storage, packaging, counting, labeling, and dispensing
of medications, and which collects, controls, and maintains all
transaction information.''
The key elements of an automated dispensing system would be the
following:
[sbull] State authorization for pharmacies to locate stock in the
automated dispensing systems at the LTCF.
[sbull] Establishment through State regulation of the necessary and
appropriate policies and protocols with respect to access to pharmacy
stock by LTCF nursing personnel, ensuring secure storage of the
controlled substances, transfer of the controlled substances from the
primary pharmacy location to the LTCF site, and related issues.
[sbull] Issuance of a DEA registration to the provider pharmacy at
the LTCF as a separate location, based on its current DEA registration
and without additional application fees.
DEA is proposing to allow the use of automated dispensing systems
as an option, not a requirement. DEA recognizes that there are reasons
why ADSs may not work in many circumstances, but believes that some
LTCFs will find ADSs a viable solution for preventing accumulation of
excess controlled substances. This technology has a number of
advantages, including the following:
[sbull] It can substantially reduce controlled substance waste,
thereby providing significant cost savings to purchasers of controlled
substances. It also can significantly reduce the time and other costs
associated with maintaining patient medication stocks and disposal of
excess stocks for LTCFs.
[sbull] With single-dose dispensing, secure storage, and controlled
access, it can help to control drug inventory and increase
accountability.
[sbull] With an increasing amount of controlled substances in use
as the LTCF population grows, it can help control the opportunities for
drug diversion.
[sbull] It recognizes advancements made in technology and provides
the option of using the most current technology in a broader array of
circumstances.
[sbull] With the current pharmacist shortage, it relieves
dispensing pharmacists of a number of manual steps involved in drug
handling.
[sbull] For consulting pharmacists in their responsibilities for
drug regimen review, it provides enhanced tools with a full range of
accurate data available online because the data are captured
automatically.
III. Use of Automated Dispensing Systems
Existing State Laws and Regulations
To implement this solution, States would need to grant approval
(i.e., a license, permit, or other authorization) for the provider
pharmacy to function at the location of the LTCF using an ADS, and
establish policies and procedures regarding system security, access,
and the like. States could define such an operation so as to avoid the
many peripheral requirements of traditional pharmacies such as sinks,
reference books, etc.
Other Options DEA Considered
As solicited by the April 25, 2001, request for information, one
commenter suggested that LTCFs should be able to obtain a limited
registration for purposes of contracting with reverse distributors for
waste disposal. DEA believes that, while this option has merit on the
issue of disposal, it does not address control of waste and it
potentially imposes additional disposal costs on LTCFs. Further, LTCFs
would need state authorization to handle controlled substances in the
manner envisioned here before DEA could issue them a DEA registration.
In addition, LTCFs would be required to comply with DEA recordkeeping
and reporting requirements.
Another suggestion was to address directly the problem of excess
medications being sent to facilities in the first place. Specifically,
the commenter suggested that practitioners' routine medication orders
not be sent to the LTCF unless actually necessitated by the patient. A
related suggestion was to change reimbursement standards that are, at
least in part, responsible for the current situation. Unfortunately,
these are not issues that DEA is empowered to address.
Yet another suggestion was to authorize limited permit pharmacies
at LTCFs 2-3 days per week. It is unclear to DEA how this option of a
``part-time'' pharmacy resolves the current problems.
Finally, there were various suggestions about a pharmacy
maintaining controlled substances as floor stock at LTCFs as an
alternative to an ADS. DEA notes that this option would still require
someone to be registered at the LTCF (either the pharmacy or the LTCF
itself). The significant concern with this option is the need to
maintain accountability and security for the controlled substances,
which DEA believes is much easier to do with an ADS.
[[Page 62257]]
DEA is not opposed to making other options available to LTCFs and
pharmacies, as long as they address the problems discussed in this
proposal, maintain strict levels of security and accountability, and
comply with Federal and State regulatory requirements.
Other Comments on the April 25, 2001 Notice
A number of commenters, including current ADS users, supported the
option of using ADSs for controlled substances at LTCFs, believing they
can reduce waste and disposal problems, eliminate opportunities for
medication errors, improve patient care, and/or reduce diversion of
controlled substances.
A number of commenters also suggested this was not a good idea,
citing primarily one or more of the following reasons:
[sbull] ADSs are expensive to finance and maintain.
[sbull] State laws and regulations will need to be changed.
[sbull] Registration at each location would be burdensome and
expensive.
[sbull] The logistics associated with use and maintenance of the
systems are complicated.
[sbull] There are substantial security concerns. Commenters
provided examples of where security issues (e.g., diversion,
misdispensing) have arisen.
[sbull] ADSs do not represent a total solution to waste/disposal
problems.
Several of these concerns are addressed elsewhere in this preamble.
To the extent DEA does not specifically address some of these issues,
DEA would reiterate that it recognizes this option will not work in all
situations. However, DEA believes that ADS systems should be an option
to be used where it does make sense and is otherwise permissible.
Medication Delivery Systems Currently Used by LTCFs
DEA is not suggesting that unit-dose delivery systems or other
medication delivery systems that most LTCFs use be replaced. DEA
recognizes that the cost of an automated dispensing system as well as
other requirements associated with its use at a LTCF may not be
warranted in many cases. Therefore, the use of an automated dispensing
system for storage and dispensing of controlled substances to residents
of LTCFs would be an option available to the provider pharmacy.
Specific Proposed Regulatory Changes
Current Federal law does not prohibit the use of ADSs for storage
and dispensing of controlled substances at LTCFs where the LTCF itself
is a DEA registrant. However, to successfully implement the approach
being proposed here requires several regulatory revisions:
[sbull] Section 1300.01 would be modified to include a definition
of automated dispensing system.
[sbull] Section 1301.17 would be modified to incorporate an
additional ``special procedure'' for the type of registrations that are
the subject of this notice. Specifically, retail pharmacies applying
for a separate registration to operate an ADS at a LTCF will need to
provide as part of their registration application an affidavit
attesting to the existence of a State license, permit, or other
authorization for activities at the LTCF.
[sbull] Section 1301.27 would be added to indicate that only retail
pharmacies may operate automated dispensing systems at long term care
facilities. The section would further indicate that a retail pharmacy
must maintain a separate registration at each long term care facility
location at which automated dispensing systems are installed and
operated, and that if more than one retail pharmacy operates an
automated dispensing system at a long term care facility, each retail
pharmacy must maintain its own separate registration at that facility.
Finally, this section indicates that retail pharmacies applying for
separate registrations to install and operate automated dispensing
systems at long term care facilities would be exempt from application
fees for those separate registrations.
[sbull] Section 1304.04 would be revised to permit a registered
retail pharmacy with one or more associated registrations at LTCFs to
keep all records for those LTCF locations at the retail pharmacy site
or other approved central location.
[sbull] Since the provider pharmacy would likely be ordering
controlled substances for multiple LTCFs that it services, Sec.
1307.11(b) which limits total distribution by a practitioner to 5
percent of all controlled substances dispensed in the course of a year
would be amended to provide an exemption for this activity.
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 business entities. This proposed rule provides the option of
using an automated dispensing system to dispense controlled substances
to patients at long term care facilities. Facilities which currently
use automated dispensing systems for the dispensing of noncontrolled
substances and, where permitted by DEA registration, for controlled
substances report in industry literature that, while there are costs
associated with the lease or purchase of an automated dispensing
system, automated dispensing systems have the following benefits:
[sbull] Significantly reduce drug waste. Various studies over the
past ten years have indicated that between 4 and 10 percent of
medications at long term care facilities are wasted. Additional reports
indicate that the use of an automated dispensing system reduces this
waste by 90 percent.
[sbull] Significant cost savings for payors. As noted previously,
automated dispensing systems have the potential to reduce the cost of
medications dispensed because medications are dispensed in a ``just in
time'' manner for administration rather than dispensing a larger
quantity of medication less frequently, which can create waste.
[sbull] Reduce nursing and pharmacy labor costs. Nurses and
pharmacy personnel no longer must prepare medications for dispensing to
individual patients. Time is also saved by nursing staff due to the
fact that medication administration records are now maintained
electronically. Often, this time is then redirected to providing
patient care.
[sbull] Reduce the potential for medication dispensing and
administration errors. Automated dispensing systems provide greater
accuracy in the dispensing and administration of medications.
Because the proposed rule does not require the use of automated
dispensing systems, DEA believes that only pharmacies and LTCFs which
find use of these systems cost-effective will adopt this approach.
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). It has been
determined that this is not a significant regulatory action because it
does not impose costs above $100 million a year or raise novel issues.
Therefore, this action has not been reviewed by the Office of
Management and Budget. Rather, this NPRM proposes to permit the
installation of automated dispensing systems at long term care
facilities by provider pharmacies, so long as state
[[Page 62258]]
regulations permit such installation. The use of automated dispensing
systems by long term care facilities provides another alternative to
address the problem of accumulation of surplus controlled substances at
long term care facilities. DEA believes that persons choosing to
utilize this method of dispensing controlled substances to patients at
long term care facilities may realize cost savings. More importantly to
DEA, the use of such systems should reduce the accumulation of excess
controlled substances at these facilities, thereby reducing the
potential for diversion of these controlled substances.
Paperwork Reduction Act
This rule proposes that a retail pharmacy currently registered with
DEA would be required to apply for separate registration at the
location of the long term care facility at which it intends to install
and operate an automated dispensing system. Application for
registration is made using currently existing DEA registration forms
(DEA Form 224 for registration and 224A for registration renewal). DEA
estimates that approximately 100 persons per year will apply for
registration to operate automated dispensing systems at long term care
facilities. Therefore, DEA is revising its OMB-approved information
collection (OMB 1117-0014) to reflect this increased burden due to this
program change.
Further, within this rulemaking DEA is proposing that at the time
of application for this separate registration at the long term care
facility by the retail pharmacy, the applicant must include with their
application for registration (DEA Form 224) an affidavit as to the
existence of State authorization to operate the automated dispensing
system at the long term care facility. DEA has provided a format for
the affidavit as part of its proposed regulations. This affidavit is
exempt from the requirements of the Paperwork Reduction Act (5 CFR
1320.3(h)(1)).
Executive Order 12988
This proposed rule meets the applicable standards set forth in
Sections 3(a) and 3(b)(2) of Executive Order 12988.
Executive Order 13132
This rule 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
$113,000,000 or more (adjusted for inflation) 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
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, Prescription drugs.
21 CFR Part 1307
Drug traffic control.
For the reasons set out above, 21 CFR parts 1300, 1301, 1304, and
1307 are proposed to be amended as follows:
PART 1300--DEFINITIONS [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 adding a new
paragraph (b)(45) to read as follows:
Sec. 1300.01 Definitions relating to controlled substances.
* * * * *
(b) * * *
(45) The term automated dispensing system means a mechanical system
that performs operations or activities, other than compounding or
administration, relative to the storage, packaging, counting, labeling,
and dispensing of medications, and which collects, controls, and
maintains all transaction information.
PART 1301--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND
DISPENSERS OF CONTROLLED SUBSTANCES [AMENDED]
3. The authority citation for part 1301 continues to read as
follows:
Authority: 21 U.S.C. 821, 822, 823, 824, 871(b), 875, 877, 956.
4. Sec. 1301.17 is proposed to be revised by redesignating
paragraph (c) as paragraph (d) and adding new paragraph (c) to read as
follows:
Sec. 1301.17 Special procedures for certain applications.
* * * * *
(c) If at the time of application for a separate registration at a
long term care facility, the retail pharmacy has been issued a license,
permit, or other form of authorization from the appropriate State
agency to install and operate an automated dispensing system for the
dispensing of controlled substances at the long term care facility, the
applicant must include with his/her application for registration (DEA
Form 224) an affidavit as to the existence of the State authorization.
Exact language for this affidavit may be found at the DEA Diversion
Control Program web site. The affidavit must include the following
information:
(1) The name and title of the corporate officer or official signing
the affidavit;
(2) The name of the corporation, partnership or sole proprietorship
operating the retail pharmacy;
(3) The name and complete address (including city, state, and Zip
code) of the retail pharmacy;
(4) The name and complete address (including city, state, and Zip
code) of the long term care facility for which DEA registration is
sought;
(5) Certification that the named retail pharmacy has been
authorized by the state Board of Pharmacy or licensing agency to
install and operate an automated dispensing system for the dispensing
of controlled substances at the named long term care facility
(including the license or permit number, if applicable);
(6) The date on which the authorization was issued;
(7) Statements attesting to the following:
(i) The affidavit is submitted to obtain a Drug Enforcement
Administration registration number;
(ii) If any information is false, the Administration may
immediately suspend the registration for this activity
[[Page 62259]]
and commence proceedings to revoke under 21 U.S.C. 824(a) because of
the danger to public health and safety;
(iii) Any false information contained in this affidavit may subject
the person signing this affidavit and the above-named corporation/
partnership/business to prosecution under 21 U.S.C. 843, the penalties
for conviction of which include imprisonment for up to 4 years, a fine
of not more than $30,000 or both;
(8) Signature of the person authorized to sign the Application for
Registration for the named retail pharmacy;
(9) Notarization of the affidavit.
* * * * *
5. Sec. 1301.27 is proposed to be added to read as follows:
Sec. 1301.27 Separate registration by retail pharmacies for
installation and operation of automated dispensing systems at long term
care facilities.
(a) A retail pharmacy may install and operate automated dispensing
systems, as defined in Sec. 1300.01 of this chapter, at long term care
facilities, pursuant to the requirements of Sec. 1301.17 of this part.
No person other than a retail pharmacy may install and operate an
automated dispensing system at a long term care facility.
(b) Retail pharmacies installing and operating automated dispensing
systems at long term care facilities must maintain a separate
registration at the location of each long term care facility at which
automated dispensing systems are located. If more than one retail
pharmacy operates automated dispensing systems at the same long term
care facility, each retail pharmacy must maintain a registration at the
long term care facility.
(c) A registered retail pharmacy applying for a separate
registration to operate an automated dispensing system for the
dispensing of controlled substances at a long term care facility is
exempt from application fees for any such additional registrations.
PART 1304--RECORDS AND REPORTS OF REGISTRANTS [AMENDED]
6. The authority citation for part 1304 continues to read as
follows:
Authority: 21 U.S.C. 821, 827, 871(b), 958(e), 965.
7. Sec. 1304.04 is proposed to be amended by revising paragraph
(a) to read as follows:
Sec. 1304.04 Maintenance of records and inventories.
(a) Except as provided in paragraphs (a)(1) and (a)(2) of this
section, every inventory and other record required to be kept under
this part shall be kept by the registrant and be available, for at
least 2 years from the date of such inventory or records, for
inspection and copying by authorized employees of the Administration.
(1) Financial and shipping records (such as invoices and packing
slips but not executed order forms subject to Sec. 1305.13 of this
chapter) may be kept at a central location, rather than at the
registered location, if the registrant has notified the Administration
of his intention to keep central records. Written notification must be
submitted by registered or certified mail, return receipt requested, in
triplicate, to the Special Agent in Charge of the Administration in the
area in which the registrant is located. Unless the registrant is
informed by the Special Agent in Charge that permission to keep central
records is denied, the registrant may maintain central records
commencing 14 days after receipt of his notification by the Special
Agent in Charge. All notifications must include the following:
(i) The nature of the records to be kept centrally.
(ii) The exact location where the records will be kept.
(iii) The name, address, DEA registration number and type of DEA
registration of the registrant whose records are being maintained
centrally.
(iv) Whether central records will be maintained in a manual or
computer readable form.
(2) A registered retail pharmacy that possesses additional
registrations for automated dispensing systems at long term care
facilities may keep all records required by this part for those
additional registered sites at the retail pharmacy or other approved
central location.
* * * * *
PART 1307--MISCELLANEOUS [AMENDED]
8. The authority citation for Part 1307 continues to read as
follows:
Authority: 21 U.S.C. 821, 822(d), 871(b).
9. Sec. 1307.11 is proposed to be amended by adding a new
paragraph (c) to read as follows:
Sec. 1307.11 Distribution by dispenser to another practitioner or
reverse distributor.
* * * * *
(c) The distributions that a registered retail pharmacy makes to
automated dispensing systems at long term care facilities for which the
pharmacy also holds registrations do not count toward the 5 percent
limit in paragraphs (a)(4) and (b) of this section.
Dated: October 24, 2003.
Laura M. Nagel,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. 03-27511 Filed 10-31-03; 8:45 am]
BILLING CODE 4410-09-P