[Federal Register Volume 70, Number 92 (Friday, May 13, 2005)]
[Rules and Regulations]
[Pages 25462-25466]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-9538]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Parts 1300, 1301, 1304, and 1307

[Docket No. DEA-240F]
RIN 1117-AA75


Preventing the Accumulation of Surplus Controlled Substances at 
Long Term Care Facilities

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Final rule.

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SUMMARY: DEA is amending its regulations to allow, where State laws 
permit, for retail pharmacy installation of automated dispensing 
systems at long term care facilities. Automated dispensing systems 
would allow dispensing of single dosage units and mitigate the problem 
of excess stocks and disposal.

DATES: Effective Date: This final rule is effective June 13, 2005.

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 1399. 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)

    DEA defines a long term care facility as ``a nursing home, 
retirement care, mental care or other facility or institution which 
provides extended health care to resident patients'' (21 CFR 
1300.01(b)(25)). Patients at LTCFs take numerous medications, including 
controlled substances. Unlike hospitals, LTCFs are rarely DEA 
registrants, (although DEA regulations do allow an LTCF to register if 
licensed by its State to handle controlled substances). 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 usually 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 controlled substance medications 
are dispensed under a prescription to the specific patients by a 
provider pharmacy; the LTCF holds the drugs in a custodial manner for 
administration to the patient. DEA permits pharmacies to dispense a 
Schedule II 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 
payers, however, 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. Consequently, 
pharmacies routinely dispense the entire prescription to the patient at 
once; the LTCF maintains the drugs and ensures that they are taken as 
prescribed.
    A result of this dispensing practice is that when patients leave 
the facility or their medications change, the LTCF may be 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.

DEA's Proposal

    To address the issue of excess controlled substances in LTCFs, DEA 
issued a Notice of Proposed Rulemaking (NPRM) (68 FR 62255; November 3, 
2003) proposing to allow a provider pharmacy to register at the site of 
the LTCF and store controlled substances in an automated dispensing 
system (ADS). An ADS is conceptually similar to a vending machine. A 
pharmacy stores bulk drugs in the machine 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 under a 
prescription. The ADS electronically records each dispensing, thus 
maintaining dispensing records for the pharmacy. Because the drugs are 
not considered dispensed until the system provides them, drugs in the 
ADS are counted as pharmacy stock. If patients do not take all of the 
drugs prescribed, the excess can be dispensed to other patients.
    DEA's proposal allowed 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.
    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 allow the use of

[[Page 25463]]

an ADS when the LTCF is not a registrant, several regulatory revisions 
are required. In the NPRM, DEA proposed the following:
     Addition of a definition of automated dispensing system to 
Sec.  1300.01.
     Modification of Sec.  1301.17 to incorporate an additional 
``special procedure'' for the type of registrations that are the 
subject of this notice. Specifically, 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.
    In general, States currently do not authorize (by license, permit, 
or other authorization) a provider pharmacy to function at the location 
of the LTCF using an ADS. States generally have not established 
policies and procedures regarding system security, access, and the 
like. States will need to amend their laws and regulations to fully 
implement this change in DEA regulations within their jurisdictions.
     Addition of a new Sec.  1301.27 to provide that only 
registered pharmacies may operate automated dispensing systems at long 
term care facilities. The section would further indicate that a 
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 pharmacy operates an automated 
dispensing system at a long term care facility, each pharmacy must 
maintain its own separate registration at that facility. Finally, this 
section indicates that 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.
     Modification of Sec.  1304.04 to permit a registered 
pharmacy with one or more associated registrations at LTCFs to keep all 
records for those LTCF locations at the pharmacy site or other approved 
central location.
     Since the provider pharmacy would likely be ordering 
controlled substances for multiple LTCFs that it services, modification 
of 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 to provide an exemption for this activity.

II. Comments Received in Response to the NPRM Published November 3, 
2003

    DEA received seven comments in response to the NPRM. The comments 
were all supportive of DEA efforts to address the issues associated 
with surplus controlled substances at LTCFs.
    One commenter cited benefits of the proposed approach in addition 
to those noted by DEA in the NPRM. This commenter also suggested that 
DEA and other Federal entities should do more than simply allow the use 
of ADSs, but rather ``encourage and enable'' LTCFs to use them. These 
additional benefits included the following:
     Private pay nursing home consumers will benefit from more 
efficient dispensing of controlled substance medications through the 
use of ADSs.
     The benefits of using ADSs are even greater if they are 
used to dispense both controlled and noncontrolled substances.
     Evidence from a pilot study in one State indicates that 
ADSs not only saved money, but also reduced opportunities for errors 
and abuse and added a level of security to the existing system.
     Dispensing machines may reduce the incidents of 
hospitalization for acute and psychiatric care because of the ability 
to order and dispense medications more quickly.
    Several commenters also noted, as DEA had noted in its NPRM, that a 
complete solution to this problem involves policies and requirements 
outside the jurisdiction of DEA, particularly in the area of 
reimbursements. In addition, one commenter reiterated a number of 
practical limitations to what DEA proposed, including the substantial 
regulatory barriers that exist at the State level, the inability to 
anticipate (and store) all of the controlled substances that might be 
needed at an LTCF, and nurse staffing shortages at LTCFs and the impact 
that might have on security and safety with ADSs. Nevertheless, these 
commenters supported the efforts of DEA to deal with the issue of 
surplus controlled substances at LTCFs.
    At the same time, several commenters offered suggestions or asked 
questions regarding the DEA proposal. These comments are addressed 
below.
    Two commenters pointed to DEA's use of the term ``retail pharmacy'' 
as being too narrow, and noted that most States allow other types of 
pharmacies to service LTCFs. DEA does not intend to limit the types of 
retail pharmacies that are eligible under this rule. As part of their 
licensing process, States may have a more limited definition of 
``retail pharmacy'' or multiple categories of pharmacy licenses. These 
regulations apply to those retail pharmacies registered with DEA, 
regardless of the type of State license the pharmacy holds. Therefore, 
DEA is clarifying the fact that only retail pharmacies are permitted to 
operate ADSs at LTCFs. DEA wishes to note that pharmacies registered 
with DEA solely as central fill pharmacies are not permitted to operate 
ADSs at LTCFs.
    One commenter asked whether the proposed rule prohibited access by 
a nurse to emergency supply controlled substances from an ADS prior to 
communication of a prescription to the pharmacy by a physician. Some 
State programs currently allow access to controlled substances from 
emergency kits that are kept at LTCFs. It will be up to each State to 
decide whether they will allow the access described by the commenter to 
occur at an LTCF where an ADS has been installed. DEA can foresee that 
permitting emergency access to an ADS prior to communication from the 
physician to the pharmacy would likely entail some special programming 
of the machine to ensure, among other things, proper control of its 
inventory. States will need to establish appropriate requirements/
procedures to ensure that emergency use of controlled substances in 
ADSs does not create new opportunities for diversion of those 
substances.
    Another commenter questioned the need for a separate pharmacy 
registration at the LTCF where its ADS is located. The commenter noted 
that there would be (superfluous) recordkeeping requirements that would 
flow between these two registered sites of the same pharmacy when 
controlled substances are stocked in the ADS. The commenter further 
suggested that they believed an ADS at an LTCF could be considered a 
secondary place of business under the statute or that another exception 
(to separate registration requirements) could be added to Sec.  
1301.12. DEA disagrees. Because this is a separate physical location 
and controlled substances are being stored and dispensed at this 
separate physical location, DEA believes it is consistent with the law 
to require a separate registration. Also, the exception suggested by 
the commenter is unlike the other exceptions now included in the 
regulations, which focus on settings where controlled substances are 
not distributed or dispensed and (except for a warehouse) where 
controlled substances are not stored.
    There will be additional recordkeeping requirements as a result of 
having a separate registration, but this is simply an essential 
requirement of DEA's diversion control program. DEA has attempted to 
minimize the burden associated with a separate registration

[[Page 25464]]

by exempting the additional registrations from application fees.
    Another commenter expressed a related concern, suggesting that by 
requiring registration at each site, a pharmacy was now accountable to 
DEA for diversion that might result because of LTCF personnel. DEA does 
not currently hold pharmacies supplying LTCFs accountable for diversion 
of dispensed medications by LTCF staff and does not believe it is 
imposing a different or greater burden on pharmacies that choose to 
register and place an ADS at an LTCF.
    DEA does believe that the use of ADSs can reduce certain types of 
diversion opportunities present at LTCFs and improve overall security 
regarding controlled substances. In addition, DEA can foresee that, 
with an ADS, a pharmacy may be able to more readily assist an LTCF in 
investigating diversion because of the automatic tracking and 
information collection that will occur in routine use of its on-site 
system.
    Two commenters expressed concern that rental payments for an ADS 
paid by an LTCF to a pharmacy might run afoul of Federal anti-kickback 
statutes if they are not ``fair market'' rental payments. Although this 
is not an issue within DEA's purview, DEA would suggest that each State 
currently has a policy/approach for handling equipment rental/purchase 
issues within their jurisdiction and that is where an LTCF should look 
for guidance. States also may address this issue when establishing 
policies and protocols for use of ADSs. Presumably, in at least some 
cases rental payments may be required. If any required payments are 
greater than the financial and other benefits an LTCF receives by using 
an ADS, then the situation is probably not one where use of an ADS is 
appropriate. As DEA stated in its proposal, the use of ADSs is an 
option, not a requirement, and there are reasons why ADSs may not work 
in many circumstances.
    One commenter expressed concern that use of an ADS would require 
changes to third-party and Medicaid billing practices, noting that most 
payment systems currently bill when the medication leaves the pharmacy, 
not after actual use by the LTCF resident or at the end of the month. 
Again, this is not an issue within DEA's control. However, DEA notes 
that the controlled substances still belong to the pharmacy until they 
are actually dispensed from the machine. Regarding billing practices, 
DEA urges all parties involved to think creatively about this and look 
at options for altering existing billing systems where ADSs are used. 
There may be potential financial and security benefits to using these 
systems and DEA urges other changes be made, where possible, to promote 
their use.
    Finally, this same commenter asked whether multiple pharmacies can 
share an ADS at an LTCF. DEA would not object to multiple pharmacies 
maintaining separate ADS' at an LTCF location; however, multiple 
pharmacies cannot share a single ADS because of the accountability 
issues surrounding the controlled substances. This would be tantamount 
to two registered pharmacies sharing one registered location and one 
storage/dispensing system, which is unacceptable to DEA. The sharing of 
an ADS by two registered pharmacies would cause stocks of controlled 
substances to be commingled, making inventory, recordkeeping, reporting 
and accountability requirements almost impossible to administer.

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 rule provides the option of using an 
automated dispensing system to dispense controlled substances to 
patients at long term care facilities. Facilities that 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:
     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.
     Significant cost savings for payers. 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.
     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.
     Reduce the potential for medication dispensing and 
administration errors. Automated dispensing systems provide greater 
accuracy in the dispensing and administration of medications.
    Because the rule does not require the use of automated dispensing 
systems, DEA believes that only retail pharmacies and LTCFs that 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 a significant regulatory action. Therefore, 
this action has been reviewed by the Office of Management and Budget. 
This final rule permits the installation of automated dispensing 
systems at long term care facilities by retail provider pharmacies, so 
long as State 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 requires a retail pharmacy currently registered with DEA 
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 has revised its 
OMB-approved information

[[Page 25465]]

collection (OMB 1117-0014) to reflect this increased burden due to this 
program change.
    Further, within this rulemaking DEA is requiring 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 regulations. This affidavit is exempt from 
the requirements of the Paperwork Reduction Act (5 CFR 1320.3(h)(1)).

Executive Order 12988

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

Executive Order 13132

    This final 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 
$115,000,000 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 final 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.


0
For the reasons set out above, 21 CFR parts 1300, 1301, 1304, and 1307 
are amended as follows:

PART 1300--DEFINITIONS

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)(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

0
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, 951, 
952, 953, 956, 957.


0
4. Section 1301.17 is amended 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 at 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 material information is false, the Administrator may 
commence proceedings to deny the application under section 304 of the 
Act (21 U.S.C. 824(a));
    (iii) Any false or fraudulent material information contained in 
this affidavit may subject the person signing this affidavit and the 
above-named corporation/partnership/business to prosecution under 
section 403 of the Act (21 U.S.C. 843);
    (8) Signature of the person authorized to sign the Application for 
Registration for the named retail pharmacy;
    (9) Notarization of the affidavit.
* * * * *

0
5. Section 1301.27 is 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, under the requirements of Sec.  1301.17. No person other 
than a registered 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

[[Page 25466]]

maintain a separate registration at the location of each long term care 
facility at which automated dispensing systems are located. If more 
than one registered 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

0
6. 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
7. Section 1304.04 is 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 records required to be kept under 
this part must 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. Sec.  1305.17 and 
1305.27 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

0
8. The authority citation for part 1307 continues to read as follows:

    Authority: 21 U.S.C. 821, 822(d), 871(b), unless otherwise 
noted.


0
9. Section 1307.11 is 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 
retail pharmacy also holds registrations do not count toward the 5 
percent limit in paragraphs (a)(1)(iv) and (b) of this section.

    Dated: May 5, 2005.
William J. Walker,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. 05-9538 Filed 5-12-05; 8:45 am]
BILLING CODE 4410-09-P