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25462 Federal Register / Vol. 70, No.

92 / Friday, May 13, 2005 / Rules and Regulations

V. Transcripts SUPPLEMENTARY INFORMATION: basis rather than dispense the entire


A transcript will be made of the quantity prescribed. Reimbursement
I. Background
proceedings of each meeting. You may rules under Medicare and Medicaid and
request a copy of a meeting transcript in Legal Authority other third party payers, however, make
writing from FDA’s Freedom of DEA enforces the Controlled daily dispensing financially unattractive
Information Office (HFI–35), Food and Substances Act (CSA) (21 U.S.C. 801 et for pharmacies; pharmacies are allowed
seq.), as amended. DEA regulations a limited number of dispensing fees
Drug Administration, 5600 Fishers
implementing this statute are published plus the calculated cost of the
Lane, rm. 12A–16, Rockville, MD 20857,
in Title 21 of the Code of Federal medication per month. Consequently,
approximately 30 working days after the
Regulations (CFR), part 1300 to 1399. pharmacies routinely dispense the
public meetings at a cost of 10 cents per
entire prescription to the patient at
page. The transcript of each public These regulations are designed to
once; the LTCF maintains the drugs and
meeting will be available for public establish a framework for the legal
ensures that they are taken as
examination at the Division of Dockets distribution of controlled substances to
prescribed.
Management (HFA–305), 5630 Fishers deter their diversion to illegal purposes A result of this dispensing practice is
Lane, rm. 1061, Rockville, MD 20852 and to ensure that there is a sufficient that when patients leave the facility or
between 9 a.m. and 4 p.m., Monday supply of these drugs for legitimate their medications change, the LTCF may
through Friday. medical purposes. Controlled be left with excess controlled
substances are those substances listed in substances, which must be disposed of
VI. Electronic Access
the schedules of the CSA and 21 CFR to avoid diversion. Because they are not
Information about the public 1308.11–1308.15, and generally include registrants, the LTCFs may not transfer
meetings, contact information, and the narcotics, stimulants, depressants, the substances to either the pharmacy
provisions of the Bioterrorism Act under hallucinogens, and anabolic steroids that supplied them or to a reverse
FDA’s jurisdiction can be accessed at that have a high potential for abuse and distributor for disposal. The LTCF must
http://www.fda.gov/oc/bioterrorism/ dependency. DEA’s regulations require dispose of the excess controlled
bioact.html and http:// that persons involved in the substances directly.
www.cfsan.fda.gov/dms/fsbtact.html. manufacture, distribution, research,
Dated: May 9, 2005. dispensing, import, and export of DEA’s Proposal
Jeffrey Shuren, controlled substances register with DEA, To address the issue of excess
Assistant Commissioner for Policy.
keep track of all stocks of controlled controlled substances in LTCFs, DEA
substances, and maintain records to issued a Notice of Proposed Rulemaking
[FR Doc. 05–9536 Filed 5–10–05; 4:13 pm]
account for all controlled substances (NPRM) (68 FR 62255; November 3,
BILLING CODE 4160–01–S
received, distributed, or otherwise 2003) proposing to allow a provider
disposed of. pharmacy to register at the site of the
DEPARTMENT OF JUSTICE Controlled Substances at Long Term LTCF and store controlled substances in
Care Facilities (LTCFs) an automated dispensing system (ADS).
Drug Enforcement Administration An ADS is conceptually similar to a
DEA defines a long term care facility vending machine. A pharmacy stores
21 CFR Parts 1300, 1301, 1304, and as ‘‘a nursing home, retirement care, bulk drugs in the machine in separate
1307 mental care or other facility or bins or containers and programs and
institution which provides extended controls the ADS remotely. Only
[Docket No. DEA–240F] health care to resident patients’’ (21 CFR authorized staff at the LTCF would have
RIN 1117–AA75 1300.01(b)(25)). Patients at LTCFs take access to its contents, which are
numerous medications, including dispensed on a single-dose basis at the
Preventing the Accumulation of controlled substances. Unlike hospitals, time of administration under a
Surplus Controlled Substances at LTCFs are rarely DEA registrants, prescription. The ADS electronically
Long Term Care Facilities (although DEA regulations do allow an records each dispensing, thus
LTCF to register if licensed by its State maintaining dispensing records for the
AGENCY: Drug Enforcement to handle controlled substances). pharmacy. Because the drugs are not
Administration (DEA), Justice. Patients at these facilities are usually considered dispensed until the system
ACTION: Final rule. seen by their personal physicians, who provides them, drugs in the ADS are
prescribe any necessary medication. counted as pharmacy stock. If patients
SUMMARY: DEA is amending its
These prescriptions are filled by retail do not take all of the drugs prescribed,
regulations to allow, where State laws pharmacies and delivered to the LTCFs
permit, for retail pharmacy installation the excess can be dispensed to other
for patients’ use. Because LTCFs usually patients.
of automated dispensing systems at long are not registrants and generally do not DEA’s proposal allowed the use of
term care facilities. Automated have physicians or pharmacists on staff, automated dispensing systems as an
dispensing systems would allow they may not order and maintain stocks option, not a requirement. DEA
dispensing of single dosage units and of controlled substances to be dispensed recognizes that there are reasons why
mitigate the problem of excess stocks under the order of a practitioner as ADSs may not work in many
and disposal. occurs in hospitals. Instead, the circumstances, but believes that some
DATES: Effective Date: This final rule is controlled substance medications are LTCFs will find ADSs a viable solution
effective June 13, 2005. dispensed under a prescription to the for preventing accumulation of excess
FOR FURTHER INFORMATION CONTACT: specific patients by a provider controlled substances.
Patricia M. Good, Chief, Liaison and pharmacy; the LTCF holds the drugs in Current Federal law does not prohibit
Policy Section, Office of Diversion a custodial manner for administration to the use of ADSs for storage and
Control, Drug Enforcement the patient. DEA permits pharmacies to dispensing of controlled substances at
Administration, Washington, DC 20537, dispense a Schedule II prescription for LTCFs where the LTCF itself is a DEA
Telephone (202) 307–7297. a LTCF patient on a daily or dosage unit registrant. However, to allow the use of

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Federal Register / Vol. 70, No. 92 / Friday, May 13, 2005 / Rules and Regulations 25463

an ADS when the LTCF is not a were all supportive of DEA efforts to holds. Therefore, DEA is clarifying the
registrant, several regulatory revisions address the issues associated with fact that only retail pharmacies are
are required. In the NPRM, DEA surplus controlled substances at LTCFs. permitted to operate ADSs at LTCFs.
proposed the following: One commenter cited benefits of the DEA wishes to note that pharmacies
• Addition of a definition of proposed approach in addition to those registered with DEA solely as central fill
automated dispensing system to noted by DEA in the NPRM. This pharmacies are not permitted to operate
§ 1300.01. commenter also suggested that DEA and ADSs at LTCFs.
• Modification of § 1301.17 to other Federal entities should do more One commenter asked whether the
incorporate an additional ‘‘special than simply allow the use of ADSs, but proposed rule prohibited access by a
procedure’’ for the type of registrations rather ‘‘encourage and enable’’ LTCFs to nurse to emergency supply controlled
that are the subject of this notice. use them. These additional benefits substances from an ADS prior to
Specifically, pharmacies applying for a included the following: communication of a prescription to the
separate registration to operate an ADS • Private pay nursing home pharmacy by a physician. Some State
at a LTCF will need to provide as part consumers will benefit from more programs currently allow access to
of their registration application an efficient dispensing of controlled controlled substances from emergency
affidavit attesting to the existence of a substance medications through the use kits that are kept at LTCFs. It will be up
State license, permit, or other of ADSs. to each State to decide whether they
authorization for activities at the LTCF. • The benefits of using ADSs are even will allow the access described by the
In general, States currently do not greater if they are used to dispense both
commenter to occur at an LTCF where
authorize (by license, permit, or other controlled and noncontrolled
an ADS has been installed. DEA can
authorization) a provider pharmacy to substances.
foresee that permitting emergency
function at the location of the LTCF • Evidence from a pilot study in one
access to an ADS prior to
using an ADS. States generally have not State indicates that ADSs not only saved
communication from the physician to
established policies and procedures money, but also reduced opportunities
the pharmacy would likely entail some
regarding system security, access, and for errors and abuse and added a level
special programming of the machine to
the like. States will need to amend their of security to the existing system.
• Dispensing machines may reduce ensure, among other things, proper
laws and regulations to fully implement control of its inventory. States will need
this change in DEA regulations within the incidents of hospitalization for acute
and psychiatric care because of the to establish appropriate requirements/
their jurisdictions. procedures to ensure that emergency
• Addition of a new § 1301.27 to ability to order and dispense
medications more quickly. use of controlled substances in ADSs
provide that only registered pharmacies
Several commenters also noted, as does not create new opportunities for
may operate automated dispensing
DEA had noted in its NPRM, that a diversion of those substances.
systems at long term care facilities. The
section would further indicate that a complete solution to this problem Another commenter questioned the
pharmacy must maintain a separate involves policies and requirements need for a separate pharmacy
registration at each long term care outside the jurisdiction of DEA, registration at the LTCF where its ADS
facility location at which automated particularly in the area of is located. The commenter noted that
dispensing systems are installed and reimbursements. In addition, one there would be (superfluous)
operated, and that if more than one commenter reiterated a number of recordkeeping requirements that would
pharmacy operates an automated practical limitations to what DEA flow between these two registered sites
dispensing system at a long term care proposed, including the substantial of the same pharmacy when controlled
facility, each pharmacy must maintain regulatory barriers that exist at the State substances are stocked in the ADS. The
its own separate registration at that level, the inability to anticipate (and commenter further suggested that they
facility. Finally, this section indicates store) all of the controlled substances believed an ADS at an LTCF could be
that pharmacies applying for separate that might be needed at an LTCF, and considered a secondary place of
registrations to install and operate nurse staffing shortages at LTCFs and business under the statute or that
automated dispensing systems at long the impact that might have on security another exception (to separate
term care facilities would be exempt and safety with ADSs. Nevertheless, registration requirements) could be
from application fees for those separate these commenters supported the efforts added to § 1301.12. DEA disagrees.
registrations. of DEA to deal with the issue of surplus Because this is a separate physical
• Modification of § 1304.04 to permit controlled substances at LTCFs. location and controlled substances are
a registered pharmacy with one or more At the same time, several commenters being stored and dispensed at this
associated registrations at LTCFs to keep offered suggestions or asked questions separate physical location, DEA believes
all records for those LTCF locations at regarding the DEA proposal. These it is consistent with the law to require
the pharmacy site or other approved comments are addressed below. a separate registration. Also, the
central location. Two commenters pointed to DEA’s exception suggested by the commenter
• Since the provider pharmacy would use of the term ‘‘retail pharmacy’’ as is unlike the other exceptions now
likely be ordering controlled substances being too narrow, and noted that most included in the regulations, which focus
for multiple LTCFs that it services, States allow other types of pharmacies on settings where controlled substances
modification of § 1307.11(b), which to service LTCFs. DEA does not intend are not distributed or dispensed and
limits total distribution by a practitioner to limit the types of retail pharmacies (except for a warehouse) where
to 5 percent of all controlled substances that are eligible under this rule. As part controlled substances are not stored.
dispensed in the course of a year to of their licensing process, States may There will be additional
provide an exemption for this activity. have a more limited definition of ‘‘retail recordkeeping requirements as a result
pharmacy’’ or multiple categories of of having a separate registration, but this
II. Comments Received in Response to pharmacy licenses. These regulations is simply an essential requirement of
the NPRM Published November 3, 2003 apply to those retail pharmacies DEA’s diversion control program. DEA
DEA received seven comments in registered with DEA, regardless of the has attempted to minimize the burden
response to the NPRM. The comments type of State license the pharmacy associated with a separate registration

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25464 Federal Register / Vol. 70, No. 92 / Friday, May 13, 2005 / Rules and Regulations

by exempting the additional may be potential financial and security • Reduce nursing and pharmacy labor
registrations from application fees. benefits to using these systems and DEA costs. Nurses and pharmacy personnel
Another commenter expressed a urges other changes be made, where no longer must prepare medications for
related concern, suggesting that by possible, to promote their use. dispensing to individual patients. Time
requiring registration at each site, a Finally, this same commenter asked is also saved by nursing staff due to the
pharmacy was now accountable to DEA whether multiple pharmacies can share fact that medication administration
for diversion that might result because an ADS at an LTCF. DEA would not records are now maintained
of LTCF personnel. DEA does not object to multiple pharmacies electronically. Often, this time is then
currently hold pharmacies supplying maintaining separate ADS’ at an LTCF redirected to providing patient care.
LTCFs accountable for diversion of location; however, multiple pharmacies • Reduce the potential for medication
dispensed medications by LTCF staff cannot share a single ADS because of dispensing and administration errors.
and does not believe it is imposing a the accountability issues surrounding Automated dispensing systems provide
different or greater burden on the controlled substances. This would greater accuracy in the dispensing and
pharmacies that choose to register and be tantamount to two registered administration of medications.
place an ADS at an LTCF. pharmacies sharing one registered Because the rule does not require the
DEA does believe that the use of ADSs location and one storage/dispensing use of automated dispensing systems,
can reduce certain types of diversion system, which is unacceptable to DEA. DEA believes that only retail
opportunities present at LTCFs and The sharing of an ADS by two registered pharmacies and LTCFs that find use of
improve overall security regarding pharmacies would cause stocks of these systems cost-effective will adopt
controlled substances. In addition, DEA controlled substances to be this approach.
can foresee that, with an ADS, a commingled, making inventory, Executive Order 12866
pharmacy may be able to more readily recordkeeping, reporting and
assist an LTCF in investigating The Deputy Assistant Administrator,
accountability requirements almost
diversion because of the automatic Office of Diversion Control, further
impossible to administer.
tracking and information collection that certifies that this rulemaking has been
will occur in routine use of its on-site Regulatory Certifications drafted in accordance with the
system. principles in Executive Order 12866
Regulatory Flexibility Act
Two commenters expressed concern Section 1(b). It has been determined that
that rental payments for an ADS paid by The Deputy Assistant Administrator, this is a significant regulatory action.
an LTCF to a pharmacy might run afoul Office of Diversion Control, hereby Therefore, this action has been reviewed
of Federal anti-kickback statutes if they certifies that this rulemaking has been by the Office of Management and
are not ‘‘fair market’’ rental payments. drafted in accordance with the Budget. This final rule permits the
Although this is not an issue within Regulatory Flexibility Act (5 U.S.C. installation of automated dispensing
DEA’s purview, DEA would suggest that 605(b)), has reviewed this regulation, systems at long term care facilities by
each State currently has a policy/ and by approving it certifies that this retail provider pharmacies, so long as
approach for handling equipment regulation will not have a significant State regulations permit such
rental/purchase issues within their economic impact on a substantial installation. The use of automated
jurisdiction and that is where an LTCF number of small business entities. This dispensing systems by long term care
should look for guidance. States also rule provides the option of using an facilities provides another alternative to
may address this issue when automated dispensing system to address the problem of accumulation of
establishing policies and protocols for dispense controlled substances to surplus controlled substances at long
use of ADSs. Presumably, in at least patients at long term care facilities. term care facilities. DEA believes that
some cases rental payments may be Facilities that currently use automated persons choosing to utilize this method
required. If any required payments are dispensing systems for the dispensing of of dispensing controlled substances to
greater than the financial and other noncontrolled substances and, where patients at long term care facilities may
benefits an LTCF receives by using an permitted by DEA registration, for realize cost savings. More importantly to
ADS, then the situation is probably not controlled substances report in industry DEA, the use of such systems should
one where use of an ADS is appropriate. literature that, while there are costs reduce the accumulation of excess
As DEA stated in its proposal, the use associated with the lease or purchase of controlled substances at these facilities,
of ADSs is an option, not a requirement, an automated dispensing system, thereby reducing the potential for
and there are reasons why ADSs may automated dispensing systems have the diversion of these controlled substances.
not work in many circumstances. following benefits:
One commenter expressed concern • Significantly reduce drug waste. Paperwork Reduction Act
that use of an ADS would require Various studies over the past ten years This rule requires a retail pharmacy
changes to third-party and Medicaid have indicated that between 4 and 10 currently registered with DEA to apply
billing practices, noting that most percent of medications at long term care for separate registration at the location
payment systems currently bill when facilities are wasted. Additional reports of the long term care facility at which
the medication leaves the pharmacy, not indicate that the use of an automated it intends to install and operate an
after actual use by the LTCF resident or dispensing system reduces this waste by automated dispensing system.
at the end of the month. Again, this is 90 percent. Application for registration is made
not an issue within DEA’s control. • Significant cost savings for payers. using currently existing DEA
However, DEA notes that the controlled As noted previously, automated registration forms (DEA Form 224 for
substances still belong to the pharmacy dispensing systems have the potential to registration and 224A for registration
until they are actually dispensed from reduce the cost of medications renewal). DEA estimates that
the machine. Regarding billing dispensed because medications are approximately 100 persons per year will
practices, DEA urges all parties involved dispensed in a ‘‘just in time’’ manner for apply for registration to operate
to think creatively about this and look administration rather than dispensing a automated dispensing systems at long
at options for altering existing billing larger quantity of medication less term care facilities. Therefore, DEA has
systems where ADSs are used. There frequently, which can create waste. revised its OMB-approved information

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Federal Register / Vol. 70, No. 92 / Friday, May 13, 2005 / Rules and Regulations 25465

collection (OMB 1117–0014) to reflect 21 CFR Part 1301 authorization. Exact language for this
this increased burden due to this Administrative practice and affidavit may be found at the DEA
program change. procedure, Drug traffic control, Security Diversion Control Program Web site.
Further, within this rulemaking DEA measures. The affidavit must include the following
is requiring that, at the time of information:
application for this separate registration 21 CFR Part 1304 (1) The name and title of the corporate
at the long term care facility by the retail Drug traffic control, Prescription officer or official signing the affidavit;
pharmacy, the applicant must include drugs. (2) The name of the corporation,
with their application for registration partnership or sole proprietorship
21 CFR Part 1307 operating the retail pharmacy;
(DEA Form 224) an affidavit as to the
existence of State authorization to Drug traffic control. (3) The name and complete address
operate the automated dispensing ■ For the reasons set out above, 21 CFR
(including city, state, and Zip code) of
system at the long term care facility. parts 1300, 1301, 1304, and 1307 are the retail pharmacy;
DEA has provided a format for the (4) The name and complete address
amended as follows:
affidavit as part of its regulations. This (including city, state, and Zip code) of
affidavit is exempt from the PART 1300—DEFINITIONS the long term care facility at which DEA
requirements of the Paperwork registration is sought;
■ 1. The authority citation for part 1300 (5) Certification that the named retail
Reduction Act (5 CFR 1320.3(h)(1)). continues to read as follows: pharmacy has been authorized by the
Executive Order 12988 Authority: 21 U.S.C. 802, 871(b), 951, state Board of Pharmacy or licensing
958(f). agency to install and operate an
This final rule meets the applicable automated dispensing system for the
standards set forth in Sections 3(a) and
■ 2. Section 1300.01 is amended by dispensing of controlled substances at
3(b)(2) of Executive Order 12988.
adding a new paragraph (b)(45) to read the named long term care facility
Executive Order 13132 as follows: (including the license or permit number,
if applicable);
This final rule does not preempt or § 1300.01 Definitions relating to controlled (6) The date on which the
modify any provision of State law; nor substances.
authorization was issued;
does it impose enforcement * * * * * (7) Statements attesting to the
responsibilities on any State; nor does it (b) * * * following:
diminish the power of any State to (45) The term automated dispensing (i) The affidavit is submitted to obtain
enforce its own laws. Accordingly, this system means a mechanical system that a Drug Enforcement Administration
rulemaking does not have federalism performs operations or activities, other registration number;
implications warranting the application than compounding or administration, (ii) If any material information is
of Executive Order 13132. relative to the storage, packaging, false, the Administrator may commence
counting, labeling, and dispensing of proceedings to deny the application
Unfunded Mandates Reform Act of 1995 medications, and which collects, under section 304 of the Act (21 U.S.C.
This rule will not result in the controls, and maintains all transaction 824(a));
expenditure by State, local, and tribal information. (iii) Any false or fraudulent material
governments, in the aggregate, or by the information contained in this affidavit
private sector, of $115,000,000 or more PART 1301—REGISTRATION OF may subject the person signing this
(adjusted for inflation) in any one year, MANUFACTURERS, DISTRIBUTORS, affidavit and the above-named
and will not significantly or uniquely AND DISPENSERS OF CONTROLLED corporation/partnership/business to
affect small governments. Therefore, no SUBSTANCES prosecution under section 403 of the
actions were deemed necessary under ■ 3. The authority citation for part 1301 Act (21 U.S.C. 843);
the provisions of the Unfunded continues to read as follows: (8) Signature of the person authorized
Mandates Reform Act of 1995. to sign the Application for Registration
Authority: 21 U.S.C. 821, 822, 823, 824, for the named retail pharmacy;
Small Business Regulatory Enforcement 871(b), 875, 877, 951, 952, 953, 956, 957. (9) Notarization of the affidavit.
Fairness Act
■ 4. Section 1301.17 is amended by * * * * *
This final rule is not a major rule as redesignating paragraph (c) as paragraph ■ 5. Section 1301.27 is added to read as
defined by Section 804 of the Small (d) and adding new paragraph (c) to read follows:
Business Regulatory Enforcement as follows:
Fairness Act of 1996. This rule will not § 1301.27 Separate registration by retail
§ 1301.17 Special procedures for certain pharmacies for installation and operation of
result in an annual effect on the
applications. automated dispensing systems at long term
economy of $100,000,000 or more; a
* * * * * care facilities.
major increase in costs or prices; or
significant adverse effects on (c) If at the time of application for a (a) A retail pharmacy may install and
competition, employment, investment, separate registration at a long term care operate automated dispensing systems,
productivity, innovation, or on the facility, the retail pharmacy has been as defined in § 1300.01 of this chapter,
ability of United States-based issued a license, permit, or other form at long term care facilities, under the
companies to compete with foreign- of authorization from the appropriate requirements of § 1301.17. No person
based companies in domestic and State agency to install and operate an other than a registered retail pharmacy
export markets. automated dispensing system for the may install and operate an automated
dispensing of controlled substances at dispensing system at a long term care
List of Subjects the long term care facility, the applicant facility.
21 CFR Part 1300 must include with his/her application (b) Retail pharmacies installing and
for registration (DEA Form 224) an operating automated dispensing systems
Definitions, Drug traffic control. affidavit as to the existence of the State at long term care facilities must

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25466 Federal Register / Vol. 70, No. 92 / Friday, May 13, 2005 / Rules and Regulations

maintain a separate registration at the (iv) Whether central records will be Federal Register a proposed revision of
location of each long term care facility maintained in a manual, or computer Part 203.
at which automated dispensing systems readable, form. The comment period was May 8,
are located. If more than one registered (2) A registered retail pharmacy that 2003, to July 8, 2002.
retail pharmacy operates automated possesses additional registrations for The Agency received comments from
dispensing systems at the same long automated dispensing systems at long eleven private voluntary organizations
term care facility, each retail pharmacy term care facilities may keep all records (PVOs) as well as comments from two
must maintain a registration at the long required by this part for those additional cooperative development organizations
term care facility. registered sites at the retail pharmacy or (CDOs). The following summarizes the
(c) A registered retail pharmacy other approved central location. principal comments and actions taken:
applying for a separate registration to * * * * * 1. Annual Documentation
operate an automated dispensing system Requirements (see § 203.5). For PVOs
for the dispensing of controlled PART 1307—MISCELLANEOUS submitting an Office of Management
substances at a long term care facility is and Budget (OMB) Circular A–133
exempt from application fees for any ■ 8. The authority citation for part 1307 Audit, the due date for submitting
such additional registrations. continues to read as follows: annual documents was changed from
Authority: 21 U.S.C. 821, 822(d), 871(b), six months to nine months following the
PART 1304—RECORDS AND unless otherwise noted. organization’s fiscal year end to take
REPORTS OF REGISTRANTS into account the time required for the
■ 9. Section 1307.11 is amended by registrant to prepare the OMB Circular
■ 6. The authority citation for part 1304 adding a new paragraph (c) to read as A–133 audit.
continues to read as follows: follows: 2. Submission of Documents. A
§ 1307.11 Distribution by dispenser to
comment expressed opposition to
Authority: 21 U.S.C. 821, 827, 871(b),
another practitioner or reverse distributor. submitting duplicate documents to
958(e), 965, unless otherwise noted.
various offices within USAID. The
■ 7. Section 1304.04 is amended by * * * * *
words ‘‘the same or’’ were deleted from
revising paragraph (a) to read as follows: (c) The distributions that a registered
203.4(d). The sentence now reads:
retail pharmacy makes to automated
§ 1304.04 Maintenance of records and ‘‘Other USAID officials may request
dispensing systems at long term care
inventories. similar information at a later date for
facilities for which the retail pharmacy
purposes of determining the PVO’s
(a) Except as provided in paragraphs also holds registrations do not count
eligibility for a particular grant or
(a)(1) and (a)(2) of this section, every toward the 5 percent limit in paragraphs
cooperative agreement.’’
inventory and other records required to (a)(1)(iv) and (b) of this section. 3. Registration Status—Transition
be kept under this part must be kept by Dated: May 5, 2005. Provisions. PVOs currently registered
the registrant and be available, for at William J. Walker, will continue to be registered under the
least 2 years from the date of such Deputy Assistant Administrator, Office of new rule. The new annual
inventory or records, for inspection and Diversion Control. documentation requirements are in
copying by authorized employees of the [FR Doc. 05–9538 Filed 5–12–05; 8:45 am] effect as of the date of the new rule. The
Administration. previous rule and the new rule are
BILLING CODE 4410–09–P
(1) Financial and shipping records available on the USAID Web site at
(such as invoices and packing slips but http://www.usaid.gov Keyword: PVO
not executed order forms subject to Registration. New applicants will be
AGENCY FOR INTERNATIONAL
§§ 1305.17 and 1305.27 of this chapter) required to submit their applications
DEVELOPMENT
may be kept at a central location, rather and documentation under the revised
than at the registered location, if the 22 CFR Part 203 Conditions of Registration and new
registrant has notified the rules.
Administration of his intention to keep Registration of Agencies for Voluntary 4. Registration of CDOs. Two
central records. Written notification Foreign Aid; Summary of Comments comments were made with regard to the
must be submitted by registered or elimination of Registration eligibility for
certified mail, return receipt requested, AGENCY: U.S. Agency for International
Development, USAID. IRS 501(c)(4) and 501(c)(6)
in triplicate, to the Special Agent in organizations, specifically cooperative
Charge of the Administration in the area ACTION: Final rule.
development organizations (CDOs). The
in which the registrant is located. SUMMARY: USAID is revising Part 203 in Agency’s intent is not to eliminate CDOs
Unless the registrant is informed by the its entirety to clarify the purposes of from the U.S. PVO Registry at http://
Special Agent in Charge that permission Registration and to emphasize that www.usaid.gov Keyword: Registry.
to keep central records is denied, the organizations must be private and Therefore, CDOs will continue to be
registrant may maintain central records voluntary in nature in order to be listed in the Registry and will continue
commencing 14 days after receipt of his registered. to be required to meet the annual
notification by the Special Agent in documentation requirements in § 203.5.
Charge. All notifications must include DATES: Effective Date: May 13, 2005.
(see § 203.12)
the following: FOR FURTHER INFORMATION CONTACT: 5. AID Form 1550–2. A comment
(i) The nature of the records to be kept Mary Q. Newton, Registrar, Office of requested that PVOs not currently
centrally. Private Voluntary Cooperation— receiving funding from the U.S.
(ii) The exact location where the American Schools & Hospitals Abroad; Government for overseas programs not
records will be kept. telephone: 202–712–4747; telefax: 202– be required to submit the AID Form
(iii) The name, address, DEA 216–3041 or e-mail: 1550–2. The suggested change was not
registration number and type of DEA mnewton@usaid.gov. adopted since AID Form 1550–2
registration of the registrant whose SUPPLEMENTARY INFORMATION: On May 7, provides current demographic
records are being maintained centrally. 2002, the Agency published in the information on each PVO as well as

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