[Federal Register Volume 74, Number 173 (Wednesday, September 9, 2009)]
[Proposed Rules]
[Pages 46396-46399]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-21698]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1301

[Docket no. DEA-321a]
RIN 1117-AB22


Identification of Institution-based Individual Practitioners

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Advance notice of proposed rulemaking.

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SUMMARY: The Drug Enforcement Administration (DEA) is soliciting public 
comments on how best to standardize the specific internal code number 
associated with each individual practitioner permitted by the hospital 
or other institutional practitioner to administer, dispense, or 
prescribe controlled substances using that institution's DEA 
registration. DEA is taking this action in response to comments it 
received to its Notice of Proposed Rulemaking regarding electronic 
prescriptions for controlled substances.

DATES: Written comments must be postmarked and electronic comments must 
be submitted on or before November 9, 2009. Commenters should be aware 
that the electronic Federal Docket Management System will not accept 
comments after Midnight Eastern Time on the last day of the comment 
period.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-321'' on all written and

[[Page 46397]]

electronic correspondence. Written comments being sent via regular or 
express mail should be sent to the Drug Enforcement Administration, 
Attention: DEA Federal Register Representative/ODL, 8701 Morrissette 
Drive, Springfield, VA 22152. Comments may be sent to DEA by sending an 
electronic message to <a href="/cdn-cgi/l/email-protection#b2d6d7d39cd6dbc4d7c0c1dbdddc9cc2dddedbd1cbf2c7c1d6ddd89cd5ddc4"><span class="__cf_email__" data-cfemail="debabbbff0bab7a8bbacadb7b1b0f0aeb1b2b7bda79eabadbab1b4f0b9b1a8">[email protected]</span></a>. Comments may also 
be sent electronically through http://www.regulations.gov using the 
electronic comment form provided on that site. An electronic copy of 
this document is also available at the http://www.regulations.gov Web 
site. DEA will accept attachments to electronic comments in Microsoft 
Word, WordPerfect, Adobe PDF, or Excel file formats only. DEA will not 
accept any file formats other than those specifically listed here.
    Please note that DEA is requesting that electronic comments be 
submitted before midnight Eastern time on the day the comment period 
closes because http://www.regulations.gov terminates the public's 
ability to submit comments at midnight Eastern time on the day the 
comment period closes. Commenters in time zones other than Eastern Time 
may want to consider this so that their electronic comments are 
received. All comments sent via regular or express mail will be 
considered timely if postmarked on the day the comment period closes.

FOR FURTHER INFORMATION CONTACT: Mark W. Caverly, Chief, Liaison and 
Policy Section, Office of Diversion Control, Drug Enforcement 
Administration, 8701 Morrissette Drive, Springfield, VA 22152; 
telephone: (202) 307-7297.

SUPPLEMENTARY INFORMATION: 
    Posting of Public Comments: Please note that all comments received 
are considered part of the public record and made available for public 
inspection online at http://www.regulations.gov and in the Drug 
Enforcement Administration's public docket. Such information includes 
personal identifying information (such as your name, address, etc.) 
voluntarily submitted by the commenter.
    If you want to submit personal identifying information (such as 
your name, address, etc.) as part of your comment, but do not want it 
to be posted online or made available in the public docket, you must 
include the phrase ``PERSONAL IDENTIFYING INFORMATION'' in the first 
paragraph of your comment. You must also place all the personal 
identifying information you do not want posted online or made available 
in the public docket in the first paragraph of your comment and 
identify what information you want redacted.
    If you want to submit confidential business information as part of 
your comment, but do not want it to be posted online or made available 
in the public docket, you must include the phrase ``CONFIDENTIAL 
BUSINESS INFORMATION'' in the first paragraph of your comment. You must 
also prominently identify confidential business information to be 
redacted within the comment. If a comment has so much confidential 
business information that it cannot be effectively redacted, all or 
part of that comment may not be posted online or made available in the 
public docket.
    Personal identifying information and confidential business 
information identified and located as set forth above will be redacted 
and the comment, in redacted form, will be posted online and placed in 
the Drug Enforcement Administration's public docket file. Please note 
that the Freedom of Information Act applies to all comments received. 
If you wish to inspect the agency's public docket file in person by 
appointment, please see the ``For Further Information'' paragraph.

DEA's Legal Authority

    DEA implements and enforces the Comprehensive Drug Abuse Prevention 
and Control Act of 1970, often referred to as the Controlled Substances 
Act (CSA) and the Controlled Substances Import and Export Act (21 
U.S.C. 801-971), (CSA), as amended. DEA publishes the implementing 
regulations for these statutes in Title 21 of the Code of Federal 
Regulations (CFR), Parts 1300 to end. These regulations are designed to 
ensure that there is a sufficient supply of controlled substances for 
medical, scientific, and other legitimate purposes and to deter the 
diversion of controlled substances to illegal purposes.
    Controlled substances are drugs that have a potential for abuse and 
psychological and physical dependence; these include substances 
classified as opioids, stimulants, depressants, hallucinogens, anabolic 
steroids, and drugs that are immediate precursors of these classes of 
substances. DEA lists controlled substances in 21 CFR part 1308. The 
substances are divided into five schedules: Schedule I substances have 
a high potential for abuse and have no accepted medical use in 
treatment in the United States. These substances may only be used for 
research, chemical analysis, or manufacture of other drugs. Schedule 
II--V substances have an accepted medical use and also have a potential 
for abuse and psychological and physical dependence.
    The CSA mandates that DEA establish a closed system of control for 
manufacturing, distribution, and dispensing of controlled substances. 
Any person who manufactures, distributes, dispenses, imports, exports, 
or conducts research or chemical analysis with controlled substances 
must register with DEA (unless exempt), keep track of all stocks of 
controlled substances, and maintain records to account for all 
controlled substances received, distributed, dispensed, or otherwise 
disposed of.

Background

    The CSA requires that every person who dispenses controlled 
substances shall obtain from the Attorney General a registration (21 
U.S.C. 822(a)(2)). Authority to issue such registrations has been 
delegated by the Attorney General to the Administrator of the Drug 
Enforcement Administration (28 CFR 0.100).
    An individual practitioner who is an agent or employee of a 
hospital or other institution registered with DEA may use the DEA 
registration of that hospital or other institution to administer, 
dispense, or prescribe controlled substances in accordance with the 
regulations (21 CFR 1301.22(c)). Specifically:

    An individual practitioner who is an agent or employee of a 
hospital or other institution may, when acting in the normal course 
of business or employment, administer, dispense, or prescribe 
controlled substances under the registration of the hospital or 
other institution which is registered in lieu of being registered 
him/herself, provided that:
    (1) Such dispensing, administering or prescribing is done in the 
usual course of his/her professional practice;
    (2) Such individual practitioner is authorized or permitted to 
do so by the jurisdiction in which he/she is practicing;
    (3) The hospital or other institution by whom he/she is employed 
has verified that the individual practitioner is so permitted to 
dispense, administer, or prescribe drugs within the jurisdiction;
    (4) Such individual practitioner is acting only within the scope 
of his/her employment in the hospital or institution;
    (5) The hospital or other institution authorizes the individual 
practitioner to administer, dispense or prescribe under the hospital 
registration and designates a specific internal code number for each 
individual practitioner so authorized. The code number shall consist 
of numbers, letters, or a combination thereof and shall be a suffix 
to the institution's DEA registration number, preceded by a hyphen 
(e.g., APO123456-10 or APO123456-A12); and
    (6) A current list of internal codes and the corresponding 
individual practitioners is kept by the hospital or other 
institution and

[[Page 46398]]

is made available at all times to other registrants and law 
enforcement agencies upon request for the purpose of verifying the 
authority of the prescribing individual practitioner. (21 CFR 
1301.22(c))

Notice of Proposed Rulemaking Regarding Electronic Prescriptions for 
Controlled Substances

    On June 27, 2008, DEA published a Notice of Proposed Rulemaking 
``Electronic Prescriptions for Controlled Substances'' [Docket No. DEA-
218, RIN 1117-AA61] (73 FR 36722). In that rule, DEA proposed that 
pharmacy applications receiving electronic prescriptions for controlled 
substances be capable of reading and retaining the full DEA 
registration number, including any extensions, or other identification 
numbers used under 21 CFR 1306.05(c). DEA further proposed that the 
full number including extensions must be retained in the prescription 
record. DEA further proposed that the pharmacy application must verify 
that the practitioner's DEA registration was valid at the time the 
prescription was signed. DEA indicated the pharmacy application may do 
this by checking the DEA CSA database or by having another entity check 
the DEA CSA database during transmission and indicate on the record 
that the check has occurred and the registration is valid. Finally, DEA 
proposed that the pharmacy application must reject prescriptions that 
were signed by practitioners without valid DEA registrations.
    Comments received. DEA received numerous comments to its Notice of 
Proposed Rulemaking regarding this issue. Approximately twenty 
commenters representing State licensing boards, pharmacy and pharmacist 
organizations, chain drug stores, and electronic prescription and 
electronic pharmacy application vendors commented regarding this issue. 
One commenter, an organization representing health system pharmacists, 
believed that whatever system is used for extensions, the system must 
allow pharmacies to validate the original DEA number and determine 
whether the DEA number belongs to a facility for which extensions are 
permissible. A standards development organization for electronic 
prescription applications asked DEA to propose an industry solution to 
extensions, such as a standard length. It noted that the same problem 
exists for paper prescriptions.
    A commenter representing grocery stores with pharmacies stated that 
DEA is placing the pharmacy in an untenable situation. The pharmacy 
would be expected to check and store a number on DEA's behalf for which 
there is no standard and over which DEA exerts no jurisdiction, as DEA 
does not specify criteria regarding the format or content of the suffix 
data for each individual practitioner using the institutional 
practitioner's registration. The commenter noted that the health-system 
or hospital choosing to employ a suffix system is tasked with the 
implementation and tracking of that process. The commenter recommended 
that DEA require the validity of the health-system DEA number be 
verified and that a health-system's use of a suffix system be guided by 
DEA directly at that user's facility.
    Various State and national pharmacy organizations, an association 
representing chain drug stores, several State boards of pharmacy, 
several chain drug stores, and several pharmacy system providers all 
stated that DEA should standardize extensions and make it clear that 
pharmacies are not responsible for checking the validity of the 
extensions.
    In response to the comments received, DEA is considering how best 
to standardize the internal code numbers assigned by institutional 
practitioners to the individual practitioners they permit to use their 
registration to administer, dispense, and prescribe controlled 
substances. DEA believes such standardization would benefit the overall 
dispensing of controlled substances by bringing a level of uniformity 
to such extensions. As commenters noted, this standardization is 
essential for DEA to require pharmacy systems to retain this 
information.
    DEA recognizes, however, that there are many institutional 
practitioners employing internal code number systems. There has never 
been standardization regarding this number, and DEA believes it 
extremely likely that institutional practitioner registrants have 
established a variety of internal code number systems. Therefore, to 
address this issue, DEA is soliciting information from the regulated 
industry and other interested members of the public regarding current 
methods being used and how best to implement industry standardization 
in this area. Specifically, DEA seeks the following information:
    <bullet> Information regarding formats used by institutional 
practitioners when establishing internal code numbers for individual 
practitioners permitted to use the institution's registration number;
    <bullet> Estimates of the number of individual practitioners using 
internal code numbers for identification purposes;
    <bullet> Estimates of the number of individual practitioners using 
internal code numbers for identification purposes in a particular 
institutional practitioner;
    <bullet> Estimates of costs to institutional practitioners if code 
numbers for individual practitioners were to be standardized and what 
changes would be associated with those costs;
    <bullet> Formats pharmacy applications could accommodate or would 
prefer, recognizing that pharmacy applications may need to be 
reprogrammed to accept this information;
    <bullet> Estimates of the costs to pharmacies and/or pharmacy 
application providers for such reprogramming;
    <bullet> Comments regarding whether pharmacies have had difficulty 
obtaining information from institutional practitioners regarding 
individual practitioners' internal code numbers and, if so, any 
proposed solutions.
    Commenters wishing to address the above topics or provide other 
information should see the ``Dates,'' ``Addresses,'' and ``Posting of 
public comments'' sections above for information regarding public 
comment procedures.

Regulatory Certifications

    This action is an Advance Notice of Proposed Rulemaking (ANPRM). 
Accordingly, the requirement of Executive Order 12866 to assess the 
costs and benefits of this action does not apply. Rather, among the 
purposes DEA has in publishing this ANPRM is to seek information from 
the public regarding the standardization of internal code numbers used 
by institutional practitioners to identify individual practitioners who 
use the institution's DEA registration to administer, dispense, or 
prescribe controlled substances. Similarly, the requirements of section 
603 of the Regulatory Flexibility Act do not apply to this action 
since, at this stage, it is an ANPRM and not a ``rule'' as defined in 
section 601 of the Regulatory Flexibility Act. Following review of the 
comments received to this ANPRM, if DEA promulgates a Notice or Notices 
of Proposed Rulemaking regarding this issue, DEA will conduct all 
analyses required by the Regulatory Flexibility Act, Executive Order 
12866, and any other statutes or Executive Orders relevant to those 
rules and in effect at the time of promulgation.


[[Page 46399]]


    Dated: August 28, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. E9-21698 Filed 9-8-09; 8:45 am]
BILLING CODE 4410-09-P


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