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###### Department of Justice

###### Drug Enforcement Administration

          - 21 CFR Part 1301
          - [Docket no. DEA-321a]
          - RIN 1117-AB22

# AGENCY:

Drug Enforcement Administration (DEA), Justice.

# ACTION:

Advance notice of proposed rulemaking.

# 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                               ( print 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                         *dea.diversion.policy@usdoj.gov*. 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                               ( print 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:
    - Information regarding formats used by institutional practitioners when establishing internal code numbers for individual practitioners permitted to use the institution's registration number;
    - Estimates of the number of individual practitioners using internal code numbers for identification purposes;
    - Estimates of the number of individual practitioners using internal code numbers for identification purposes in a particular institutional practitioner;
    - 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;
    - Formats pharmacy applications could accommodate or would prefer, recognizing that pharmacy applications may need to be reprogrammed to accept this information;
    - Estimates of the costs to pharmacies and/or pharmacy application providers for such reprogramming;
    - 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.

      ( print 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