Date="06/15/94" Citation="59 FR 30738" Group="legal" Type="PROPOSED RULE" Department="DEPARTMENT OF JUSTICE" Agency="DRUG ENFORCEMENT ADMINISTRATION (DEA), JUSTICE" Subject="Exemption of Agents and Employees; Affiliated Practitioners"

DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1301 Exemption of Agents and Employees; Affiliated Practitioners AGENCY: Drug Enforcement Administration (DEA), Justice. ACTION: Proposed rule.

DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1301 Exemption of Agents and Employees; Affiliated Practitioners AGENCY: Drug Enforcement Administration (DEA), Justice. ACTION: Proposed rule. + ------------------------------------------------------------ SUMMARY: DEA proposes to amend the language under title 21, Code of Federal Regulations (21 CFR) regarding the exemption of agents and employees from the requirement for individual registration when administering, dispensing, or prescribing controlled substances in the course of their official duties or business. The amendments will make the exemption granted to agents and employees of a registrant more consistent with the recent regulatory changes involving Mid-Level Practitioners (MLP) and the fee exemption for practitioners employed by Federal, state and local government hospitals or other institutions. DATES: Written comments or objections must be received on or before August 15, 1994. ADDRESSES: Comments and objections should be submitted in quintuplicate to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537, Attention: DEA Federal Register Representative/CCR. FOR FURTHER INFORMATION CONTACT: G. Thomas Gitchel, Chief, Liaison and Policy Section, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537, Telephone (202) 307-7297. SUPPLEMENTARY INFORMATION: DEA is proposing to amend the language under 21 CFR, sec 1301.24 regarding the circumstances under which agents or employees of a DEA registrant may administer, dispense, or prescribe controlled substances in the course of their official duties or business without being required to obtain an individual registration. Specifically, sec 1301.24(b) is proposed to be amended to allow that an individual practitioner who acts as an agent or employee of another individual practitioner, other than a mid-level practitioner (MLP), may administer and dispense (other than by prescription) controlled substances in the normal course of his/her official duties or business under the registration of the employer or principal practitioner. Section 1301.24(c) is proposed to be amended to allow an individual practitioner who is an agent or employee of a hospital or other institution to administer, dispense, or prescribe controlled substances under the registration of the hospital or other institution in lieu of becoming individually registered. The provisions outlined under sec 1301.24(c)(1) through (c)(6) set forth the procedures under which an individual practitioner could prescribe utilizing the hospital or other institution's registration number. These changes are being proposed to make the circumstances under which agents or employees of a DEA registrant may administer, dispense, or prescribe controlled substances more consistent with recent developments with respect to MLPs and Federal, state or local government practitioners. During and immediately following the development of regulatory revisions concerning MLPs and persons exempt from the registration or reregistration application fees, DEA received a number of comments and questions from both individual practitioners and associations regarding the exemption of agents and employees of other DEA registrants. The comments and questions made it apparent that the current language in sec 1301.24 is not entirely consistent with the intent of the new developments. The proposed revisions to sec 1301.24 will allow that, (1) an individual practitioner who acts as an agent or employee of another individual registered practitioner (other than an MLP) may administer or dispense controlled substances, to the extent authorized under the laws of the jurisdiction in which he or she practices, under the registration of the principal practitioner, in lieu of being registered him/himself; and (2) an individual practitioner who is an agent or employee of a hospital or other institution which is registered with DEA may administer, dispense, or prescribe controlled substances under the registration of the hospital or other institution in lieu of being registered individually, provided that the requirements regarding prescribing as set forth in sec 1301.24(c)(1) through (c)(6) are complied with. The Deputy Assistant Administrator, Office of Diversion Control, hereby certifies that this proposed rulemaking will have no significant impact upon entities whose interests must be considered under the Regulatory Flexibility Act, 5 U.S.C. 601 et seq. This proposed rule expands an existing regulatory provision to accommodate recent changes regarding MLPs and government practitioners. This proposed rule is not a significant regulatory action and therefore has not been reviewed by the Office of Management and Budget pursuant to Executive Order 12866. This action has been analyzed in accordance with the principles and criteria in Executive Order 12612, and it has been determined that the proposed rule does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment. List of Subjects in 21 CFR Part 1301 Administrative practice and procedure, Drug Enforcement Administration, Drug Traffic Control, Security measures. For reasons set out above, it is proposed that 21 CFR part 1301 be amended as follows: PART 1301-[AMENDED] 1. The authority citation for part 1301 continues to read as follows: Authority: 21 U.S.C. 821, 822, 823, 824, 871(b), 875, 877. 2. Section 1301.24 is proposed to be amended by revising paragraphs (b), (c) introductory text and (c)(5) to read as follows: sec 1301.24 Exemption of agents and employees; affiliated practitioners. * * * * * (b) An individual practitioner, as defined in sec 1304.02 of this chapter, who is an agent or employee of another individual practitioner (other than a mid-level practitioner) registered to dispense controlled substances may, when acting in the normal course of business or employment, administer or dispense (other than by issuance of prescription) controlled substances if and to the extent that such individual practitioner is authorized or permitted to do so by the jurisdiction in which he or she practices, under the registration of the employer or principal practitioner in lieu of being registered him/herself. (c) An individual practitioner, as defined in Section 1304.02 of this chapter, 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: * * * * * (5) The hospital or other institution authorizes the individual practitioner to dispense or prescribe under the hospital registration and designates a specific internal code number for each individual practioner 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., AP0123456-10 or AP0123456-A12; and * * * * * Dated: June 6, 1994. Gene R. Haislip, Deputy Assistant Administrator, Office of Diversion Control. [FR Doc. 94-14470 Filed 6-14-94; 8:45 am] BILLING CODE 4410-09-M ------------------------------------------------------ The Contents entry for this article reads as follows: Manufacturers, distributors, and dispensers of controlled substances; registration: Agents and employees, exemptions; affiliated practitioners, 30738