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Rules - Prior to 1998

Federal Register /Vol. 56, No. 148 / Thursday, August 1, 1991 / Rules and Regulations

56 FR 36727-01, 1991 WL 142350 (F.R.)

[Page 36727]


Drug Enforcement Administration

21 CFR Part 1301

Registration of Manufacturers, Distributors, and Dispensers of Controlled Substances

AGENCY: Drug Enforcement Administration (DEA); Justice.

ACTION: Final rule.

SUMMARY: This final rule modifies the existing language found in 21 CFR 1301.76(a) regarding the employment by any registrant of any person who has had an application for registration denied, or has had a registration revoked, at any time. This final rule extends that prohibition to any person who has been convicted of a felony relating to controlled substances or who has surrendered a registration as a consequence of a controlled substance investigation.

EFFECTIVE DATE: August 1, 1991.

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: A notice of proposed rulemaking was published in the Federal Register on February 4, 1991 (56 FR 4182) to modify 21 CFR 1301.76(a) by adding additional grounds which would prohibit a registrant from hiring an individual for a position which would require access to controlled substances. The additional conditions which would preclude employment cited were the conviction of a felony relating to controlled substances, or the surrender of a registration as a consequence of controlled substance investigation. The proposed rulemaking provided an opportunity for interested parties to comment in writing on or before April 5, 1991.

A total of seven comments were received regarding this proposal. One strongly supported the proposed rule, and encouraged that it be expanded to include the exclusion of anyone convicted of a drug related misdemeanor from a position which would require access to controlled substances. The basis for this recommendation is that a person convicted of a drug related misdemeanor has demonstrated that he or she should not be entrusted with access to controlled substances. The commenter's point is well taken. Application of this regulation should not hinge on a quirk of law under which a particular crime may be a felony in one state and a misdemeanor in another. However, since the Notice of Proposed Rulemaking mentioned only felonies, expanding its scope would cause undue delay of this final rule. Therefore, DEA is reviewing this comment for consideration as a future proposal.

It should be noted that the existing regulation, as well as the proposed amendment, is intended to prevent a DEA registrant from hiring, as an agent or employee, an individual who would probably be denied a DEA registration if he or she applied for his or her own registration as a practitioner or applied on behalf of a pharmacy owned or principally operated by the individual. To hire such a person, the registrant must obtain a waiver under circumstances which clearly show that the registrant has been fully informed about the proposed employee's past experience with controlled substances and that the registrant intends to take adequate measures to ensure that no increased risk of diversion is occasioned by the proposed employment.

The decision not to include persons convicted of misdemeanors should not create a loophole through which many individuals will attempt to evade coverage by the regulation. 21 U.S.C. 823(f) and 824(a)(4) authorize the DEA to revoke or deny a registration upon a finding that such registration would be inconsistent with the public interest. One factor in ascertaining whether a registration is in the public interest is the registrant's or applicant's past conviction record under Federal or State laws regarding the manufacture, distribution or dispensing of controlled substances. The statutory sections cited above do not differentiate between felonies and misdemeanors. Furthermore, the statute permits DEA to revoke or deny a registration based upon the underlying conduct which led to the criminal charges, without respect to conviction. Hence, any registrant who has been convicted of a drug related crime, or whose conduct has led to consideration of criminal charges, is likely to have had a registration revoked, an application denied or surrendered a registration for cause.

The remaining six comments, which were received from a number of associations and licensing boards representing both the nursing and pharmacy professions, concerned the effect that the proposed rule would have on pharmacists or nurses who were successfully participating in a state sanctioned recovery program from chemical dependency. Most concluded that if such an individual either surrendered a state license to practice while suffering from chemical dependency or had such a license suspended for the same cause, that they would be precluded by this proposed rule from future employment within their profession. On this basis, they opposed the proposal, and recommended that it be amended to contain an exemption for individuals participating in monitored recovery programs. These objections appear to be based on a misinterpretation of the proposal. It would appear from the comments that the term "registration" was interpreted to mean any form of registration or licensure which may be required for an individual nurse or pharmacist to practice in a state or other jurisdiction. In fact, the proposed regulation refers only to individuals who have had a DEA registration denied, revoked, or have surrendered a DEA registration for cause. Since the majority of nurses and pharmacists are not DEA registrants, but rather agents of the DEA registered hospitals, pharmacies, physicians, or other entities by whom or by which they are employed, this argument is moot. In addition, the regulation would have no effect on an individual who voluntarily ceased practice due to retirement, etc. or who temporarily surrendered a state license which participating in a recovery program, since the DEA registration, if any, would not routinely be affected by such an action alone. The wording of the final rule will be modified to clarify this point.

General Comments

This amendment will not require any additional paperwork or recordkeeping burden beyond normal business practices and is intended to clarify the present requirements and to extend the prohibition against hiring individuals who had previously had a DEA registration revoked, or had an application for registration denied to individuals who have been convicted of a drug related felony, or who have surrendered a DEA registration for cause.

The Deputy Assistant Administrator, Office of Diversion Control, hereby certifies that the final rule will not have significant impact upon entities whose interest must be considered under the Regulatory Flexibility Act, 5 U.S.C. 601, et seq. The changes will not impose any additional regulatory requirements. They will clarify and extend the conditions which preclude a registrant from hiring certain individuals for positions which require access to controlled substances. The final rule is not a major rule for the purposes of Executive Order (E.O.) 12291 of February 17, 1981. Pursuant to section 3(c)(3) and 3(e)(2)(C) of E.O. 12292, this final rule has been submitted for review to the Office of Management and Budget.

This action has been analyzed in accordance with the principles and criteria contained in E.O. 12612, and it has been determined that the final rule does not have sufficient federalism implications to warrant the preparation of Federalism Assessment.

List of Subjects in 21 CFR Part 1301

Drug Enforcement Administration, Drug traffic control, Registration of manufacturers, distributors, and dispensers of controlled substances.

For reasons set out above, 21 CFR part 1301 is amended as follows:


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 1301.76 is amended by revising paragraph (a) to read as follows:

§ 1301.76 Other security controls for practitioners.

(a) The registrant shall not employ, as an agent or employee who has access to controlled substances, any person who has been convicted of a felony offense relating to controlled substances or who, at any time, had an application for registration with the DEA denied, had a DEA registration revoked or has surrendered a DEA registration for cause. For purposes of this subsection, the term "for cause" means a surrender in lieu of, or as a consequence of, any federal or state administrative, civil or criminal action resulting from an investigation of the individual's handling of controlled substances.

* * * * *

Dated: June 20, 1991.

Gene R. Haislip,
Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration.

[FR Doc. 91-18168 Filed 7-31-91; 8:45 am]


NOTICE: This is an unofficial version. An official version of this publication may be obtained directly from the Government Publishing Office (GPO).

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