Source: https://www.deadiversion.usdoj.gov/fed_regs/rules/prior_1998/fr0601_1993.htm
Timestamp: 2019-03-19 09:47:12
Document Index: 15266511

Matched Legal Cases: ['art 1304', 'art 1301', 'arts 1301', '§ 1301', '§ 1301', '§ 1301', '§ 1304', '§ 1304', '§ 1301', 'arts 1301', 'ART 1301', '§ 1301', '§ 1301', '§ 1304', '§ 1304', 'ART 1304', '§ 1304', '§ 1304']

Federal Register /Vol. 58, No. 103 / Tuesday, June 1, 1993 / Rules and Regulations
[Page 31171]
[Page 31172]
SUMMARY: This final rule amends part 1304 to define the term “mid-level practitioner” (MLP) and allow DEA, as needed, to inspect and copy certain state required documents relating to a MLP's authority to dispense controlled substances; and amends part 1301 to clarify the exemption from the registration requirement of practitioners in institutions and agents or employees of registered practitioners, and the conditions under which MLPs may conduct research as a coincident activity to their registration.
Together with these amendments, DEA will establish a new category of registration, MLP, under which advanced practice nurses, physician assistants, and others will receive individual DEA registrations granting controlled substances privileges consistent with the authority granted them under state law.
EFFECTIVE DATE: July 1, 1993, except that practitioner registrations currently held by MLPs will be converted to the MLP category by no later than June 1, 1993.
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: On July 29, 1992, a notice of proposed rulemaking was published in the Federal Register (57 FR 33465). DEA proposed to amend parts 1301 and 1304 to define MLP, establish requirements with respect to research activities, the availability of records, and existing exemptions. Further, DEA would create a new category of practitioner registration under which individuals meeting the proposed definition of mid-level practitioner would be issued individual DEA registrations.
A total of 47 comments regarding the proposal were received. The majority of the commentors, 34, supported the proposal. Of the remainder, 12 commentors felt the proposal should be withdrawn and one commentor simply noted that its state law did not allow MLPs to handle controlled substances.
Commentors expressed concern regarding the overall structure of the proposed rule in the following general areas:
Use of the term “Dispense”: There were seven comments regarding the use of the term “dispense”, which is defined differently under state and Federal laws. For purposes of this rule, the Federal definition of the term must be used. Dispense is defined under section 802 of the Controlled Substances Act (CSA) (title 21, United States Code, 801 et seq.) as “ *** to deliver a controlled substance to an ultimate user or research subject by, or pursuant to the lawful order of, a practitioner, including the prescribing and administering of a controlled substance * * *” Thus, any person who administers, prescribes, or dispenses directly, i.e., effects the physical delivery of a controlled substance to the ultimate user or its agent, would be subject to the registration requirement unless exempted by law or pursuant to title 21, Code of Federal Regulations (CFR), §§ 1301.24-1301.29.
One commentor understood the definition to mean that an individual who administers, but does not prescribe, controlled substances would not be dispensing within the meaning of the definition. The acts of administering and prescribing controlled substances, either singly or in combination, are dispensing within the meaning of the definition. Any person who administers controlled substances is subject to the registration requirement unless exempted by law or regulation. The traditional act of a nurse administering in a hospital or office setting as an employee of an authorized registrant (doctor or hospital) does not require registration and is unaffected by this rule. The commentor also raised questions regarding the exemption from registration of independent contractors. DEA cannot provide a general response regarding circumstances involving the conditions of specific contracts. In cases other than those in which the contract specifies the individual will act as an agent of the registrant, the exemption from the registration requirement will depend upon the specific conditions under which the individual will handle controlled substances.
Four commentors questioned whether registered nurses who administer controlled substances or pharmacists who dispense controlled substances directly should obtain DEA registrations. These individuals administer or dispense controlled substances (other than by prescription) as employees of DEA registrants. As noted earlier regarding nurses, individuals engaging in such activities in the normal course of their activities as employees of an authorized registrant are not subject to the registration requirement.
Issuance of individual DEA registrations to MLPs: Coincident with the amendments of the regulations, DEA is establishing a separate category of practitioner registration under which mid-level practitioners will be issued individual DEA registrations. The DEA numbers issued to MLPs will differ in format from the DEA numbers issued to traditional practitioners. This will enable pharmacists and wholesalers to distinguish between the different categories of practitioners and alert them to the need to verify that the registrants are authorized to engage in such transactions. The registration numbers issued to MLPs will begin with the letter M rather than the letters A or B which appear in the registration numbers held by traditional practitioners.
MLPs will use the existing DEA Forms 224 and 224a to apply for registration. Since pursuant to 21 U.S.C. 823(f), DEA registers practitioners to handle controlled substances if the applicant is authorized to do so by the state in which he/she practices, when applying for registration or reregistration, MLPs will be required to certify on their application form the extent of the controlled substances authority they have been granted by the state, including whether they may administer, dispense directly, or prescribe controlled substances.
MLPs who currently hold practitioner registrations will be converted to an MLP registration by DEA. Conversion will consist of the assignment of a new registration number under the MLP format and issuance of a new registration certificate. Upon receipt of their new certificates, MLPs will be required to return their old registration certificates to DEA. DEA will give all affected registrants advance notice of the conversion of their numbers. The authority of MLPs to handle controlled substances will not be affected in any way by the conversion.
One commentor requested that DEA use a letter other than M in the first position of the registration number to avoid duplication of the format the state uses for its controlled substances registration numbers. M is the most appropriate character in the limited number of letters which remain available for DEA's use.
Two commentors expressed concern that the issuance of registration numbers to MLPs implies that DEA approves of the expansion of MLP's authority to prescribe controlled substances. Issuance of a registration to an individual who has been approved by the appropriate state authorities to handle controlled substances is not a discretionary matter, the requirement is established in 21 U.S.C. 823(f).
One commentor requested that DEA include a requirement in the final rule that in cases where MLPs have “dependent” authority, the name of the
[Page 31173]
supervising physician be included on the MLP prescriptions. DEA registrations are issued to persons to allow them to carry out controlled substance activities to the extent that they are authorized by the state in which they practice. All controlled substance activities carried out under an individual DEA registration are the ultimate responsibility of that registrant; cosignature would imply otherwise. However, where a state establishes requirements which go beyond those of DEA, the stricter requirement would apply.
Three commentors objected to the issuance of DEA registrations to MLPs on the grounds that MLPs do not have the education, training or experience necessary to allow them to properly dispense controlled substances. One commentor further questioned the variances in the authority granted to MLPs by the different states and the lack of assurance that there existed consistent standards regarding education, training, and experience. While DEA recognizes the commentors concerns, the authority of the states to regulate the practice of medicine, which includes setting the standards and requisite levels of education, training and experience is well established. However, in exercising its responsibility to review registrations for consistency with the public interest, DEA does take an interest in the circumstances and conditions under which state authority is granted. DEA plans to work with the appropriate state authorities and industry to encourage consistency and clarity of standards of education, training and the scope of controlled substance authority for MLPs.
Four commentors objected to the use of a separate category of registration for MLPs on the grounds that MLPs either practice medicine in the same manner as, or have been granted the same prescribing authority as traditional practitioners. This rule applies solely to controlled substance authority, not the authority to practice medicine. Further, the controlled substance authority granted to MLPs varies not only from state to state, but, often from MLP to MLP within a state at the discretion of the board or of a collaborating physician. The different format registration number serves as an indicator to pharmacists and wholesalers to be alert to the probability that the MLP's controlled substance authority may be subject to specific state restrictions.
Three commentors noted that the new number would not adequately reflect the authority granted to MLPs by the states, and recommended that the numbers be modified to differentiate between MLPs who have plenary authority and those who have derivative authority through a collaborative or supervisory relationship with a licensed physician. In light of the vast variety of levels of authority granted to MLPs, it is not possible to identify the scope solely in the registration number issued. DEA has adopted an approach by which it is possible to identify that MLPs may be subject to unique restrictions on their controlled substance authority, and allow the responsible parties in the distribution chain to contact the appropriate state officials to verify what authority the MLP has been granted.
Use of the title Mid-Level Practitioner: Seven commentors expressed concern that the title mid-level practitioner is demeaning and reflects a lesser level of health care, and that the regulations should refer to “advanced practice nurses and physician assistants.” The title MLP is not the exclusive domain of advanced practice nurses and physician assistants. It applies to any individual practitioner other than a traditional practitioner, present or future, who is, or could be, granted some level of controlled substance authority by state authorities. The suggested title cannot be accepted since it does not reflect the variety of health care professionals DEA seeks to cover.
Registration of MLPs will increase the potential for abuse and diversion of controlled substances and overburden already strained local regulatory forces: Seven commentors objected to registering MLPs on these grounds. There has been no significant evidence supporting allegations that MLPs will or will not increase the potential for the diversion of abuse of controlled substances. With respect to regulatory resources, DEA cannot subordinate the requirements of Federal law to the availability of local resources. Since registration of MLPs does not occur until after a local determination regarding prescribing authority has been made, the appropriate forum for such issues is at the point the state considers expanding prescribing authority.
Separate registration for independent activities: Section 1301.22(b)(6) allows a person registered to dispense controlled substances to conduct research and instructional activities with those substances. The amended paragraph will clarify that MLPs may conduct research coincident to their practitioner registration only if expressly authorized by state statute.
Four commentors objected to the amendment of this section on the grounds that MLPs should be allowed the same authority as traditional practitioners. Current state practices in granting MLPs authority are such that it is not clear that the authority to conduct research as a coincident activity is intended. It is imperative that a state's intent that MLPs be allowed to conduct research with controlled substances be explicit. The commentor provided no documentation, nor has DEA identified any state which has determined such activities are within the approved scope of practice of any MLPs currently certified to dispense controlled substances.
Exemption of agents and employees; affiliated practitioners: Section 1301.24 provides for the exemption of agents or employees of DEA registrants from the registration requirement when they dispense controlled substances in the normal course of their employment or business.
One commentor objected to the use of the term affiliated practitioners in the title to § 1301.24 in light of the withdrawal of DEA's original proposal to define affiliated practitioners and exempt them from the registration requirement. Affiliated practitioner, which has been part of the title since the early 1970's, refers to any individual practitioner, rather than solely to a mid-level practitioner, who is affiliated with a DEA registrant.
Paragraph 1301.24(b) is being amended to provide that an individual practitioner, whether traditional or mid-level, may not act as an agent or employee of a mid-level practitioner for purposes of dispensing controlled substances.
Because of its specificity, paragraph (c) has been amended to include MLPs in the group of individual practitioners who may dispense controlled substances under the registration number of their employing hospital or other institution.
One commentor recommended that DEA not allow mid-level practitioners to register if they would qualify for exemption under § 1301.24(b). The section was provided to allow individual practitioners the option of exemption from the registration requirement; it is not grounds for excluding persons from registration.
Definition of Mid-Level Practitioner: The amendment to § 1304.02 to define mid-level practitioner generated a number of comments regarding the listing of the traditional practitioner activities (physician, dentist, etc.) and the examples of mid-level practitioner activities (nurse practitioners, physician assistants. etc.). With regard to the traditional practitioners, it was often noted that it is redundant to list osteopaths and ophthalmologists
[Page 31174]
separately from physicians since they are physicians. DEA concurs and the list will be revised to read “* * * a physician, dentist, veterinarian, or podiatrist.” With respect to the examples of MLP activities, the question was raised whether the wording could inadvertently lead persons to believe that the examples listed were exclusive and it was recommended that clinical nurse specialists be included in the examples. This portion of the definition will be amended to begin “Examples of mid-level practitioners include, but are not limited to * * *” and clinical nurse specialists will be included.
An objection was received from a commentor regarding DEA's failure to include optometrists in the traditional practitioner group. DEA's decision to not include optometrists in the traditional practitioner group is based on the fact that optometrists are not granted controlled substances prescribing authority in the majority of states and that the authority they are granted varies from state to state. In at least one state optometrists are subject to regulatory requirements regarding collaborative or supervisory arrangements with licensed physicians as part of their practice. Under the circumstances, optometrists are accurately classified as MLPs.
One commentor expressed concern that by defining them separately, DEA would not hold MLPs responsible for compliance with regulations governing the controlled substances activities of traditional practitioners. An MLP is defined as “ ** * an individual practitioner ** * other than ** *, therefore, any law or regulation which applies to a practitioner or individual practitioner would apply equally to an MLP, unless specifically excepted.
One commentor noted that the inclusion of the United States in the definition as a party which would license, register or permit an MLP to dispense a controlled substance might lead people to believe that legal authority to dispense could be achieved solely through registration by DEA. The definition of MLP is consistent with the definition of individual practitioner. DEA has long held that individuals practicing in a Federal jurisdiction must be licensed by a state before they may obtain a DEA registration. (See 21 U.S.C. 802(21) and 823(f) and 21 CFR 1304.02(d))
One commentor requested that the definition be modified to require that an MLP must be specifically authorized to dispense controlled substances by state statute in order to obtain a DEA registration. Again, the definition was written to remain consistent with the wording of the definition of individual practitioner. It has been DEA's experience that the definition will clearly limit the issuance of registrations to those individuals who have been properly authorized by the appropriate state authorities to dispense controlled substances.
Regarding the question of consistency of the definitions, it was found that the proposed definition of MLP used the word “in” (rather than the word “by” which is used in the definition of individual practitioner in 21 CFR 1304.02(d)) in the phrase “* * * who is licensed, registered, or otherwise permitted in the United States * * *” To remain fully consistent with the definition of individual practitioner, the definition of mid-level practitioner has been changed to use the word “by” in the referenced phrase.
Persons required to keep records and file reports: The proposal amended § 1304.03 by the addition of a new paragraph requiring that registered MLPs maintain protocols, practice guidelines, agreements and other documents required by the state in a readily retrievable manner and make them available to authorized employees of DEA for inspection and copying. The regulation encompasses those documents that state law requires an MLP to maintain. If state law does not require that an MLP maintain documents relating to their authority to dispense controlled substances then this requirement would not apply.
Three commentors understood this requirement to be the avenue by which DEA would confirm an MLP's state authority to dispense controlled substances prior to issuing a DEA registration. Issuance of a DEA registration is based on the verification by the appropriate state authority that the applicant is authorized to dispense controlled substances. The purpose of this requirement is to allow DEA timely access to state required documents outlining an MLPs specific authority to dispense controlled substances, if needed, during an inspection or investigation.
Further, four commentors found that itemizing the various documents (protocols, practice guidelines, agreements and other documents) was wordy, redundant, and could lead the reader to believe that all MLPs must maintain the specific format documents listed. DEA will reword the paragraph to require that “Each registered mid-level practitioner shall maintain in a readily retrievable manner those documents required by the state in which he/she practices describing the conditions and extent of his/her authorization to dispense controlled substances and shall make such documents available for inspection and copying by authorized employees of the Administration. Examples of such documentation include protocols, practice guidelines or practice agreements.”
The Deputy Assistant Administrator, Office of Diversion Control, hereby certifies that this final rule will have no significant economic impact upon entities whose interests must be considered under the Regulatory Flexibility Act, 5 U.S.C. 601 et seq. Certain states have granted a new category of practitioners, MLPS, the authority to dispense controlled substances, thus making those MLPs subject to the registration requirement in § 1301.21. This final rule establishes the administrative process by which DEA may issue MLP registrations. This final rule is not a major rule for the purposes of Executive Order (E.O.) 12291 of February 17, 1981.
Pursuant to Sections 3(c)(3) and 3(e)(2)(c) of E.O. 12291, this final rule has been submitted to the Office of Management and Budget for review, and approval of that office has been requested pursuant to the provisions of the Paperwork Reduction Act of 1980, 44 U.S.C. et seq.
Modifications in many state practice acts related to controlled substance dispensing have created the need for MLPs to be registered with DEA under existing regulations. This final rule establishes the administrative process by which DEA will issue the MLP registration. Accordingly, it is not subject to the moratorium on regulations ordered by the President of the United States.
This action has been analyzed in accordance with the principles and criteria in E.O. 12612, and it has been determined that the final rule does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment.
For reasons set out above, 21 CFR parts 1301 and 1304 are amended as follows:
PART 1301-[AMENDED]
[Page 31175]
Authority 21 U.S.C. 821, 822, 823, 824, 871(b), 875, 877.
2. Section 1301.22 is amended by revising paragraph (b)(6) as follows: § 1301.22 Separate registration for independent activities.
3. Section 1301.24 is amended by revising paragraphs (b) and (c) introductory text to read as follows:
§ 1301.24. Exemption of agents and employees; affiliated practitioners.
(b) An individual practitioner, as defined in § 1304.02 of this chapter (other than an intern, resident, foreign- trained physician, or physician on the staff of a Veterans Administration facility or physician who is an agent or employee of the Health Bureau of the Canal Zone Government), who is an agent or employee of another practitioner (other than a mid-level practitioner) registered to dispense controlled substances may, when acting in the usual course of his/her employment, administer and 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/she practices, under the registration of the employer or principal practitioner in lieu of being registered him/herself. (For example, a staff physician employed by a hospital need not be registered individually to administer and dispense, other than by prescribing, controlled substances within the hospital.)
(c) An individual practitioner, as defined in § 1304.02 of this chapter, who is an intern, resident, mid-level practitioner, foreign-trained physician or physician on the staff of a Veterans Administration facility or physician who is an agent or employee of the Health Bureau of the Canal Zone Government, may dispense, administer and prescribe controlled substances under the registration of the hospital or other institution which is registered and by whom he/she is employed in lieu of being registered him/herself, provided that:
PART 1304-[AMENDED]
2. Section 1304.02 is amended by redesignating the current paragraphs (f) through (i) as paragraphs (g) through (j)and adding a new paragraph (f) to read as follows:
§ 1304.02. Definitions.
(f) The term mid-level practitioner means an individual practitioner (as defined in § 1304.02(d)), other than a physician, dentist, veterinarian, or podiatrist, who is licensed, registered, or otherwise permitted by the United States or the jurisdiction in which he/she practices, to dispense a controlled substance in the course of professional practice. Examples of mid-level practitioners include, but are not limited to, health care providers such as nurse practitioners, nurse midwives, nurse anesthetists, clinical nurse specialists and physician assistants who are authorized to dispense controlled substances by the state in which they practice.
3. Section 1304.03 is amended by redesignating the current paragraphs (e) through (g) as paragraphs (f) through (h), adding a new paragraph (e), and revising new paragraph (h) as follows:
(e) Each registered mid-level practitioner shall maintain in a readily retrievable manner those documents required by the state in which he/she practices which describe the conditions and extent of his/her authorization to dispense controlled substances and shall make such documents available for inspection and copying by authorized employees of the Administration. Examples of such documentation include protocols, practice guidelines or practice agreements.
Dated: December 31, 1992.
Deputy Assistant Administrator, Office of Diversion Control
(FR Doc. 93-12727 Filed 5-28-93; 8:45 am)