The proposed rule amendments are intended to clarify the rule with regard to prescribing of controlled substances by physician assistants.  

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    DEPARTMENT OF HEALTH

    Board of Medicine

    RULE NO.:RULE TITLE:

    64B8-30.008Formulary

    PURPOSE AND EFFECT: The proposed rule amendments are intended to clarify the rule with regard to prescribing of controlled substances by physician assistants.

    SUMMARY: The proposed rule amendments delete the prohibition on prescribing of controlled substances by physician assistants. Pursuant to recent statutory changes, the rule amendments prohibit the prescribing of psychiatric mental health controlled substances to children under 18 years of age; and limit the prescribing of Schedule II controlled substances to a 7 day supply.

    SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION: The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.

    The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: During discussion of the economic impact of this rule at its Board meeting, the Board concluded that this rule change will not have any impact on licensees and their businesses or the businesses that employ them. The rule amendments remove the current restriction on the prescribing of controlled substances by physician assistants, thus providing less regulation. The rule will not increase any fees, business costs, personnel costs, will not decrease profit opportunities, and will not require any specialized knowledge to comply. This change will not increase any direct or indirect regulatory costs. Hence, the Board determined that a Statement of Estimated Regulatory Costs (SERC) was not necessary and that the rule will not require ratification by the Legislature. No person or interested party submitted additional information regarding the economic impact at that time.

    Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

    RULEMAKING AUTHORITY: 458.309, 458.347(4)(f)1. FS.

    LAW IMPLEMENTED: 458.347(4)(e), (f), 458.3295, 456.044 FS.

    IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

    THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Claudia Kemp, J.D., Executive Director, Board of Medicine/MQA, 4052 Bald Cypress Way, Bin # C03, Tallahassee, Florida 32399-3253

     

    THE FULL TEXT OF THE PROPOSED RULE IS:

     

    64B8-30.008 Formulary.

    (1) Physician Assistants approved to prescribe medicinal drugs under the provisions of Section 458.347(4)(e) or 459.022(4)(e), F.S., are not authorized to prescribe the following medicinal drugs, in pure form or combination:

    (a) Controlled substances, as defined in Chapter 893, F.S.

    (a)(b) General, spinal or epidural anesthetics;

    (b)(c) Radiographic contrast materials;

    (c) Psychiatric mental health controlled substances for children younger than 18 years of age.

    (2) The prescription of Schedule II controlled substances as listed in s. 893.03, F.S., is limited to a 7-day supply.

    (3)(2) A supervising physician may delegate to a prescribing physician assistant only such authorized medicinal drugs as are used in the supervising physician’s practice, not listed in subsection (1).

    (4)(3) Subject to the requirements of this subsection, Sections 456.44, 458.347, 458.3295, and 459.022, and 459.0137, F.S., and the rules enacted thereunder, drugs not appearing on this formulary may be delegated by a supervising physician to a prescribing physician assistant to prescribe.

    (5)(4) Nothing herein prohibits a supervising physician from delegating to a physician assistant the authority to order medicinal drugs for a hospitalized patient of the supervising physician, nor does anything herein prohibit a supervising physician from delegating to a physician assistant the administration of a medicinal drug under the direction and supervision of the physician.

    Rulemaking Authority 458.309, 458.347(4)(f)1. FS. Law Implemented 458.347(4)(e), (f), 456.044, 458.3295 FS. History–New 3-12-94, Formerly 61F6-17.0038, Amended 11-30-94, 2-22-95, 1-24-96, 11-13-96, 3-26-97, Formerly 59R-30.008, Amended 11-26-97, 1-11-99, 12-28-99, 6-20-00, 11-13-00, 2-15-02, 7-30-03, 8-2-09,                             .

     

    NAME OF PERSON ORIGINATING PROPOSED RULE: Council on Physician Assistants

    NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Board of Medicine

    DATE PROPOSED RULE APPROVED BY AGENCY HEAD: June 3, 2016

    DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: June 22, 2016

Document Information

Comments Open:
7/7/2016
Summary:
The proposed rule amendments delete the prohibition on prescribing of controlled substances by physician assistants. Pursuant to recent statutory changes, the rule amendments prohibit the prescribing of psychiatric mental health controlled substances to children under 18 years of age; and limit the prescribing of Schedule II controlled substances to a 7 day supply.
Purpose:
The proposed rule amendments are intended to clarify the rule with regard to prescribing of controlled substances by physician assistants.
Rulemaking Authority:
458.309, 458.347(4)(f)1. FS.
Law:
458.347(4)(e), (f), 458.3295, 456.044 FS.
Contact:
Claudia Kemp, J.D., Executive Director, Board of Medicine/MQA, 4052 Bald Cypress Way, Bin # C03, Tallahassee, Florida 32399-3253.
Related Rules: (1)
64B8-30.008. Formulary