The proposed rule amendments are intended to set forth the appropriate information to be included in the medical record regarding the administration of compounded medications to patients.  

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    DEPARTMENT OF HEALTH

    Board of Medicine

    RULE NO.:RULE TITLE:

    64B8-9.003Standards for Adequacy of Medical Records

    PURPOSE AND EFFECT: The proposed rule amendments are intended to set forth the appropriate information to be included in the medical record regarding the administration of compounded medications to patients.

    SUMMARY: The proposed rule amendments require physicians to maintain specific information in the medical records when administering compounded medications to patients.

    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, based upon the expertise and experience of its members, 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, 458.331(1)(m), (v) FS.

    LAW IMPLEMENTED: 456.061, 458.331(1)(g), (h), (k), (m), (t), (v), (gg), (hh) 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: Allison M. Dudley, 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:

    64B8-9.003 Standards for Adequacy of Medical Records.

    (1) through (3) No change.

    (4) Medical records in which compounded medications are administered to a patient in an office setting must contain, at a minimum, the following information:

    (a) The name and concentration of medication administered;

    (b) The lot number of the medication administered;

    (c) The expiration date of the medication administered;

    (d) The name of the compounding pharmacy or manufacturer;

    (e) The site of administration on the patient;

    (f) The amount of medication administered; and

    (g) The date medication administered.

    (5) (4) No change.

    (6) (5) No change.

    Rulemaking Authority 458.309, 458.331(1)(m), (v) FS. Law Implemented 456.061, 458.331(1)(g), (h), (k), (m), (t), (v), (gg), (hh) FS. History–New 1-1-92, Formerly 21M-27.003, Amended 1-12-94, Formerly 61F6-27.003, Amended 9-3-95, Formerly 59R-9.003, Amended 8-20-02. 9-11-06,_________.

     

    NAME OF PERSON ORIGINATING PROPOSED RULE: Surgical Care Committee, Board of Medicine

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

    DATE PROPOSED RULE APPROVED BY AGENCY HEAD: June 7, 2013

    DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: February 27, 2013

Document Information

Comments Open:
7/1/2013
Summary:
The proposed rule amendments require physicians to maintain specific information in the medical records when administering compounded medications to patients.
Purpose:
The proposed rule amendments are intended to set forth the appropriate information to be included in the medical record regarding the administration of compounded medications to patients.
Rulemaking Authority:
458.309, 458.331(1)(m), (v) FS.
Law:
456.061, 458.331(1)(g), (h), (k), (m), (t), (v), (gg), (hh) FS.
Contact:
Allison M. Dudley, J.D., Executive Director, Board of Medicine/MQA, 4052 Bald Cypress Way, Bin # C03, Tallahassee, Florida 32399-3253.
Related Rules: (1)
64B8-9.003. Standards for Adequacy of Medical Records