The Board proposes the rule amendment to clarify the provision for the utilization of an inventory system for injectables and other medicinal drugs required by the Pharmacy Services Committee.  

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    DEPARTMENT OF HEALTH

    Board of Pharmacy

    RULE NO.:RULE TITLE:

    64B16-28.702Modified Class II Institutional Pharmacies

    PURPOSE AND EFFECT: The Board proposes the rule amendment to clarify the provision for the utilization of an inventory system for injectables and other medicinal drugs required by the Pharmacy Services Committee.

    SUMMARY: The provision for the utilization of an inventory system for injectables and other medicinal drugs required by the Pharmacy Services Committee will be clarified.

    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: 465.005, 465.022 FS.

    LAW IMPLEMENTED: 465.019(2)(c), 465.022 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 Dudley, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin C04, Tallahassee, Florida 32399-3254

     

    THE FULL TEXT OF THE PROPOSED RULE IS:

     

    64B16-28.702 Modified Class II Institutional Pharmacies.

    (1) through (5) No change.

    (6) Drugs as defined in Section 465.003(7), F.S., stocked in Modified Class II Institutional Pharmacies, Type “A” and Type “B” as provided herein, shall be those drugs generally utilized in the treatment modalities encompassed within the health care scope of the particular institutional care entity. The protocol and the policy and procedure manual for Type “A” and Type “B” Modified Class II Institutional Pharmacies shall contain definitive information as to drugs and strengths thereof to be stocked.

    (a) No change.

    (b) The policy and procedure manual of facilities which are issued Type B Modified Class II Institutional Permits shall provide the following:

    1. through 3. No change.

    4. Provisions for the utilization of a perpetual inventory system for all controlled substances., injectables and other medicinal drugs as required by the Pharmacy Services Committee.

    5. Provisions for the utilization of an inventory system for injectables and other medicinal drugs as required by the Pharmacy Services Committee.

    6.5. No change.

    7.6. No change.

    (c) No change.

    (7) through (8) No change.

    Rulemaking Authority 465.005, 465.022 FS. Law Implemented 465.019(2)(c), 465.022 FS. History–New 4-22-82, Amended 11-5-85, Formerly 21S-1.37, Amended 4-16-86, Formerly 21S-1.037, Amended 7-31-91, Formerly 21S-28.702, 61F10-28.702, Amended 9-4-96, Formerly 59X-28.702, Amended 10-15-01, 7-14-14,                                  .

     

    NAME OF PERSON ORIGINATING PROPOSED RULE: Board of Pharmacy

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

    DATE PROPOSED RULE APPROVED BY AGENCY HEAD: October 7, 2015

    DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: December 8, 2015

Document Information

Comments Open:
1/19/2016
Summary:
The provision for the utilization of an inventory system for injectables and other medicinal drugs required by the Pharmacy Services Committee will be clarified.
Purpose:
The Board proposes the rule amendment to clarify the provision for the utilization of an inventory system for injectables and other medicinal drugs required by the Pharmacy Services Committee.
Rulemaking Authority:
465.005, 465.022 FS.
Law:
465.019(2)(c), 465.022 FS.
Contact:
Allison Dudley, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin C04, Tallahassee, Florida 32399-3254.
Related Rules: (1)
64B16-28.702. Modified Class II Institutional Pharmacies