The Board proposes the rule amendment in order to provide updated references to requirements.  


  • RULE NO: RULE TITLE
    64B16-28.902: Nuclear Pharmacy - Minimum Requirements
    PURPOSE AND EFFECT: The Board proposes the rule amendment in order to provide updated references to requirements.
    SUMMARY: Referenced requirements will be updated.
    SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: No Statement of Estimated Regulatory Cost was prepared. The Board determined the proposed rule will not have an impact on small business.
    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.
    SPECIFIC AUTHORITY: 465.005, 465.022 FS.
    LAW IMPLEMENTED: 465.0193, 465.022(1) FS.
    IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN FAW.
    THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Rebecca R. Poston, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin #C04, Tallahassee, Florida 32399-3253

    THE FULL TEXT OF THE PROPOSED RULE IS:

    64B16-28.902 Nuclear Pharmacy – Minimum Requirements.

    In order to insure compliance with the general safety requirements as previously set forth above, the following minimum requirements shall be met by a nuclear pharmacy. These requirements are in addition to the general requirements for space and equipment for other types of pharmacies, the requirements of the Department of Health for the control of radiation hazards, and the applicable requirements of the Federal Food and Drug Administration. Such minimum permit requirements are set forth as follows:

    (1) through (3) No change.

    (4) Current references:

    (a) through (e) No change.

    (f) Title 10 C.F.R., Code of Federal Regulations, FDA Regulations, January 8, 2008;

    (g) Title 21 C.F.R.Code of Federal Regulations, DEA Regulations, Jamuary 8, 2008;

    (h)(g) Title 49 C.F.R., Code of Federal Regulations, Department of Transportation Regulations;

    (i)(h) United States Pharmacopeia/National Formulary;

    (i) USP-DI.

    It shall be acceptable, in lieu of an actual hard copy, to maintain these materials in a readily available electronic data format.

    Rulemaking Specific Authority 465.005, 465.022 FS. Law Implemented 465.0193, 465.022(1) FS. History–New 1-7-76, Formerly 21S-3.04, Amended 12-11-86, 4-4-88, Formerly 21S-3.004, Amended 7-31-91, Formerly 21S-28.902, 61F10-28.902, Amended 2-26-95, Formerly 59X-28.902, Amended 4-26-01, 4-5-05,________.


    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: September 10, 2009
    DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: August 28, 2009

Document Information

Comments Open:
10/2/2009
Summary:
Referenced requirements will be updated.
Purpose:
The Board proposes the rule amendment in order to provide updated references to requirements.
Rulemaking Authority:
465.005, 465.022 FS.
Law:
465.0193, 465.022(1) FS.
Contact:
Rebecca R. Poston, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin #C04, Tallahassee, Florida 32399-3253
Related Rules: (1)
64B16-28.902. Nuclear Pharmacy - Minimum Requirements