The board proposes the rule development to update and correct the terminology and labeling requirements for nuclear pharmacies.

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NO.:RULE TITLE:

64B16-28.901Nuclear Pharmacy – General Requirements

PURPOSE AND EFFECT: The board proposes the rule development to update and correct the terminology and labeling requirements for nuclear pharmacies.

SUMMARY: The proposed rule amendments are necessary to update and correct the terminology and labeling requirements for nuclear pharmacies.

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, 456.022 FS.

LAW IMPLEMENTED: 465.003(14), 465.0126, 465.014 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: Mark Whitten, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin C04, Tallahassee, Florida 32399-3254

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64B16-28.901 Nuclear Pharmacy – General Requirements.

(1) through (7) No change.

(8) A nuclear pharmacist upon receiving an oral prescription order for a radiopharmaceutical shall immediately have the prescription order reduced to writing. The pharmacist may delegate this duty to a registered pharmacy technician only as authorized by Rule 64B16-27.410, F.A.C. The prescription order shall contain at least the following:

(a) No change.

(b) The date of distribution and the time of calibration administration of the radiopharmaceutical;

(c) through (e) No change.

(f) The serial number assigned to the prescription order for the radiopharmaceutical;

(f)(g) Any specific instructions; and

(g)(h) The initials of the person who received the prescription order.

(h)(i) The patient’s name must be obtained and recorded prior to dispensing, if the prescription order is for a therapeutic or blood product radiopharmaceutical.

(9) The immediate outer container shield of a radiopharmaceutical to be dispensed shall be labeled with:

(a) through (m) No change.

(n) Molybdenum 99 content to USP limits, applies only to Tc 99m TC 99M products; and

(o) The name of the patient for therapeutic or blood-product radiopharmaceuticals or the words “Physician’s Use Only” for diagnostic radiopharmaceuticals in the absence of a patient name. If the prescription order is for a therapeutic or blood-product radiopharmaceutical, the patient’s name must be obtained and recorded prior to dispensing. The requirements of this subsection shall be met when the name of the patient is readily retrievable from the physician upon demand.

(p) No change.

(10) No change.

Rulemaking Authority 465.005, 465.022 FS. Law Implemented 465.003(14), 465.0126, 465.014 FS. History–New 1-7-76, Formerly 21S-3.03, Amended 12-11-86, 4-4-88, Formerly 21S-3.003, 21S-28.901, 61F10-28.901, Amended 2-26-95, Formerly 59X-28.901, Amended 4-5-05, 1-1-10,__________.

 

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: August 13, 2013

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: September 6, 2013