The board proposes the rule amendment to correct a rule citation and update the period of time for records to be maintained as applicable to all pharmacies.

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NO.:RULE TITLE:

64B16-28.140Record Maintenance Systems for Community, Special-Limited Community, Special-Closed Systems, Special-Parenteral/Enteral, and Nuclear Permits

PURPOSE AND EFFECT: The board proposes the rule amendment to correct a rule citation and update the period of time for records to be maintained as applicable to all pharmacies.

SUMMARY: The proposed rule amendments are necessary to delete an outdated citation to a repealed rule and insert the correct rule citation, update general record maintenance requirements to four instead of two years to be compatible with statutory requirements and biennial inspections, and make the rule applicable to all pharmacies. All similar pharmacy rules will be updated to be consistent with this record maintenance change.

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, 465.0155, 465.022 FS.

LAW IMPLEMENTED: 465.003(14); 465.022, 465.026, 893.07 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: Tammy Collins, Acting Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin C04, Tallahassee, Florida 32399-3254

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64B16-28.140 Record Maintenance Systems for All Pharmacy Community, Special-Limited Community, Special-Closed Systems, Special-Parenteral/Enteral, and Nuclear Permits.

(1) Requirements for records maintained in a data processing system.

(a) through (c) No change.

(d) Original prescriptions, including prescriptions received as provided for in Rule 64B16-27.1003 64B16-28.130, F.A.C., Transmission of Prescription Orders, shall be reduced to a hard copy if not received in written form. All original prescriptions shall be retained for a period of not less than four (4) two years from date of last filling. To the extent authorized by 21 C.F.R. Section 1304.04, a pharmacy may, in lieu of retaining the actual original prescriptions, use an electronic imaging recordkeeping system, provided such system is capable of capturing, storing, and reproducing the exact image of the prescription, including the reverse side of the prescription if necessary, and that such image be retained for a period of no less than four (4) two years from the date of last filling.

(e) No change.

(f) Requirements for back-up systems.

1. No change.

2. Data processing systems shall have a workable (electronic) data retention system which can produce an audit trail of drug usage for the preceding four (4) two years as specified in Rule 64B16-27.800, F.A.C.

(g) Change or discontinuance of a data processing system.

1. through 2. No Change.

3. Maintenance of purged records. Information purged from a data processing system must be maintained by the pharmacy for four (4) two years from the date of initial entry into the data processing system.

(h) No Change.

(2) No Change.

(3) Records of dispensing.

(a) through (d) No Change.

(e) In lieu of producing the printout described in paragraphs (b) and (c) of this section, the pharmacy shall maintain a log book in which each individual pharmacist using the data processing system shall sign a statement each day, attesting to the fact that the information entered into the data processing system that day has been reviewed by him or her and is correct as entered. Such log book shall be maintained at the pharmacy employing such a system for a period of four (4) two years after the date of dispensing provided, however, that the data processing system can produce the hard-copy printout on demand by an authorized agent of the Department of Health. If no printer is available on site, the hard-copy printout shall be available within 48 hours with a certification by the individual providing the printout, which states that the printout is true and correct as of the date of entry and such information has not been altered, amended or modified.

(f) through (h) No change.

(4) through (6) No change.

Rulemaking Specific Authority 465.005, 465.0155, 465.022 FS. Law Implemented 465.003(14), 465.022, 465.026, 893.07 FS. History–New 3-16-94, Formerly 61F10-28.140, Amended 3-12-97, 6-4-97, Formerly 59X-28.140, Amended 10-29-97, 6-15-98, 11-11-98, 10-15-01,___________.

 

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: December 4, 2013

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: January 6, 2014