The Board proposes the rule amendment to clarify definitions and update the rule.

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NO.:RULE TITLE:

64B16-28.608Automated Filling Systems within a Pharmacy

PURPOSE AND EFFECT: The Board proposes the rule amendment to clarify definitions and update the rule.

SUMMARY: The rule will be updated and definitions 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, 465.0155, FS.

LAW IMPLEMENTED: 465.003(17), 465.0155, 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: C. Erica White, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin C04, Tallahassee, Florida 32399-3254.

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64B16-28.608 Automated Filling Systems within a Pharmacy.

(1) Definitions. The following definitions shall be applicable for purposes of this rule:

(a) No change.

(b) “Electronic verification process” means an electronic verification, bar code verification, weight verification, radio frequency identification (RFID), or similar electronic process or system that accurately verifies medication has been properly prepared for dispensing by dispensed and labeled by, or loaded into, an automated filling system.

(c) “Manufacturer Unit of Use Package” means a drug dispensed in the manufacturer’s original and sealed packaging, or in the original and sealed packaging of a repackager, without additional manipulation or preparation by the pharmacy, except for application of the pharmacy label.

(d) through (e) No change.

(f) “Load” means assigning new medications for new NDC numbers to the system, which must be completed by an onsite pharmacist.

(2)  The system drug identifier database shall be maintained by a pharmacist and shall not be delegated.

(3)(2) No change.

(3) Medication Loading. System must be loaded by an onsite pharmacist.

(4) No change.

(5) The pharmacist verification requirements of subsection (4) shall be deemed satisfied if:

(a) No change.

(b) The system is fully automated from the time the medication is stocked loaded into the machine until a completed, labeled and sealed prescription is produced by the system that is ready for dispensing to the patient. No manual intervention with the medication may occur after the medication is stocked loaded into the system. For purposes of this section, manual intervention shall not include preparing a finished prescription for mailing, delivery, or storage;

(c) through (d) No change.

(e) A pharmacist verifies the correct medication, either the Manufacturer Unit of Use Package, Repacked, or Prepacked container, was properly stocked, filled and stocked loaded in the system. Alternatively, an electronic verification process may be used to verify a Mmanufacturer Uunit of Uuse Ppackage, repackaged, or prepacked containers;

(f) The medication to be dispensed is selected, filled, labeled, or sealed in the prescription container by the system or dispensed by the system in a Mmanufacturer’s Uunit of Uuse Ppackage, repacked, or prepacked container;

(g) An electronic verification process is used to verify the proper prescription label has been affixed to the correct medication, prepackaged medication or Mmanufacturer Uunit of Uuse Ppackage, for the correct patient; and

(h) No change.

(6) The pharmacist verification requirements of subsection (4) shall be deemed satisfied for a system that is not fully automated when all or part of the system is used for Manufacturer Unit of Use Packages if:

(a) The system utilizes an Electronic Verification Process to verify that the correct drug matches the correct prescription label;

(b) The Electronic Verification Process activities are undertaken by a pharmacist, pharmacy intern, or registered pharmacy technician under the supervision of a pharmacist, as each are defined by subsection 64B16-27.1001(7), F.A.C. and consistent with Section 64B16-27.4001, F.A.C.

(c) An audit trail is maintained for the prescription from the beginning of the system to the dispensing from the system, and maintained for four (4) years.

(7)(6) Policies and Procedures. Pharmacies verifying prescriptions pursuant to subsections (5) or (6) of this rule shall establish and follow written policies and procedures to ensure the proper, safe, and secure functioning of the system. Policies and procedures shall be reviewed annually by the prescription department manager or consultant pharmacist of record and shall be maintained in the pharmacy’s records for a minimum of four (4) years. The required annual review shall be documented in the pharmacy’s records and made available upon request. At a minimum, the pharmacy shall establish and follow policies and procedures for:

(a) Maintaining the system and any accompanying electronic verification process system in good working order;

(b) Ensuring the integrity of the drug identity database and identification of persons responsible for database entries

(b)(c)Ensuring accurate filling, loading, and stocking, and verification of the system, as applicable;

(d)(c) No change.

(e)(d) Testing the accuracy of the system and any accompanying electronic verification process system. At a minimum, the system and electronic verification process shall be tested before the first use of the system or restarting the system and upon any modification to the system or electronic verification process that changes or alters the filling or electronic verification process;

(f)(e) Training persons authorized to access, stock, restock, or utilize load the system in equipment use and operations, as applicable;

(g)(f) through (i)(h) No change.

(j)(i) Identifying and recording persons responsible for stocking, loading and filling the system;

(k)(j) through (l)(k) No change.

(8)(7) No change.

Rulemaking Authority 465.005, 465.0155 FS. Law Implemented 465.003(17), 465.0155 FS. History‒New 3-24-14,    .

 

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: June 6, 2017

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: November 16, 2016