The Board proposes the amendment to update the rule regarding definitions, general and additional requirements.

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NO.:RULE TITLE:

64B16-28.141Requirements for an Automated Pharmacy System in a Community Pharmacy

PURPOSE AND EFFECT: The Board proposes the amendment to update the rule regarding definitions, general and additional requirements.

SUMMARY: The rule will be updated regarding definitions, general and additional requirements.

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: 465.018, 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: 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:

 

64B16-28.141 Requirements for use of an Automated Pharmacy System by in a Community Pharmacy.

(1) Definitions: .

(a) “Automated pharmacy system (APS)” means a mechanical system, located within or adjacent to the prescription department, that performs operations or activities, other than compounding or administration, relative to storage, packaging, dispensing, or distribution of medication, and which collects, controls, and maintains all transaction information. 

(b) “Establishment” means one general physical location that may extend to one or more contiguous suites, units, floors, or buildings operated and controlled exclusively by entities under common operation and control. Where multiple buildings are under common ownership, operation, and control, an intervening thoroughfare does not affect the contiguous nature of the buildings.

(c) “Pharmacist” means a pharmacist as defined by section 465.003, FS. 

(2) General Requirements. A pharmacy may use an automated pharmacy system provided that:

(a) The automated pharmacy system is located within the prescription department, adjacent to the prescription department, or is located on the establishment of the licensed pharmacy, and the operation of the automated pharmacy system is under the supervision of a pharmacist. An automated pharmacy system that is not located within the prescription department shall be operated as an extension of the licensed pharmacy and the automated pharmacy system shall not require an independent and separate community pharmacy permit.  An automated pharmacy system that is not located within the prescription department shall have conspicuously displayed on the automated pharmacy system the name, address, contact information and the permit number of the community pharmacy that is responsible for the operation of the automated pharmacy system.

(b)(a) The pharmacy develops and maintains a policy and procedure manual that includes:

1. through 7. No change.

(c)(b) The system ensures that each prescription is dispensed in compliance with the definition of dispense as defined by section 465.003, F.S., and the practice of the profession of pharmacy. The system shall include a mechanism to ensure that the patient or an authorized agent of the patient has a means to communicate with a pharmacist responsible for dispensing the medical drug product.  The means of communication may include in person, electronic, digital, or telephonic. 

(d)(c) The system shall maintain a readily retrievable electronic record to identify all pharmacists, pharmacy interns, registered pharmacy technicians, or other personnel involved in the dispensing of a prescription.

(e)(d) No change.

(3) Additional Requirements for Patient Accessed Automated Pharmacy Systems. A pharmacy may use a patient accessed automated pharmacy system, provided that:

(a)  The requirements in subsection (2) above are met. Meets the requirements in subsection (2) above.

(b) Except as provided in paragraph (d) below, tThe stocking or restocking of a medicinal drug shall only be completed by the following:

1. a Florida pharmacist;

2. a pharmacy intern under the direct and immediate personal supervision of a pharmacist; or

3. a registered pharmacy technician under the direct supervision of a pharmacist. , except as provided in paragraph (c) below. 

(c) Access to the Automated Pharmacy System in the absence of a pharmacist for purposes of servicing and maintenance by non-pharmacy licensed personnel shall be permitted provided that the system is capable of tracking individual access and preventing unauthorized access, and the system employs user based access or other technology that will prevent access to areas of the dispensing cabinet where drugs are stored. If the system does not employ such technology, access to the system for servicing and maintenance is permitted only under the direct supervision of a pharmacist.

(d)(c) If the automated pharmacy system uses removable cartridges or containers to store the drug or uses unit of use packages, the stocking or restocking of the cartridges,  or containers or unit of use packages may occur at a licensed repackaging facility and may be sent to the provider pharmacy to be loaded by personnel designated by the pharmacist if:

1. A Florida pharmacist verifies the cartridge, or container or unit of use packages have has been properly filled and labeled.

2. The individual cartridge, or container or unit of use package is transported to the provider pharmacy in a secure, tamper-evident container.

3. The automated pharmacy system uses a bar code verification, electronic verification, weight verification, radio frequency identification (RFID) or similar process to ensure that the cartridge, or container or unit of use package is accurately loaded into the automated pharmacy system.

4. The Florida pharmacist verifying the filling and labeling retains is responsibility responsible if the cartridge, or container or unit of use package is stocked or restocked incorrectly by the personnel designated to load the cartridges or containers.

(e)(d) The automated pharmacy system must use at least two separate verifications, such as bar code verification, electronic verification, weight verification, radio frequency identification (RFID), visual verification or similar process to ensure that the proper medication is being dispensed from the automated system.

(f)(e) No change.

(g)(f) The record of transactions with the patient accessed automated pharmacy system shall be available to authorized agents of the Department of Health.  The record of transactions shall include:

1. through 9. No change.

(4) The Florida pharmacist responsible for filling, verifying, or loading or supervising the automated pharmacy system shall be responsible for her or his individual action.

(5) No change.

Rulemaking Authority 465.005, 465.022 FS. Law Implemented 465.018, 465.022 FS. History–New 11-29-04, Amended 12-30-07, 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 15, 2017

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