The Board proposes the rule amendment in order to update the rule concerning the delivering and returning of medication.

 

DEPARTMENT OF HEALTH
Board of Pharmacy

RULE NO: RULE TITLE
64B16-28.450: Centralized Prescription Filling

PURPOSE AND EFFECT: The Board proposes the rule amendment in order to update the rule concerning the delivering and returning of medication.

SUBJECT AREA TO BE ADDRESSED: Centralized Prescription Filling, Delivering and Returning.

SPECIFIC AUTHORITY: 465.003, 465.005, 465.0265 FS.

LAW IMPLEMENTED: 465.003(16), 465.0265 FS.

IF REQUESTED IN WRITING AND NOT DEEMED UNNECESSARY BY THE AGENCY HEAD, A RULE DEVELOPMENT WORKSHOP WILL BE NOTICED IN THE NEXT AVAILABLE FLORIDA ADMINISTRATIVE WEEKLY.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE DEVELOPMENT AND A COPY OF THE PRELIMINARY DRAFT IS: Rebecca Poston, Executive Director, Board of Pharmacy/MQA, 4052 Bald Cypress Way, Bin C04, Tallahassee, Florida 32399-3254

THE PRELIMINARY TEXT OF THE PROPOSED RULE DEVELOPMENT IS:

 

64B16-28.450 Centralized Prescription Filling, Delivering & Returning.

(1) As used herein:

(a) The term “originating receiving pharmacy” means a pharmacy wherein the prescription which will be filled by the central fill supplier pharmacy is initially presented. A “receiving pharmacy” is also the pharmacy which will dispense the medication once the prescription has been filled by the supplier pharmacy and then delivered to the receiving pharmacy; and,

(b) The term “central fill supplier pharmacy” means a pharmacy which performs centralized prescription filling, delivering, and returning for one or more originating receiving pharmacies.

(2) Pharmacies acting as the central fill supplier pharmacy must be authorized to dispense medications under the provisions of Chapter 465, F.S., and the rules promulgated thereto.

(3) A community pharmacy which acts as the central fill supplier pharmacy and which notifies the Board that its pharmacy practice is limited only to such practice shall be exempt from the following rules:

(a) Rule 64B16-28.1035, F.A.C., Patient Consultation Area;

(b) The signage requirement of subsection 64B16-28.109(1), F.A.C.; and

(c) Rule 64B16-28.404, F.A.C., Regulation of Daily Operating Hours.

(4) All central fill supplying and originating receiving pharmacies engaged in centralized prescription filling shall create and keep current a Policy and Procedure Manual which shall:

(a) Be maintained at the locations of the central fill supplying and originating receiving pharmacies;

(b) Include the information required in Sections 465.0265(2)(a)-(f), F.S.

(5) Delivery of medications. Delivery of medications must be made in a timely manner. The originating and central fill pharmacies shall each be identified on the prescription container. Delivery of medications by the supplying originating or central fill pharmacy shall only be made to the receiving pharmacy for dispensing. Such delivery must be made in a timely manner.

(a) Delivery by central fill pharmacy to ultimate consumer. A central fill pharmacy may deliver medications for an originating pharmacy to the ultimate consumer or the consumer’s agent under the following conditions:

1. The pharmacies are under the same ownership or have a written contract specifying the services to be provided by each pharmacy, the responsibilities of each pharmacy, and the manner in which each pharmacy will comply with federal and state laws, rules and regulations.

2. The pharmacies shall have a pharmacist available 40 hours a week, either in person or via two-way communication technology, such as a telephone, to provide patient counseling.

3. The pharmacies shall include a toll-free number that allows the patient to reach a pharmacist for the purposes of patient counseling.

4. The pharmacies shall each be identified on the prescription container label. The originating pharmacy shall be identified with pharmacy name and address. The central fill pharmacy may be identified by a code available at the originating pharmacy.

5. The central fill pharmacy shall only deliver via carrier to the ultimate consumer or the consumer’s agent those medications which could have been delivered via carrier by the originating pharmacy.

6. The central fill pharmacy shall not deliver to the ultimate consumer or consumer’s agent substances listed as controlled substances under Chapter 893, F.S.

(b) The delivery of a filled prescription by a central fill pharmacy to the ultimate consumer or the consumer’s agent pursuant to a contract with an originating pharmacy shall not be considered dispensing within the definition set forth in Section 465.003(6), F.S.

(c) Each pharmacist that performs a specific function within the processing of the prescription shall be responsible for any errors or omissions committed by that pharmacist during the performance of that specific function.

(6) The supplying and receiving pharmacy shall each be identified on the prescription container label. The receiving pharmacy shall be identified with pharmacy name and address. The supplying pharmacy may be identified by a code available at the receiving pharmacy. Prescription and labeling requirements for pharmacies participating in central prescription filling, delivering and returning:

(a) Prescriptions may be transmitted electronically from an originating pharmacy to a central fill pharmacy including via facsimile. The originating pharmacy transmitting the prescription information must:

1. Write the word “central fill” on the face of the original prescription and record the name, address, and DEA registration number if a controlled substance of the originating pharmacy to which the prescription has been transmitted and the name of the originating pharmacy’s pharmacist transmitting the prescription, and the date of transmittal;

2. Ensure all the information required to be on a prescription pursuant to Sections 456.042 and 893.04, F.S., is transmitted to the central fill pharmacy either on the face of the prescription or in the electronic transmission of information;

3. Indicate in the information transmitted the number of refills already dispensed and the number of refills remaining;

4. Maintain the original prescription for a period of two years from the date the prescription was last refilled.

5. Keep a record of receipt of the filled prescription, including the date of receipt, the method of delivery (private, common or contract carrier) and the name of the originating pharmacy’s employee accepting delivery.

(b) The central fill pharmacy receiving the transmitted prescription must:

1. Keep a copy of the prescription if sent via facsimile, or an electronic record of all the information transmitted by the originating pharmacy, including the name, address, and DEA registration number, if a controlled substance, of the originating pharmacy transmitting the prescription;

2. Keep a record of the date of receipt of the transmitted prescription, the name of the licensed pharmacist filling the prescription, and dates of filling or refilling of the prescription;

3. Keep a record of the date the filled prescription was delivered to the originating pharmacy and the method of delivery (private, common or contract carrier).

4. A central fill pharmacy’s pharmacist filling a written or emergency oral prescription for a controlled substance listed in Schedule II shall affix to the package a label showing the date of filing, the receiving pharmacy ‘s name and address, a unique identifier (i.e. the supplying pharmacy’s DEA registration number) indicating the prescription was filled at the central fill pharmacy, the serial number of the prescription, the name of the patient, the name of the prescribing practitioner, and directions for use and cautionary statements, if any, contained in such prescription or required by law.

Specific Authority 465.003, 465.005, 465.0265 FS. Law Implemented 465.003(16), 465.0265 FS. History–New 9-23-03, Amended 7-27-04,_________.