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

(1) As used herein:

(a) The term “originating pharmacy” means a pharmacy wherein the prescription which will be filled by the central fill pharmacy is initially presented; and

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

(2) Pharmacies acting as the central fill pharmacy must:

(a) Be authorized to dispense medications under the provisions of Chapter 465, F.S., and the rules promulgated thereto, and

(b) Have the same owner as the originating pharmacy or have a written contract specifying the services to be provided by each pharmacy, the responsibilities of each pharmacy, and the manner in which the pharmacies will comply with federal and state laws, rules, and regulations.

(3) All central fill and originating 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 and originating pharmacies;

(b) Include the information required by paragraphs 465.0265(2)(a)-(f), F.S.;

(c) Designate the types of medications that may and may not be filled by the central fill pharmacy;

(d) Set forth procedures for communicating orders from the originating pharmacy to the central fill pharmacy;

(e) Set forth procedures for securely transporting the filled prescriptions from the central fill pharmacy to the originating pharmacy; and

(f) Designate the specific services provided and the duties and responsibilities of the central fill and originating pharmacies.

(4) The central fill and originating pharmacy 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. 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. Electronically record in the pharmacy record keeping system or document on the face of the original prescription that the prescription has been filled at a central fill pharmacy. If a controlled substance, write the word “central fill” on the face of the original prescription and record the name, address, and DEA registration number 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 456.0392 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 four (4) years from the date the prescription was last filled.

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 filling, the originating pharmacy’s name and address, a unique identifier (e.g., the central fill 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.

(5) Delivery of medications. All deliveries of medications from the central fill pharmacy to the originating pharmacy or to the ultimate consumer must be made in a timely manner.

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

1. The pharmacies are under the same ownership or have a written contract specifying the services to be provided by each pharmacy, including delivery services to the ultimate consumer or the consumer’s agent.

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 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.

5. 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 community 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) A Class II institutional central fill pharmacy may only deliver medications to the originating pharmacy.

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

(7) A community pharmacy which acts as the central fill 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 64B16-28.1081, F.A.C., Regulation of Daily Operating Hours.

Rulemaking Authority 465.005, 465.0155, 465.0265 FS. Law Implemented 465.003(16), 465.019, 465.022, 465.0265 FS. History–New 9-23-03, Amended 7-27-04, 4-28-08, 2-5-14, 8-27-15, 3-15-16.