Current through Reg. 50, No. 187; September 24, 2024
(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
Sections 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.
New 9-23-03, Amended 7-27-04, 4-28-08, 2-5-14, 8-27-15,
3-15-16.
