Florida Administrative Code
64 - DEPARTMENT OF HEALTH
64B16 - Board of Pharmacy
Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS
Section 64B16-28.607 - Automated Pharmacy System - Long-Term Care, Hospice, and Prison
Universal Citation: FL Admin Code R 64B16-28.607
Current through Reg. 50, No. 187; September 24, 2024
(1) Definitions.
(a) "Automated pharmacy system" means a
mechanical system that performs operations or activities, other than
compounding or administration, relative to the storage, packaging, counting,
labeling, and delivery of a medicinal drug, and which collects, controls, and
maintains a record of each transaction.
(b) "Provider pharmacy" means a pharmacy that
provides pharmacy services by using an automated pharmacy system at a remote
site.
(c) "Remote site" means a
long term care facility or hospice licensed under chapter 400, F.S., or a state
correctional institution operated under Chapter 944, F.S., that is not located
at the same location as the provider pharmacy, at which pharmacy services are
provided using an automated pharmacy system.
(d) "Controlled substance" means a substance
listed in Chapter 893, F.S., or 21 C.F.R. Part 1308.
(2) Provider Pharmacy Requirements.
(a) A provider pharmacy may provide pharmacy
services to a long term care facility or hospice licensed under Chapter 400 or
429, F.S., or a state correctional institution operated under Chapter 944,
F.S., through the use of an automated pharmacy system.
(b) An automated pharmacy system shall only
be used to provide pharmacy services to an inpatient or a resident of the
remote site.
(c) Supervision of the
automated pharmacy system shall be the responsibility of a Florida pharmacist
employed by the provider pharmacy.
(d) Every medicinal drug stored in the
automated pharmacy system shall be owned by the provider pharmacy.
(e) An automated pharmacy system shall be
under the supervision of a pharmacist employed by the provider pharmacy. The
pharmacist need not be physically present at the remote site if the system is
supervised electronically.
(f) A
provider pharmacy shall have policies and procedures to ensure adequate
security.
(3) Prescription Department Manager Requirements.
(a) The prescription department manager shall
ensure that the automated pharmacy system complies with Chapter 893, F.S., and
21 C.F.R., relating to the regulation of controlled substances, for each
automated pharmacy system that contains a controlled substance.
(b) The prescription department manager shall
ensure that the use of an automated pharmacy system does not compromise patient
confidentiality.
(c) The
prescription department manager or a designee shall:
1. Authorize or deny access to the data from
an automated pharmacy system or to a drug stored inside the automated pharmacy
system.
2. Document the training of
each person who has access to the data from an automated pharmacy system or to
a drug stored inside the automated pharmacy
system.
(4) Automated Pharmacy System Requirements.
(a) A
medicinal drug stored in bulk or unit-of-use in an automated pharmacy system is
part of the inventory of the provider pharmacy and is not part of the inventory
of any other pharmacy permit for the facility.
(b) A medicinal drug may be removed from an
automated pharmacy system for administration to a patient only after a
prescription or order has been received and approved by a pharmacist at the
provider pharmacy. This provision does not apply to a medication designated as
an emergency medication if the automated pharmacy system is also used as an
emergency medication kit in compliance with Section
400.142, F.S., and Rule
59A-4.112, F.A.C.
(c) A pharmacist at the provider pharmacy
shall control all operations of the automated pharmacy system and approve
release of the initial dose of a prescription or order. A subsequent dose from
an approved prescription or order may be released without additional approval
of a pharmacist. However, any change made in a prescription or order shall
require a new approval by a pharmacist to release the drug.
(d) A pharmacist at the provider pharmacy
shall comply with the patient record requirements in Rule
64B16-27.800, F.A.C., and
prospective drug use review requirements in Rule
64B16-27.810, F.A.C., for every
medicinal drug delivered through an automated pharmacy system.
(e) If the facility where pharmacy services
are being provided maintains a medication administration record that includes
directions for use of the medication, a unit dose medication may be utilized if
the provider pharmacy or the automated pharmacy system identifies and records
the dispensing pharmacy, the prescription or order number, the name of the
patient, and the name of the prescribing practitioner for each medicinal drug
delivered.
(f) Stocking or
Restocking of an Automated Pharmacy System.
1.
The stocking or restocking of a medicinal drug in an automated pharmacy system
at the remote site shall be completed by a pharmacist or other licensed
personnel, except as provided in subparagraph 2., below, of this
subsection.
2. If the automated
pharmacy system uses removable cartridges or containers to store the drug, the
stocking or restocking of the cartridges or containers may occur at the
provider pharmacy and be sent to the remote site to be loaded by personnel
designated by the pharmacist if:
a. A
pharmacist verifies the cartridge or container has been properly filled and
labeled.
b. The individual
cartridge or container is transported to the remote site in a secure,
tamper-evident container.
c. The
automated pharmacy system uses bar code verification, electronic verification,
or similar process to assure that the cartridge or container is accurately
loaded into the automated pharmacy system.
(g) A medicinal drug that has been removed
from the automated pharmacy system shall not be replaced into the system unless
a pharmacist has examined the medication, the packaging, and the labeling and
determined that reuse of the medication is appropriate.
(h) Medication to be returned to the provider
pharmacy's stock shall meet the requirements of Rule
64B16-28.118,
F.A.C.
(5) Security Requirements.
(a) If a provider pharmacy
intends to store a controlled substance in an automated pharmacy system:
1. It shall maintain a separate DEA
registration for each remote site at which a controlled substance is stored,
unless the automated pharmacy system is solely used as an emergency kit
pursuant to Rule 59A-4.112, F.A.C.
2. It may utilize one DEA registration to
include multiple automated pharmacy systems located at a single
address.
(b) A provider
pharmacy shall only store a medicinal drug at a remote site within an automated
pharmacy system which is locked by a mechanism that prevents access to a drug
or to data by unauthorized personnel.
(c) Access to the drugs shall be limited to a
pharmacist or a registered pharmacy technician employed by the provider
pharmacy or licensed personnel in the facility or institution who are
authorized to administer medication.
(d) An automated pharmacy system that
contains a controlled substance shall prohibit simultaneous access to multiple
drug entities, drug strengths, or dosage forms of controlled
substances.
(6) Emergency medication. If an automated pharmacy system is utilized for both a medication ordered for a specific patient and an emergency medication for which the review of a pharmacist is not required:
(a) The
emergency medication shall be stored separately from other patient
medications.
(b) The record shall
identify the storage location from which the medication was released.
(c) The record shall include the name of the
medication, the patient, the prescriber, the person who accessed the automated
pharmacy system, and the date and time of the release.
(7) Record Keeping Requirements.
(a) The record of transactions with the
automated pharmacy system shall be maintained in a readily retrievable
manner.
(b) The record shall be
available to an authorized agent of the Department of Health or the Board of
Pharmacy.
(c) The record shall
include:
1. Name or identification of the
patient or resident.
2. Name,
strength and dosage form of the drug product released.
3. Quantity of drug released.
4. Date and time of each release of a
drug.
5. Name of provider
pharmacy.
6. Prescription number or
order number.
7. Name of
prescribing practitioner.
8.
Identity of the pharmacist who approved the prescription or order.
9. Identity of the person to whom the drug
was released.
(d) A
record of every transaction with the automated pharmacy system shall be
maintained for four (4) years.
Rulemaking Authority 465.005, 465.022 FS. Law Implemented 465.019, 465.022, 465.0235 FS.
New 4-22-07, Amended 1-1-10, 7-14-14, 10-29-19.
Disclaimer: These regulations may not be the most recent version. Florida may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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