Current through Reg. 50, No. 187; September 24, 2024
A Special-Limited Community Permit shall be obtained by a
Class II or Class III Institutional Pharmacy that dispenses medicinal drugs,
including controlled substances to:
(1) Employees, medical staff and their
dependents for their personal use;
(2) Patients of the hospital who are under a
continuation of a course of therapy not to exceed a three (3) day
supply;
(3) Patients obtaining
medical services in the facility's emergency room and, whenever it is otherwise
appropriate, as indicated in the applicant's policy and procedure manual; and,
(4) Discharged patients of the
hospital who are under a continuation of a course of therapy using multi-dose
medicinal drugs if the following requirements are met:
(a) The label affixed to a container used in
dispensing multi-dose medicinal drugs contains at least the following
information:
1. The name of and contact
information of the pharmacy.
2. The
name of the prescriber.
3. The name
of the patient.
4. The date of the
original filling and any applicable expiration date.
5. The prescription number or other
prescription identification adequate to readily identify the
prescription.
6. The directions for
use.
7. The name, strength, and
size of the medicinal drug dispensed; and,
8. The quantity of the drug in the
container.
(b) The
patient is deemed competent to handle and administer the multi-dose medicinal
drug.
(c) A specific order is
written by the patient's physician to authorize that the multi-dose medicinal
drug is appropriate to dispense upon discharge.
(d) Before the hospital dispenses a
multi-dose medicinal drug as specified in subsection (4) of this rule, the
hospital shall establish protocols to ensure the following:
1. Infection control during transport and
handling of multi-dose medicinal drug containers that have been in contact with
a patient.
2. Patient or caregiver
education on administration of the multi-dose medicinal drug if necessary on an
individual basis.
(e) A
"multi-dose medicinal drug" as used in this rule means, but is not limited to,
commercially available multi-dose packages such as inhalers, ocular products,
insulin vials or pens, otic products, bulk antibiotic suspensions, topical
agents, and methylprednisolone dose packets dispensed to inpatients, provided
in containers that may exceed a three (3) day supply, and are intended to be
continued by the patient on an outpatient basis but not to be re-filled by the
hospital. Controlled substances are not considered multi-dose medicinal drugs
as defined in this rule.
Rulemaking Authority 465.005, 465.022 FS. Law Implemented
465.0196 FS.
New 7-31-91, Formerly 21S-28.810, 61F10-28.810, 59X-28.810,
Amended 7-17-05, 2-10-14, 9-27-18.
