Current through Reg. 50, No. 187; September 24, 2024
(1) Modified Class II Institutional
Pharmacies are those Institutional Pharmacies which provide specialized
pharmacy services restricted in scope of practice and designed to provide
certain health care pharmacy services that are not generally obtainable from
other pharmacy permittees. These specialized institutional pharmacy practices
are generally identifiable with short-term or primary care treatment modalities
in entities such as primary alcoholism treatment centers, free-standing
emergency rooms, rapid in/out surgical centers, certain county health programs,
and correctional institutions. Medicinal drugs may not be administered, except
to patients of the institution for use on the premises of the institution, in
any facility which has been issued a Modified Class II Institutional Pharmacy
Permit. All medicinal drugs as defined by Section
465.003(7),
F.S., which are stocked in these pharmacies are only to be administered on
premises as defined by Section
465.003(1),
F.S., to inpatients on an inpatient or in-program basis. In-program patients
are defined as those patients who have met program admission criteria required
by the institution.
(2) Modified
Class II Institutional Pharmacies are categorized according to the type of
specialized pharmaceutical delivery system utilized and the following criteria
(Categories are designated as Type "A, " Type "B, " and Type "C"):
(a) The type of the medicinal drug delivery
system utilized at the facility, either a patient-specific or bulk drug system,
and, the quantity of the medicinal drug formulary at the facility.
(b) Type "A" Modified Class II Institutional
Pharmacies provide pharmacy services in a facility which has a formulary of not
more than 15 medicinal drugs, excluding those medicinal drugs contained in an
emergency box, and in which the medicinal drugs are stored in bulk and in which
the consultant pharmacist shall provide on-site consultations not less than
once every month, unless otherwise directed by the Board after review of the
policy and procedure manual.
(c)
Type "B" Modified Class II Institutional Pharmacies provide pharmacy services
in a facility in which medicinal drugs are stored in the facility in patient
specific form and in bulk form and which has an expanded drug formulary, and in
which the consultant pharmacist shall provide on-site consultations not less
than once per month, unless otherwise directed by the Board after review of the
policy and procedure manual.
(d)
Type "C" Modified Class II Institutional Pharmacies provide pharmacy services
in a facility in which medicinal drugs are stored in the facility in patient
specific form and which has an expanded drug formulary, and in which the
consultant pharmacist shall provide onsite consultations not less than once per
month, unless otherwise directed by the Board after review of the policy and
procedure manual.
(3) All
Modified Class II Institutional Pharmacies shall be under the control and
supervision of a certified consultant pharmacist.
(4) The consultant pharmacist of record for
the Modified Class II Institutional Pharmacy shall be responsible for
establishing a written protocol and a policy and procedure manual for the
implementation of a drug delivery system to be utilized and the requirements of
this rule.
(5) A copy of the
permittee's policy and procedure manual as provided herein shall accompany the
permit application. The original policy and procedure manual shall be kept
within the Modified Class II Institutional Pharmacy and shall be available for
inspection by the Department of Health.
(6) Drugs as defined in Section
465.003(7),
F.S., stocked in Modified Class II Institutional Pharmacies, Type "A, " and
Type "B, " as provided herein, shall be those drugs generally utilized in the
treatment modalities encompassed within the health care scope of the particular
institutional care entity. The protocol and the policy and procedure manual for
Type "A, " and Type "B, " Modified Class II Institutional Pharmacies shall
contain definitive information as to drugs and strengths thereof to be stocked.
(a) The policy and procedure manual of
facilities which are issued Type A Modified Class II Institutional Permits
shall provide the following:
1. Definitive
information as to drugs and strengths to be stored.
2. The establishment of a Pharmacy Services
Committee which shall meet at least annually.
3. Provisions for the handling of the
emergency box including the utilization of separate logs for
recordkeeping.
4. Provisions for
the secure ordering, storage and recordkeeping of all medicinal drugs at the
facility.
5. Provisions for the
utilization of proof-of-use forms for all medicinal drugs within the
facility.
6. A diagram of the
facility and the security and storage of the medicinal drugs.
7. Provisions for maintaining the records of
consultations for not less than four (4) years at the facility which shall be
stored onsite and available for inspection by the Department of
Health.
(b) The policy
and procedure manual of facilities which are issued Type B Modified Class II
Institutional Permits shall provide the following:
1. The establishment of a Pharmacy Services
Committee which shall meet at least annually.
2. Provisions for the handling of the
emergency box including the utilization of separate logs for
recordkeeping.
3. Provisions for
the secure ordering, storage and recordkeeping of all medicinal drugs at the
facility.
4. Provisions for the
utilization of a perpetual inventory system for all controlled
substances.
5. Provisions for the
utilization of an inventory system for injectables and other medicinal drugs as
required by the Pharmacy Services Committee.
6. A diagram of the facility and the security
and storage of the medicinal drugs.
7. Provisions for maintaining the records of
consultations for not less than four (4) years at the facility which shall be
stored on-site and available for inspection by the Department of
Health.
(c) The policy
and procedure manual of facilities which are issued Type C Modified Class II
Institutional Permit shall provide the following:
1. The establishment of a Pharmacy Services
Committee which shall meet at least annually.
2. Provisions for the handling of the
emergency box including the utilization of separate logs for
recordkeeping.
3. Provisions for
the secure ordering, storage and recordkeeping of all medicinal drugs at the
facility.
4. Provisions for the
utilization of a Medication Administration Record (MAR) for all medicinal drugs
administered to patients of the facility.
5. A diagram of the facility and the security
and storage of the medicinal drugs.
6. Provisions for maintaining the records of
consultations for not less than four (4) years at the facility which shall be
stored on-site and available for inspection by the Department of
Health.
(7)
Controlled drugs as defined in Chapter 893, F.S., stocked as provided herein
within a Type "A" Modified Class II Institutional Pharmacy shall be stocked in
unit size not to exceed 100 dosage units unless an exception thereto is granted
by the Board of Pharmacy. Proof of use record sheets showing patient's name,
date of administration, initials of person administering drug, and other
pertinent control requirements are required for both controlled and
noncontrolled substance medicinal drugs in Type "A" Modified Class II
Institutional Pharmacies.
(8) A
Modified Class II institutional pharmacy may contract with a Special
Parenteral/Enteral Extended Scope pharmacy for the pharmacy services provided
for by Rule 64B16-28.860, F.A.C.
(a) Special Parenteral/Enteral Extended Scope
pharmacies and institutional pharmacy permits shall create and comply with
Policy and Procedure Manuals that delineate duties and responsibilities of each
entity including the following provisions:
1.
The institutional pharmacy permit shall maintain records appropriate to ensure
the provision of proper patient care.
2. The institutional pharmacy permit designee
shall inspect and log in all medicinal drugs provided by the Special
Parenteral/Enteral Extended Scope pharmacy.
(b) Such Policy and Procedure manuals shall
be made available to the Board or Department upon request.
(c) Prior to contracting for such services
the institutional pharmacy shall ensure that the Special Parenteral/Enteral
Extended Scope pharmacy is licensed under the provisions of Rule
64B16-28.860,
F.A.C.
Rulemaking Authority 465.005, 465.022 FS. Law Implemented
465.019(2)(c), 465.022 FS.
New 4-22-82, Amended 11-5-85, Formerly 21S-1.37, Amended
4-16-86, Formerly 21S-1.037, Amended 7-31-91, Formerly 21S-28.702,
61F10-28.702, Amended 9-4-96, Formerly 59X-28.702, Amended 10-15-01, 7-14-14,
3-15-16.
