Fla. Admin. Code Ann. R. 64B16-28.702 - Modified Class II Institutional Pharmacies
(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.
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.
(9) A Modified Class II
institutional pharmacy engaged in sterile compounding for immediate use only is
exempt from the permitting requirements set forth in Rule 64B16-28.802, F.A.C.,
except for USP 800, NIOSH table 1 compounded sterile products, as referenced by
USP 797 and incorporated into Rule 64B16-27.797, F.A.C.
Notes
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.
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