1. (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. (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”):

   1. (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.
   2. (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.
   3. (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.
   4. (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. (3) All Modified Class II Institutional Pharmacies shall be under the control and supervision of a certified consultant pharmacist.
4. (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. (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. (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.

   1. (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.

   2. (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.

   3. (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. (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. (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. (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.

Rulemaking Authority 465.005, 465.022 FS. Law Implemented 465.019(2)(c), 465.022 FS. History–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, 3-24-25.