Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B16 - Board of Pharmacy › Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS › Section 64B16-28.702 - Modified Class II Institutional Pharmacies

Current through Reg. 50, No. 138; July 16, 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.