Florida Statutes 465.019 – Institutional pharmacies; permits
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(1) Any institution desiring to operate an institutional pharmacy shall apply to the department. If the board certifies that the application complies with the laws of the state and the rules of the board governing pharmacies, the department shall issue the permit.
(2) The following classes of institutional pharmacies are established:
(a) “Class I institutional pharmacies” are those institutional pharmacies in which all medicinal drugs are administered from individual prescription containers to the individual patient and in which medicinal drugs are not dispensed on the premises, except that nursing homes licensed under part II of chapter 400 may purchase medical oxygen for administration to residents. No medicinal drugs may be dispensed in a Class I institutional pharmacy.
Terms Used In Florida Statutes 465.019
- Acute and postacute hospital care at home: means acute and postacute health care services provided in a clinically qualified patient's permanent residence, as defined in…. See Florida Statutes 465.003
- Administration: means the obtaining and giving of a single dose of medicinal drugs by a legally authorized person to a patient for her or his consumption. See Florida Statutes 465.003
- Board: means the Board of Pharmacy. See Florida Statutes 465.003
- Common control: means the power to direct or cause the direction of the management and policies of a person or an organization, whether by ownership of stock, voting rights, contract, or otherwise. See Florida Statutes 465.003
- community pharmacy: includes every location where medicinal drugs are compounded, dispensed, stored, or sold or where prescriptions are filled or dispensed on an outpatient basis. See Florida Statutes 465.003
- Compounding: means combining, mixing, or altering the ingredients of one or more drugs or products to create another drug or product. See Florida Statutes 465.003
- Consultant pharmacist: means a pharmacist licensed by the department and certified as a consultant pharmacist pursuant to…. See Florida Statutes 465.003
- Department: means the Department of Health. See Florida Statutes 465.003
- drugs: means those substances or preparations commonly known as "prescription" or "legend" drugs which are required by federal or state law to be dispensed only on a prescription, but shall not include patents or proprietary preparations as hereafter defined. See Florida Statutes 465.003
- Institutional formulary system: means a method whereby the medical staff evaluates, appraises, and selects those medicinal drugs or proprietary preparations which in the medical staff's clinical judgment are most useful in patient care, and which are available for dispensing by a practicing pharmacist in a Class II or Class III institutional pharmacy. See Florida Statutes 465.003
- institutional pharmacy: includes every location in a hospital, clinic, nursing home, dispensary, sanitarium, extended care facility, or other facility, hereinafter referred to as "health care institutions" where medicinal drugs are compounded, dispensed, stored, or sold. See Florida Statutes 465.003
- other pharmaceutical services: means monitoring the patient's drug therapy and assisting the patient in the management of his or her drug therapy, and includes reviewing, and making recommendations regarding, the patient's drug therapy and health care status in communication with the patient's prescribing health care provider as licensed under chapter 458, chapter 459, chapter 461, or chapter 466, or a similar statutory provision in another jurisdiction, or such provider's agent or such other persons as specifically authorized by the patient; and initiating, modifying, or discontinuing drug therapy for a chronic health condition under a collaborative pharmacy practice agreement. See Florida Statutes 465.003
- Pharmacist: means any person licensed pursuant to this chapter to practice the profession of pharmacy. See Florida Statutes 465.003
- Pharmacy: includes a community pharmacy, an institutional pharmacy, a nuclear pharmacy, a special pharmacy, and an Internet pharmacy. See Florida Statutes 465.003
- Prescription: includes any order for drugs or medicinal supplies written or transmitted by any means of communication by a duly licensed practitioner authorized by the laws of the state to prescribe such drugs or medicinal supplies and intended to be dispensed by a pharmacist. See Florida Statutes 465.003
(b) “Class II institutional pharmacies” are those institutional pharmacies which employ the services of a registered pharmacist or pharmacists who, in practicing institutional pharmacy, shall provide dispensing and consulting services on the premises to patients of that institution, for use on the premises of that institution. However, an institutional pharmacy located in an area or county included in an emergency order or proclamation of a state of emergency declared by the Governor may provide dispensing and consulting services to individuals who are not patients of the institution. However, a single dose of a medicinal drug may be obtained and administered to a patient on a valid physician’s drug order under the supervision of a physician or charge nurse, consistent with good institutional practice procedures. The obtaining and administering of such single dose of a medicinal drug shall be pursuant to drug-handling procedures established by a consultant pharmacist. Medicinal drugs may be dispensed in a Class II institutional pharmacy, but only in accordance with the provisions of this section.
(c) “Modified Class II institutional pharmacies” are those institutional pharmacies in short-term, primary care treatment centers that meet all the requirements for a Class II permit, except space and equipment requirements.
(d)1. “Class III institutional pharmacies” are those institutional pharmacies, including central distribution facilities, affiliated with a hospital which provide the same services that are authorized by a Class II institutional pharmacy permit. Class III institutional pharmacies may also:
a. Dispense, distribute, compound, and fill prescriptions for medicinal drugs for inpatient treatment or for patients receiving acute and postacute hospital care at home.
b. Prepare prepackaged drug products.
c. Conduct other pharmaceutical services for the affiliated hospital and for entities under common control that are each permitted under this chapter to possess medicinal drugs.
d. Provide the services in sub-subparagraphs a.-c. to an entity under common control which holds an active health care clinic establishment permit as required under s. 499.01(2)(r).
2. A Class III institutional pharmacy shall maintain policies and procedures addressing:
a. The consultant pharmacist responsible for pharmaceutical services.
b. Safe practices for the preparation, dispensing, prepackaging, distribution, and transportation of medicinal drugs and prepackaged drug products.
c. Recordkeeping to monitor the movement, distribution, and transportation of medicinal drugs and prepackaged drug products.
d. Recordkeeping of pharmacy staff responsible for each step in the preparation, dispensing, prepackaging, transportation, and distribution of medicinal drugs and prepackaged drug products.
e. Medicinal drugs and prepackaged drug products that may not be safely distributed among Class III institutional pharmacies.
(3) Medicinal drugs shall be stocked, stored, compounded, dispensed, or administered in any health care institution only when that institution has secured an institutional pharmacy permit from the department.
(4)(a) Medicinal drugs shall be dispensed by an institutional pharmacy to outpatients only when that institution has secured a community pharmacy permit from the department. However, medicinal drugs may be dispensed by a hospital that operates a Class II or Class III institutional pharmacy to a patient of the hospital’s emergency department or a hospital inpatient upon discharge if a prescriber, as defined in s. 465.025(1), treating the patient in such hospital determines that the medicinal drug is warranted and that community pharmacy services are not readily accessible, geographically or otherwise, to the patient. Such prescribing and dispensing must be for a supply of the drug that will last for the greater of the following:
1. Up to 48 hours; or
2. Through the end of the next business day.
(b) Notwithstanding subparagraph (a)1., if a state of emergency has been declared and is in effect for an area of this state pursuant to s. 252.36, a supply of a medicinal drug which will last up to 72 hours may be prescribed and dispensed under paragraph (a) in that area.
(c) A prescriber as defined in s. 465.025(1) who prescribes medicinal drugs under this subsection may provide the patient with a prescription for such drug for use beyond the initial prescription period if the prescriber determines that such use is warranted. Any prescribing or dispensing of a controlled substance under this subsection must comply with the applicable requirements of ss. 456.44 and 465.0276.
(d) The board may adopt rules to implement this subsection.
(5) All institutional pharmacies shall be under the professional supervision of a consultant pharmacist, and the compounding and dispensing of medicinal drugs shall be done only by a licensed pharmacist. Every institutional pharmacy that employs or otherwise uses registered pharmacy technicians shall have a written policy and procedures manual specifying those duties, tasks, and functions that a registered pharmacy technician is allowed to perform.
(6) In a Class II or Class III institutional pharmacy, an institutional formulary system may be adopted with approval of the medical staff for the purpose of identifying those medicinal drugs, proprietary preparations, biologics, biosimilars, and biosimilar interchangeables that may be dispensed by the pharmacists employed in such institution. A facility with a Class II or Class III institutional pharmacy permit which is operating under the formulary system shall establish policies and procedures for the development of the system in accordance with the joint standards of the American Hospital Association and American Society of Hospital Pharmacists for the utilization of a hospital formulary system, which formulary shall be approved by the medical staff.