CHAPTER 450
PHARMACY EXAMINING BOARD
450.02 Pharmacy examining board.
450.03 Pharmacist; licensure.
450.05 Pharmacist licensed in other state; licensure.
450.06 Pharmacy; licensure.
450.07 Manufacturers and distributors; licensure.
450.09 Pharmacy practice.
450.10 Disciplinary proceedings; immunity; orders.
450.11 Prescription drugs and prescription devices.
450.12 Labeling of prescription drugs and prescription drug products.
450.125 Drugs for animal use.
450.13 Using drug product equivalent in dispensing prescriptions.
450.15 Placing prescription drugs prohibited.
450.155 Exhibition, display or advertisement of certain vending machines by use of certain material prohibited.
450.16 Sale of contraceptives prohibited in certain areas.
Ch. 450 Cross-reference
Cross-reference: See definitions in s.
440.01.
450.01
450.01
Definitions. In this chapter:
450.01(1)
(1) "Administer" means the direct application of a prescribed drug or device, whether by injection, ingestion or any other means, to the body of a patient or research subject by:
450.01(1)(a)
(a) A practitioner or his or her authorized agent; or
450.01(1)(b)
(b) The patient or research subject at the direction of the practitioner.
450.01(2)
(2) "Board" means the pharmacy examining board.
450.01(3)
(3) "Compound" means to mix, combine or put together various ingredients or drugs for the purpose of dispensing.
450.01(5)
(5) "Deliver" or "delivery" means the actual, constructive or attempted transfer of a drug or device from one person to another.
450.01(6)
(6) "Device" means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar or related article, including any component, part or accessory, which does not achieve any of its principal intended purposes through chemical action within or on the body of a person or other animal, is not dependent upon being metabolized for the achievement of any of its principal intended purposes and is:
450.01(6)(a)
(a) Recognized by the U.S. pharmacopoeia and national formulary or official homeopathic pharmacopoeia of the United States, or any supplement to either of them;
450.01(6)(b)
(b) Intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease or other conditions in persons or other animals; or
450.01(6)(c)
(c) Intended to affect the structure or any function of the body of persons or other animals.
450.01(7)
(7) "Dispense" means to deliver a prescribed drug or device to an ultimate user or research subject by or pursuant to the prescription order of a practitioner, including the compounding, packaging or labeling necessary to prepare the prescribed drug or device for delivery.
450.01(8)
(8) "Distribute" means to deliver, other than by administering or dispensing.
450.01(10)(a)
(a) Any substance recognized as a drug in the official U.S. pharmacopoeia and national formulary or official homeopathic pharmacopoeia of the United States or any supplement to either of them;
450.01(10)(b)
(b) Any substance intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease or other conditions in persons or other animals;
450.01(10)(c)
(c) Any substance other than a device or food intended to affect the structure or any function of the body of persons or other animals; or
450.01(10)(d)
(d) Any substance intended for use as a component of any article specified in
pars. (a) to
(c) but does not include gases or devices or articles intended for use or consumption in or for mechanical, industrial, manufacturing or scientific applications or purposes.
450.01(11)
(11) "Drug product" means a specific drug or drugs in a specific dosage form and strength from a known source of manufacture.
450.01(13)
(13) "Manufacturing" means making, assembling, processing or modifying devices, or mixing, producing or preparing drugs in dosage forms by encapsulating, entableting or other process, or packaging, repackaging or otherwise changing the container, wrapper or label of any package containing a drug or device in furtherance of the distribution of the drug or device from the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer.
450.01(13m)
(13m) "Nonprescription drug product" means any nonnarcotic drug product which may be sold without a prescription order and which is prepackaged for use by consumers and labeled in accordance with the requirements of state and federal law.
450.01(14)
(14) "Patient" means the person or other animal for whom drug products or devices are prescribed or to whom drug products or devices are dispensed or administered.
450.01(16)
(16) "Practice of pharmacy" means any of the following:
450.01(16)(b)
(b) Compounding, packaging, labeling, dispensing and the coincident distribution of drugs and devices.
450.01(16)(d)
(d) Proper and safe storage of drugs and devices and maintaining proper records of the drugs and devices.
450.01(16)(e)
(e) Providing information on drugs or devices which may include, but is not limited to, advice relating to therapeutic values, potential hazards and uses.
450.01(16)(g)
(g) Supervision of pharmacist supportive personnel.
450.01(16)(h)
(h) Making therapeutic alternate drug selections in accordance with written guidelines or procedures previously established by a pharmacy and therapeutics committee of a hospital and approved by the hospital's medical staff and by an individual physician for his or her patients for the period of each patient's stay within the hospital.
450.01(16)(i)
(i) Drug regimen screening, including screening for therapeutic duplication, drug-to-drug interactions, incorrect dosage, incorrect duration of treatment, drug allergy reactions and clinical abuse or misuse.
450.01(16)(j)
(j) Performing any act necessary to manage a pharmacy.
450.01(17)
(17) "Practitioner" means a person licensed in this state to prescribe and administer drugs or licensed in another state and recognized by this state as a person authorized to prescribe and administer drugs.
450.01(18)
(18) "Prescribed drug or device" means any drug or device prescribed by a practitioner.
450.01(19)
(19) "Prescription" means a drug or device prescribed by a practitioner.
450.01(20)(a)
(a) Any drug, drug product or drug-containing preparation which is subject to
21 USC 353 (b) or
21 CFR 201.105.
450.01(20)(b)
(b) Any controlled substance included in schedules II to V of
ch. 961, whether by statute or rule, except substances which by law may be dispensed without the prescription order of a practitioner. Controlled substances are included within this definition for purposes of
s. 450.11 (3),
(4) (a) and
(8) only and for violations thereof punishable under
s. 450.11 (9).
450.01(21)
(21) "Prescription order" means a written or oral order by a practitioner for a drug or device for a particular patient.
450.01 Annotation
Vitamins not intended for use in the diagnosis, cure, investigation, treatment or prevention of diseases are not drugs within the meaning of this section. 66 Atty. Gen. 137.
450.02
450.02
Pharmacy examining board. 450.02(1)
(1) The department shall keep a record of the proceedings and a register of the names and places of practice or business of pharmacies, manufacturers, distributors and other persons licensed under this chapter, and the books, registers and records of the department shall be prima facie evidence of the matters recorded.
450.02(2)
(2) The board shall adopt rules defining the active practice of pharmacy. The rules shall apply to all applicants for licensure under
s. 450.05.
450.02(3)(a)
(a) Relating to the manufacture of drugs and the distribution and dispensing of prescription drugs.
450.02(3)(b)
(b) Establishing security standards for pharmacies.
450.02(3)(c)
(c) Relating to the manufacture, distribution and dispensing of hypodermic syringes, needles and other objects used, intended for use or designed for use in injecting a drug.
450.02(3)(d)
(d) Necessary for the administration and enforcement of this chapter and
ch. 961.
450.02(3)(e)
(e) Establishing minimum standards for the practice of pharmacy.
450.02(3)(f)
(f) Establishing procedures for identifying pharmacists impaired by alcohol or other drugs or physical or mental disability or disease and for assisting those pharmacists in obtaining treatment.
450.02(4)
(4) The board may not promulgate a rule which does any of the following:
450.02(4)(a)
(a) Limits to a pharmacist the authority to sell or in any way interferes with the sale of nonnarcotic nonprescription drugs that are prepackaged for consumer use and labeled in compliance with all applicable state and federal laws.
450.03
450.03
Pharmacist; licensure. 450.03(1)
(1) No person may engage in the practice of pharmacy or use the title "pharmacist" or sell, give away or barter drugs unless the person is licensed as a pharmacist by the board. This subsection does not apply to:
450.03(1)(b)
(b) The sale of any nonprescription drug product, in an original unbroken package, which complies with
21 USC 301 to
392.
