Disciplinary proceedings; immunity; orders.
Prescription drugs and prescription devices.
Labeling of prescription drugs and prescription drug products.
Drugs for animal use.
Using drug product equivalent in dispensing prescriptions.
Placing prescription drugs prohibited.
Exhibition, display or advertisement of certain vending machines by use of certain material prohibited.
Sale of contraceptives prohibited in certain areas.
Ch. 450 Cross-reference
See definitions in s. 440.01
In this chapter:
"Administer" means the direct application of a vaccine or a prescribed drug or device, whether by injection, ingestion or any other means, to the body of a patient or research subject by any of the following:
A practitioner or his or her authorized agent.
A patient or research subject at the direction of a practitioner.
"Board" means the pharmacy examining board.
"Compound" means to mix, combine or put together various ingredients or drugs for the purpose of dispensing.
"Deliver" or "delivery" means the actual, constructive or attempted transfer of a drug or device from one person to another.
"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:
Recognized by the U.S. pharmacopoeia and national formulary or official homeopathic pharmacopoeia of the United States, or any supplement to either of them;
Intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease or other conditions in persons or other animals; or
Intended to affect the structure or any function of the body of persons or other animals.
"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.
"Distribute" means to deliver, other than by administering or dispensing.
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;
Any substance intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease or other conditions in persons or other animals;
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
Any substance intended for use as a component of any article specified in pars. (a)
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.
"Drug product" means a specific drug or drugs in a specific dosage form and strength from a known source of manufacture.
"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.
"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.
"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.
"Practice of pharmacy" means any of the following:
Compounding, packaging, labeling, dispensing and the coincident distribution of drugs and devices.
Proper and safe storage of drugs and devices and maintaining proper records of the drugs and devices.
Providing information on drugs or devices which may include, but is not limited to, advice relating to therapeutic values, potential hazards and uses.
Supervision of pharmacist supportive personnel.
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.
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.
Performing any act necessary to manage a pharmacy.
Administering prescribed drug products and devices under s. 450.035 (1r)
and, pursuant to vaccination protocols, vaccines.
"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.
"Prescribed drug or device" means any drug or device prescribed by a practitioner.
"Prescription" means a drug or device prescribed by a practitioner.
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)
only and for violations thereof punishable under s. 450.11 (9)
"Prescription order" means an order transmitted orally, electronically or in writing by a practitioner for a drug or device for a particular patient.
"Vaccination protocol" means a written protocol agreed to by a physician, as defined in s. 448.01 (5)
, and a pharmacist that establishes procedures and record-keeping and reporting requirements for the administration of a vaccine by a pharmacist for a period specified in the protocol that may not exceed 2 years.
Vitamins not intended for use in the diagnosis, cure, investigation, treatment, or prevention of diseases are not drugs under this section. 66 Atty. Gen. 137.
Pharmacy examining board. 450.02(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.
The board shall adopt rules defining the active practice of pharmacy. The rules shall apply to all applicants for licensure under s. 450.05
The pharmacy examining board shall, after consultation with the medical examining board and the board of nursing, promulgate rules that establish criteria for approving courses under ss. 450.035 (1r)
and 450.085 (1)
The board shall promulgate rules that establish requirements and procedures for the administration of a drug product or device, as defined in s. 450.035 (1g)
, by a pharmacist under s. 450.035 (1r)
. Notwithstanding s. 15.08 (5) (b)
, the board may promulgate rules under this paragraph only if the rules are identical to rules recommended by the pharmacist advisory council. The board may amend or repeal rules promulgated under this paragraph only upon the recommendation of the pharmacist advisory council.
The board shall periodically prepare and distribute letters, bulletins or other types of notice to pharmacists that identify the courses that are approved for purposes of ss. 450.035 (1r)
and 450.085 (1)
The board may promulgate rules:
Relating to the manufacture of drugs and the distribution and dispensing of prescription drugs.
Establishing security standards for pharmacies.
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.
Necessary for the administration and enforcement of this chapter and ch. 961
Establishing minimum standards for the practice of pharmacy.
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.
The board may not promulgate a rule which does any of the following:
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.
Pharmacist advisory council.
The pharmacist advisory council shall recommend rules for promulgation by the board under s. 450.02 (2g) (b)
and may recommend the amendment or repeal of any rules promulgated under s. 450.02 (2g) (b)
. A unanimous vote of the members of the pharmacist advisory council is required for the council to make a recommendation under this section.
History: 1997 a. 68
; 1997 a. 237
Pharmacist; licensure. 450.03(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:
The sale of any nonprescription drug product, in an original unbroken package, which complies with 21 USC 301