New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 39 - STATE BOARD OF PHARMACY › Subchapter 1 - GENERAL PROVISIONS › Section 13:39-1.2 - Definitions

Current through Register Vol. 56, No. 14, July 15, 2024
The following words and terms when used in this chapter shall have the following meanings, unless the context clearly indicates otherwise.
"Address of record" means an address designated by a licensee or registrant, which is part of the public record and may be disclosed upon request. "Address of record" may be a licensee's or registrant's home, business, or mailing address, but shall not be a post office box, unless the licensee or registrant also provides another address that includes a street, city, state, and zip code.
"Biological product" means a "biological product" as defined in subsection (i) of section 351 of the Public Health Service Act ( 42 U.S.C. §
										262(i) ), and refers to a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein other than a chemically synthesized polypeptide, or analogous product, or arsphenamine or any derivative of arsphenamine or any other trivalent organic arsenic compound, applicable to the prevention, treatment, or cure of a disease or condition of human beings.
"Board" means the New Jersey State Board of Pharmacy.
"Compounding" means the preparation, mixing, assembling, packaging and labeling of a drug or device as the result of a practitioner's prescription or initiative based on the relationship of the practitioner or patient with the pharmacist in the course of professional practice or for the purpose of, or incident to, research, teaching or chemical analysis and not for sale or dispensing. Compounding also includes the preparation of drugs or devices in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns.
"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 is required under Federal or State law to be prescribed by an authorized prescriber and dispensed by a pharmacist, in the usual scope of pharmacy practice.
"Dispense or dispensing" means the procedure entailing the interpretation of a practitioner's prescription or medication order for a drug, biological or device, and, pursuant to that order, the proper selection, measuring, compounding, labeling and packaging in a proper container for the subsequent administration to, or use by, a patient. The act of dispensing shall include all necessary consultation by the pharmacist.
"Drug or medication" means:
1. Articles recognized in the official United States Pharmacopoeia/National Formulary, official Homeopathic Pharmacopoeia of the United States, or any official supplement to any of them;
2. Articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in human beings or animals;
3. Articles (other than food) intended to affect the structure of any function of the body of human beings or animals; and
4. Articles intended for use as components of any article specified in 1, 2 or 3 above, but not including devices or their components, parts or accessories.
"Immediate personal supervision" means that the pharmacist is physically present in the compounding/dispensing area when interns, externs and pharmacy technicians are performing delegated duties, and the pharmacist conducts any necessary in-process checks and the final check in preparation and compounding of medications, including the checking of each ingredient used, the quantity of each ingredient whether weighed, measured or counted, the finished label and the accuracy and appropriateness of the actions of pharmacy technicians, interns and externs.
"Interchangeable" means "interchangeable" as defined in subsection (i) of section 351 of the Public Health Service Act ( 42 U.S.C. §
										262(i) ) and indicated as interchangeable by the Federal Food and Drug Administration in the "Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations," sometimes referred to as the "Purple Book."
"Legend drug or device" means any drug or device that:
1. Bears, at a minimum, the symbol "Rx only" or words of similar import; and/or
2. Requires a prescription or order by a practitioner.
"Pharmaceutical services" means all patient-oriented services provided by a pharmacist or other pharmacy personnel specific to their scope of practice. These services shall be concerned with, but not limited to: interpreting the prescription or medication order; selecting, preparing, compounding, packaging, labeling, distributing, and dispensing prescribed drugs; the proper and safe storage of drugs; the monitoring of drug therapy; the reporting and recording of adverse drug reactions and the provision of appropriate drug information; and teaching and counseling on the proper and safe use of drugs and medications.
"Pharmacist" means an individual holding an active license to engage in the practice of pharmacy in this State.
"Pharmacy" means a location permitted by the Board to engage in the practice of pharmacy in this State.
"Pharmacy extern" or "extern" means a "pharmacy extern" as defined at 13:39-2.6(a).
"Pharmacy intern" or "intern" means a "pharmacy intern" as defined at 13:39-2.6(a).
"Pharmacy technician" means an individual registered with the Board and who works under the immediate personal supervision of a pharmacist in compliance with 13:39-6.15. For purposes of this definition, interns, externs, cashiers, stocking and clerical help are not pharmacy technicians.
"Practitioner" means an individual currently licensed, registered or otherwise authorized by the jurisdiction in which the individual practices to administer or prescribe drugs and/or devices in the course of professional practice.
"Prescription" means a lawful order of a practitioner for a drug, device or diagnostic agent for a specific patient.
"Professional judgment" means judiciousness and discretion based upon thorough knowledge and sound application of the specialized body of knowledge specific to the practice of pharmacy, and an understanding of the relationship of this knowledge and its application to the well-being of the patient and to the judgment of the practitioner.
"Therapeutically equivalent" means a therapeutic equivalence rating of "A" as has been listed by the Federal Food and Drug Administration in the "Approved Drug Products with Therapeutic Equivalence Evaluations," sometimes referred to as the "Orange Book."