§ 5-19.1-2 - Definitions.
SECTION 5-19.1-2
§ 5-19.1-2 Definitions. – (a) "Board" means the Rhode Island board of pharmacy.
(b) "Change of ownership" means:
(1) In the case of a pharmacy, manufacturer, or wholesaler,which is a partnership, any change which results in a new partner acquiring acontrolling interest in the partnership;
(2) In the case of a pharmacy, manufacturer or wholesalerwhich is a sole proprietorship, the transfer of the title and property toanother person;
(3) In the case of a pharmacy, manufacturer, or wholesalerwhich is a corporation:
(i) A sale, lease exchange, or other disposition of all orsubstantially all of the property and assets of the corporation; or
(ii) A merger of the corporation into another corporation; or
(iii) The consolidation of two (2) or more corporations,resulting in the creation of a new corporation; or
(iv) In the case of a pharmacy, manufacturer, or wholesalerwhich is a business corporation, any transfer of corporate stock which resultsin a new person acquiring a controlling interest in the corporation; or
(v) In the case of a pharmacy, manufacturer, or wholesalerwhich is a non-business corporation, any change in membership, which results ina new person acquiring a controlling vote in the corporation.
(c) "Compounding" means the act of combining two (2) or moreingredients as a result of a practitioner's prescription or medication orderoccurring in the course of professional practice based upon the individualneeds of a patient and a relationship between the practitioner, patient, andpharmacist. Compounding does not mean the routine preparation, mixing orassembling of drug products that are essentially copies of a commerciallyavailable product. Compounding shall only occur in the pharmacy where the drugor device is dispensed to the patient or caregiver and includes the preparationof drugs or devices in anticipation of prescription orders based upon routine,regularly observed prescribing patterns.
(d) "Controlled substance" means a drug or substance, or animmediate precursor of such drug or substance, so designated under or pursuantto the provisions of chapter 28 of title 21.
(e) "Deliver" or "delivery" means the actual, constructive,or attempted transfer from one person to another of a drug or device, whetheror not there is an agency relationship.
(f) "Device" means instruments, apparatus, and contrivances,including their components, parts, and accessories, intended:
(1) For use in the diagnosis, cure, mitigation, treatment, orprevention of disease in man or other animals; or
(2) To affect the structure or any function of the body ofman or other animals.
(g) "Director" means the director of the Rhode Island statedepartment of health.
(h) "Dispense" means the interpretation of a prescription ororder for a drug, biological, or device and, pursuant to that prescription ororder, the proper selection, measuring, compounding, labeling, or packagingnecessary to prepare that prescription or order for delivery or administration.
(i) "Distribute" means the delivery of a drug or device otherthan by administering or dispensing.
(j) "Drug" means:
(1) Articles recognized in the official United StatesPharmacopoeia or the Official Homeopathic Pharmacopoeia of the U.S.;
(2) Substances intended for use in the diagnosis, cure,mitigation, treatment, or prevention of disease in man, woman or other animals;
(3) Substances (other than food) intended to affect thestructure or any function of the body of man, woman or other animals; or
(4) Substances intended for use as a component of anysubstances specified in subdivision (1), (2), or (3) of this subsection and§ 5-19-1(16), but not including devices or their component parts oraccessories.
(k) "Equivalent and interchangeable" means having the samegeneric name, dosage form, and labeled potency, meeting standards of the UnitedStates Pharmacopoeia or National Formulary, or their successors, if applicable,and not found in violation of the requirements of the United States Food andDrug Administration, or its successor agency, or the Rhode Island department ofhealth.
(l) "Intern" means:
(1) A graduate of an American Council on PharmaceuticalEducation (ACPE) accredited program of pharmacy;
(2) A student who is enrolled in at least the first year of aprofessional ACPE accredited program of pharmacy; or
(3) A graduate of a foreign college of pharmacy who hasobtained full certification from the FPGEC (Foreign Pharmacy GraduateEquivalency Commission) administered by the National Association of Boards ofPharmacy.
(m) "Legend drugs" means any drugs, which are required by anyapplicable federal or state law or regulation to be dispensed on prescriptiononly or are restricted to use by practitioners only.
(n) "Manufacture" means the production, preparation,propagation, compounding, or processing of a drug or other substance or deviceor the packaging or repackaging.
(o) "Non-legend" or "nonprescription drugs" means any drugs,which may be lawfully sold without a prescription.
(p) "Person" means an individual, corporation, government,subdivision or agency, business trust, estate, trust, partnership orassociation, or any other legal entity.
(q) "Pharmaceutical care" is the provision of drugs and otherpharmaceutical services intended to achieve outcomes related to cure orprevention of a disease, elimination or reduction of a patient's symptoms, orarresting or slowing of a disease process. "Pharmaceutical care" includes thejudgment of a pharmacist in dispensing an equivalent and interchangeable drugor device in response to a prescription, after appropriate communication withthe prescriber and the patient.
(r) "Pharmacist-in-charge" means a pharmacist licensed inthis state as designated by the owner as the person responsible for theoperation of a pharmacy in conformance with all laws and regulations pertinentto the practice of pharmacy and who is personally in full and actual charge ofsuch pharmacy and personnel.
(s) "Pharmacy" means that portion or part of a premise whereprescriptions are compounded and dispensed, including that portion utilized forthe storage of prescription or legend drugs.
(t) "Pharmacy technician" means an individual who meetsminimum qualifications established by the board, which are less than thoseestablished by this chapter as necessary for licensing as a pharmacist, andworks under the direction and supervision of a licensed pharmacist.
(u) "Practice of pharmacy" means the interpretation,evaluation, and implementation of medical orders; the dispensing ofprescription drug orders; participation in drug and device selection; thecompounding of prescription drugs; drug regimen reviews and drug or drugrelated research; the administration of adult immunizations pursuant to a validprescription or physician approved protocol and in accordance with regulations,to include training requirements as promulgated by the department of health;provision of patient counseling and the provision of those acts or servicesnecessary to provide pharmaceutical care; and/or the responsibility for thesupervision for compounding and labeling of drugs and devices (except labelingby a manufacturer, repackager, or distributor of non-prescription drugs andcommercially packaged legend drugs and devices), proper and safe storage ofdrugs and devices, and maintenance of proper records for them. Nothing in thisdefinition shall be construed to limit or otherwise affect the scope ofpractice of any other profession.
(v) "Practitioner" means a physician, dentist, veterinarian,nurse or other person duly authorized by law in the state in which theypractice to prescribe drugs.
(w) "Preceptor" means a pharmacist registered to engage inthe practice of pharmacy in this state, who has the responsibility for traininginterns.
(x) "Prescription" means an order for drugs or devices issuedby the practitioner duly authorized by law in the state in which he or shepractices to prescribe drugs or devices in the course of his or herprofessional practice for a legitimate medical purpose.
(y) "Wholesaler" means a person who buys drugs or devices forresale and distribution to corporations, individuals, or entities other thanconsumers.