§ 318:1 — Definitions
In this chapter:
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In this chapter:
I. "Administer" means an act whereby a single dose of a drug is instilled into the body of, applied to the body of, or otherwise given to a person or animal for immediate consumption or use.
I-a. "Advanced practice registered nurse" means a person licensed to practice as an advanced practice registered nurse in this state pursuant to RSA 326-B:18.
II. "At retail" means the dispensing of drugs or medicines pursuant to the order of a physician, dentist, veterinarian, or advanced practice registered nurse, whether or not such drugs or medicines are dispensed for a valuable consideration.
III. "Board", when not otherwise limited, means the New Hampshire pharmacy board.
III-a. "Compounding" means the preparation, mixing, assembling, packaging or labeling of a drug or device as a result of a practitioner's prescription drug order or initiative based on the pharmacist-patient-prescriber relationship in the course of professional practice or, for the purpose of, or as an incident, to research, teaching, or chemical analysis, but not selling or dispensing. "Compounding" also includes the preparation of drugs or devices in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns. "Compounding" shall not include the reconstitution of powdered formulations before dispensing or the addition of flavoring. "Compounding" shall not include the simple addition of flavoring, nor shall it include the preparation of a single dose of a nonhazardous commercially available drug or licensed biologic for administration within 2 hours of preparation to an individual patient when done in accordance with the manufacturer's approved labeling or instructions consistent with that labeling.
IV. "Dentist" means a practitioner of dentistry duly registered under the laws of this or some other state.
V. "Dispense" means to distribute, leave with, give away, dispose of, deliver, or sell one or more doses of a drug that will be administered or taken at a later date, time, or location and shall include the transfer of more than a single dose of a medication from one container to another and the labeling or otherwise identifying a container holding more than a single dose of a drug.
V-a. "Distributor" means a person or persons who supply or facilitate the supply of prescription drugs to persons other than consumers.
VI. "Drugs", when not otherwise limited, means all substances used as medicines or in the practice of medicine.
VI-a. "Fee splitting" means any discount, rebate, dividend, shared income, or economic benefit from the sale of prescription medicine by a pharmacist or pharmacy with an individual licensed to prescribe medicine or such individual's spouse or dependent children.
VI-b. "Emergency medical care provider" means a person licensed to provide emergency medical care under RSA 151-B.
VI-c. "Foreign pharmacy graduate" is a pharmacist whose undergraduate pharmacy degree was conferred outside the United States by a pharmacy school listed in the World Directory of Schools of Pharmacy published by the World Health Organization.
VI-d. "FPGEC" means the Foreign Pharmacy Graduate Equivalency Committee administered by the National Association of Boards of Pharmacy.
VI-e. "FPGEE" means the Foreign Pharmacy Graduate Equivalency Examination administered by the National Association of Boards of Pharmacy and recognized and approved by the board.
VI-f. "Hormonal contraceptives" means pills, patches, and rings which the United States Food and Drug Administration (FDA) classifies as available by prescription for the purpose of contraception or emergency contraception. It does not include similar items classified as "over the counter" by the FDA, intrauterine devices, shots, or intradermal implants.
VI-g. "Law enforcement officer" means any officer of the state or political subdivision of the state who is empowered by law to conduct investigations of or to make arrests for offenses enumerated in this chapter.
VII. "Licensed pharmacist" or "pharmacist", when not otherwise limited, means a person holding a license under RSA 318:18 and who is, therefore, legally authorized to practice the profession of pharmacy in this state.
VII-a. "Limited retail drug distributor" means a distributor of legend devices or medical gases delivered directly to the consumer pursuant to a practitioner's prescription order, or federally funded clinics operated under contract with the department of health and human services and drug abuse treatment centers, where legend and controlled drugs are held, stored, or dispensed to patients pursuant to the order of an authorized practitioner.
VII-b. "Mail-order pharmacy" means a pharmacy that is located in a state of the United States, other than this state, whose primary business is to dispense a prescription drug or device under a prescription drug order and to deliver the drug or device to a patient, including a patient in this state, by the United States mail, a common carrier, or a delivery service. Mail-order pharmacies include, but are not limited to, pharmacies that do business via the Internet or other electronic media.
VIII. "Manufacturing" means the production, preparation, propagation, conversion or processing of a drug or device, either directly or indirectly, by large volume extraction from substances of natural origin, or independently by means of chemical or biological synthesis, and includes any packaging or repackaging of a substance or labeling or relabeling of its container, and the promotion and marketing of such drugs and devices for resale. Manufacturing shall be governed by Good Manufacturing Practices as adopted and enforced by the federal Food and Drug Administration.
IX. "Medicine", when not otherwise limited, means a drug or preparation of drugs in suitable form for use as a curative or remedial substance.
IX-a. "Nurse" means a person licensed to perform registered nursing as defined in RSA 326-B.
X. [Repealed.]
XI. "Pharmacy," when not otherwise limited, means the place registered by the office of professional licensure and certification where the profession of pharmacy is practiced and where drugs, chemicals, medicines, prescriptions, or poisons are compounded, dispensed, stored, or retailed.
XI-a. "Pharmacy benefits manager" means "pharmacy benefits manager" as defined in RSA 402-N:1, VIII.
XI-b. "Pharmacy technician" means a person, other than a pharmacist or a pharmacy intern, either registered or certified by the office of professional licensure and certification for the purpose of assisting a pharmacist in the practice of pharmacy.
XI-aa. "Pharmacy intern" means a person who is registered by the office of professional licensure and certification pursuant to RSA 318:15-b and:
(a) Is enrolled in a professional degree program of a school or college of pharmacy that has been approved by the board and is satisfactorily progressing toward meeting the requirements for licensure as a pharmacist starting no earlier than 4 months prior to the third year of study; or
(b) Is a graduate of an approved professional degree program of a school or college of pharmacy or is a graduate who has established educational equivalency by obtaining a Foreign Pharmacy Graduate Examination Committee (FPGEC) Certificate, who is currently licensed by the office for the purpose of obtaining practical experience as a requirement for licensure as a pharmacist; or
(c) Is a qualified applicant awaiting examination for licensure or meeting board requirements for re-licensure; or
(d) Is participating in a residency or fellowship program.
XII. "Physician" means a practitioner of medicine duly licensed under the laws of this or some other state.
XII-a. "Physician associate" means a person licensed as a physician associate under RSA 328-D.
XII-b. "Podiatrist" means a person authorized by law to practice podiatry in this state pursuant to RSA 315.
XIII. "Poisons", when not otherwise limited, means any drug, chemical medicine or preparation liable to be destructive to adult human life in quantities of 60 grains or less.
XIV. "Practice of pharmacy" means the professional acts performed by a pharmacist and shall include the interpretation and evaluation of prescription orders; the administration, compounding, dispensing, labeling and distribution of drugs and devices; the participation in drug selection and drug-related device selection; drug evaluation; utilization or regimen review; the monitoring of drug therapy and use; medication therapy management in accordance with collaborative pharmacy practice agreements; the proper and safe storage and distribution of drugs and devices, and the proper maintenance of proper records; the responsibility of advising, when necessary or when regulated, of therapeutic values, hazards, and use of drugs and devices; the initiating, ordering, administering, and analyzing of FDA approved Emergency Use Authorization SARS-CoV-2 (COVID-19) point-of-care diagnostic kits (COVID-19 tests or test kits) to detect SARS-CoV-2 or its antibodies, so long as the pharmacist has received the adequate education and training to do so; and the offering or performing of these acts, services, operations, or transactions necessary in the conduct, operation, management, and control of pharmacy.
XV. "Practitioner" or "licensed practitioner" means any person who is lawfully entitled to prescribe, administer, dispense or distribute legend drugs to patients.
XV-a. "Practitioner-patient relationship" means a medical connection between a licensed practitioner and a patient that includes an in-person exam or an exam using telemedicine, as defined in RSA 310, provided the health care practitioner: (i) verifies the identity of the patient receiving health care services through telemedicine; (ii) discloses to the patient the health care practitioner's name, contact information, and the type of health occupation license held by the health care practitioner; (iii) obtains oral or written consent from the patient or from the patient's parent or guardian, if state law requires the consent of a parent or guardian for use of telemedicine services; and (iv) meets the standard of care. A health care practitioner shall complete or review a history, a diagnosis, a treatment plan appropriate for the practitioner's scope of practice, and documentation of all prescription drugs including name and dosage. A practitioner may prescribe for a patient whom the practitioner does not have a practitioner-patient relationship under the following circumstances: for a patient of another practitioner for whom the prescriber is taking call; for a patient examined by another New Hampshire licensed practitioner; or for medication on a short-term basis for a new patient prior to the patient's first appointment. The definition of a practitioner-patient relationship shall not apply to a practitioner licensed in another state who is consulting to a New Hampshire licensed practitioner with whom the patient has a relationship.
XVI. "Prescription" means a verbal, or written, or facsimile or electronically transmitted order for drugs, medicines and devices by a practitioner licensed in the United States, to be compounded and dispensed by licensed pharmacists in a duly registered pharmacy, and to be kept on file for a period of 4 years. A written order shall include an electronic transmission prescription received and retained in a form complying with rules adopted pursuant to RSA 318:5-a, XV. Prescriptions may also apply to the finished products dispensed or administered by the licensed pharmacist in the registered pharmacy, on order of a licensed practitioner as defined in this section.
XVI-a. "Prescription device" or "legend device" means an instrument, apparatus, implement, machine, contrivance, implant, or other similar or related article, including any component part or accessory, which is restricted for distribution and use only upon the order of a licensed practitioner.
XVII. "Prescription drug", "legend drug," or "potent drug" means:
(a) A drug which under federal law is required, prior to being dispensed or delivered, to be labelled with any of the following statements:
(1) "Caution federal law prohibits dispensing without prescription", or
(2) "Caution federal law restricts this drug to use by or on the order of the licensed veterinarian", or
(3) "RX only", or
(b) A drug which is required by any applicable federal or state law or regulation to be dispensed on prescription only or is restricted to use by practitioners.
XVIII. "Nonprescription or proprietary medicine" shall mean non-narcotic medicines or drugs which may be sold without a prescription and which are prepackaged for use by the consumer and labeled in accordance with the requirements of the laws of this state and the federal government, provided that this definition shall not include the following:
(a) A drug, the label of which bears substantially either the statement "Caution-federal law prohibits dispensing without prescription" or "Warning-may be habit forming."
(b) A drug intended for injection.
XIX. "Supervision" means under the direct charge or direction and does not contemplate absence of the person responsible for providing such supervision, except where permitted by rules of the board under RSA 318:5-a, XIV.
XIX-a. "TOEFL" is the Test of English as a Foreign Language, as administered by American College Testing (ACT), or its successor, and certified by the FPGEC.
XX. "Veterinarian" means a practitioner of veterinary medicine duly registered under the laws of this or some other state.
XXI. "Wholesaler" means a person with facilities in or outside this state who obtains drugs for distribution or delivery to persons other than consumers.
XXII. "Automated pharmacy system" means mechanical systems that perform operations or activities, other than compounding or administration, relative to the storage, packaging, dispensing, or distribution of medications, and which collects, controls, and maintains all transaction information.
XXIII. "Central prescription processing" means the processing by a pharmacy of a request from another pharmacy to fill or refill a prescription drug order or to perform processing functions, such as dispensing, drug utilization review, claims adjudication, refill authorizations, and therapeutic interventions.
XXIV. "Electronic transmission prescription" means both image transmissions of a prescription order for which a facsimile of the order is received by a pharmacy from a licensed prescriber, and data transmissions of a prescription order, other than an electronic image transmission prescription, that is electronically transmitted by computer link, modem, or other computer communication device from a licensed prescriber to a pharmacy.
XXIV-a. "Electronic signature" means an electronic sound, symbol, or process attached to or logically associated with a record and executed or adopted by a person with the intent to sign the record.
XXV. "Attending practitioner" means the physician or advanced practice registered nurse who has the primary responsibility for the treatment and care of the patient.
XXVI. "Collaborative pharmacy practice" means the practice of pharmacy whereby one or more pharmacists jointly agree, on a voluntary basis, to work in conjunction with one or more attending practitioners under written protocol whereby the collaborating pharmacist or pharmacists may perform medication therapy management authorized by the attending practitioner or practitioners under certain specified conditions and limitations.
XXVII. "Collaborative pharmacy practice agreement" means a written and signed specific agreement between a pharmacist and an attending practitioner, that provides for collaborative pharmacy practice for the purpose of medication therapy management for the patient.
XXVIII. "Medication therapy management" means the review of medication therapy regimens of patients by a pharmacist for the purpose of evaluating and rendering advice to a practitioner, or evaluating and modifying the medication regimen in accordance with the collaborative pharmacy practice agreement. Decisions involving medication therapy management shall be made in the best interest of the patient. Medication therapy management shall be limited to:
(a) Implementing, modifying, and managing medication therapy according to the terms of the collaborative pharmacy practice agreement;
(b) Collecting and reviewing patient histories within the context of needs for pharmacy practice;
(c) Obtaining and checking vital signs, such as pulse, temperature, blood pressure, and respiration;
(d) Ordering laboratory tests as specifically set out in the collaborative pharmacy practice agreement between the pharmacist and the attending practitioner that are specific to the medication or protocol-driven;
(e) Formulating a medication treatment plan that will be shared with the patient's attending practitioner;
(f) Monitoring and evaluating the patient's response to therapy, including safety and effectiveness;
(g) Performing a comprehensive medication review, in conjunction with the attending practitioner, to identify, resolve, and prevent medication-related problems, including adverse drug events;
(h) Documenting the care delivered and, if applicable, communicating essential information to the patient's other health care providers; and
(i) Providing education and training designed to enhance patient understanding and the appropriate use of his or her medications.
XXIX. "Reverse distributor" means a person or persons who facilitate the removal, disposal, or destruction of prescription drugs to persons other than consumers.
XXX. "Outsourcing facility" means a facility at one geographic location or address that is engaged in the compounding of sterile drugs, has elected to register as an outsourcing facility, and complies with all of the requirements of section 503B of the Federal Food, Drug, and Cosmetic Act.
XXXI. (a) "Research organization" means an entity, including a biotechnology company or research institute, whose primary goal is to conduct fundamental research, industrial research, or experimental development relating to drug products, disease and drug diagnostics, and/or drug manufacturing technologies.
(b) A "research organization" shall not include:
(1) A "sponsor," "sponsor-investigator," or "contract research organization" as such terms are defined in 21 C.F.R. section 312.3;
(2) An "applicant" as such term is defined in 21 C.F.R. section 314.3; a "manufacturer," "processor," "packer," or "distributor" as such terms are used in the Federal Food, Drug, and Cosmetic Act (21 U.S.C. section 301 et. seq.); or
(3) A "manufacturer" or "applicant" as such terms are used in 21 C.F.R. section 601.2.
XXXII. "Researcher" means a qualified person representing a research organization licensed by the office of professional licensure and certification pursuant to RSA 318:51-f.
XXXIII. "Licensed advanced pharmacy technician" means a person licensed by the office of professional licensure and certification who:
(a) May perform all functions allowed by federal or state law and approved by the board, under the supervision of a licensed pharmacist who is physically on premises and holds an unrestricted license issued by the office.
(b) May conduct product verification, process refills, verify repackaging of drugs, and perform other pharmacist tasks not required to be completed by a licensed pharmacist.
(c) May perform duties allowed by either certified or registered pharmacy technicians.
(d) Shall not interpret or evaluate a prescription or drug order, verify a compounded drug, or counsel or advise individuals related to the clinical use of a medication.
XXXIV. "Remote processing" means accessing the pharmacy database to perform non-dispensing activities other than at a licensed pharmacy. The pharmacy shall establish controls to protect the confidentiality and integrity of patient information, as required by HIPAA, and prevent any patient information from being downloaded, duplicated, or removed from the electronic database.
XXXV. "Non-dispensing activities" are activities permitted under that individual's scope of practice that do not require the physical possession of prescription drugs. Non-dispensing activities include, but are not limited to, prescription transfers, drug utilization reviews, product verification tasks, claims adjudications, refill authorizations, entering patient and prescription information into a pharmacy's electronic database, any other task permitted under that individual's scope of practice that does not require the physical possession of prescription drugs, or other activities established by rules of the board adopted pursuant to RSA 541-A.
XXXVI. "Nicotine cessation therapy" means medications which the United States Food and Drug Administration (FDA) classifies as available by prescription or without a prescription for the purpose of nicotine cessation.
XXXVII. "Permit holder" means the entity that owns or operates the pharmacy licensed to operate in the state and is responsible for the facility and overall operation of the pharmacy.
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