This chapter may be known as the Pharmacy Act.
The board shall adopt regulations regarding the issuance of a temporary license to practice pharmacy.
The board shall adopt regulations regarding the issuance of an emergency permit to practice pharmacy.
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Four members constitute a quorum for the transaction of business. However, when the board meets for the purpose of examining applications for licensure, three members of the board constitute a quorum.
This chapter does not apply to the safe storage, preservation, dispensing, or control of drugs in a federally operated hospital or institution.
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A person may not assume or use the title 'pharmacist,' or any variation of the title, or hold out to be a pharmacist, without being licensed.
A member of the board may be removed from office by the governor for cause.
Article 02. LICENSING AND REGISTRATION
The board shall establish requirements for continuing education in pharmacy that must be satisfied before a license issued under this chapter may be renewed.
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It is the purpose of this chapter to promote, preserve, and protect the public health, safety, and welfare by and through the effective control and regulation of the practice of pharmacy.
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Members of the board are entitled to reimbursement for actual travel expenses incidental to the discharge of their duties and, while in the performance of their duties, are entitled to the per diem expenses allowed by law.
A pharmacist shall disclose the price of filling any prescription when requested by the consumer.
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The board shall comply with AS 44.62 (Administrative Procedure Act).
A person may not display in a place of business the characteristic pharmacy symbol of 'Rx' in any form unless the business has a pharmacist licensed under this chapter.
The board shall meet at least three times each year at the call of the president for the transaction of business properly before it. The president shall also call the board into session when requested in writing by at least two members. Meetings may be held telephonically.
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If a pharmacist fails to apply for renewal of a license within five years from the expiration of the license, the person must pass an examination for license renewal, except that a person who has continually practiced pharmacy in another state under a license issued by the authority of that state may renew an expired license in this state upon fulfillment of the requirements that may be established by the board.
This chapter does not affect the practice of medicine by a licensed medical doctor and does not limit a licensed medical doctor, osteopath, podiatrist, physician assistant, advanced nurse practitioner, dentist, veterinarian, dispensing optician, or optometrist in supplying a patient with any medicinal preparation or article within the scope of the person's license.
The practice of pharmacy is declared to be a professional practice affecting the public health, safety, and welfare and is subject to regulation and control in the public interest. It is further declared to be a matter of public interest that only qualified persons be permitted to engage in the practice of pharmacy, and to ensure the quality of drugs and related devices distributed in the state.
The board may consider a complaint based upon the alleged violation of any provision of this chapter and may, by a majority vote of a quorum, dismiss the complaint, reprimand a licensee, or take other punitive action as the nature of the facts warrant. Orders issued by the board shall be in writing, signed by a majority and filed with the secretary of the board. The accused shall receive an authenticated copy of the order.
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Nothing in this chapter amends, modifies, repeals or otherwise changes any provision of AS 11.71, AS 17.30, or AS 17.20 (the Alaska Food, Drug and Cosmetic Act).
The examination or examinations shall be prepared to measure the competence of the applicant to engage in the practice of pharmacy. The board may employ, cooperate, and contract with an organization or consultant in the preparation and grading of an examination, but shall retain sole discretion and responsibility for determining which applicants have successfully passed the examinations.
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Article 04. UNLAWFUL ACTS
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(a) A person may not use or exhibit the title 'pharmacist,' 'assistant pharmacist,' or 'druggist,' or the descriptive term 'pharmacy,' 'drug store,' 'drug sundries,' or other similar title or term containing the word 'drug,' in any business premises, or in an advertisement through the media of press, or publication, or by radio or television, unless the business has a licensed pharmacist in regular and continuous employment.
(b) [Repealed by Sec. 21 ch 166 SLA 1980].
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(a) Unless the prescription indicates that it is to be dispensed only as written, the pharmacist may, with the consent of the patient, substitute an equivalent drug product.
(b) A pharmacist who substitutes an equivalent drug product in compliance with this section and applicable regulations incurs no greater liability in filling the prescription than would be incurred in filling the prescription by dispensing the prescribed name brand product.
(a) In addition to other information that may be required under state or federal laws or regulations, a pharmacist, when dispensing a brand-name prescription drug order, shall include the generic drug name that is an equivalent drug product for the drug dispensed.
(b) The generic drug name required under (a) of this section shall be placed directly on the container's label near the brand name.
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Article 03. DUTIES OF LICENSED PHARMACISTS
Information maintained by a pharmacist in the patient's records or that is communicated to the patient as part of patient counseling is confidential and may be released only to
(1) the patient or as the patient directs;
(2) a practitioner or pharmacist when, in the pharmacist's professional judgment, release is necessary to protect the patient's health and well-being; and
(3) other persons or governmental agencies authorized by law to receive confidential information.
(a) Except as provided in (b) of this section the board may not regulate the sale of patent or nonprescription drugs that are prepackaged for use by the consumer, are in their original, unbroken packaging, and are labeled in accordance with requirements of the federal government.
(b) The board may regulate the sale and distribution of patent or nonprescription drugs under AS 44.62.250 when the regulation is required by an emergency to protect the public health and safety.
(a) An applicant for licensure by examination shall obtain practical experience in the practice of pharmacy concurrent with or after college attendance, or both, under terms and conditions the board shall determine.
(b) The board shall establish licensure requirements for interns and standards for internship or other training programs that are necessary to qualify an applicant for the licensure examination and shall also determine the qualifications of preceptors used in practical experience programs.
(a) A person who violates a provision of this chapter is guilty of a class B misdemeanor.
(b) A person who violates the provisions of AS 08.80.295 is punishable by a civil fine in an amount established by the board in a schedule or schedules establishing the amount of civil fine for a particular violation. The schedule or schedules shall be adopted by the board by regulation. Any civil fine imposed under this section may be appealed in the manner provided for appeals in AS 44.62 (Administrative Procedure Act).
Article 05. GENERAL PROVISIONS
(a) A hospital, clinic, nursing home, infirmary, or related facility that dispenses drugs for outpatient treatment shall have a licensed pharmacist in charge of the dispensary, except that prescriptions may be compounded and dispensed by or under the supervision of the prescribing physician.
(b) The board shall issue a license to a hospital drug room, nursing home drug room, or related facility that dispenses drugs from bulk supply for inpatient treatment, providing the facility employs a licensed pharmacist on a continual or consultant basis.
(a) There is created the Board of Pharmacy, composed of seven members, five of whom shall be pharmacists licensed in the state who have been actively engaged in the practice of pharmacy in the state for a period of three years immediately preceding their appointment. Two shall be persons with no direct financial interest in the health care industry. Whenever possible, the board shall include at least one member from each judicial district.
(b) An officer elected by the board serves a term of one year and may not serve more than four consecutive full terms in a specific office.
(a) Each pharmacy shall have a pharmacist-in-charge. Whenever an applicable law or regulation requires or prohibits action by a pharmacy, responsibility shall be that of the owner and the pharmacist-in-charge, whether the owner is a sole proprietor, partnership, association, corporation, or otherwise. The pharmacist-in-charge shall ensure compliance with all laws and regulations governing the operation of the pharmacy. A licensed pharmacist appointed as pharmacist-in-charge of a pharmacy shall immediately advise the board of that appointment.
(b) A license may not be issued to a pharmacy unless there is a licensed registered pharmacist-in-charge whose name appears on the face of the license.
The Department of Commerce, Community, and Economic Development shall set fees under AS 08.01.065 for the following:
(1) examination;
(2) reexamination;
(3) investigation for licensing by license transfer;
(4) pharmacist license;
(5) temporary license;
(6) pharmacy technician license;
(7) pharmacy intern license;
(8) emergency permit;
(9) license amendment or replacement;
(10) registration or licensure of a facility classified under AS 08.80.157(b).
An applicant for licensure as a pharmacist shall
(1) be fluent in the reading, writing, and speaking of the English language;
(2) furnish the board with at least two affidavits from reputable citizens that the applicant has known for at least one year attesting to the applicant's good moral character;
(3) be a graduate of a college in a degree program approved by the board;
(4) pass an examination or examinations given by the board or acceptable to the board under the score transfer process administered by the National Association of Boards of Pharmacy;
(5) have completed internship training or another program that has been approved by the board or demonstrated to the board's satisfaction that the applicant has experience in the practice of pharmacy that meets or exceeds the minimum internship requirements of the board.
If another jurisdiction allows licensure in that jurisdiction of a pharmacist licensed in this state under conditions similar to those in this section, the board may license as a pharmacist in this state a person licensed as a pharmacist in the other jurisdiction if the person
(1) submits a written application to the board on a form required by the board;
(2) is at least 18 years of age;
(3) is of good moral character;
(4) possesses at the time of the request for licensure as a pharmacist in this state the qualifications necessary to be eligible for licensure in this state;
(5) has engaged in the practice of pharmacy for at least one year or has met the internship requirements of this state within the one-year period immediately before applying for a license under this section;
(6) presents proof satisfactory to the board that the person is currently licensed as a pharmacist in the other jurisdiction and does not currently have a pharmacist license suspended, revoked, or otherwise restricted except for failure to apply for renewal or failure to obtain the required continuing education credits;
(7) has passed an examination approved by the board that tests the person's knowledge of Alaska laws relating to pharmacies and pharmacists and the regulations adopted under those laws; and
(8) pays all required fees.
(a) The board is responsible for the control and regulation of the practice of pharmacy.
(b) In order to fulfill its responsibilities, the board has the powers necessary for implementation and enforcement of this chapter, including the power to
(1) elect a president and secretary from its membership and adopt rules for the conduct of its business;
(2) license by examination or by license transfer the applicants who are qualified to engage in the practice of pharmacy;
(3) assist the department in inspections and investigations for violations of this chapter, or of any other state or federal statute relating to the practice of pharmacy;
(4) adopt regulations to carry out the purposes of this chapter;
(5) establish and enforce compliance with professional standards and rules of conduct for pharmacists engaged in the practice of pharmacy;
(6) determine standards for recognition and approval of degree programs of schools and colleges of pharmacy whose graduates shall be eligible for licensure in this state, including the specification and enforcement of requirements for practical training, including internships;
(7) establish for pharmacists and pharmacies minimum specifications for the physical facilities, technical equipment, personnel, and procedures for the storage, compounding, and dispensing of drugs or related devices, and for the monitoring of drug therapy;
(8) enforce the provisions of this chapter relating to the conduct or competence of pharmacists practicing in the state, and the suspension, revocation, or restriction of licenses to engage in the practice of pharmacy;
(9) license and regulate the training, qualifications, and employment of pharmacy interns and pharmacy technicians;
(10) issue licenses to persons engaged in the manufacture and distribution of drugs and related devices.
(a) The board may deny a license to an applicant or, after a hearing, impose a disciplinary sanction authorized under AS 08.01.075 on a person licensed under this chapter when the board finds that the applicant or licensee, as applicable,
(1) secured or attempted to secure a license through deceit, fraud, or intentional misrepresentation;
(2) engaged in deceit, fraud, or intentional misrepresentation in the course of providing professional services or engaging in professional activities;
(3) advertised professional services in a false or misleading manner;
(4) has been convicted of a felony or has been convicted of another crime that affects the applicant's or licensee's ability to practice competently and safely;
(5) intentionally or negligently engaged in or permitted the performance of patient care by persons under the applicant's or licensee's supervision that does not conform to minimum professional standards regardless of whether actual injury to the patient occurred;
(6) failed to comply with this chapter, with a regulation adopted under this chapter, or with an order of the board;
(7) is incapable of engaging in the practice of pharmacy with reasonable skill, competence, and safety for the public because of
(A) professional incompetence;
(B) failure to keep informed of or use current professional theories or practices;
(C) addiction or severe dependency on alcohol or a drug that impairs the applicant's or licensee's ability to practice safely;
(D) physical or mental disability; or
(E) other factors determined by the board;
(8) engaged in conduct involving moral turpitude or gross immorality;
(9) made a controlled substance available to a person except upon prescription issued by a person licensed to prescribe controlled substances;
(10) was convicted of selling federal legend drugs without the prescription of a person licensed to prescribe federal legend drugs;
(11) violated state or federal laws or regulations pertaining to drugs or pharmacies;
(12) failed to report relevant information to the board about a pharmacist or pharmacy intern that the applicant or licensee knew or suspected was incapable of engaging in the practice of pharmacy with reasonable skill, competence, and safety to the public;
(13) aided another person to engage in the practice of pharmacy or to use the title of 'pharmacist' or 'pharmacy intern' without a license; or
(14) engaged in unprofessional conduct, as defined in regulations of the board.
(b) The board may place under seal all drugs that are owned by or in the possession, custody, or control of a licensee at the time a license is suspended or revoked or at the time the board refuses to renew a license. Except for perishable items, the drugs may not be disposed of until the licensee has exhausted administrative and judicial remedies relating to the licensing action. Perishable items may be sold upon order of the court with the proceeds to be deposited with the court. The board shall notify the Department of Health and Social Services about drugs placed under seal under this subsection.
(a) A facility engaged in the practice of pharmacy or in the manufacture, production, or wholesale distribution of drugs or devices, and a pharmacy where drugs or devices are dispensed, shall be licensed by the board, and shall renew the license at intervals determined by the board. If operations are conducted at more than one location, each location shall be licensed by the board.
(b) The board may by regulation determine the licensure classifications of facilities and establish minimum standards for the facilities.
(c) The board shall establish by regulation the criteria that a facility must meet to qualify for licensure in each classification. The board may issue licenses with varying restrictions to facilities when the board considers it necessary to protect the public interest.
(d) The board may deny or refuse to renew a license if it determines that the granting or renewing of the license would not be in the public interest.
(e) Licenses issued by the board are not transferable or assignable.
(f) The board shall specify by regulation the minimum standards for responsibility of a facility or pharmacy that has employees or personnel engaged in the practice of pharmacy or engaged in the manufacture, wholesale distribution, production, or use of drugs or devices in the conduct of its business.
(g) A licensed facility shall report to the board
(1) permanent closing;
(2) change of ownership; management, location, or pharmacist-in-charge of a pharmacy;
(3) theft or loss of drugs or devices as defined by regulations of the board;
(4) conviction of an employee of violation of a state or federal drug law;
(5) disasters, accidents, theft, destruction, or loss relating to records required to be maintained by state or federal law;
(6) occurrences of significant adverse drug reactions as defined by regulations of the board;
(7) other matters and occurrences the board may require by regulation.
(h) The board may suspend, revoke, deny, or refuse to renew the license of a facility or pharmacy on the following grounds;
(1) the finding by the board of violations of a federal, state, or local law relating to the practice of pharmacy, drug samples, wholesale or retail drug or device distribution, or distribution of controlled substances;
(2) a felony conviction under federal, state, or local law of an owner of the facility or pharmacy or of an employee of the facility or pharmacy;
(3) the furnishing of false or fraudulent material in an application made in connection with drug or device manufacturing or distribution;
(4) suspension or revocation by federal, state, or local government of a license currently or previously held by the applicant for the manufacture or distribution of drugs or devices, including controlled substances;
(5) obtaining remuneration by fraud, misrepresentation, or deception;
(6) dealing with drugs or devices that are known or should have been known to be stolen drugs or devices;
(7) dispensing or distributing drugs or devices directly to patients by a wholesale drug distributor other than a pharmacy;
(8) violation of this chapter or a regulation adopted under this chapter.
(i) The board's regulations under (b) - (d) and (f) of this section may not establish more stringent licensing requirements for the facilities governed by AS 08.80.390 than are set out in AS 08.80.390 .
(j) This section does not apply to the offices of physicians, osteopaths, podiatrists, physician assistants, advanced nurse practitioners, dentists, veterinarians, dispensing opticians, or optometrists.
(a) A pharmacy located outside of the state that regularly ships, mails, or delivers prescription drugs to consumers in the state shall register with the board.
(b) A pharmacy registering with the board under (a) of this section shall furnish to the board annually
(1) the location, names, and titles of all principal corporate officers and of all pharmacists who are dispensing prescription drugs to residents of the state;
(2) a copy of a current valid license, permit, or registration to conduct operations in the jurisdiction in which it is located, and a copy of the most recent report resulting from an inspection of the pharmacy by the regulatory or licensing agency of the jurisdiction in which the pharmacy is located;
(3) a sworn statement indicating that the pharmacy complies with all lawful directions and requests for information from the regulatory or licensing authority of the jurisdiction in which the pharmacy is licensed; and
(4) proof satisfactory to the board that the pharmacy maintains its records of prescription drugs dispensed to persons in the state so that the records are readily retrievable from the records of other prescription drugs dispensed by the pharmacy.
(c) A pharmacy subject to this section shall, during its regular hours of operation, provide a toll-free telephone service to facilitate communication between persons in the state and a pharmacist at the pharmacy who has access to records concerning the dispensing of prescription drugs to persons in the state. The toll-free number and the hours that the service is available shall be disclosed on a label affixed to each container of drugs dispensed to persons in the state. The telephone service shall be available at least 40 hours a week and at least six days a week.
(d) The board may, after a hearing, deny, revoke, or suspend the registration of a pharmacy located outside of the state and subject to this section if the pharmacy fails to comply with the requirements of this section, AS 17.20.080 - 17.20.135, or AS 17.30.020 - 17.30.080, or if the license, permit, or registration of the pharmacy is denied, revoked, or suspended by the licensing or regulatory agency of the jurisdiction in which the pharmacy is located.
(e) A pharmacy located outside of the state that is subject to this section but is not registered with the board under this section may not ship, mail, or deliver prescription drugs into the state and may not advertise its services in the state.
(f) A pharmacy subject to this section shall appoint a registered agent in the state who is empowered to accept, on behalf of the pharmacy, process, notice, and demand required or permitted by law to be served upon the pharmacy. If the pharmacy fails to appoint an agent under this subsection, if the registered agent cannot with reasonable diligence be found at the registered office, or if the registration of the pharmacy is suspended or revoked, the commissioner of commerce, community, and economic development is an agent upon whom process, notice, or demand may be served. Service is made upon the commissioner in the same manner as provided for corporations under AS 10.06.175 (b), except that for the purposes of AS 10.06.175 (b)(2)(A), the address shall be the last registered address of the pharmacy as shown by the records of the board.
(g) The board shall by regulation define 'regularly' for this section.
In this chapter, unless the context otherwise requires,
(1) 'administer' means the direct application of a drug to the body of a patient or research subject by injection, inhalation, ingestion, or other means;
(2) 'board' means the Board of Pharmacy;
(3) 'compounding' means the preparation, mixing, assembling, packaging, or labeling of a drug or device (A) as the result of a practitioner's prescription drug order or initiative based on the relationship of the practitioner, patient, and pharmacist in the course of professional practice or (B) for the purpose of, or as an 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;
(4) 'controlled substance' has the meaning given in AS 11.71.900 ;
(5) 'deliver' or 'delivery' means the actual, constructive, or attempted transfer of a drug or device from one person to another, whether or not for consideration;
(6) 'device' means an instrument, apparatus, implement, machine, contrivance, implant, or other similar or related article, including a component part or accessory, that is required under federal law to bear the label 'Caution: Federal or state law requires dispensing by or on the order of a physician';
(7) 'dispense' or 'dispensing' means the preparation and delivery of a drug or device to a patient or patient's agent under a lawful order of a practitioner in a suitable container appropriately labeled for subsequent administration to, or use by, a patient;
(8) 'distribute' means the delivery of a drug or device other than by administering or dispensing;
(9) 'drug' means an article recognized as a drug in an official compendium, or supplement to an official compendium; an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animal; an article other than food, intended to affect the structure or function of the body of man or animal; and an article intended for use as a component of an article specified in this paragraph but does not include devices or their components, parts, or accessories;
(10) 'drug regimen review' includes evaluation of the prescription drug order and patient record for
(A) known allergies;
(B) rational therapy-contraindications;
(C) reasonable dose and route of administration;
(D) reasonable directions for use;
(E) duplication of therapy;
(F) drug-drug, drug-food, and drug-disease interactions;
(G) adverse drug reactions; and
(H) proper utilization, including over- or under-utilization, and optimum therapeutic outcomes;
(11) 'equivalent drug product' means a drug product that has the same established name, active ingredients, strength or concentration, dosage form, and route of administration and that is formulated to contain the same amount of active ingredients in the same dosage form and to meet the same compendia or other applicable standards for strength, quality, purity, and identity, but that may differ in characteristics such as shape, scoring configuration, packaging, excipients including colors, flavors, preservatives, and expiration time;
(12) 'intern' means an individual who is
(A) currently licensed by this state to engage in the practice of pharmacy while under the personal supervision of a pharmacist and is satisfactorily progressing toward meeting the requirements for licensure as a pharmacist; or
(B) a graduate from a college of pharmacy who is currently licensed by the board for the purpose of obtaining practical experience as a requirement for licensure as a pharmacist;
(13) 'labeling' means the process of preparing and affixing a label to a drug container, exclusive, however, of the labeling by a manufacturer, packer, or distributor of a nonprescription drug or commercially packed legend drug or device;
(14) 'legend drug' means a prescription drug;
(15) 'manufacturing' means the production, preparation, propagation, conversion, or processing of a drug or device, either directly or indirectly, by extraction from a substance of natural origin or independently by means of chemical or biological synthesis, and includes packaging or repackaging of a substance or labeling or relabeling of its container, and the promotion and marketing of drugs or devices; 'manufacturing' also includes the preparation and promotion of commercially available products from bulk compounds for resale by pharmacies, practitioners, or other persons;
(16) 'nonprescription drug' means a nonnarcotic medicine or drug that may be sold without a prescription and that is prepackaged for use by the consumer and labeled in accordance with the requirements of the statutes and regulations of the state and the federal government;
(17) 'outpatient dispensing' means dispensing drugs for administration outside of the hospital pharmacy's control;
(18) 'owner' means the owner of a place of business for wholesaling, retailing, compounding, or dispensing drugs, medicines, or poisons;
(19) 'patient counseling' means the communication by the pharmacist of information, as defined in the regulations of the board, to the patient or care giver in order to improve therapy by ensuring proper use of drugs and devices;
(20) 'person' has the meaning given in AS 01.10.060 and also includes a governmental agency;
(21) 'pharmaceutical care' is the provision of drug therapy and other pharmaceutical patient care services intended to achieve outcomes related to the cure or prevention of a disease, elimination or reduction of a patient's symptoms, or arresting or slowing of a disease process as defined in regulations of the board;
(22) 'pharmacist' means an individual currently licensed by this state to engage in the practice of pharmacy;
(23) 'pharmacist-in-charge' means a pharmacist who accepts responsibility for operation of a pharmacy in a manner that complies with laws and regulations applicable to the practice of pharmacy and the distribution of drugs and who is personally in charge of the pharmacy and the pharmacy's personnel;
(24) 'pharmacy' means a place in this state where drugs are dispensed and pharmaceutical care is provided and a place outside of this state that is subject to licensure or registration under AS 08.80.157 (b);
(25) 'pharmacy located outside of the state' means a pharmacy that prepares or mixes prescription drugs outside of the state, regardless of the location at which those drugs may be shipped, mailed, or delivered to the consumer;
(26) 'pharmacy technician' means a supportive staff member who works under the immediate supervision of a pharmacist;
(27) 'practice of pharmacy' means the interpretation, evaluation, and dispensing of prescription drug orders in the patient's best interest; participation in drug and device selection, drug administration, drug regimen reviews, and drug or drug-related research; provision of patient counseling and the provision of those acts or services necessary to provide pharmaceutical care; and the responsibility for: compounding and labeling of drugs and devices except labeling by a manufacturer, repackager, or distributor of nonprescription drugs and commercially packaged legend drugs and devices; proper and safe storage of drugs and devices; and maintenance of proper records for them;
(28) 'practitioner' means an individual currently licensed, registered, or otherwise authorized by the jurisdiction in which the individual practices to prescribe and administer drugs in the course of professional practice;
(29) 'preceptor' means an individual who is currently licensed by the board, meets the qualifications as a preceptor under the regulations of the board, and participates in the instructional training of pharmacy interns;
(30) 'prescription drug' means a drug that, under federal law, before being dispensed or delivered, is required to be labeled with either of the following statements: (A) 'Caution: Federal law prohibits dispensing without prescription'; (B) 'Caution: Federal law restricts this drug to use by, or on the order of, a licensed veterinarian'; or a drug that is required by an applicable federal or state law or regulation to be dispensed only under a prescription drug order or is restricted to use by practitioners only;
(31) 'prescription drug order' means a lawful order of a practitioner for a drug or device for a specific patient;
(32) 'prospective drug use review' means a review of the patient's drug therapy and prescription drug order, as defined in the regulations of the board, before dispensing the drug as part of a drug regimen review;
(33) 'significant adverse drug reaction' means a drug-related incident that may result in serious harm, injury, or death to the patient;
(34) 'substitution' means to dispense without the prescriber's expressed authorization, an equivalent drug product in place of the prescribed drug;
(35) 'wholesale' means sale by a manufacturer, wholesale dealer, distributor, or jobber to a person who sells, or intends to sell, directly to the user;
(36) 'wholesale drug distributor' means anyone engaged in wholesale distribution of drugs, including but not limited to manufacturers; repackagers; own-label distributors; private label distributors; jobbers; brokers; warehouses, including manufacturers' and distributors' warehouses; chain drug warehouses; wholesale drug warehouses; independent wholesale drug traders; and retail pharmacies that conduct wholesale distributions.
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