SB 158: "An Act relating to pharmacists and pharmacies."
00SENATE BILL NO. 158 01 "An Act relating to pharmacists and pharmacies." 02 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF ALASKA: 03 * Section 1. AS 08.02.010(a) is amended to read: 04 (a) An acupuncturist licensed under AS 08.06, an audiologist licensed under 05 AS 08.11, a person licensed in the state as a chiropractor under AS 08.20, a dentist 06 under AS 08.36, a marital and family therapist licensed under AS 08.63, a medical 07 practitioner or osteopath under AS 08.64, a direct-entry midwife certified under 08 AS 08.65, a registered nurse under AS 08.68, an optometrist under AS 08.72, a 09 licensed [REGISTERED] pharmacist under AS 08.80, a physical therapist or 10 occupational therapist licensed under AS 08.84, a psychologist under AS 08.86, or a 11 clinical social worker licensed under AS 08.95, shall use as professional identification 12 appropriate letters or a title after that person's name which represents that person's 13 specific field of practice. The letters or title shall appear on all signs, stationery, or 14 other advertising in which the person offers or displays personal professional services
01 to the public. In addition, a person engaged in the practice of medicine or osteopathy 02 as defined in AS 08.64.380, or a person engaged in any manner in the healing arts who 03 diagnoses, treats, tests, or counsels other persons in relation to human health or disease 04 and uses the letters "M.D." or the title "doctor" or "physician" or another title that 05 tends to show that the person is willing or qualified to diagnose, treat, test, or counsel 06 another person, shall clarify the letters or title by adding the appropriate specialist 07 designation, if any, such as "dermatologist", "radiologist", "audiologist", "naturopath", 08 or the like. 09 * Sec. 2. AS 08.80 is amended by adding new sections to read: 10 Sec. 08.80.003. PRACTICE OF PHARMACY AS A PROFESSION. The 11 practice of pharmacy is declared to be a professional practice affecting the public 12 health, safety, and welfare and is subject to regulation and control in the public 13 interest. It is further declared to be a matter of public interest that only qualified 14 persons be permitted to engage in the practice of pharmacy, and to ensure the quality 15 of drugs and related devices distributed in the state. This chapter shall be liberally 16 construed to carry out these objectives and purposes. 17 Sec. 08.80.005. STATEMENT OF PURPOSE. It is the purpose of this chapter 18 to promote, preserve, and protect the public health, safety, and welfare by and through 19 the effective control and regulation of the practice of pharmacy; the licensure of 20 pharmacists; and the licensure, control, and regulation of all sites and persons, in or 21 out of this state, that distribute, manufacture, or sell drugs within the state. 22 * Sec. 3. AS 08.80.010 is amended by adding a new subsection to read: 23 (b) An officer elected by the board serves a term of one year and may not 24 serve more than four consecutive full terms in a specific office. 25 * Sec. 4. AS 08.80.030 is repealed and reenacted to read: 26 Sec. 08.80.030. POWERS AND DUTIES OF THE BOARD. (a) The board 27 is responsible for the control and regulation of the practice of pharmacy. 28 (b) In order to fulfill its responsibilities, the board has the powers necessary 29 for implementation and enforcement of this chapter, including the power to 30 (1) elect a president and secretary from its membership and adopt rules 31 for the conduct of its business;
01 (2) license by examination or by license transfer the applicants who are 02 qualified to engage in the practice of pharmacy; 03 (3) assist the department in inspections and investigations for violations 04 of this chapter, or of any other state or federal statute relating to the practice of 05 pharmacy; 06 (4) adopt regulations to carry out the purposes of this chapter; 07 (5) establish and enforce compliance with professional standards and 08 rules of conduct for pharmacists engaged in the practice of pharmacy; 09 (6) determine standards for recognition and approval of degree 10 programs of schools and colleges of pharmacy whose graduates shall be eligible for 11 licensure in this state, including the specification and enforcement of requirements for 12 practical training, including internships; 13 (7) establish minimum specifications for the physical facilities, 14 technical equipment, personnel, and procedures for the storage, compounding, and 15 dispensing of drugs or related devices, and for the monitoring of drug therapy; 16 (8) establish minimum standards for the purity and quality of drugs and 17 related devices within the practice of pharmacy; 18 (9) enforce the provisions of this chapter relating to the conduct or 19 competence of pharmacists practicing in the state, and the suspension, revocation, or 20 restriction of licenses to engage in the practice of pharmacy; 21 (10) license and regulate the training, qualifications, and employment 22 of pharmacy interns and pharmacy technicians; 23 (11) seize any drugs and related devices found by the board to 24 constitute an imminent danger to the public health and welfare; 25 (12) issue licenses to persons engaged in the manufacture and 26 distribution of drugs and related devices. 27 * Sec. 5. AS 08.80 is amended by adding a new section to read: 28 Sec. 08.80.047. EMBARGO POWERS. (a) A member of the board or an 29 agent of the board who has probable cause to believe that a drug or device is 30 adulterated or misbranded within the meaning of AS 17.20 shall affix to the drug or 31 device a tag or other appropriate marking giving notice that the drug or device is or
01 is suspected of being adulterated or misbranded and has been detained or embargoed, 02 and warning all persons not to remove or dispose of the drug or device by sale or 03 otherwise until permission for removal or disposal is given by the board, its agent, or 04 a court. 05 (b) After affixing the tag or other marking under (a) of this section, the board 06 shall petition the court to condemn the drug or device. If the court determines that the 07 drug or device is not adulterated or misbranded, the board shall direct the immediate 08 removal of the tag or other marking. If the court finds that the drug or device is 09 adulterated or misbranded, the court shall order that the drug or device be destroyed 10 at the expense of its owner under the supervision of a member of the board or an agent 11 of the board except that if the court finds that the drug or device can be corrected by 12 proper labeling or processing, the court may direct that the drug or device be delivered 13 to the owner for labeling or processing under the supervision of a member of the board 14 or an agent of the board, with expenses of supervision to be paid by the owner. 15 * Sec. 6. AS 08.80.060 is amended to read: 16 Sec. 08.80.060. MEETINGS OF THE BOARD. The board shall meet at least 17 three times [ONCE] each year at the call of the president for the transaction of 18 business properly before it. The president shall also call the board into session when 19 requested in writing by at least two members. The secretary shall give at least 30 20 days' written notice to all members before a meeting. 21 * Sec. 7. AS 08.80 is amended by adding a new section to read: 22 Sec. 08.80.065. EXECUTIVE SECRETARY OF THE BOARD. The 23 Department of Commerce and Economic Development may, in consultation with the 24 board, employ a person to serve as executive secretary of the board. 25 * Sec. 8. AS 08.80.070 is amended to read: 26 Sec. 08.80.070. QUORUM. Four members constitute a quorum for the 27 transaction of business. However, when the board meets for the purpose of examining 28 applications for licensure [REGISTRATION], three members of the board constitute 29 a quorum. 30 * Sec. 9. AS 08.80.105 is repealed and reenacted to read: 31 Sec. 08.80.105. REMOVAL OF BOARD MEMBERS. A board member may
01 be removed only for cause based on 02 (1) refusal or inability of the member to perform the member's duties 03 on the board in an efficient, responsible, and professional manner; 04 (2) misuse of office by the member to obtain personal, pecuniary, or 05 material gain or advantage for the member or another person through the member's 06 official position; 07 (3) violation by the member of the laws governing the practice of 08 pharmacy or the distribution of drugs. 09 * Sec. 10. AS 08.80.110 is repealed and reenacted to read: 10 Sec. 08.80.110. QUALIFICATIONS FOR LICENSURE BY EXAMINATION. 11 An applicant for licensure as a pharmacist shall 12 (1) be fluent in the reading, writing, and speaking of the English 13 language; 14 (2) furnish the board with at least two affidavits from reputable citizens 15 that the applicant has known for at least one year attesting to the applicant's good 16 moral character; 17 (3) be a graduate of a college of pharmacy recognized by the American 18 Council on Pharmaceutical Education or, if the applicant has received a bachelor of 19 science degree in pharmacy or an equivalent degree from an institution located outside 20 of the United States and its territories, possess the Foreign Pharmacy Graduate 21 Equivalency Committee certificate issued by the Foreign Pharmacy Graduate 22 Equivalency Committee of the National Association of Boards of Pharmacy 23 Foundation; 24 (4) pass an examination or examinations given by the board or 25 acceptable to the board under the score transfer process administered by the National 26 Association of Boards of Pharmacy; 27 (5) have completed internship training or another program that has been 28 approved by the board or demonstrated to the board's satisfaction that the applicant has 29 experience in the practice of pharmacy that meets or exceeds the minimum internship 30 requirements of the board. 31 * Sec. 11. AS 08.80.116 is repealed and reenacted to read:
01 Sec. 08.80.116. INTERNSHIP AND OTHER TRAINING PROGRAMS. (a) 02 An applicant for licensure by examination shall obtain practical experience in the 03 practice of pharmacy concurrent with or after college attendance, or both, under terms 04 and conditions the board shall determine. 05 (b) The board shall establish licensure requirements for interns and standards 06 for internship or other training programs that are necessary to qualify an applicant for 07 the licensure examination and shall also determine the qualifications of preceptors used 08 in practical experience programs. 09 * Sec. 12. AS 08.80.120 is repealed and reenacted to read: 10 Sec. 08.80.120. GRADING AND CONTENT OF EXAMINATION. The 11 examination or examinations shall be prepared to measure the competence of the 12 applicant to engage in the practice of pharmacy. The board may employ, cooperate, 13 and contract with an organization or consultant in the preparation and grading of an 14 examination, but shall retain sole discretion and responsibility for determining which 15 applicants have successfully passed the examinations. 16 * Sec. 13. AS 08.80 is amended by adding new sections to read: 17 Sec. 08.80.145. RECIPROCITY; LICENSE TRANSFER. If another 18 jurisdiction allows licensure in that jurisdiction of a pharmacist licensed in this state 19 under conditions similar to those in this section, the board may license as a pharmacist 20 in this state a person licensed as a pharmacist in the other jurisdiction if the person 21 (1) submits a written application to the board on a form required by the 22 board; 23 (2) is at least 18 years of age; 24 (3) is of good moral character; 25 (4) possessed at the time of initial licensure as a pharmacist in the 26 other jurisdiction the qualifications necessary to have been eligible for licensure at that 27 time in this state; 28 (5) has engaged in the practice of pharmacy for at least one year or has 29 met the internship requirements of this state within the one-year period immediately 30 before applying for a license under this section; 31 (6) presents proof satisfactory to the board that the person is currently
01 licensed as a pharmacist in the other jurisdiction and has never had a pharmacist 02 license suspended, revoked, or otherwise restricted except for failure to apply for 03 renewal or failure to obtain the required continuing education credits; and 04 (7) pays all required fees. 05 Sec. 08.80.147. RENEWAL OF LICENSURE. If a pharmacist fails to apply 06 for renewal of a license within five years from the expiration of the license, the person 07 must pass an examination for license renewal, except that a person who has continually 08 practiced pharmacy in another state under a license issued by the authority of that state 09 may renew an expired license in this state upon fulfillment of the requirements that 10 may be established by the board. 11 * Sec. 14. AS 08.80.150 is repealed and reenacted to read: 12 Sec. 08.80.150. TEMPORARY LICENSE. The board shall adopt regulations 13 regarding the issuance of a temporary license to practice pharmacy. 14 * Sec. 15. AS 08.80.155 is repealed and reenacted to read: 15 Sec. 08.80.155. EMERGENCY PERMIT. The board shall adopt regulations 16 regarding the issuance of an emergency permit to practice pharmacy. 17 * Sec. 16. AS 08.80.157 is repealed and reenacted to read: 18 Sec. 08.80.157. LICENSING OF FACILITIES. (a) A facility engaged in the 19 practice of pharmacy or in the manufacture, production, sale, or distribution of drugs 20 or devices, and a pharmacy where drugs or devices are dispensed, shall be licensed by 21 the board, and shall renew the license at intervals determined by the board. If 22 operations are conducted at more than one location, each location shall be licensed by 23 the board. 24 (b) The board may by regulation determine the licensure classifications of 25 facilities and establish minimum standards for the facilities. 26 (c) The board shall establish by regulation the criteria that a facility must meet 27 to qualify for licensure in each classification. The board may issue licenses with 28 varying restrictions to facilities when the board considers it necessary to protect the 29 public interest. 30 (d) The board may deny or refuse to renew a license if it determines that the 31 granting or renewing of the license would not be in the public interest.
01 (e) Licenses issued by the board are not transferable or assignable. 02 (f) The board shall specify by regulation the minimum standards for 03 responsibility of a facility or pharmacy that has employees or personnel engaged in the 04 practice of pharmacy or engaged in the manufacture, distribution, production, sale, or 05 use of drugs or devices in the conduct of its business. 06 (g) A licensed facility shall report to the board 07 (1) permanent closing; 08 (2) change of ownership, management, location, or pharmacist-in-charge 09 of a pharmacy; 10 (3) theft or loss of drugs or devices as defined by regulations of the 11 board; 12 (4) conviction of an employee of violation of a state or federal drug 13 law; 14 (5) disasters, accidents, theft, destruction, or loss relating to records 15 required to be maintained by state or federal law; 16 (6) occurrences of significant adverse drug reactions as defined by 17 regulations of the board; 18 (7) other matters and occurrences the board may require by regulation. 19 (h) The board may suspend, revoke, deny, or refuse to renew the license of a 20 facility or pharmacy on the following grounds: 21 (1) the finding by the board of violations of a federal, state, or local 22 law relating to the practice of pharmacy, drug samples, wholesale or retail drug or 23 device distribution, or distribution of controlled substances; 24 (2) a felony conviction under federal, state, or local law of the facility, 25 pharmacy, or an employee of the facility or pharmacy; 26 (3) the furnishing of false or fraudulent material in an application made 27 in connection with drug or device manufacturing or distribution; 28 (4) suspension or revocation by federal, state, or local government of 29 a license currently or previously held by the applicant for the manufacture or 30 distribution of drugs or devices, including controlled substances; 31 (5) obtaining remuneration by fraud, misrepresentation, or deception;
01 (6) dealing with drugs or devices that are known or should have been 02 known to be stolen drugs or devices; 03 (7) dispensing or distributing drugs or devices directly to patients by 04 a wholesale drug distributor other than a pharmacy; 05 (8) violation of this chapter or a regulation adopted under this chapter. 06 * Sec. 17. AS 08.80.160 is amended to read: 07 Sec. 08.80.160. FEES. The Department of Commerce and Economic 08 Development shall set fees under AS 08.01.065 for the following: 09 (1) examination; 10 (2) reexamination; 11 (3) investigation for licensing by license transfer [CREDENTIALS]; 12 (4) pharmacist license; 13 (5) temporary license; 14 (6) wholesale drug distributor [DEALER] license; 15 (7) retail pharmacy license; 16 (8) pharmacy intern license [REGISTRATION]; 17 (9) emergency permit; 18 (10) hospital pharmacy license (inpatient and outpatient); 19 (11) hospital drug room license (inpatient); 20 (12) nursing home and related facilities license for inpatient dispensing; 21 (13) license amendment or replacement; 22 (14) registration of a pharmacy located outside of the state. 23 * Sec. 18. AS 08.80 is amended by adding a new section to read: 24 Sec. 08.80.165. CONTINUING EDUCATION REQUIREMENTS. The board 25 shall establish requirements for continuing education in pharmacy that must be satisfied 26 before a license issued under this chapter may be renewed. 27 * Sec. 19. AS 08.80.261 is amended to read: 28 Sec. 08.80.261. GROUNDS FOR IMPOSITION OF DISCIPLINARY 29 SANCTIONS. The board may, after a hearing, impose a disciplinary sanction 30 authorized under AS 08.01.075 on a person licensed under this chapter when the 31 board finds that the licensee
01 (1) secured a license through deceit, fraud, or intentional 02 misrepresentation; 03 (2) engaged in deceit, fraud, or intentional misrepresentation in the 04 course of providing professional services or engaging in professional activities; 05 (3) advertised professional services in a false or misleading manner; 06 (4) has been convicted of a felony or has been convicted of another 07 [OTHER] crime that affects the licensee's ability to continue to practice competently 08 and safely; 09 (5) intentionally or negligently engaged in or permitted the performance 10 of patient care by persons under the licensee's supervision that does not conform to 11 minimum professional standards regardless of whether actual injury to the patient 12 occurred; 13 (6) failed to comply with this chapter, with a regulation adopted under 14 this chapter, or with an order of the board; 15 (7) is incapable of engaging in the practice of pharmacy with 16 reasonable skill, competence, and safety for the public because of [CONTINUED 17 TO PRACTICE AFTER BECOMING UNFIT DUE TO] 18 (A) professional incompetence; 19 (B) failure to keep informed of or use current professional 20 theories or practices; 21 (C) addiction or severe dependency on alcohol or a drug that 22 impairs the licensee's ability to practice safely; 23 (D) physical or mental disability; or 24 (E) other factors determined by the board; 25 (8) engaged in [LEWD OR IMMORAL] conduct involving moral 26 turpitude or gross immorality [IN CONNECTION WITH THE DELIVERY OF 27 PROFESSIONAL SERVICE TO PATIENTS]; 28 (9) [MADE A CONTROLLED SUBSTANCE AVAILABLE TO A 29 PERSON EXCEPT UPON PRESCRIPTION ISSUED BY A PERSON LICENSED TO 30 PRESCRIBE CONTROLLED SUBSTANCES; 31 (10) WAS CONVICTED OF SELLING FEDERAL LEGEND DRUGS
01 WITHOUT THE PRESCRIPTION OF A PERSON LICENSED TO PRESCRIBE 02 FEDERAL LEGEND DRUGS; 03 (11)] violated state or federal laws or regulations pertaining to [THE 04 PROVISION OF ADEQUATE SECURITY FOR DANGEROUS] drugs or 05 pharmacies; 06 (10) failed to report relevant information to the board about a 07 pharmacist or pharmacy intern that the licensee knew or suspected was incapable 08 of engaging in the practice of pharmacy with reasonable skill, competence, and 09 safety to the public; 10 (11) aided another person to engage in the practice of pharmacy 11 or to use the title of "pharmacist" or "pharmacy intern" without a license; or 12 (12) engaged in unprofessional conduct, as defined in regulations 13 of the board. 14 * Sec. 20. AS 08.80.261 is amended by adding a new subsection to read: 15 (b) The board may place under seal all drugs that are owned by or in the 16 possession, custody, or control of a licensee at the time a license is suspended or 17 revoked or at the time the board refuses to renew a license. Except for perishable 18 items, the drugs may not be disposed of until the licensee has exhausted administrative 19 and judicial remedies relating to the licensing action. Perishable items may be sold 20 upon order of the court with the proceeds to be deposited with the court. 21 * Sec. 21. AS 08.80.295 is repealed and reenacted to read: 22 Sec. 08.80.295. SUBSTITUTION OF EQUIVALENT DRUG PRODUCTS. 23 (a) Unless the prescription indicates that it is to be dispensed only as written, the 24 pharmacist may, with the consent of the patient, substitute an equivalent drug product. 25 (b) A pharmacist who substitutes an equivalent drug product in compliance 26 with this section and applicable regulations incurs no greater liability in filling the 27 prescription than would be incurred in filling the prescription by dispensing the 28 prescribed name brand product. 29 * Sec. 22. AS 08.80 is amended by adding a new section to read: 30 Sec. 08.80.315. CONFIDENTIALITY OF RECORDS. Information maintained 31 by a pharmacist in the patient's records or that is communicated to the patient as part
01 of patient counseling is confidential and may be released only to 02 (1) the patient or as the patient directs; 03 (2) a practitioner or pharmacist when, in the pharmacist's professional 04 judgment, release is necessary to protect the patient's health and well-being; and 05 (3) other persons or governmental agencies authorized by law to receive 06 confidential information. 07 * Sec. 23. AS 08.80.330(a) is amended to read: 08 (a) Each pharmacy shall have a pharmacist-in-charge. Whenever an 09 applicable law or regulation requires or prohibits action by a pharmacy, 10 responsibility shall be that of the owner and the pharmacist-in-charge, whether 11 the owner is a sole proprietor, partnership, association, corporation, or otherwise 12 [IF THE OWNER OF A PHARMACY IS NOT A LICENSED PHARMACIST, THE 13 OWNER SHALL PLACE A LICENSED PHARMACIST, DESIGNATED THE 14 MANAGER, IN FULL CHARGE AND CONTROL OF THE PHARMACY]. The 15 pharmacist-in-charge [MANAGER] shall ensure compliance with all laws and 16 regulations governing the operation of the pharmacy. A licensed pharmacist appointed 17 as pharmacist-in-charge [MANAGER] of a pharmacy shall immediately advise the 18 board of that appointment. 19 * Sec. 24. AS 08.80.400 is amended to read: 20 Sec. 08.80.400. PRACTICE OF MEDICINE NOT AFFECTED. Except as 21 provided in (b) of this section, this [THIS] chapter does not affect the practice of 22 medicine by a licensed medical doctor, and does not limit a licensed medical doctor 23 in supplying a patient with any medicinal preparation or article that the licensed 24 medical doctor considers proper. 25 * Sec. 25. AS 08.80.400 is amended by adding a new subsection to read: 26 (b) A person authorized to compound drugs or to dispense drugs in the 27 practice of a profession other than as a licensed pharmacist shall meet the same 28 standards, record keeping requirements, and all other requirements for the dispensing 29 of drugs that are applicable to pharmacists. 30 * Sec. 26. AS 08.80.410 is amended to read: 31 Sec. 08.80.410. USE OF TERM "PHARMACIST'' PROHIBITED. A person
01 may not assume or use the title "pharmacist," or any variation of the title, or hold out 02 to be a pharmacist, without being licensed [REGISTERED]. 03 * Sec. 27. AS 08.80.430 is amended to read: 04 Sec. 08.80.430 USE OF PHARMACY SYMBOLS PROHIBITED. A person 05 may not display in a place of business the characteristic pharmacy symbol of "Rx" in 06 any form [BOTTLES, OR GLOBES, WHICH ARE COLORED OR CONTAIN 07 COLORED LIQUIDS] unless the business has a pharmacist licensed [AND 08 REGISTERED] under this chapter [ON DUTY UNDER AS 08.80.320]. 09 * Sec. 28. AS 08.80.480(4) is amended to read: 10 (4) "drug" means an article recognized as a drug in an official 11 compendium, or supplement to an official compendium [IN THE OFFICIAL 12 UNITED STATES PHARMACOPOEIA, OFFICIAL HOMEOPATHIC 13 PHARMACOPOEIA OF THE UNITED STATES, OR OFFICIAL NATIONAL 14 FORMULARY]; an article intended for use in the diagnosis, cure, mitigation, 15 treatment, or prevention of disease in man or animal; an article other than food, 16 intended to affect the structure or function of the body of man or animal; and an article 17 intended for use as a component of an article specified in this paragraph but does not 18 include devices or their components, parts, or accessories; 19 * Sec. 29. AS 08.80.480(11) is repealed and reenacted to read: 20 (11) "pharmacy" means a place in this state where drugs are dispensed 21 and pharmaceutical care is provided and a place outside of this state where drugs are 22 dispensed and pharmaceutical care is provided to residents of this state; 23 * Sec. 30. AS 08.80.480(14) is repealed and reenacted to read: 24 (14) "prescription drug" means a drug that, under federal law, before 25 being dispensed or delivered, is required to be labeled with either of the following 26 statements: (A) "Caution: Federal law prohibits dispensing without prescription"; (B) 27 "Caution: Federal law restricts this drug to use by, or on the order of, a licensed 28 veterinarian"; or a drug that is required by an applicable federal or state law or 29 regulation to be dispensed only under a prescription drug order or is restricted to use 30 by practitioners only; 31 * Sec. 31. AS 08.80.480 is amended by adding new paragraphs to read:
01 (21) "administer" means the direct application of a drug to the body of 02 a patient or research subject by injection, inhalation, ingestion, or other means; 03 (22) "compounding" means the preparation, mixing, assembling, 04 packaging, or labeling of a drug or device (A) as the result of a practitioner's 05 prescription drug order or initiative based on the relationship of the practitioner, 06 patient, and pharmacist in the course of professional practice or (B) for the purpose of, 07 or as an incident to, research, teaching, or chemical analysis and not for sale or 08 dispensing; "compounding" also includes the preparation of drugs or devices in 09 anticipation of prescription drug orders based on routine, regularly observed 10 prescribing patterns; 11 (23) "deliver" or "delivery" means the actual, constructive, or attempted 12 transfer of a drug or device from one person to another, whether or not for 13 consideration; 14 (24) "device" means an instrument, apparatus, implement, machine, 15 contrivance, implant, or other similar or related article, including a component part or 16 accessory, that is required under federal law to bear the label "Caution: Federal or state 17 law requires dispensing by or on the order of a physician"; 18 (25) "dispense" or "dispensing" means the preparation and delivery of 19 a drug or device to a patient or patient's agent under a lawful order of a practitioner 20 in a suitable container appropriately labeled for subsequent administration to, or use 21 by, a patient; 22 (26) "distribute" means the delivery of a drug or device other than by 23 administering or dispensing; 24 (27) "drug regimen review" includes evaluation of the prescription drug 25 order and patient record for 26 (A) known allergies; 27 (B) rational therapy-contraindications; 28 (C) reasonable dose and route of administration; 29 (D) reasonable directions for use; 30 (E) duplication of therapy; 31 (F) drug-drug, drug-food, and drug-disease interactions;
01 (G) adverse drug reactions; and 02 (H) proper utilization, including over- or under-utilization, and 03 optimum therapeutic outcomes; 04 (28) "equivalent drug product" means a drug product that has the same 05 established name, active ingredients, strength or concentration, dosage form, and route 06 of administration and that is formulated to contain the same amount of active 07 ingredients in the same dosage form and to meet the same compendia or other 08 applicable standards for strength, quality, purity, and identity, but that may differ in 09 characteristics such as shape, scoring configuration, packaging, excipients including 10 colors, flavors, preservatives, and expiration time; 11 (29) "intern" means an individual who is 12 (A) currently licensed by this state to engage in the practice of 13 pharmacy while under the personal supervision of a pharmacist and is 14 satisfactorily progressing toward meeting the requirements for licensure as a 15 pharmacist; or 16 (B) a graduate from a college of pharmacy who is currently 17 licensed by the board for the purpose of obtaining practical experience as a 18 requirement for licensure as a pharmacist; 19 (30) "labeling" means the process of preparing and affixing a label to 20 a drug container, exclusive, however, of the labeling by a manufacturer, packer, or 21 distributor of a nonprescription drug or commercially packed legend drug or device; 22 (31) "legend drug" means a prescription drug; 23 (32) "manufacturing" means the production, preparation, propagation, 24 conversion, or processing of a drug or device, either directly or indirectly, by 25 extraction from a substance of natural origin or independently by means of chemical 26 or biological synthesis, and includes packaging or repackaging of a substance or 27 labeling or relabeling of its container, and the promotion and marketing of drugs or 28 devices; "manufacturing" also includes the preparation and promotion of commercially 29 available products from bulk compounds for resale by pharmacies, practitioners, or 30 other persons; 31 (33) "patient counseling" means the communication by the pharmacist
01 of information, as defined in the regulations of the board, to the patient or care giver 02 in order to improve therapy by ensuring proper use of drugs and devices; 03 (34) "person" has the meaning given in AS 01.10.060 and also includes 04 a governmental agency; 05 (35) "pharmaceutical care" is the provision of drug therapy and other 06 pharmaceutical patient care services intended to achieve outcomes related to the cure 07 or prevention of a disease, elimination or reduction of a patient's symptoms, or 08 arresting or slowing of a disease process as defined in regulations of the board; 09 (36) "pharmacist" means an individual currently licensed by this state 10 to engage in the practice of pharmacy; 11 (37) "pharmacist-in-charge" means a pharmacist who accepts 12 responsibility for operation of a pharmacy in a manner that complies with laws and 13 regulations applicable to the practice of pharmacy and the distribution of drugs and 14 who is personally in charge of the pharmacy and the pharmacy's personnel; 15 (38) "pharmacy technician" means a supportive staff member who 16 works under the immediate supervision of a pharmacist; 17 (39) "practice of pharmacy" means the interpretation, evaluation, and 18 dispensing of prescription drug orders in the patient's best interest; participation in drug 19 and device selection, drug administration, drug regimen reviews, and drug or drug-related research; provision of patien 20 counseling and the provision of those acts or 21 services necessary to provide pharmaceutical care; and the responsibility for: 22 compounding and labeling of drugs and devices except labeling by a manufacturer, 23 repackager, or distributor of nonprescription drugs and commercially packaged legend 24 drugs and devices; proper and safe storage of drugs and devices; and maintenance of 25 proper records for them; 26 (40) "practitioner" means an individual currently licensed, registered, 27 or otherwise authorized by the jurisdiction in which the individual practices to 28 prescribe and administer drugs in the course of professional practice; 29 (41) "preceptor" means an individual who is currently licensed by the 30 board, meets the qualifications as a preceptor under the regulations of the board, and 31 participates in the instructional training of pharmacy interns;
01 (42) "prescription drug order" means a lawful order of a practitioner 02 for a drug or device for a specific patient; 03 (43) "prospective drug use review" means a review of the patient's drug 04 therapy and prescription drug order, as defined in the regulations of the board, before 05 dispensing the drug as part of a drug regimen review; 06 (44) "significant adverse drug reaction" means a drug-related incident 07 that may result in serious harm, injury, or death to the patient; 08 (45) "substitution" means to dispense without the prescriber's expressed 09 authorization, an equivalent drug product in place of the prescribed drug; 10 (46) "wholesale drug distributor" means anyone engaged in wholesale 11 distribution of drugs, including but not limited to manufacturers; repackagers; own-label distributors; private label 12 distributors; jobbers; brokers; warehouses, including 13 manufacturers' and distributors' warehouses; chain drug warehouses; wholesale drug 14 warehouses; independent wholesale drug traders; and retail pharmacies that conduct 15 wholesale distributions. 16 * Sec. 32. AS 08.80.040, 08.80.130, 08.80.220, 08.80.230, 08.80.240, 08.80.270, 08.80.280, 17 08.80.290, 08.80.300, 08.80.310, 08.80.320, 08.80.340, 08.80.350, 08.80.360, 08.80.365, 18 08.80.370, 08.80.390, 08.80.440, 08.80.475, 08.80.480(2), 08.80.480(5), 08.80.480(6), 19 08.80.480(7), 08.80.480(13), 08.80.480(16), 08.80.480(17), 08.80.480(18), and 08.80.480(20) 20 are repealed.