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HCS CSSB 158(HES): "An Act relating to pharmacists and pharmacies."

00HOUSE CS FOR CS FOR SENATE BILL NO. 158(HES) 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. 16  Sec. 08.80.005. STATEMENT OF PURPOSE. It is the purpose of this chapter 17 to promote, preserve, and protect the public health, safety, and welfare by and through 18 the effective control and regulation of the practice of pharmacy. 19 * Sec. 3. AS 08.80.010 is amended by adding a new subsection to read: 20  (b) An officer elected by the board serves a term of one year and may not 21 serve more than four consecutive full terms in a specific office. 22 * Sec. 4. AS 08.80.030 is repealed and reenacted to read: 23  Sec. 08.80.030. POWERS AND DUTIES OF THE BOARD. (a) The board 24 is responsible for the control and regulation of the practice of pharmacy. 25  (b) In order to fulfill its responsibilities, the board has the powers necessary 26 for implementation and enforcement of this chapter, including the power to 27  (1) elect a president and secretary from its membership and adopt rules 28 for the conduct of its business; 29  (2) license by examination or by license transfer the applicants who are 30 qualified to engage in the practice of pharmacy; 31  (3) assist the department in inspections and investigations for violations

01 of this chapter, or of any other state or federal statute relating to the practice of 02 pharmacy; 03  (4) adopt regulations to carry out the purposes of this chapter; 04  (5) establish and enforce compliance with professional standards and 05 rules of conduct for pharmacists engaged in the practice of pharmacy; 06  (6) determine standards for recognition and approval of degree 07 programs of schools and colleges of pharmacy whose graduates shall be eligible for 08 licensure in this state, including the specification and enforcement of requirements for 09 practical training, including internships; 10  (7) establish for pharmacists and pharmacies minimum specifications 11 for the physical facilities, technical equipment, personnel, and procedures for the 12 storage, compounding, and dispensing of drugs or related devices, and for the 13 monitoring of drug therapy; 14  (8) enforce the provisions of this chapter relating to the conduct or 15 competence of pharmacists practicing in the state, and the suspension, revocation, or 16 restriction of licenses to engage in the practice of pharmacy; 17  (9) license and regulate the training, qualifications, and employment of 18 pharmacy interns and pharmacy technicians; 19  (10) issue licenses to persons engaged in the manufacture and 20 distribution of drugs and related devices. 21 * Sec. 5. AS 08.80.060 is amended to read: 22  Sec. 08.80.060. MEETINGS OF THE BOARD. The board shall meet at least 23 three times [ONCE] each year at the call of the president for the transaction of 24 business properly before it. The president shall also call the board into session when 25 requested in writing by at least two members. Meetings may be held telephonically 26 [THE SECRETARY SHALL GIVE AT LEAST 30 DAYS' WRITTEN NOTICE TO 27 ALL MEMBERS BEFORE A MEETING]. 28 * Sec. 6. AS 08.80.070 is amended to read: 29  Sec. 08.80.070. QUORUM. Four members constitute a quorum for the 30 transaction of business. However, when the board meets for the purpose of examining 31 applications for licensure [REGISTRATION], three members of the board constitute

01 a quorum. 02 * Sec. 7. AS 08.80.110 is repealed and reenacted to read: 03  Sec. 08.80.110. QUALIFICATIONS FOR LICENSURE BY EXAMINATION. 04 An applicant for licensure as a pharmacist shall 05  (1) be fluent in the reading, writing, and speaking of the English 06 language; 07  (2) furnish the board with at least two affidavits from reputable citizens 08 that the applicant has known for at least one year attesting to the applicant's good 09 moral character; 10  (3) be a graduate of a college in a degree program approved by the 11 board; 12  (4) pass an examination or examinations given by the board or 13 acceptable to the board under the score transfer process administered by the National 14 Association of Boards of Pharmacy; 15  (5) have completed internship training or another program that has been 16 approved by the board or demonstrated to the board's satisfaction that the applicant 17 has experience in the practice of pharmacy that meets or exceeds the minimum 18 internship requirements of the board. 19 * Sec. 8. AS 08.80.116 is repealed and reenacted to read: 20  Sec. 08.80.116. INTERNSHIP AND OTHER TRAINING PROGRAMS. (a) 21 An applicant for licensure by examination shall obtain practical experience in the 22 practice of pharmacy concurrent with or after college attendance, or both, under terms 23 and conditions the board shall determine. 24  (b) The board shall establish licensure requirements for interns and standards 25 for internship or other training programs that are necessary to qualify an applicant for 26 the licensure examination and shall also determine the qualifications of preceptors used 27 in practical experience programs. 28 * Sec. 9. AS 08.80.120 is repealed and reenacted to read: 29  Sec. 08.80.120. GRADING AND CONTENT OF EXAMINATION. The 30 examination or examinations shall be prepared to measure the competence of the 31 applicant to engage in the practice of pharmacy. The board may employ, cooperate,

01 and contract with an organization or consultant in the preparation and grading of an 02 examination, but shall retain sole discretion and responsibility for determining which 03 applicants have successfully passed the examinations. 04 * Sec. 10. AS 08.80 is amended by adding new sections to read: 05  Sec. 08.80.145. RECIPROCITY; LICENSE TRANSFER. If another 06 jurisdiction allows licensure in that jurisdiction of a pharmacist licensed in this state 07 under conditions similar to those in this section, the board may license as a pharmacist 08 in this state a person licensed as a pharmacist in the other jurisdiction if the person 09  (1) submits a written application to the board on a form required by the 10 board; 11  (2) is at least 18 years of age; 12  (3) is of good moral character; 13  (4) possesses at the time of the request for licensure as a pharmacist 14 in this state the qualifications necessary to be eligible for licensure in this state; 15  (5) has engaged in the practice of pharmacy for at least one year or has 16 met the internship requirements of this state within the one-year period immediately 17 before applying for a license under this section; 18  (6) presents proof satisfactory to the board that the person is currently 19 licensed as a pharmacist in the other jurisdiction and does not currently have a 20 pharmacist license suspended, revoked, or otherwise restricted except for failure to 21 apply for renewal or failure to obtain the required continuing education credits; 22  (7) has passed an examination approved by the board that tests the 23 person's knowledge of Alaska laws relating to pharmacies and pharmacists and the 24 regulations adopted under those laws; and 25  (8) pays all required fees. 26  Sec. 08.80.147. RENEWAL OF LICENSURE. If a pharmacist fails to apply 27 for renewal of a license within five years from the expiration of the license, the person 28 must pass an examination for license renewal, except that a person who has continually 29 practiced pharmacy in another state under a license issued by the authority of that state 30 may renew an expired license in this state upon fulfillment of the requirements that 31 may be established by the board.

01 * Sec. 11. AS 08.80.150 is repealed and reenacted to read: 02  Sec. 08.80.150. TEMPORARY LICENSE. The board shall adopt regulations 03 regarding the issuance of a temporary license to practice pharmacy. 04 * Sec. 12. AS 08.80.155 is repealed and reenacted to read: 05  Sec. 08.80.155. EMERGENCY PERMIT. The board shall adopt regulations 06 regarding the issuance of an emergency permit to practice pharmacy. 07 * Sec. 13. AS 08.80.157 is repealed and reenacted to read: 08  Sec. 08.80.157. LICENSING OF FACILITIES. (a) A facility engaged in the 09 practice of pharmacy or in the manufacture, production, or wholesale distribution of 10 drugs or devices, and a pharmacy where drugs or devices are dispensed, shall be 11 licensed by the board, and shall renew the license at intervals determined by the board. 12 If operations are conducted at more than one location, each location shall be licensed 13 by the board. 14  (b) The board may by regulation determine the licensure classifications of 15 facilities and establish minimum standards for the facilities. 16  (c) The board shall establish by regulation the criteria that a facility must meet 17 to qualify for licensure in each classification. The board may issue licenses with 18 varying restrictions to facilities when the board considers it necessary to protect the 19 public interest. 20  (d) The board may deny or refuse to renew a license if it determines that the 21 granting or renewing of the license would not be in the public interest. 22  (e) Licenses issued by the board are not transferable or assignable. 23  (f) The board shall specify by regulation the minimum standards for 24 responsibility of a facility or pharmacy that has employees or personnel engaged in the 25 practice of pharmacy or engaged in the manufacture, wholesale distribution, 26 production, or use of drugs or devices in the conduct of its business. 27  (g) A licensed facility shall report to the board 28  (1) permanent closing; 29  (2) change of ownership, management, location, or pharmacist-in-charge 30 of a pharmacy; 31  (3) theft or loss of drugs or devices as defined by regulations of the

01 board; 02  (4) conviction of an employee of violation of a state or federal drug 03 law; 04  (5) disasters, accidents, theft, destruction, or loss relating to records 05 required to be maintained by state or federal law; 06  (6) occurrences of significant adverse drug reactions as defined by 07 regulations of the board; 08  (7) other matters and occurrences the board may require by regulation. 09  (h) The board may suspend, revoke, deny, or refuse to renew the license of a 10 facility or pharmacy on the following grounds: 11  (1) the finding by the board of violations of a federal, state, or local 12 law relating to the practice of pharmacy, drug samples, wholesale or retail drug or 13 device distribution, or distribution of controlled substances; 14  (2) a felony conviction under federal, state, or local law of an owner 15 of the facility or pharmacy or of an employee of the facility or pharmacy; 16  (3) the furnishing of false or fraudulent material in an application made 17 in connection with drug or device manufacturing or distribution; 18  (4) suspension or revocation by federal, state, or local government of 19 a license currently or previously held by the applicant for the manufacture or 20 distribution of drugs or devices, including controlled substances; 21  (5) obtaining remuneration by fraud, misrepresentation, or deception; 22  (6) dealing with drugs or devices that are known or should have been 23 known to be stolen drugs or devices; 24  (7) dispensing or distributing drugs or devices directly to patients by 25 a wholesale drug distributor other than a pharmacy; 26  (8) violation of this chapter or a regulation adopted under this chapter. 27  (i) The board's regulations under (b) - (d) and (f) of this section may not 28 establish more stringent licensing requirements for the facilities governed by 29 AS 08.80.390 than are set out in AS 08.80.390. 30  (j) This section does not apply to the offices of physicians, osteopaths, 31 podiatrists, physician assistants, advanced nurse practitioners, dentists, veterinarians,

01 dispensing opticians, or optometrists. 02 * Sec. 14. AS 08.80.160 is amended to read: 03  Sec. 08.80.160. FEES. The Department of Commerce and Economic 04 Development shall set fees under AS 08.01.065 for the following: 05  (1) examination; 06  (2) reexamination; 07  (3) investigation for licensing by license transfer [CREDENTIALS]; 08  (4) pharmacist license; 09  (5) temporary license; 10  (6) pharmacy technician [WHOLESALE DRUG DEALER] license; 11  (7) [RETAIL PHARMACY LICENSE; 12  (8)] pharmacy intern license [REGISTRATION]; 13  (8) [(9)] emergency permit; 14  (9) [(10) HOSPITAL PHARMACY LICENSE (INPATIENT AND 15 OUTPATIENT); 16  (11) HOSPITAL DRUG ROOM LICENSE (INPATIENT); 17  (12) NURSING HOME AND RELATED FACILITIES LICENSE FOR 18 INPATIENT DISPENSING; 19  (13)] license amendment or replacement; 20  (10) [(14)] registration or licensure of a facility classified under 21 AS 08.80.157(b) [PHARMACY LOCATED OUTSIDE OF THE STATE]. 22 * Sec. 15. AS 08.80 is amended by adding a new section to read: 23  Sec. 08.80.165. CONTINUING EDUCATION REQUIREMENTS. The board 24 shall establish requirements for continuing education in pharmacy that must be satisfied 25 before a license issued under this chapter may be renewed. 26 * Sec. 16. AS 08.80.261 is amended to read: 27  Sec. 08.80.261. GROUNDS FOR IMPOSITION OF DISCIPLINARY 28 SANCTIONS. The board may, after a hearing, impose a disciplinary sanction 29 authorized under AS 08.01.075 on a person licensed under this chapter when the 30 board finds that the licensee 31  (1) secured a license through deceit, fraud, or intentional

01 misrepresentation; 02  (2) engaged in deceit, fraud, or intentional misrepresentation in the 03 course of providing professional services or engaging in professional activities; 04  (3) advertised professional services in a false or misleading manner; 05  (4) has been convicted of a felony or has been convicted of another 06 [OTHER] crime that affects the licensee's ability to continue to practice competently 07 and safely; 08  (5) intentionally or negligently engaged in or permitted the performance 09 of patient care by persons under the licensee's supervision that does not conform to 10 minimum professional standards regardless of whether actual injury to the patient 11 occurred; 12  (6) failed to comply with this chapter, with a regulation adopted under 13 this chapter, or with an order of the board; 14  (7) is incapable of engaging in the practice of pharmacy with 15 reasonable skill, competence, and safety for the public because of [CONTINUED 16 TO PRACTICE AFTER BECOMING UNFIT DUE TO] 17  (A) professional incompetence; 18  (B) failure to keep informed of or use current professional 19 theories or practices; 20  (C) addiction or severe dependency on alcohol or a drug that 21 impairs the licensee's ability to practice safely; 22  (D) physical or mental disability; or 23  (E) other factors determined by the board; 24  (8) engaged in [LEWD OR IMMORAL] conduct involving moral 25 turpitude or gross immorality [IN CONNECTION WITH THE DELIVERY OF 26 PROFESSIONAL SERVICE TO PATIENTS]; 27  (9) made a controlled substance available to a person except upon 28 prescription issued by a person licensed to prescribe controlled substances; 29  (10) was convicted of selling federal legend drugs without the 30 prescription of a person licensed to prescribe federal legend drugs; 31  (11) violated state or federal laws or regulations pertaining to [THE

01 PROVISION OF ADEQUATE SECURITY FOR DANGEROUS] drugs or 02 pharmacies; 03  (12) failed to report relevant information to the board about a 04 pharmacist or pharmacy intern that the licensee knew or suspected was incapable 05 of engaging in the practice of pharmacy with reasonable skill, competence, and 06 safety to the public; 07  (13) aided another person to engage in the practice of pharmacy 08 or to use the title of "pharmacist" or "pharmacy intern" without a license; or 09  (14) engaged in unprofessional conduct, as defined in regulations 10 of the board. 11 * Sec. 17. AS 08.80.261 is amended by adding a new subsection to read: 12  (b) The board may place under seal all drugs that are owned by or in the 13 possession, custody, or control of a licensee at the time a license is suspended or 14 revoked or at the time the board refuses to renew a license. Except for perishable 15 items, the drugs may not be disposed of until the licensee has exhausted administrative 16 and judicial remedies relating to the licensing action. Perishable items may be sold 17 upon order of the court with the proceeds to be deposited with the court. The board 18 shall notify the Department of Health and Social Services about drugs placed under 19 seal under this subsection. 20 * Sec. 18. AS 08.80.295 is repealed and reenacted to read: 21  Sec. 08.80.295. SUBSTITUTION OF EQUIVALENT DRUG PRODUCTS. 22 (a) Unless the prescription indicates that it is to be dispensed only as written, the 23 pharmacist may, with the consent of the patient, substitute an equivalent drug product. 24  (b) A pharmacist who substitutes an equivalent drug product in compliance 25 with this section and applicable regulations incurs no greater liability in filling the 26 prescription than would be incurred in filling the prescription by dispensing the 27 prescribed name brand product. 28 * Sec. 19. AS 08.80 is amended by adding a new section to read: 29  Sec. 08.80.315. CONFIDENTIALITY OF RECORDS. Information maintained 30 by a pharmacist in the patient's records or that is communicated to the patient as part 31 of patient counseling is confidential and may be released only to

01  (1) the patient or as the patient directs; 02  (2) a practitioner or pharmacist when, in the pharmacist's professional 03 judgment, release is necessary to protect the patient's health and well-being; and 04  (3) other persons or governmental agencies authorized by law to receive 05 confidential information. 06 * Sec. 20. AS 08.80.330(a) is amended to read: 07  (a) Each pharmacy shall have a pharmacist-in-charge. Whenever an 08 applicable law or regulation requires or prohibits action by a pharmacy, 09 responsibility shall be that of the owner and the pharmacist-in-charge, whether 10 the owner is a sole proprietor, partnership, association, corporation, or otherwise 11 [IF THE OWNER OF A PHARMACY IS NOT A LICENSED PHARMACIST, THE 12 OWNER SHALL PLACE A LICENSED PHARMACIST, DESIGNATED THE 13 MANAGER, IN FULL CHARGE AND CONTROL OF THE PHARMACY]. The 14 pharmacist-in-charge [MANAGER] shall ensure compliance with all laws and 15 regulations governing the operation of the pharmacy. A licensed pharmacist appointed 16 as pharmacist-in-charge [MANAGER] of a pharmacy shall immediately advise the 17 board of that appointment. 18 * Sec. 21. AS 08.80.400 is amended to read: 19  Sec. 08.80.400. OTHER LICENSEES [PRACTICE OF MEDICINE] NOT 20 AFFECTED. This chapter does not affect the practice of medicine by a licensed 21 medical doctor, and does not limit a licensed medical doctor, osteopath, podiatrist, 22 physician assistant, advanced nurse practitioner, dentist, veterinarian, dispensing 23 optician, or optometrist in supplying a patient with any medicinal preparation or 24 article within the scope of the person's license [THAT THE LICENSED MEDICAL 25 DOCTOR CONSIDERS PROPER]. 26 * Sec. 22. AS 08.80.410 is amended to read: 27  Sec. 08.80.410. USE OF TERM "PHARMACIST'' PROHIBITED. A person 28 may not assume or use the title "pharmacist," or any variation of the title, or hold out 29 to be a pharmacist, without being licensed [REGISTERED]. 30 * Sec. 23. AS 08.80.430 is amended to read: 31  Sec. 08.80.430 USE OF PHARMACY SYMBOLS PROHIBITED. A person

01 may not display in a place of business the characteristic pharmacy symbol of "Rx" in 02 any form [BOTTLES, OR GLOBES, WHICH ARE COLORED OR CONTAIN 03 COLORED LIQUIDS] unless the business has a pharmacist licensed [AND 04 REGISTERED] under this chapter [ON DUTY UNDER AS 08.80.320]. 05 * Sec. 24. AS 08.80.480(4) is amended to read: 06  (4) "drug" means an article recognized as a drug in an official 07 compendium, or supplement to an official compendium [IN THE OFFICIAL 08 UNITED STATES PHARMACOPOEIA, OFFICIAL HOMEOPATHIC 09 PHARMACOPOEIA OF THE UNITED STATES, OR OFFICIAL NATIONAL 10 FORMULARY]; an article intended for use in the diagnosis, cure, mitigation, 11 treatment, or prevention of disease in man or animal; an article other than food, 12 intended to affect the structure or function of the body of man or animal; and an article 13 intended for use as a component of an article specified in this paragraph but does not 14 include devices or their components, parts, or accessories; 15 * Sec. 25. AS 08.80.480(11) is repealed and reenacted to read: 16  (11) "pharmacy" means a place in this state where drugs are dispensed 17 and pharmaceutical care is provided and a place outside of this state that is subject to 18 licensure or registration under AS 08.80.157(b); 19 * Sec. 26. AS 08.80.480(14) is repealed and reenacted to read: 20  (14) "prescription drug" means a drug that, under federal law, before 21 being dispensed or delivered, is required to be labeled with either of the following 22 statements: (A) "Caution: Federal law prohibits dispensing without prescription"; (B) 23 "Caution: Federal law restricts this drug to use by, or on the order of, a licensed 24 veterinarian"; or a drug that is required by an applicable federal or state law or 25 regulation to be dispensed only under a prescription drug order or is restricted to use 26 by practitioners only; 27 * Sec. 27. AS 08.80.480 is amended by adding new paragraphs to read: 28  (21) "administer" means the direct application of a drug to the body of 29 a patient or research subject by injection, inhalation, ingestion, or other means; 30  (22) "compounding" means the preparation, mixing, assembling, 31 packaging, or labeling of a drug or device (A) as the result of a practitioner's

01 prescription drug order or initiative based on the relationship of the practitioner, 02 patient, and pharmacist in the course of professional practice or (B) for the purpose of, 03 or as an incident to, research, teaching, or chemical analysis and not for sale or 04 dispensing; "compounding" also includes the preparation of drugs or devices in 05 anticipation of prescription drug orders based on routine, regularly observed 06 prescribing patterns; 07  (23) "deliver" or "delivery" means the actual, constructive, or attempted 08 transfer of a drug or device from one person to another, whether or not for 09 consideration; 10  (24) "device" means an instrument, apparatus, implement, machine, 11 contrivance, implant, or other similar or related article, including a component part or 12 accessory, that is required under federal law to bear the label "Caution: Federal or state 13 law requires dispensing by or on the order of a physician"; 14  (25) "dispense" or "dispensing" means the preparation and delivery of 15 a drug or device to a patient or patient's agent under a lawful order of a practitioner 16 in a suitable container appropriately labeled for subsequent administration to, or use 17 by, a patient; 18  (26) "distribute" means the delivery of a drug or device other than by 19 administering or dispensing; 20  (27) "drug regimen review" includes evaluation of the prescription drug 21 order and patient record for 22  (A) known allergies; 23  (B) rational therapy-contraindications; 24  (C) reasonable dose and route of administration; 25  (D) reasonable directions for use; 26  (E) duplication of therapy; 27  (F) drug-drug, drug-food, and drug-disease interactions; 28  (G) adverse drug reactions; and 29  (H) proper utilization, including over- or under-utilization, and 30 optimum therapeutic outcomes; 31  (28) "equivalent drug product" means a drug product that has the same

01 established name, active ingredients, strength or concentration, dosage form, and route 02 of administration and that is formulated to contain the same amount of active 03 ingredients in the same dosage form and to meet the same compendia or other 04 applicable standards for strength, quality, purity, and identity, but that may differ in 05 characteristics such as shape, scoring configuration, packaging, excipients including 06 colors, flavors, preservatives, and expiration time; 07  (29) "intern" means an individual who is 08  (A) currently licensed by this state to engage in the practice of 09 pharmacy while under the personal supervision of a pharmacist and is 10 satisfactorily progressing toward meeting the requirements for licensure as a 11 pharmacist; or 12  (B) a graduate from a college of pharmacy who is currently 13 licensed by the board for the purpose of obtaining practical experience as a 14 requirement for licensure as a pharmacist; 15  (30) "labeling" means the process of preparing and affixing a label to 16 a drug container, exclusive, however, of the labeling by a manufacturer, packer, or 17 distributor of a nonprescription drug or commercially packed legend drug or device; 18  (31) "legend drug" means a prescription drug; 19  (32) "manufacturing" means the production, preparation, propagation, 20 conversion, or processing of a drug or device, either directly or indirectly, by 21 extraction from a substance of natural origin or independently by means of chemical 22 or biological synthesis, and includes packaging or repackaging of a substance or 23 labeling or relabeling of its container, and the promotion and marketing of drugs or 24 devices; "manufacturing" also includes the preparation and promotion of commercially 25 available products from bulk compounds for resale by pharmacies, practitioners, or 26 other persons; 27  (33) "patient counseling" means the communication by the pharmacist 28 of information, as defined in the regulations of the board, to the patient or care giver 29 in order to improve therapy by ensuring proper use of drugs and devices; 30  (34) "person" has the meaning given in AS 01.10.060 and also includes 31 a governmental agency;

01  (35) "pharmaceutical care" is the provision of drug therapy and other 02 pharmaceutical patient care services intended to achieve outcomes related to the cure 03 or prevention of a disease, elimination or reduction of a patient's symptoms, or 04 arresting or slowing of a disease process as defined in regulations of the board; 05  (36) "pharmacist" means an individual currently licensed by this state 06 to engage in the practice of pharmacy; 07  (37) "pharmacist-in-charge" means a pharmacist who accepts 08 responsibility for operation of a pharmacy in a manner that complies with laws and 09 regulations applicable to the practice of pharmacy and the distribution of drugs and 10 who is personally in charge of the pharmacy and the pharmacy's personnel; 11  (38) "pharmacy technician" means a supportive staff member who 12 works under the immediate supervision of a pharmacist; 13  (39) "practice of pharmacy" means the interpretation, evaluation, and 14 dispensing of prescription drug orders in the patient's best interest; participation in 15 drug and device selection, drug administration, drug regimen reviews, and drug or 16 drug-related research; provision of patient counseling and the provision of those acts 17 or services necessary to provide pharmaceutical care; and the responsibility for: 18 compounding and labeling of drugs and devices except labeling by a manufacturer, 19 repackager, or distributor of nonprescription drugs and commercially packaged legend 20 drugs and devices; proper and safe storage of drugs and devices; and maintenance of 21 proper records for them; 22  (40) "practitioner" means an individual currently licensed, registered, 23 or otherwise authorized by the jurisdiction in which the individual practices to 24 prescribe and administer drugs in the course of professional practice; 25  (41) "preceptor" means an individual who is currently licensed by the 26 board, meets the qualifications as a preceptor under the regulations of the board, and 27 participates in the instructional training of pharmacy interns; 28  (42) "prescription drug order" means a lawful order of a practitioner 29 for a drug or device for a specific patient; 30  (43) "prospective drug use review" means a review of the patient's drug 31 therapy and prescription drug order, as defined in the regulations of the board, before

01 dispensing the drug as part of a drug regimen review; 02  (44) "significant adverse drug reaction" means a drug-related incident 03 that may result in serious harm, injury, or death to the patient; 04  (45) "substitution" means to dispense without the prescriber's expressed 05 authorization, an equivalent drug product in place of the prescribed drug; 06  (46) "wholesale drug distributor" means anyone engaged in wholesale 07 distribution of drugs, including but not limited to manufacturers; repackagers; own- 08 label distributors; private label distributors; jobbers; brokers; warehouses, including 09 manufacturers' and distributors' warehouses; chain drug warehouses; wholesale drug 10 warehouses; independent wholesale drug traders; and retail pharmacies that conduct wholesale 11 distributions. 12 * Sec. 28. AS 08.80.040, 08.80.130, 08.80.140, 08.80.220, 08.80.230, 08.80.240, 08.80.270, 13 08.80.280, 08.80.290, 08.80.300, 08.80.310, 08.80.320, 08.80.340, 08.80.350, 08.80.360, 14 08.80.365, 08.80.370, 08.80.440, 08.80.480(2), 08.80.480(5), 08.80.480(6), 08.80.480(7), 15 08.80.480(13), 08.80.480(16), 08.80.480(17), 08.80.480(18), and 08.80.480(20) are repealed.