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HB 112: "An Act relating to the Board of Pharmacy; relating to the practice of pharmacy; relating to pharmacies; relating to prescription drug manufacturers; relating to prescriptions for epinephrine; relating to the administration of epinephrine; and providing for an effective date."

00 HOUSE BILL NO. 112 01 "An Act relating to the Board of Pharmacy; relating to the practice of pharmacy; 02 relating to pharmacies; relating to prescription drug manufacturers; relating to 03 prescriptions for epinephrine; relating to the administration of epinephrine; and 04 providing for an effective date." 05 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF ALASKA: 06 * Section 1. AS 08.80.010(a) is amended to read: 07 (a) There is created the Board of Pharmacy, composed of seven members, five 08 of whom shall be pharmacists licensed in the state who have been actively engaged in 09 the practice of pharmacy in the state for a period of three years immediately preceding 10 their appointment. One shall be a pharmacy technician licensed in the state for a 11 period of two years immediately preceding appointment. One [TWO] shall be a 12 person [PERSONS] with no direct financial interest in the health care industry. 13 Whenever possible, the board shall include at least one member from each judicial 14 district.

01 * Sec. 2. AS 08.80.030(b) is amended to read: 02 (b) In order to fulfill its responsibilities, the board has the powers necessary 03 for implementation and enforcement of this chapter, including the power to 04 (1) elect a president and secretary from its membership and adopt rules 05 for the conduct of its business; 06 (2) license by examination or by license transfer the applicants who are 07 qualified to engage in the practice of pharmacy; 08 (3) assist the department in inspections and investigations for 09 violations of this chapter, or of any other state or federal statute relating to the practice 10 of pharmacy; 11 (4) adopt regulations to carry out the purposes of this chapter; 12 (5) establish and enforce compliance with professional standards and 13 rules of conduct for pharmacists engaged in the practice of pharmacy; 14 (6) determine standards for recognition and approval of degree 15 programs of schools and colleges of pharmacy whose graduates shall be eligible for 16 licensure in this state, including the specification and enforcement of requirements for 17 practical training, including internships; 18 (7) establish for pharmacists and pharmacies minimum specifications 19 for the physical facilities, technical equipment, personnel, and procedures for the 20 storage, compounding, and dispensing of drugs or related devices, and for the 21 monitoring of drug therapy, including independent monitoring of drug therapy; 22 (8) enforce the provisions of this chapter relating to the conduct or 23 competence of pharmacists practicing in the state, and the suspension, revocation, or 24 restriction of licenses to engage in the practice of pharmacy; 25 (9) license and regulate the training, qualifications, and employment of 26 pharmacy interns and pharmacy technicians; 27 (10) license and regulate the qualifications of entities and 28 individuals [ISSUE LICENSES TO PERSONS] engaged in the manufacture or 29 [AND] distribution of drugs and related devices; 30 (11) establish and maintain a controlled substance prescription 31 database as provided in AS 17.30.200;

01 (12) establish standards for the independent prescribing and 02 administration of vaccines and related emergency medications under AS 08.80.168, 03 including the completion of an immunization training program approved by the board 04 and an epinephrine auto-injector training program under AS 17.22.020(b); 05 (13) establish standards for the independent prescribing and dispensing 06 by a pharmacist of an opioid overdose drug under AS 17.20.085, including the 07 completion of an opioid overdose training program approved by the board; 08 (14) require that a licensed pharmacist who dispenses a schedule II, 09 III, or IV controlled substance under federal law to a person in the state register 10 with the controlled substance prescription database under AS 17.30.200(n); 11 (15) establish the qualifications and duties of the executive 12 administrator and delegate authority to the executive administrator that is necessary to 13 conduct board business; 14 (16) license and inspect the facilities of pharmacies, manufacturers, 15 wholesale drug distributors, third-party logistics providers, and outsourcing facilities 16 located outside the state under AS 08.80.159; 17 (17) license Internet-based pharmacies providing services to 18 residents in the state; 19 (18) adopt regulations pertaining to retired pharmacist status. 20 * Sec. 3. AS 08.80.145 is amended to read: 21 Sec. 08.80.145. Reciprocity; license transfer. If another jurisdiction allows 22 licensure in that jurisdiction of a pharmacist licensed in this state under conditions 23 similar to those in this section, the board may license as a pharmacist in this state a 24 person licensed as a pharmacist in the other jurisdiction if the person 25 (1) submits a written application to the board on a form required by the 26 board; 27 (2) is at least 18 years of age; 28 (3) [IS OF GOOD MORAL CHARACTER; 29 (4)] possesses at the time of the request for licensure as a pharmacist in 30 this state the qualifications necessary to be eligible for licensure in this state; 31 (4) [(5)] has engaged in the practice of pharmacy for at least one year

01 [OR HAS MET THE INTERNSHIP REQUIREMENTS OF THIS STATE WITHIN 02 THE ONE-YEAR PERIOD] immediately before applying for a license under this 03 section; 04 (5) [(6)] presents proof satisfactory to the board that the person is 05 currently licensed as a pharmacist in the other jurisdiction and does not currently have 06 a pharmacist license suspended, revoked, or otherwise restricted except for failure to 07 apply for renewal or failure to obtain the required continuing education credits; 08 (6) [(7)] has passed an examination approved by the board that tests 09 the person's knowledge of Alaska laws relating to pharmacies and pharmacists and the 10 regulations adopted under those laws; and 11 (7) [(8)] pays all required fees. 12 * Sec. 4. AS 08.80.157(k) is amended to read: 13 (k) This section applies to pharmacies, manufacturers, wholesale drug 14 distributors, third-party logistics providers, and outsourcing facilities located outside 15 the state under AS 08.80.159. 16 * Sec. 5. AS 08.80.159(a) is amended to read: 17 (a) Before shipping, mailing, distributing, or delivering a prescription drug 18 [DRUGS] to a person [LICENSEE] in the state or advertising in the state, a 19 pharmacy, manufacturer, wholesale drug distributor, third-party logistics provider, 20 or an outsourcing facility that is located outside the state shall 21 (1) obtain a license under AS 08.80.157; 22 (2) appoint an agent on whom process can be served in the state; and 23 (3) authorize inspection of the facility by a designee of the board under 24 (c) of this section. 25 * Sec. 6. AS 08.80.159(c) is amended to read: 26 (c) Upon application by a pharmacy, manufacturer, wholesale drug 27 distributor, third-party logistics provider, or an outsourcing facility for a license under 28 this section, the board may 29 (1) require an inspection of the applicant's facility located outside the 30 state; and 31 (2) approve a designee to conduct the inspection.

01 * Sec. 7. AS 08.80.160 is amended to read: 02 Sec. 08.80.160. Fees. The Department of Commerce, Community, and 03 Economic Development shall set fees under AS 08.01.065 for the following: 04 (1) examination; 05 (2) reexamination; 06 (3) investigation for licensing by license transfer; 07 (4) pharmacist license; 08 (5) temporary license; 09 (6) pharmacy technician license; 10 (7) pharmacy intern license; 11 (8) emergency permit; 12 (9) license amendment or replacement; 13 (10) [REGISTRATION OR] licensure of a facility classified under 14 AS 08.80.157(b). 15 * Sec. 8. AS 08.80.168 is amended by adding a new subsection to read: 16 (e) A pharmacist may independently administer epinephrine to a patient or 17 prescribe epinephrine auto-injectors to a person who has completed a training program 18 approved by the board under AS 17.22.020(b). 19 * Sec. 9. AS 08.80.270(a) is amended to read: 20 (a) The board shall employ an executive administrator to carry out the duties 21 established under (b) of this section. The executive administrator is the principal 22 executive officer of the board. The executive administrator is in the partially exempt 23 service under AS 39.25.120 and is entitled to receive a monthly salary equal to a step 24 in range 23 on the salary schedule set out in AS 39.27.011(a). If the executive 25 administrator has a pharmacist license, the executive administrator is entitled to 26 a monthly salary based on the salary classification for pharmacists. 27 * Sec. 10. AS 08.80.420(a) is amended to read: 28 (a) A person may not use or exhibit the title "pharmacist," "assistant 29 pharmacist," or "druggist," or the descriptive term "pharmacy," "drug store," "drug 30 sundries," "apothecary," or other similar title or term containing the word "drug," in 31 any business premises [,] or in an advertisement through the media of press [,] or

01 publication, or by radio or television, unless the business has a licensed pharmacist in 02 regular and continuous employment. 03 * Sec. 11. AS 12.62.400(a) is amended to read: 04 (a) To obtain a national criminal history record check for determining a 05 person's qualifications for a license, permit, registration, employment, or position, a 06 person shall submit the person's fingerprints to the department with the fee established 07 by AS 12.62.160. The department may submit the fingerprints to the Federal Bureau 08 of Investigation to obtain a national criminal history record check of the person for the 09 purpose of evaluating a person's qualifications for 10 (1) a license or conditional contractor's permit to manufacture, sell, 11 offer for sale, possess for sale or barter, traffic in, or barter an alcoholic beverage 12 under AS 04.11; 13 (2) licensure as a mortgage lender, a mortgage broker, or a mortgage 14 loan originator under AS 06.60; 15 (3) admission to the Alaska Bar Association under AS 08.08; 16 (4) licensure as a collection agency operator under AS 08.24; 17 (5) a certificate of fitness to handle explosives under AS 08.52; 18 (6) licensure as a massage therapist under AS 08.61; 19 (7) licensure to practice nursing or certification as a nurse aide under 20 AS 08.68; 21 (8) certification as a real estate appraiser under AS 08.87; 22 (9) a position involving supervisory or disciplinary power over a minor 23 or dependent adult for which criminal justice information may be released under 24 AS 12.62.160(b)(9); 25 (10) a teacher certificate under AS 14.20; 26 (11) a registration or license to operate a marijuana establishment 27 under AS 17.38; 28 (12) admittance to a police training program under AS 18.65.230 or for 29 certification as a police officer under AS 18.65.240 if that person's prospective 30 employer does not have access to a criminal justice information system; 31 (13) licensure as a security guard under AS 18.65.400 - 18.65.490;

01 (14) a concealed handgun permit under AS 18.65.700 - 18.65.790; 02 (15) licensure as an insurance producer, managing general agent, 03 reinsurance intermediary broker, reinsurance intermediary manager, surplus lines 04 broker, or independent adjuster under AS 21.27; 05 (16) serving and executing process issued by a court by a person 06 designated under AS 22.20.130; 07 (17) a school bus driver license under AS 28.15.046; 08 (18) licensure as an operator or an instructor for a commercial driver 09 training school under AS 28.17; 10 (19) registration as a broker-dealer, agent, investment adviser 11 representative, or investment adviser under AS 45.56.300 - 45.56.350; 12 (20) licensure, license renewal, certification, certification renewal, or 13 payment from the Department of Health of an individual and an entity subject to the 14 requirements for a criminal history check under AS 47.05.310, including 15 (A) a public home care provider described in AS 47.05.017; 16 (B) a provider of home and community-based waiver services 17 financed under AS 47.07.030(c); 18 (C) a case manager to coordinate community mental health 19 services under AS 47.30.530; 20 (D) an entity listed in AS 47.32.010(b) and (c), including an 21 owner, officer, director, member, partner, employee, volunteer, or contractor of 22 an entity; or 23 (E) an individual or entity not described in (A) - (D) of this 24 paragraph that is required by statute or regulation to be licensed or certified by 25 the Department of Health or that is eligible to receive payments, in whole or in 26 part, from the Department of Health to provide for the health, safety, and 27 welfare of persons who are served by the programs administered by the 28 Department of Health; 29 (21) employment as a village public safety officer under AS 18.65.672 30 or certification as a village public safety officer under AS 18.65.682; 31 (22) licensure, license renewal, certification, or certification renewal

01 by the Department of Family and Community Services of an individual or entity, or 02 payment from the Department of Family and Community Services to an individual or 03 entity, subject to the requirements for a criminal history check under AS 47.05.310 for 04 a foster home, child placement agency, and runaway shelter listed in AS 47.32.010(c), 05 including an owner, officer, director, member, partner, employee, volunteer, or 06 contractor of an entity; 07 (23) licensure as a pharmacist or pharmacy technician under 08 AS 08.80. 09 * Sec. 12. AS 17.22.010 is amended to read: 10 Sec. 17.22.010. Prescription, purchase, and administration of epinephrine 11 by a trained individual. An individual who is 18 years of age or older may obtain a 12 prescription for, purchase, and, in an emergency situation, administer epinephrine to 13 another person using 14 [(1)] an auto-injector, if the individual has successfully completed a 15 training program approved by the board [DEPARTMENT] under as 17.22.020(b) [; 16 OR 17 (2) AN AMPULE, IF THE INDIVIDUAL HAS SUCCESSFULLY 18 COMPLETED A TRAINING PROGRAM APPROVED BY THE DEPARTMENT 19 UNDER AS 17.22.020(c)]. 20 * Sec. 13. AS 17.22.020(a) is amended to read: 21 (a) The board [DEPARTMENT] shall adopt standards for the approval of a 22 training program [PROGRAMS] for the use of 23 [(1)] epinephrine auto-injectors [; AND 24 (2) EPINEPHRINE AMPULES]. 25 * Sec. 14. AS 17.22.020(b) is amended to read: 26 (b) The board [DEPARTMENT] shall approve an auto-injector training 27 program that meets standards adopted under (a) [(a)(1)] of this section. The standards 28 must require an epinephrine auto-injector program to provide training in 29 (1) techniques on how to recognize symptoms of severe asthmatic or 30 allergic reactions, including anaphylaxis; 31 (2) standards and procedures for the storage of epinephrine auto-

01 injectors and administration of epinephrine using auto-injectors; and 02 (3) emergency follow-up procedures. 03 * Sec. 15. AS 17.22.030 is amended to read: 04 Sec. 17.22.030. Applicability. This chapter does not apply to a person who is 05 authorized under another law to administer epinephrine [OR TO A PERSON WHO IS 06 PRESCRIBED EPINEPHRINE FOR PERSONAL USE]. 07 * Sec. 16. AS 17.22.040 is amended to read: 08 Sec. 17.22.040. Liability of certified individual. A claim for relief may not be 09 brought against an individual who has successfully completed an auto-injector [A] 10 training program approved by the board [DEPARTMENT] under AS 17.22.020 for an 11 act or omission relating to the administration of epinephrine to another individual in an 12 emergency situation if the individual who completed the training program acted in 13 good faith under the authority granted by this chapter. 14 * Sec. 17. AS 17.22.090 is amended by adding a new paragraph to read: 15 (3) "board" means the Board of Pharmacy. 16 * Sec. 18. AS 08.80.110(2), 08.80.158; AS 17.22.020(c), and 17.22.090(1) are repealed. 17 * Sec. 19. The uncodified law of the State of Alaska is amended by adding a new section to 18 read: 19 TRANSITION: EFFECT ON CURRENT REGISTERED PHARMACIES. On and 20 after the effective date of sec. 18 of this Act, a pharmacy registered under AS 08.80.158 on 21 the effective date of sec. 18 of this Act may continue to ship, mail, or deliver prescription 22 drugs to consumers in the state under the registration until the registration expires normally 23 under AS 08.80. 24 * Sec. 20. The uncodified law of the State of Alaska is amended by adding a new section to 25 read: 26 TRANSITION: REGULATIONS. The Board of Pharmacy and the Department of 27 Commerce, Community, and Economic Development may adopt regulations necessary to 28 implement the changes made by this Act. The regulations take effect under AS 44.62 29 (Administrative Procedure Act), but not before the effective date of the relevant provision of 30 this Act implemented by the regulation. 31 * Sec. 21. Section 20 of this Act takes effect immediately under AS 01.10.070(c).

01 * Sec. 22. Except as provided in sec. 21 of this Act, this Act takes effect November 26, 02 2023.