CSHB 112(L&C): "An Act relating to the Board of Pharmacy; relating to the practice of pharmacy; relating to pharmacies; relating to prescription drug manufacturers; relating to licensing and registration requirements for certain wholesale drug distributors; relating to prescriptions for epinephrine; relating to the administration of epinephrine; and providing for an effective date."
00 CS FOR HOUSE BILL NO. 112(L&C) 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 licensing and registration requirements for certain wholesale drug distributors; relating 04 to prescriptions for epinephrine; relating to the administration of epinephrine; and 05 providing for an effective date." 06 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF ALASKA: 07 * Section 1. AS 08.80.010(a) is amended to read: 08 (a) There is created the Board of Pharmacy, composed of seven members, five 09 of whom shall be pharmacists licensed in the state who have been actively engaged in 10 the practice of pharmacy in the state for a period of three years immediately preceding 11 their appointment. One shall be a pharmacy technician licensed in the state for a 12 period of two years immediately preceding appointment. One [TWO] shall be a 13 person [PERSONS] with no direct financial interest in the health care industry.
01 Whenever possible, the board shall include at least one member from each judicial 02 district. 03 * Sec. 2. AS 08.80.030(b) is amended to read: 04 (b) In order to fulfill its responsibilities, the board has the powers necessary 05 for implementation and enforcement of this chapter, including the power to 06 (1) elect a president and secretary from its membership and adopt rules 07 for the conduct of its business; 08 (2) license by examination or by license transfer the applicants who are 09 qualified to engage in the practice of pharmacy; 10 (3) assist the department in inspections and investigations for 11 violations of this chapter, or of any other state or federal statute relating to the practice 12 of pharmacy; 13 (4) adopt regulations to carry out the purposes of this chapter; 14 (5) establish and enforce compliance with professional standards and 15 rules of conduct for pharmacists engaged in the practice of pharmacy; 16 (6) determine standards for recognition and approval of degree 17 programs of schools and colleges of pharmacy whose graduates shall be eligible for 18 licensure in this state, including the specification and enforcement of requirements for 19 practical training, including internships; 20 (7) establish for pharmacists and pharmacies minimum specifications 21 for the physical facilities, technical equipment, personnel, and procedures for the 22 storage, compounding, and dispensing of drugs or related devices, and for the 23 monitoring of drug therapy, including independent monitoring of drug therapy; 24 (8) enforce the provisions of this chapter relating to the conduct or 25 competence of pharmacists practicing in the state, and the suspension, revocation, or 26 restriction of licenses to engage in the practice of pharmacy; 27 (9) license and regulate the training, qualifications, and employment of 28 pharmacy interns and pharmacy technicians; 29 (10) license and regulate the qualifications of entities and 30 individuals [ISSUE LICENSES TO PERSONS] engaged in the manufacture or 31 [AND] distribution of drugs and related devices;
01 (11) establish and maintain a controlled substance prescription 02 database as provided in AS 17.30.200; 03 (12) establish standards for the independent prescribing and 04 administration of vaccines and related emergency medications under AS 08.80.168, 05 including the completion of an immunization training program approved by the board 06 and an epinephrine auto-injector training program under AS 17.22.020(b); 07 (13) establish standards for the independent prescribing and dispensing 08 by a pharmacist of an opioid overdose drug under AS 17.20.085, including the 09 completion of an opioid overdose training program approved by the board; 10 (14) require that a licensed pharmacist who dispenses a schedule II, 11 III, or IV controlled substance under federal law to a person in the state register 12 with the controlled substance prescription database under AS 17.30.200(n); 13 (15) establish the qualifications and duties of the executive 14 administrator and delegate authority to the executive administrator that is necessary to 15 conduct board business; 16 (16) license and inspect the facilities of pharmacies, manufacturers, 17 wholesale drug distributors, third-party logistics providers, and outsourcing facilities 18 located outside the state under AS 08.80.159; 19 (17) license Internet-based pharmacies providing services to 20 residents in the state; 21 (18) adopt regulations pertaining to retired pharmacist status. 22 * Sec. 3. AS 08.80.145 is amended to read: 23 Sec. 08.80.145. Reciprocity; license transfer. If another jurisdiction allows 24 licensure in that jurisdiction of a pharmacist licensed in this state under conditions 25 similar to those in this section, the board may license as a pharmacist in this state a 26 person licensed as a pharmacist in the other jurisdiction if the person 27 (1) submits a written application to the board on a form required by the 28 board; 29 (2) is at least 18 years of age; 30 (3) [IS OF GOOD MORAL CHARACTER; 31 (4)] possesses at the time of the request for licensure as a pharmacist in
01 this state the qualifications necessary to be eligible for licensure in this state; 02 (4) [(5)] has engaged in the practice of pharmacy for at least one year 03 [OR HAS MET THE INTERNSHIP REQUIREMENTS OF THIS STATE WITHIN 04 THE ONE-YEAR PERIOD] immediately before applying for a license under this 05 section; 06 (5) [(6)] presents proof satisfactory to the board that the person is 07 currently licensed as a pharmacist in the other jurisdiction and does not currently have 08 a pharmacist license suspended, revoked, or otherwise restricted except for failure to 09 apply for renewal or failure to obtain the required continuing education credits; 10 (6) [(7)] has passed an examination approved by the board that tests 11 the person's knowledge of Alaska laws relating to pharmacies and pharmacists and the 12 regulations adopted under those laws; and 13 (7) [(8)] pays all required fees. 14 * Sec. 4. AS 08.80.157(h) is amended to read: 15 (h) The board may suspend, revoke, deny, or refuse to renew the license of a 16 facility or pharmacy on the following grounds: 17 (1) the finding by the board of violations of a federal, state, or local 18 law relating to the practice of pharmacy, drug samples, wholesale or retail drug or 19 device distribution, or distribution of controlled substances; 20 (2) a felony conviction under federal, state, or local law of an owner of 21 the facility or pharmacy or of an employee of the facility or pharmacy; 22 (3) the furnishing of false or fraudulent material in an application made 23 in connection with drug or device manufacturing or distribution; 24 (4) suspension or revocation by federal, state, or local government of a 25 license currently or previously held by the applicant for the manufacture or 26 distribution of drugs or devices, including controlled substances; 27 (5) obtaining remuneration by fraud, misrepresentation, or deception; 28 (6) dealing with drugs or devices that are known or should have been 29 known to be stolen drugs or devices; 30 (7) dispensing or distributing drugs or devices directly to patients by a 31 wholesale drug distributor other than a pharmacy unless
01 (A) the drug or device is a dialysate, drug composed solely 02 of fluids, electrolytes, and sugars, or device that is 03 (i) necessary to perform home dialysis; 04 (ii) approved by the United States Food and Drug 05 Administration, as required by federal law; and 06 (iii) delivered in its original, sealed, and labeled 07 packaging only upon the receipt of a physician's order; and 08 (B) the wholesale drug distributor 09 (i) delivers the dialysate drug or device directly to a 10 patient with end-stage renal disease, or to the patient's designee, 11 for the patient's self-administration of dialysis therapy; 12 (ii) uses a bar code scanning and verification system 13 confirming that the dialysate drug or device selected to fill the 14 patient-specific order matches the information on the patient- 15 specific label; and 16 (iii) has additional secondary accuracy and delivery 17 checks in place; and 18 (C) a licensed pharmacist serves as a consultant to the 19 wholesale drug distributor to 20 (i) conduct a retrospective audit of 10 percent of the 21 dialysate drug and device orders provided directly to patients 22 processed by the wholesale drug distributor every month; and 23 (ii) perform assessments at least twice monthly to 24 ensure quality of product storage, handling, and distribution by the 25 wholesale drug distributor, and to ensure product expiration dates 26 are later than three months after the date of assessment; 27 (8) violation of this chapter or a regulation adopted under this chapter. 28 * Sec. 5. AS 08.80.157(k) is amended to read: 29 (k) This section applies to pharmacies, manufacturers, wholesale drug 30 distributors, third-party logistics providers, and outsourcing facilities located outside 31 the state under AS 08.80.159.
01 * Sec. 6. AS 08.80.159(a) is amended to read: 02 (a) Before shipping, mailing, distributing, or delivering a prescription drug 03 [DRUGS] to a person [LICENSEE] in the state or advertising in the state, a 04 pharmacy, manufacturer, wholesale drug distributor, third-party logistics provider, 05 or an outsourcing facility that is located outside the state shall 06 (1) obtain a license under AS 08.80.157; 07 (2) appoint an agent on whom process can be served in the state; and 08 (3) authorize inspection of the facility by a designee of the board under 09 (c) of this section. 10 * Sec. 7. AS 08.80.159(c) is amended to read: 11 (c) Upon application by a pharmacy, manufacturer, wholesale drug 12 distributor, third-party logistics provider, or an outsourcing facility for a license under 13 this section, the board may 14 (1) require an inspection of the applicant's facility located outside the 15 state; and 16 (2) approve a designee to conduct the inspection. 17 * Sec. 8. AS 08.80.160 is amended to read: 18 Sec. 08.80.160. Fees. The Department of Commerce, Community, and 19 Economic Development shall set fees under AS 08.01.065 for the following: 20 (1) examination; 21 (2) reexamination; 22 (3) investigation for licensing by license transfer; 23 (4) pharmacist license; 24 (5) temporary license; 25 (6) pharmacy technician license; 26 (7) pharmacy intern license; 27 (8) emergency permit; 28 (9) license amendment or replacement; 29 (10) [REGISTRATION OR] licensure of a facility classified under 30 AS 08.80.157(b). 31 * Sec. 9. AS 08.80.168 is amended by adding a new subsection to read:
01 (e) A pharmacist may independently administer epinephrine to a patient or 02 prescribe epinephrine auto-injectors to a person who has completed a training program 03 approved by the board under AS 17.22.020(b). 04 * Sec. 10. AS 08.80.270(a) is amended to read: 05 (a) The board shall employ an executive administrator to carry out the duties 06 established under (b) of this section. The executive administrator is the principal 07 executive officer of the board. The executive administrator is in the partially exempt 08 service under AS 39.25.120 and is entitled to receive a monthly salary equal to a step 09 in range 23 on the salary schedule set out in AS 39.27.011(a). If the executive 10 administrator has a pharmacist license, the executive administrator is entitled to 11 a monthly salary based on the salary classification for pharmacists. 12 * Sec. 11. AS 08.80.420(a) is amended to read: 13 (a) A person may not use or exhibit the title "pharmacist," "assistant 14 pharmacist," or "druggist," or the descriptive term "pharmacy," "drug store," "drug 15 sundries," "apothecary," or other similar title or term containing the word "drug," in 16 any business premises [,] or in an advertisement through the media of press [,] or 17 publication, or by radio or television, unless the business has a licensed pharmacist in 18 regular and continuous employment. 19 * Sec. 12. AS 12.62.400(a) is amended to read: 20 (a) To obtain a national criminal history record check for determining a 21 person's qualifications for a license, permit, registration, employment, or position, a 22 person shall submit the person's fingerprints to the department with the fee established 23 by AS 12.62.160. The department may submit the fingerprints to the Federal Bureau 24 of Investigation to obtain a national criminal history record check of the person for the 25 purpose of evaluating a person's qualifications for 26 (1) a license or conditional contractor's permit to manufacture, sell, 27 offer for sale, possess for sale or barter, traffic in, or barter an alcoholic beverage 28 under AS 04.11; 29 (2) licensure as a mortgage lender, a mortgage broker, or a mortgage 30 loan originator under AS 06.60; 31 (3) admission to the Alaska Bar Association under AS 08.08;
01 (4) licensure as a collection agency operator under AS 08.24; 02 (5) a certificate of fitness to handle explosives under AS 08.52; 03 (6) licensure as a massage therapist under AS 08.61; 04 (7) licensure to practice nursing or certification as a nurse aide under 05 AS 08.68; 06 (8) certification as a real estate appraiser under AS 08.87; 07 (9) a position involving supervisory or disciplinary power over a minor 08 or dependent adult for which criminal justice information may be released under 09 AS 12.62.160(b)(9); 10 (10) a teacher certificate under AS 14.20; 11 (11) a registration or license to operate a marijuana establishment 12 under AS 17.38; 13 (12) admittance to a police training program under AS 18.65.230 or for 14 certification as a police officer under AS 18.65.240 if that person's prospective 15 employer does not have access to a criminal justice information system; 16 (13) licensure as a security guard under AS 18.65.400 - 18.65.490; 17 (14) a concealed handgun permit under AS 18.65.700 - 18.65.790; 18 (15) licensure as an insurance producer, managing general agent, 19 reinsurance intermediary broker, reinsurance intermediary manager, surplus lines 20 broker, or independent adjuster under AS 21.27; 21 (16) serving and executing process issued by a court by a person 22 designated under AS 22.20.130; 23 (17) a school bus driver license under AS 28.15.046; 24 (18) licensure as an operator or an instructor for a commercial driver 25 training school under AS 28.17; 26 (19) registration as a broker-dealer, agent, investment adviser 27 representative, or investment adviser under AS 45.56.300 - 45.56.350; 28 (20) licensure, license renewal, certification, certification renewal, or 29 payment from the Department of Health of an individual and an entity subject to the 30 requirements for a criminal history check under AS 47.05.310, including 31 (A) a public home care provider described in AS 47.05.017;
01 (B) a provider of home and community-based waiver services 02 financed under AS 47.07.030(c); 03 (C) a case manager to coordinate community mental health 04 services under AS 47.30.530; 05 (D) an entity listed in AS 47.32.010(b) and (c), including an 06 owner, officer, director, member, partner, employee, volunteer, or contractor of 07 an entity; or 08 (E) an individual or entity not described in (A) - (D) of this 09 paragraph that is required by statute or regulation to be licensed or certified by 10 the Department of Health or that is eligible to receive payments, in whole or in 11 part, from the Department of Health to provide for the health, safety, and 12 welfare of persons who are served by the programs administered by the 13 Department of Health; 14 (21) employment as a village public safety officer under AS 18.65.672 15 or certification as a village public safety officer under AS 18.65.682; 16 (22) licensure, license renewal, certification, or certification renewal 17 by the Department of Family and Community Services of an individual or entity, or 18 payment from the Department of Family and Community Services to an individual or 19 entity, subject to the requirements for a criminal history check under AS 47.05.310 for 20 a foster home, child placement agency, and runaway shelter listed in AS 47.32.010(c), 21 including an owner, officer, director, member, partner, employee, volunteer, or 22 contractor of an entity; 23 (23) licensure as a pharmacist or pharmacy technician under 24 AS 08.80. 25 * Sec. 13. AS 17.22.010 is amended to read: 26 Sec. 17.22.010. Prescription, purchase, and administration of epinephrine 27 by a trained individual. An individual who is 18 years of age or older may obtain a 28 prescription for, purchase, and, in an emergency situation, administer epinephrine to 29 another person using 30 [(1)] an auto-injector, if the individual has successfully completed a 31 training program approved by the board [DEPARTMENT] under as 17.22.020(b) [;
01 OR 02 (2) AN AMPULE, IF THE INDIVIDUAL HAS SUCCESSFULLY 03 COMPLETED A TRAINING PROGRAM APPROVED BY THE DEPARTMENT 04 UNDER AS 17.22.020(c)]. 05 * Sec. 14. AS 17.22.020(a) is amended to read: 06 (a) The board [DEPARTMENT] shall adopt standards for the approval of a 07 training program [PROGRAMS] for the use of 08 [(1)] epinephrine auto-injectors [; AND 09 (2) EPINEPHRINE AMPULES]. 10 * Sec. 15. AS 17.22.020(b) is amended to read: 11 (b) The board [DEPARTMENT] shall approve an auto-injector training 12 program that meets standards adopted under (a) [(a)(1)] of this section. The standards 13 must require an epinephrine auto-injector program to provide training in 14 (1) techniques on how to recognize symptoms of severe asthmatic or 15 allergic reactions, including anaphylaxis; 16 (2) standards and procedures for the storage of epinephrine auto- 17 injectors and administration of epinephrine using auto-injectors; and 18 (3) emergency follow-up procedures. 19 * Sec. 16. AS 17.22.030 is amended to read: 20 Sec. 17.22.030. Applicability. This chapter does not apply to a person who is 21 authorized under another law to administer epinephrine [OR TO A PERSON WHO IS 22 PRESCRIBED EPINEPHRINE FOR PERSONAL USE]. 23 * Sec. 17. AS 17.22.040 is amended to read: 24 Sec. 17.22.040. Liability of certified individual. A claim for relief may not be 25 brought against an individual who has successfully completed an auto-injector [A] 26 training program approved by the board [DEPARTMENT] under AS 17.22.020 for an 27 act or omission relating to the administration of epinephrine to another individual in an 28 emergency situation if the individual who completed the training program acted in 29 good faith under the authority granted by this chapter. 30 * Sec. 18. AS 17.22.090 is amended by adding a new paragraph to read: 31 (3) "board" means the Board of Pharmacy.
01 * Sec. 19. AS 08.80.110(2), 08.80.158; AS 17.22.020(c), and 17.22.090(1) are repealed. 02 * Sec. 20. The uncodified law of the State of Alaska is amended by adding a new section to 03 read: 04 TRANSITION: EFFECT ON CURRENT REGISTERED PHARMACIES. On and 05 after the effective date of sec. 19 of this Act, a pharmacy registered under AS 08.80.158 on 06 the effective date of sec. 19 of this Act may continue to ship, mail, or deliver prescription 07 drugs to consumers in the state under the registration until the registration expires normally 08 under AS 08.80. 09 * Sec. 21. The uncodified law of the State of Alaska is amended by adding a new section to 10 read: 11 TRANSITION: REGULATIONS. The Board of Pharmacy and the Department of 12 Commerce, Community, and Economic Development may adopt regulations necessary to 13 implement the changes made by this Act. The regulations take effect under AS 44.62 14 (Administrative Procedure Act), but not before the effective date of the relevant provision of 15 this Act implemented by the regulation. 16 * Sec. 22. Section 21 of this Act takes effect immediately under AS 01.10.070(c). 17 * Sec. 23. Section 4 of this Act takes effect May 7, 2023. 18 * Sec. 24. Except as provided in secs. 22 and 23 of this Act, this Act takes effect 19 November 26, 2023.