Alaska State Legislature

Home
Bill & Laws
Bills
HCS CSSB 37(RLS) Detail
FullText

txt

HCS CSSB 37(RLS): "An Act relating to the Board of Pharmacy; relating to the licensing of certain entities and inspection of certain facilities located outside the state; relating to drug supply chain security; creating a position of executive administrator for the Board of Pharmacy; reducing the membership of the Alaska Commercial Fisheries Entry Commission to two individuals; relating to the duties of the commissioner serving as chair of the commission; providing that a single commissioner may exercise all powers and duties of the commission if there is a vacancy on the commission; providing for commissioner compensation; relating to tie votes of the commission; and providing for an effective date."

00 HOUSE CS FOR CS FOR SENATE BILL NO. 37(RLS) 01 "An Act relating to the Board of Pharmacy; relating to the licensing of certain entities 02 and inspection of certain facilities located outside the state; relating to drug supply chain 03 security; creating a position of executive administrator for the Board of Pharmacy; 04 reducing the membership of the Alaska Commercial Fisheries Entry Commission to two 05 individuals; relating to the duties of the commissioner serving as chair of the 06 commission; providing that a single commissioner may exercise all powers and duties of 07 the commission if there is a vacancy on the commission; providing for commissioner 08 compensation; relating to tie votes of the commission; and providing for an effective 09 date." 10 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF ALASKA: 11 * Section 1. AS 08.80.030(b) is amended to read: 12 (b) In order to fulfill its responsibilities, the board has the powers necessary

01 for implementation and enforcement of this chapter, including the power to 02 (1) elect a president and secretary from its membership and adopt rules 03 for the conduct of its business; 04 (2) license by examination or by license transfer the applicants who are 05 qualified to engage in the practice of pharmacy; 06 (3) assist the department in inspections and investigations for 07 violations of this chapter, or of any other state or federal statute relating to the practice 08 of pharmacy; 09 (4) adopt regulations to carry out the purposes of this chapter; 10 (5) establish and enforce compliance with professional standards and 11 rules of conduct for pharmacists engaged in the practice of pharmacy; 12 (6) determine standards for recognition and approval of degree 13 programs of schools and colleges of pharmacy whose graduates shall be eligible for 14 licensure in this state, including the specification and enforcement of requirements for 15 practical training, including internships; 16 (7) establish for pharmacists and pharmacies minimum specifications 17 for the physical facilities, technical equipment, personnel, and procedures for the 18 storage, compounding, and dispensing of drugs or related devices, and for the 19 monitoring of drug therapy; 20 (8) enforce the provisions of this chapter relating to the conduct or 21 competence of pharmacists practicing in the state, and the suspension, revocation, or 22 restriction of licenses to engage in the practice of pharmacy; 23 (9) license and regulate the training, qualifications, and employment of 24 pharmacy interns and pharmacy technicians; 25 (10) issue licenses to persons engaged in the manufacture and 26 distribution of drugs and related devices; 27 (11) establish and maintain a controlled substance prescription 28 database as provided in AS 17.30.200; 29 (12) establish standards for the independent administration by a 30 pharmacist of vaccines and related emergency medications under AS 08.80.168, 31 including the completion of an immunization training program approved by the board;

01 (13) establish standards for the independent dispensing by a 02 pharmacist of an opioid overdose drug under AS 17.20.085, including the completion 03 of an opioid overdose training program approved by the board; 04 (14) require that a licensed pharmacist register with the controlled 05 substance prescription database under AS 17.30.200(o); 06 (15) establish the qualifications and duties of the executive 07 administrator and delegate authority to the executive administrator that is 08 necessary to conduct board business. 09 * Sec. 2. AS 08.80.030(b), as amended by sec. 1 of this Act, is amended to read: 10 (b) In order to fulfill its responsibilities, the board has the powers necessary 11 for implementation and enforcement of this chapter, including the power to 12 (1) elect a president and secretary from its membership and adopt rules 13 for the conduct of its business; 14 (2) license by examination or by license transfer the applicants who are 15 qualified to engage in the practice of pharmacy; 16 (3) assist the department in inspections and investigations for 17 violations of this chapter, or of any other state or federal statute relating to the practice 18 of pharmacy; 19 (4) adopt regulations to carry out the purposes of this chapter; 20 (5) establish and enforce compliance with professional standards and 21 rules of conduct for pharmacists engaged in the practice of pharmacy; 22 (6) determine standards for recognition and approval of degree 23 programs of schools and colleges of pharmacy whose graduates shall be eligible for 24 licensure in this state, including the specification and enforcement of requirements for 25 practical training, including internships; 26 (7) establish for pharmacists and pharmacies minimum specifications 27 for the physical facilities, technical equipment, personnel, and procedures for the 28 storage, compounding, and dispensing of drugs or related devices, and for the 29 monitoring of drug therapy; 30 (8) enforce the provisions of this chapter relating to the conduct or 31 competence of pharmacists practicing in the state, and the suspension, revocation, or

01 restriction of licenses to engage in the practice of pharmacy; 02 (9) license and regulate the training, qualifications, and employment of 03 pharmacy interns and pharmacy technicians; 04 (10) issue licenses to persons engaged in the manufacture and 05 distribution of drugs and related devices; 06 (11) establish and maintain a controlled substance prescription 07 database as provided in AS 17.30.200; 08 (12) establish standards for the independent administration by a 09 pharmacist of vaccines and related emergency medications under AS 08.80.168, 10 including the completion of an immunization training program approved by the board; 11 (13) establish standards for the independent dispensing by a 12 pharmacist of an opioid overdose drug under AS 17.20.085, including the completion 13 of an opioid overdose training program approved by the board; 14 (14) require that a licensed pharmacist register with the controlled 15 substance prescription database under AS 17.30.200(o); 16 (15) establish the qualifications and duties of the executive 17 administrator and delegate authority to the executive administrator that is necessary to 18 conduct board business; 19 (16) license and inspect the facilities of wholesale drug 20 distributors, third-party logistics providers, and outsourcing facilities located 21 outside the state under AS 08.80.159. 22 * Sec. 3. AS 08.80.030 is amended by adding a new subsection to read: 23 (c) The minimum specifications for facilities, equipment, personnel, and 24 procedures for the compounding, storage, and dispensing of drugs established under 25 (b)(7) of this section must be consistent with the requirements of 21 U.S.C. 201 - 208 26 (Drug Supply Chain Security Act). 27 * Sec. 4. AS 08.80.157 is amended by adding a new subsection to read: 28 (k) This section applies to wholesale drug distributors, third-party logistics 29 providers, and outsourcing facilities located outside the state under AS 08.80.159. 30 * Sec. 5. AS 08.80 is amended by adding a new section to read: 31 Sec. 08.80.159. Licensing and inspection of facilities outside of state. (a)

01 Before shipping, mailing, or delivering prescription drugs to a licensee in the state or 02 advertising in the state, a wholesale drug distributor, third-party logistics provider, or 03 an outsourcing facility that is located outside the state shall 04 (1) obtain a license under AS 08.80.157; 05 (2) appoint an agent on whom process can be served in the state; and 06 (3) authorize inspection of the facility by a designee of the board under 07 (c) of this section. 08 (b) In addition to the requirements of (a) of this section, an outsourcing facility 09 shall 10 (1) register as an outsourcing facility with the United States Food and 11 Drug Administration; and 12 (2) comply with the requirements of 21 U.S.C. 503B (Drug Quality 13 and Security Act of 2013). 14 (c) Upon application by a wholesale drug distributor, third-party logistics 15 provider, or an outsourcing facility for a license under this section, the board may 16 (1) require an inspection of the applicant's facility located outside the 17 state; and 18 (2) approve a designee to conduct the inspection. 19 (d) The board shall adopt regulations necessary to implement this section. 20 * Sec. 6. AS 08.80 is amended by adding a new section to article 2 to read: 21 Sec. 08.80.270. Executive administrator of the board. (a) The board shall 22 employ an executive administrator to carry out the duties established under (b) of this 23 section. The executive administrator is the principal executive officer of the board. 24 The executive administrator is in the partially exempt service under AS 39.25.120 and 25 is entitled to receive a monthly salary equal to a step in Range 23 on the salary 26 schedule set out in AS 39.27.011(a). 27 (b) The executive administrator shall 28 (1) perform duties associated with the licensing and regulation of 29 licensees under this chapter as prescribed by the board; and 30 (2) serve as a liaison to the legislative and executive branches of state 31 government, the media, and other state pharmacy boards.

01 * Sec. 7. AS 08.80.480 is amended by adding new paragraphs to read: 02 (37) "outsourcing facility" means a facility at one geographic location 03 or address that is engaged in the compounding of sterile drugs for a facility at another 04 geographic location; 05 (38) "third-party logistics provider" means an entity that provides or 06 coordinates warehousing or other logistics services for a product in interstate 07 commerce on behalf of a manufacturer, wholesale distributor, or dispenser of the 08 product, and that does not take ownership of the product or have responsibility to 09 direct the sale or disposition of the product. 10 * Sec. 8. AS 16.43.020 is amended to read: 11 Sec. 16.43.020. Alaska Commercial Fisheries Entry Commission. (a) There 12 is established the Alaska Commercial Fisheries Entry Commission as a regulatory and 13 quasi-judicial agency of the state. The commission consists of two [THREE] members 14 appointed by the governor and confirmed by the legislature in joint session. 15 (b) The governor shall designate one member of the commission as chair 16 [CHAIRMAN] of the commission. The designated member serves [DESIGNATED 17 SHALL SERVE] as chair [CHAIRMAN] for a term of two years [,] and may be 18 designated chair [CHAIRMAN] for successive two-year terms. The member serving 19 as chair also serves as executive director of the commission and, as executive 20 director, is responsible for and has authority over the internal administrative and 21 personnel practices and procedures of the commission. 22 * Sec. 9. AS 16.43.030(c) is amended to read: 23 (c) If there is a [A] vacancy on the commission, [DOES NOT IMPAIR THE 24 AUTHORITY OF] a single commissioner may [QUORUM OF COMMISSIONERS 25 TO] exercise all the powers and perform all the duties of the commission. 26 * Sec. 10. AS 16.43.040 is amended to read: 27 Sec. 16.43.040. Quorum. Unless there is a vacancy on the commission, two 28 [TWO] members of the commission constitute a quorum for the transaction of 29 business, for the performance of a duty, or for the exercise of a power of the 30 commission. 31 * Sec. 11. AS 16.43.050 is amended to read:

01 Sec. 16.43.050. Qualifications. The commission shall consist of two [THREE] 02 members with a broad range of professional experience, neither [NONE] of whom 03 has a vested economic interest in an interim-use permit, entry permit, commercial 04 fishing vessel or gear, or in any fishery resource processing or marketing business. 05 * Sec. 12. AS 16.43.060 is amended to read: 06 Sec. 16.43.060. Compensation. Members of the commission are in the exempt 07 service and are entitled to a monthly salary. The member serving as chair is paid a 08 salary equal to a step in Range 27, and the other commissioner is paid a salary 09 equal to a step in Range 24, of the salary schedule in AS 39.27.011. 10 * Sec. 13. AS 16.43.110 is amended by adding a new subsection to read: 11 (f) In case of a tie vote between commissioners in an adjudicatory proceeding, 12 the decision of the hearing officer is the final administrative decision of the 13 commission subject to review by a superior court under AS 44.62 (Administrative 14 Procedure Act). 15 * Sec. 14. AS 16.43.960(d) is amended to read: 16 (d) Except when there is a vacancy as provided in AS 16.43.030(c), the 17 [THE] show cause hearing shall be conducted before a quorum of commissioners and 18 shall be presided over by a hearing officer appointed by the commission who shall rule 19 on the presentation of evidence and other procedural matters. Hearings shall be 20 conducted in accordance with regulations adopted under AS 16.43.110(b). 21 * Sec. 15. AS 39.25.120(c)(7) is amended to read: 22 (7) the principal executive officer of the following boards, councils, or 23 commissions: 24 (A) Alaska Public Broadcasting Commission; 25 (B) Professional Teaching Practices Commission; 26 (C) Parole Board; 27 (D) Board of Nursing; 28 (E) Real Estate Commission; 29 (F) Alaska Royalty Oil and Gas Development Advisory Board; 30 (G) Alaska State Council on the Arts; 31 (H) Alaska Police Standards Council;

01 (I) Alaska Commission on Aging; 02 (J) Alaska Mental Health Board; 03 (K) State Medical Board; 04 (L) Governor's Council on Disabilities and Special Education; 05 (M) Advisory Board on Alcoholism and Drug Abuse; 06 (N) Statewide Suicide Prevention Council; 07 (O) State Board of Registration for Architects, Engineers, and 08 Land Surveyors; 09 (P) Alaska Health Care Commission; 10 (Q) Board of Pharmacy; 11 * Sec. 16. The uncodified law of the State of Alaska is amended by adding a new section to 12 read: 13 APPLICABILITY. AS 16.43.060, as amended by sec. 12 of this Act, applies to the 14 compensation of commissioners of the Alaska Commercial Fisheries Entry Commission 15 appointed after the effective date of this Act. 16 * Sec. 17. The uncodified law of the State of Alaska is amended by adding a new section to 17 read: 18 TRANSITION: REGULATIONS. The Department of Commerce, Community, and 19 Economic Development and the Board of Pharmacy may adopt regulations necessary to 20 implement the changes made by this Act. The regulations take effect under AS 44.62 21 (Administrative Procedure Act), but not before the effective date of the relevant provision of 22 this Act implemented by the regulation. 23 * Sec. 18. Sections 1, 6, and 8 - 17 of this Act take effect immediately under 24 AS 01.10.070(c). 25 * Sec. 19. Except as provided in sec. 18 of this Act, this Act takes effect July 1, 2019.