CSHB 9(L&C): "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; and providing for an effective date."
00 CS FOR HOUSE BILL NO. 9(L&C) 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; and 04 providing for an effective date." 05 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF ALASKA: 06 * Section 1. AS 08.80.030(b) is amended to read: 07 (b) In order to fulfill its responsibilities, the board has the powers necessary 08 for implementation and enforcement of this chapter, including the power to 09 (1) elect a president and secretary from its membership and adopt rules 10 for the conduct of its business; 11 (2) license by examination or by license transfer the applicants who are 12 qualified to engage in the practice of pharmacy; 13 (3) assist the department in inspections and investigations for 14 violations of this chapter, or of any other state or federal statute relating to the practice
01 of pharmacy; 02 (4) adopt regulations to carry out the purposes of this chapter; 03 (5) establish and enforce compliance with professional standards and 04 rules of conduct for pharmacists engaged in the practice of pharmacy; 05 (6) determine standards for recognition and approval of degree 06 programs of schools and colleges of pharmacy whose graduates shall be eligible for 07 licensure in this state, including the specification and enforcement of requirements for 08 practical training, including internships; 09 (7) establish for pharmacists and pharmacies minimum specifications 10 for the physical facilities, technical equipment, personnel, and procedures for the 11 storage, compounding, and dispensing of drugs or related devices, and for the 12 monitoring of drug therapy; 13 (8) enforce the provisions of this chapter relating to the conduct or 14 competence of pharmacists practicing in the state, and the suspension, revocation, or 15 restriction of licenses to engage in the practice of pharmacy; 16 (9) license and regulate the training, qualifications, and employment of 17 pharmacy interns and pharmacy technicians; 18 (10) issue licenses to persons engaged in the manufacture and 19 distribution of drugs and related devices; 20 (11) establish and maintain a controlled substance prescription 21 database as provided in AS 17.30.200; 22 (12) establish standards for the independent administration by a 23 pharmacist of vaccines and related emergency medications under AS 08.80.168, 24 including the completion of an immunization training program approved by the board; 25 (13) establish standards for the independent dispensing by a 26 pharmacist of an opioid overdose drug under AS 17.20.085, including the completion 27 of an opioid overdose training program approved by the board; 28 (14) establish the qualifications and duties of the executive 29 administrator and delegate authority to the executive administrator that is 30 necessary to conduct board business. 31 * Sec. 2. AS 08.80.030(b), as amended by sec. 1 of this Act, is amended to read:
01 (b) In order to fulfill its responsibilities, the board has the powers necessary 02 for implementation and enforcement of this chapter, including the power to 03 (1) elect a president and secretary from its membership and adopt rules 04 for the conduct of its business; 05 (2) license by examination or by license transfer the applicants who are 06 qualified to engage in the practice of pharmacy; 07 (3) assist the department in inspections and investigations for 08 violations of this chapter, or of any other state or federal statute relating to the practice 09 of pharmacy; 10 (4) adopt regulations to carry out the purposes of this chapter; 11 (5) establish and enforce compliance with professional standards and 12 rules of conduct for pharmacists engaged in the practice of pharmacy; 13 (6) determine standards for recognition and approval of degree 14 programs of schools and colleges of pharmacy whose graduates shall be eligible for 15 licensure in this state, including the specification and enforcement of requirements for 16 practical training, including internships; 17 (7) establish for pharmacists and pharmacies minimum specifications 18 for the physical facilities, technical equipment, personnel, and procedures for the 19 storage, compounding, and dispensing of drugs or related devices, and for the 20 monitoring of drug therapy; 21 (8) enforce the provisions of this chapter relating to the conduct or 22 competence of pharmacists practicing in the state, and the suspension, revocation, or 23 restriction of licenses to engage in the practice of pharmacy; 24 (9) license and regulate the training, qualifications, and employment of 25 pharmacy interns and pharmacy technicians; 26 (10) issue licenses to persons engaged in the manufacture and 27 distribution of drugs and related devices; 28 (11) establish and maintain a controlled substance prescription 29 database as provided in AS 17.30.200; 30 (12) establish standards for the independent administration by a 31 pharmacist of vaccines and related emergency medications under AS 08.80.168,
01 including the completion of an immunization training program approved by the board; 02 (13) establish standards for the independent dispensing by a 03 pharmacist of an opioid overdose drug under AS 17.20.085, including the completion 04 of an opioid overdose training program approved by the board; 05 (14) establish the qualifications and duties of the executive 06 administrator and delegate authority to the executive administrator that is necessary to 07 conduct board business; 08 (15) license and inspect the facilities of wholesale drug 09 distributors, third-party logistics providers, and outsourcing facilities located 10 outside the state under AS 08.80.159. 11 * Sec. 3. AS 08.80.030 is amended by adding a new subsection to read: 12 (c) The minimum specifications for facilities, equipment, personnel, and 13 procedures for the compounding, storage, and dispensing of drugs established under 14 (b)(7) of this section must be consistent with the requirements of 21 U.S.C. 201 - 208 15 (Drug Supply Chain Security Act). 16 * Sec. 4. AS 08.80.157 is amended by adding a new subsection to read: 17 (k) This section applies to wholesale drug distributors, third-party logistics 18 providers, and outsourcing facilities located outside the state under AS 08.80.159. 19 * Sec. 5. AS 08.80 is amended by adding a new section to read: 20 Sec. 08.80.159. Licensing and inspection of facilities outside of state. (a) 21 Before shipping, mailing, or delivering prescription drugs to a licensee in the state or 22 advertising in the state, a wholesale drug distributor, third-party logistics provider, or 23 an outsourcing facility that is located outside the state shall 24 (1) obtain a license under AS 08.80.157; 25 (2) appoint an agent on whom process can be served in the state; and 26 (3) authorize inspection of the facility by a designee of the board under 27 (c) of this section. 28 (b) In addition to the requirements of (a) of this section, an outsourcing facility 29 shall 30 (1) register as an outsourcing facility with the United States Food and 31 Drug Administration; and
01 (2) comply with the requirements of 21 U.S.C. 503B (Drug Quality 02 and Security Act of 2013). 03 (c) Upon application by a wholesale drug distributor, third-party logistics 04 provider, or an outsourcing facility for a license under this section, the board may 05 (1) require an inspection of the applicant's facility located outside the 06 state; and 07 (2) approve a designee to conduct the inspection. 08 (d) The board shall adopt regulations necessary to implement this section. 09 * Sec. 6. AS 08.80 is amended by adding a new section to article 2 to read: 10 Sec. 08.80.270. Executive administrator of the board. (a) The board shall 11 employ an executive administrator to carry out the duties established under (b) of this 12 section. The executive administrator is the principal executive officer of the board. 13 The executive administrator is in the partially exempt service under AS 39.25.120 and 14 is entitled to receive a monthly salary equal to a step in Range 23 on the salary 15 schedule set out in AS 39.27.011(a). 16 (b) The executive administrator shall 17 (1) perform duties associated with the licensing and regulation of 18 licensees under this chapter as prescribed by the board; and 19 (2) serve as a liaison to the legislative and executive branches of state 20 government, the media, and other state pharmacy boards. 21 * Sec. 7. AS 08.80.480 is amended by adding new paragraphs to read: 22 (37) "outsourcing facility" means a facility at one geographic location 23 or address that is engaged in the compounding of sterile drugs for a facility at another 24 geographic location; 25 (38) "third-party logistics provider" means an entity that provides or 26 coordinates warehousing or other logistics services for a product in interstate 27 commerce on behalf of a manufacturer, wholesale distributor, or dispenser of the 28 product, and that does not take ownership of the product or have responsibility to 29 direct the sale or disposition of the product. 30 * Sec. 8. AS 39.25.120(c)(7) is amended to read: 31 (7) the principal executive officer of the following boards, councils, or
01 commissions: 02 (A) Alaska Public Broadcasting Commission; 03 (B) Professional Teaching Practices Commission; 04 (C) Parole Board; 05 (D) Board of Nursing; 06 (E) Real Estate Commission; 07 (F) Alaska Royalty Oil and Gas Development Advisory Board; 08 (G) Alaska State Council on the Arts; 09 (H) Alaska Police Standards Council; 10 (I) Alaska Commission on Aging; 11 (J) Alaska Mental Health Board; 12 (K) State Medical Board; 13 (L) Governor's Council on Disabilities and Special Education; 14 (M) Advisory Board on Alcoholism and Drug Abuse; 15 (N) Statewide Suicide Prevention Council; 16 (O) State Board of Registration for Architects, Engineers, and 17 Land Surveyors; 18 (P) Alaska Health Care Commission; 19 (Q) Board of Pharmacy; 20 * Sec. 9. The uncodified law of the State of Alaska is amended by adding a new section to 21 read: 22 TRANSITION: REGULATIONS. The Department of Commerce, Community, and 23 Economic Development and the Board of Pharmacy may adopt regulations necessary to 24 implement the changes made by this Act. The regulations take effect under AS 44.62 25 (Administrative Procedure Act), but not before the effective date of the relevant provision of 26 this Act implemented by the regulation. 27 * Sec. 10. Sections 1, 6, 8, and 9 of this Act take effect immediately under AS 01.10.070(c). 28 * Sec. 11. Except as provided in sec. 10 of this Act, this Act takes effect July 1, 2018.