SB 201: "An Act relating to the Board of Pharmacy; relating to the licensing and inspection of certain facilities located outside the state; relating to drug supply chain security; and creating a position of executive administrator for the Board of Pharmacy."
00 SENATE BILL NO. 201 01 "An Act relating to the Board of Pharmacy; relating to the licensing and inspection of 02 certain facilities located outside the state; relating to drug supply chain security; and 03 creating a position of executive administrator for the Board of Pharmacy." 04 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF ALASKA: 05 * Section 1. AS 08.80.030(b) is amended to read: 06 (b) In order to fulfill its responsibilities, the board has the powers necessary 07 for implementation and enforcement of this chapter, including the power to 08 (1) elect a president and secretary from its membership and adopt rules 09 for the conduct of its business; 10 (2) license by examination or by license transfer the applicants who are 11 qualified to engage in the practice of pharmacy; 12 (3) assist the department in inspections and investigations for 13 violations of this chapter, or of any other state or federal statute relating to the practice 14 of pharmacy;
01 (4) adopt regulations to carry out the purposes of this chapter; 02 (5) establish and enforce compliance with professional standards and 03 rules of conduct for pharmacists engaged in the practice of pharmacy; 04 (6) determine standards for recognition and approval of degree 05 programs of schools and colleges of pharmacy whose graduates shall be eligible for 06 licensure in this state, including the specification and enforcement of requirements for 07 practical training, including internships; 08 (7) establish for pharmacists and pharmacies minimum specifications 09 for the physical facilities, technical equipment, personnel, and procedures for the 10 storage, compounding, and dispensing of drugs or related devices, and for the 11 monitoring of drug therapy; 12 (8) enforce the provisions of this chapter relating to the conduct or 13 competence of pharmacists practicing in the state, and the suspension, revocation, or 14 restriction of licenses to engage in the practice of pharmacy; 15 (9) license and regulate the training, qualifications, and employment of 16 pharmacy interns and pharmacy technicians; 17 (10) issue licenses to persons engaged in the manufacture and 18 distribution of drugs and related devices; 19 (11) establish and maintain a controlled substance prescription 20 database as provided in AS 17.30.200; 21 (12) establish standards for the independent administration by a 22 pharmacist of vaccines and related emergency medications under AS 08.80.168, 23 including the completion of an immunization training program approved by the board; 24 (13) license and inspect the facilities of wholesale drug distributors 25 and outsourcing facilities located outside the state under AS 08.80.159; 26 (14) establish the qualifications and duties of the executive 27 administrator and delegate authority to the executive administrator that is 28 necessary to conduct board business. 29 * Sec. 2. AS 08.80.030 is amended by adding a new subsection to read: 30 (c) The minimum specifications for facilities, equipment, personnel, and 31 procedures for the compounding, storage, and dispensing of drugs established under
01 (b)(7) of this section must be consistent with the requirements of 21 U.S.C. 201 - 208 02 (Drug Supply Chain Security Act). 03 * Sec. 3. AS 08.80.157 is amended by adding a new subsection to read: 04 (k) This section applies to wholesale drug distributors and outsourcing 05 facilities located outside the state under AS 08.80.159. 06 * Sec. 4. AS 08.80 is amended by adding a new section to read: 07 Sec. 08.80.159. Licensing and inspection of facilities outside of state. (a) 08 Before shipping, mailing, or delivering prescription drugs to a licensee in the state or 09 advertising in the state, a wholesale drug distributor or outsourcing facility that is 10 located outside the state shall 11 (1) obtain a license under AS 08.80.157; 12 (2) appoint an agent on whom process can be served in the state; and 13 (3) authorize inspection of the facility by a designee of the board under 14 (b) of this section. 15 (b) In addition to the requirements of (a) of this section, an outsourcing facility 16 shall 17 (1) register as an outsourcing facility with the United States Food and 18 Drug Administration; and 19 (2) comply with the requirements of 21 U.S.C. 503B (Drug Quality 20 and Security Act of 2013). 21 (c) Upon application by a wholesale drug distributor or outsourcing facility for 22 a license under this section, the board may 23 (1) require an inspection of a facility located outside the state; and 24 (2) approve a designee to conduct the inspection. 25 (d) The board shall adopt regulations necessary to implement this section. 26 * Sec. 5. AS 08.80 is amended by adding a new section to article 2 to read: 27 Sec. 08.80.270. Executive administrator of the board. (a) The board shall 28 employ an executive administrator to carry out the duties established under (b) of this 29 section. 30 (b) The executive administrator shall 31 (1) perform duties associated with the licensing and regulation of
01 licensees under this chapter as prescribed by the board; and 02 (2) serve as a liaison to the legislative and executive branches of state 03 government, the media, and other state pharmacy boards. 04 * Sec. 6. AS 08.80.480 is amended by adding a new paragraph to read: 05 (37) "outsourcing facility" means a facility at one geographic location 06 or address that is engaged in the compounding of sterile drugs for a facility at another 07 geographic location.