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30th Legislature(2017-2018)

Bill Text 30th Legislature


00 Enrolled SB 37                                                                                                          
01 Relating to the Board of Pharmacy; relating to the licensing of certain entities and inspection                         
02 of certain facilities located outside the state; relating to drug supply chain security; creating a                     
03 position of executive administrator for the Board of Pharmacy; reducing the membership of                               
04 the Alaska Commercial Fisheries Entry Commission to two individuals; relating to the duties                             
05 of the commissioner serving as chair of the commission; providing that a single commissioner                            
06 may exercise all powers and duties of the commission if there is a vacancy on the                                       
07 commission; providing for commissioner compensation; relating to tie votes of the                                       
08 commission; and providing for an effective date.                                                                        
09                           _______________                                                                               
10    * Section 1. AS 08.80.030(b) is amended to read:                                                                     
11            (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 secs. 201 - 208, P.L.                                
26       113-54 (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. 353b (Drug Quality and                                                   
13       Security Act).                                                                                                    
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. When there is a                                          
19 vacancy in the executive director position, the member serving as chair is                                            
20 responsible for and has authority over the internal administrative and personnel                                      
21       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 equal to a step in Range 25 [27] of the                            
08       salary schedule in AS 39.27.011.                                                                                  
09    * Sec. 13. AS 16.43.110 is amended by adding a new subsection to read:                                               
10 (f)  In case of a tie vote between commissioners in an adjudicatory proceeding,                                         
11 the decision of the hearing officer is the final administrative decision of the                                         
12 commission subject to review by a superior court under AS 44.62 (Administrative                                         
13       Procedure Act).                                                                                                   
14    * Sec. 14. AS 16.43.960(d) is amended to read:                                                                       
15 (d)  Except when there is a vacancy as provided in AS 16.43.030(c), the                                               
16 [THE] show cause hearing shall be conducted before a quorum of commissioners and                                        
17 shall be presided over by a hearing officer appointed by the commission who shall rule                                  
18 on the presentation of evidence and other procedural matters. Hearings shall be                                         
19       conducted in accordance with regulations adopted under AS 16.43.110(b).                                           
20    * Sec. 15. AS 39.25.120(c)(7) is amended to read:                                                                    
21 (7)  the principal executive officer of the following boards, councils, or                                              
22       commissions:                                                                                                      
23                      (A)  Alaska Public Broadcasting Commission;                                                        
24                      (B)  Professional Teaching Practices Commission;                                                   
25                      (C)  Parole Board;                                                                                 
26                      (D)  Board of Nursing;                                                                             
27                      (E)  Real Estate Commission;                                                                       
28                      (F)  Alaska Royalty Oil and Gas Development Advisory Board;                                        
29                      (G)  Alaska State Council on the Arts;                                                             
30                      (H)  Alaska Police Standards Council;                                                              
31                      (I)  Alaska Commission on Aging;                                                                   
01                      (J)  Alaska Mental Health Board;                                                                   
02                      (K)  State Medical Board;                                                                          
03                      (L)  Governor's Council on Disabilities and Special Education;                                     
04                      (M)  Advisory Board on Alcoholism and Drug Abuse;                                                  
05                      (N)  Statewide Suicide Prevention Council;                                                         
06                      (O)  State Board of Registration for Architects, Engineers, and                                    
07            Land Surveyors;                                                                                              
08                      (P)  Alaska Health Care Commission;                                                                
09                      (Q)  Board of Pharmacy;                                                                          
10    * Sec. 16. The uncodified law of the State of Alaska is amended by adding a new section to                           
11 read:                                                                                                                   
12  APPLICABILITY. AS 16.43.060, as amended by sec. 12 of this Act, applies to the                                         
13 compensation of commissioners of the Alaska Commercial Fisheries Entry Commission                                       
14 appointed after the effective date of sec. 12 of this Act.                                                              
15    * Sec. 17. The uncodified law of the State of Alaska is amended by adding a new section to                           
16 read:                                                                                                                   
17 TRANSITION: REGULATIONS. The Department of Commerce, Community, and                                                     
18 Economic Development and the Board of Pharmacy may adopt regulations necessary to                                       
19 implement the changes made by secs. 1 - 7 of this Act. The regulations take effect under                                
20 AS 44.62 (Administrative Procedure Act), but not before the effective date of the relevant                              
21 provision of this Act implemented by the regulation.                                                                    
22    * Sec. 18. Sections 1, 6, and 8 - 17 of this Act take effect immediately under                                       
23 AS 01.10.070(c).                                                                                                        
24    * Sec. 19. Except as provided in sec. 18 of this Act, this Act takes effect July 1, 2019.                            
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