00                      CS FOR HOUSE BILL NO. 96(HSS)                                                                     
01 "An Act relating to licensing and registration requirements for certain wholesale drug                                  
02 distributors; and providing for an effective date."                                                                     
03 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF ALASKA:                                                                
04    * Section 1. AS 08.80.157(h) is amended to read:                                                                   
05            (h)  The board may suspend, revoke, deny, or refuse to renew the license of a                                
06       facility or pharmacy on the following grounds:                                                                    
07                 (1)  the finding by the board of violations of a federal, state, or local                               
08       law relating to the practice of pharmacy, drug samples, wholesale or retail drug or                               
09       device distribution, or distribution of controlled substances;                                                    
10                 (2)  a felony conviction under federal, state, or local law of an owner of                              
11       the facility or pharmacy or of an employee of the facility or pharmacy;                                           
12                 (3)  the furnishing of false or fraudulent material in an application made                              
13       in connection with drug or device manufacturing or distribution;                                                  
14                 (4)  suspension or revocation by federal, state, or local government of a                               

01       license currently or previously held by the applicant for the manufacture or                                      
02       distribution of drugs or devices, including controlled substances;                                                
03                 (5)  obtaining remuneration by fraud, misrepresentation, or deception;                                  
04                 (6)  dealing with drugs or devices that are known or should have been                                   
05       known to be stolen drugs or devices;                                                                              
06                 (7)  dispensing or distributing drugs or devices directly to patients by a                              
07       wholesale drug distributor other than a pharmacy unless                                                       
08                      (A)  the drug or device is a dialysate, drug composed solely                                   
09            of fluids, electrolytes, and sugars, or device that is                                                   
10                           (i)  necessary to perform home dialysis;                                                  
11 (ii)  approved by the United States Food and Drug                                                                   
12                 Administration, as required by federal law; and                                                     
13 (iii)  delivered in its original, sealed, and labeled                                                               
14                 packaging only upon the receipt of a physician's order; and                                         
15                      (B)  the wholesale drug distributor                                                            
16 (i)  delivers the dialysate drug or device directly to a                                                            
17 patient with end-stage renal disease, or to the patient's designee,                                                 
18                 for the patient's self-administration of dialysis therapy;                                          
19 (ii)  uses a bar code scanning and verification system                                                              
20 confirming that the dialysate drug or device selected to fill the                                                   
21 patient-specific order matches the information on the patient-                                                      
22                 specific label; and                                                                                 
23 (iii)  has additional secondary accuracy and delivery                                                               
24                 checks in place; and                                                                                
25 (C)  a licensed pharmacist serves as a consultant to the                                                            
26            wholesale drug distributor to                                                                            
27 (i)  conduct a retrospective audit of 10 percent of the                                                             
28 dialysate drug and device orders provided directly to patients                                                      
29                 processed by the wholesale drug distributor every month; and                                        
30 (ii)  perform assessments at least twice monthly to                                                                 
31 ensure quality of product storage, handling, and distribution by the                                                

01                 wholesale drug distributor;                                                                         
02                 (8)  violation of this chapter or a regulation adopted under this chapter.                              
03    * Sec. 2. This Act takes effect May 7, 2023.