00                              HOUSE BILL NO. 96                                                                          
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, or device that is                                
09                           (i)  necessary to perform home dialysis;                                                  
10                           (ii)  approved by the United States Food and Drug                                         
11                 Administration, as required by federal law; and                                                     
12                           (iii)  delivered in its original, sealed, and labeled                                     
13                 packaging and only upon the receipt of a physician's order; and                                     
14                      (B)  the wholesale drug distributor delivers the dialysate,                                    
15            drug, or device directly to a patient with end-stage renal disease, or to the                            
16            patient's designee, for the patient's self-administration of dialysis therapy;                           
17                 (8)  violation of this chapter or a regulation adopted under this chapter.                              
18    * Sec. 2. This Act takes effect May 7, 2023.