SB 32: "An Act relating to biological products; relating to the practice of pharmacy; relating to the Board of Pharmacy; and providing for an effective date."

00                             SENATE BILL NO. 32                                                                          
01 "An Act relating to biological products; relating to the practice of pharmacy; relating to                              
02 the Board of Pharmacy; and providing for an effective date."                                                            
03 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF ALASKA:                                                                
04    * Section 1. AS 08.80.030 is amended by adding a new subsection to read:                                           
05            (c)  The board shall post and maintain a link to the United States Food and                                  
06       Drug Administration's list of all currently approved interchangeable biological                                   
07       products on the board's Internet website.                                                                         
08    * Sec. 2. AS 08.80.294 is amended to read:                                                                         
09            Sec. 08.80.294.  Information about equivalent generic drugs and                                          
10       interchangeable biological products.  (a) In addition to other information that may                           
11       be required under state or federal laws or regulations, a pharmacist, when dispensing a                           
12       brand-name prescription drug order that is                                                                    
13                 (1)  not a biological product, shall include the generic drug name that                             
14       is an equivalent drug product for the drug dispensed;                                                         
01                 (2)  a biological product, shall include the dispensed product's                                    
02                      (A)  proprietary name, if available; or                                                        
03                      (B)  proper name.                                                                              
04            (b)  The generic drug name or proprietary or proper biological product                                   
05       name required under (a) of this section shall be placed directly on the container's label                     
06       near the brand name.                                                                                              
07    * Sec. 3. AS 08.80.294 is amended by adding a new subsection to read:                                              
08            (c)  In this section,                                                                                        
09                 (1)  "proper name" means a name that reflects scientific characteristics                                
10       of the product such as chemical structure and pharmacological properties;                                         
11 (2)  "proprietary name" means a name that is trademarked and                                                            
12       registered for private use.                                                                                       
13    * Sec. 4. AS 08.80.295 is amended to read:                                                                         
14 Sec. 08.80.295.  Substitution of equivalent drug products or                                                        
15 interchangeable biological products.  (a) Unless the prescription indicates that it is                              
16 to be dispensed only as written, the pharmacist may, with the consent of the patient,                                   
17       substitute an equivalent drug product or interchangeable biological product.                                  
18 (b)  A pharmacist who substitutes an equivalent drug product or                                                     
19 interchangeable biological product in compliance with this section and applicable                                   
20 regulations incurs no greater liability in filling the prescription than would be incurred                              
21       in filling the prescription by dispensing the prescribed name brand product.                                      
22    * Sec. 5. AS 08.80.295 is amended by adding new subsections to read:                                               
23 (c)  Except as provided in (d) of this section, if an interchangeable biological                                        
24 product exists for a biological product prescribed to a patient, the dispensing                                         
25 pharmacist or the pharmacist's designee shall communicate to the prescribing                                            
26 practitioner information regarding the biological product provided to the patient,                                      
27 including the name and manufacturer of the biological product. The communication                                        
28 must be provided within three business days after dispensing the biological product as                                  
29       follows:                                                                                                          
30 (1)  by making an entry that is electronically accessible to the                                                        
31       prescribing practitioner through                                                                                  
01                      (A)  an interoperable electronic medical records system;                                           
02                      (B)  an electronic prescribing technology;                                                         
03                      (C)  a pharmacy benefit management system; or                                                      
04                      (D)  a pharmacy record; or                                                                         
05 (2)  if the pharmacist or the pharmacist's designee is unable to make an                                                
06 entry through one of the means provided under (1) of this subsection, by facsimile                                      
07 transmission, telephone communication, electronic mail transmission, or transmission                                    
08       by other prevailing means, to the prescribing practitioner.                                                       
09            (d)  The dispensing pharmacist or the pharmacist's designee is not required to                               
10 communicate information under (c) of this section if the dispensed biological product                                   
11 is a refill of a prescription and is the same as the biological product that was dispensed                              
12       on the previous filling of the prescription.                                                                      
13 (e)  Entry into an electronic records system as described under (c)(1) of this                                          
14       section is presumed to provide notice to the prescribing practitioner.                                            
15 (f)  A pharmacist shall maintain a record of a dispensed biological product for                                         
16       a minimum of two years after the date of the dispensing.                                                          
17 (g)  In this section, "designee" means an agent or employee of the dispensing                                           
18 pharmacist whom the dispensing pharmacist has authorized to communicate the                                             
19       information required under (c) of this section.                                                                   
20    * Sec. 6. AS 08.80.480(34) is amended to read:                                                                     
21 (34)  "substitute" ["SUBSTITUTION"] means to dispense, without                                                  
22       the prescriber's expressed authorization,                                                                         
23 (A)  an equivalent drug product in place of the prescribed drug;                                                
24            or                                                                                                       
25 (B)  an interchangeable biological product in place of the                                                          
26            prescribed biological product;                                                                           
27    * Sec. 7. AS 08.80.480 is amended by adding new paragraphs to read:                                                
28 (37)  "biological product" means a product that is applicable to the                                                    
29 prevention, treatment, or cure of a disease or condition of human beings, and is a                                      
30 virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or                                          
31 derivative, allergenic product, protein other than a chemically synthesized                                             
01       polypeptide, or analogous product, or arsphenamine or derivative of arsphenamine or                               
02       any other trivalent organic arsenic compound;                                                                     
03                 (38)  "interchangeable biological product" means a biological product                                   
04       that the United States Food and Drug Administration has determined                                                
05                      (A)  meets the standards for interchangeability under 42 U.S.C.                                    
06            262(k)(4); or                                                                                                
07 (B)  is therapeutically equivalent to another biological product                                                        
08 under the most recent edition or supplement of the United States Food and                                               
09 Drug Administration's Approved Drug Products with Therapeutic Equivalence                                               
10            Evaluations.                                                                                                 
11    * Sec. 8. The uncodified law of the State of Alaska is amended by adding a new section to                          
12 read:                                                                                                                   
13 TRANSITION: REGULATIONS. The Board of Pharmacy may adopt regulations                                                    
14 necessary to implement the changes made by this Act. The regulations take effect under                                  
15 AS 44.62 (Administrative Procedure Act), but not before the effective date of the relevant                              
16 provision of this Act implemented by the regulation.                                                                    
17    * Sec. 9. Section 8 of this Act takes effect July 1, 2017.                                                         
18    * Sec. 10. Except as provided in sec. 9 of this Act, this Act takes effect January 1, 2018.