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S.F. No. 1184 - Substitution of Biological Products
 
Author: Senator Carla J. Nelson
 
Prepared By: Katie Cavanor, Senate Counsel (651/296-3801)
 
Date: March 13, 2017



 

SF1184 applies the generic drug substitution requirements to biological products when there is a less expensive interchangeable biological product available.

Section 1 (151.01, subd. 5) modifies the definition of a drug within chapter 151 by striking “vaccines and biologicals” and inserting “biological products, other than blood or blood components.”

Section 2 (151.01, subd. 40) adds a definition of “biological product.”

Section 3 (151.01, subd. 41) defines “interchangeable biological product.”

Section 4 (151.21) subdivision 3 modifies the substitution section by requiring a pharmacist when a biological product is prescribed, to dispense a less expensive interchangeable biological product if available, after disclosing the substitution to the purchaser, unless the purchaser objects or the prescriber has required that the prescription be dispensed as written.  Specifies that a pharmacist shall not substitute a biological product unless the U.S. Food and Drug Administration (FDA) has determined the substituted biological product is interchangeable with the prescribed biological product.

Subdivision 10, Paragraph (a) requires the dispensing pharmacist or the pharmacist’s designee within five business days following the dispensing of a biological product to communicate to the prescriber the name and manufacturer of the biological product dispensed. 

Paragraph (b) specifies that the communication be conveyed by making the entry electronically accessible to the prescriber.

Paragraph (c) specifies that entry into an electronic records system is presumed to provide notice to the prescriber.

Paragraph (d) requires the pharmacist when electronic communication is not possible to communicate with the prescriber using mail, facsimile, telephone, or other secure means of electronic transmission.  

Paragraph (e) specifies that the communication of the name and manufacturer of the biological product dispensed is not required if there is no FDA approved interchangeable biological product for the product prescribed; or the prescription is being refilled with the same  biological product.

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