summary
Introduced
In Committee
Crossed Over
Passed
Dead
Signed/Enacted/Adopted
05/31/2013
05/31/2013
Introduced Session
2013 Regular Session
Bill Summary
Permits class II institutional pharmacy formulary to include include biologics, biosimilars, & biosimilar interchangeables; provides requirements for pharmacist to dispense substitute biological product that is determined to be biosimilar to & interchangeable for prescribed biological product; provides notification requirements for pharmacist in class II or modified class II institutional pharmacy; requires Board of Pharmacy to maintain current list of interchangeable biosimilar products.
AI Summary
This bill allows Class II institutional pharmacies, which are pharmacies within hospitals or similar facilities, to include biologics, biosimilars, and biosimilar interchangeables in their approved drug lists, known as formularies. A biologic is a drug made from living organisms, while a biosimilar is a highly similar version of an already approved biologic. A biosimilar interchangeable means that the U.S. Food and Drug Administration (FDA) has determined that the biosimilar can be expected to have the same clinical result as the original biologic and can be switched back and forth. The bill outlines requirements for pharmacists when dispensing a biosimilar interchangeable product, including ensuring the FDA has approved it as interchangeable, checking if the prescribing doctor has specifically prohibited substitution, and notifying the patient of the substitution. For pharmacists in Class II or modified Class II institutional pharmacies, this notification must be recorded in the institution's medical records. Additionally, the Board of Pharmacy will be responsible for maintaining an up-to-date public list of all FDA-approved interchangeable biosimilar products.
Committee Categories
Health and Social Services
Sponsors (13)
Matt Hudson (R)*,
Shev Jones (D)*,
Larry Ahern (R),
Ben Albritton (R),
Jason Brodeur (R),
Matthew Caldwell (R),
Joseph Gibbons (D),
Ed Hooper (R),
Travis Hutson (R),
José Oliva (R),
Kathleen Peters (R),
Cary Pigman (R),
Daniel Raulerson (R),
Other Sponsors (2)
Health and Human Services Committee (House), Health Quality Subcommittee (House)
Last Action
Chapter No. 2013-102 (on 06/03/2013)
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