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Bill > H0365


FL H0365

FL H0365
Pharmacy


summary

Introduced
In Committee
Crossed Over
Passed
Dead
Signed/Enacted/Adopted
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)

Other Sponsors (2)

Health and Human Services Committee (House), Health Quality Subcommittee (House)

Last Action

Chapter No. 2013-102 (on 06/03/2013)

bill text


bill summary

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bill summary

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bill summary

Document Type Source Location
House Committee Amendment #957105 http://www.flsenate.gov/Session/Bill/2013/0365/Amendment/957105/PDF
House Committee Amendment #902755 http://www.flsenate.gov/Session/Bill/2013/0365/Amendment/902755/PDF
House Committee Amendment #525115 http://www.flsenate.gov/Session/Bill/2013/0365/Amendment/525115/PDF
House Committee Amendment #905001 http://www.flsenate.gov/Session/Bill/2013/0365/Amendment/905001/PDF
House Floor Amendment #623427 http://www.flsenate.gov/Session/Bill/2013/0365/Amendment/623427/PDF
House Committee Amendment #857387 http://www.flsenate.gov/Session/Bill/2013/0365/Amendment/857387/PDF
House Committee Amendment #574911 http://www.flsenate.gov/Session/Bill/2013/0365/Amendment/574911/PDF
Senate Floor Amendment #683776 http://www.flsenate.gov/Session/Bill/2013/0365/Amendment/683776/HTML
House Floor Substitute Amendment #212165 http://www.flsenate.gov/Session/Bill/2013/0365/Amendment/212165/PDF
Vote http://www.flsenate.gov/Session/Bill/2013/0365/FloorVotes/XzlJ7gVVOYD%3DPL%3DDFIbkR8cnSgkKvA%3D%7C14%2FPublic%2FVotes%2FBill%2F20130430%2FSenateVote%5Fh0365e1012%2EPDF
Vote http://www.flsenate.gov/Session/Bill/2013/0365/FloorVotes/s0rCtbv2%2FQvpZMykHRocvrSGt4w%3D%7C14%2FPublic%2FVotes%2FAmendment%2F20130417%2FHouseVote%5Fh0365c2135%2EPDF
Vote http://www.flsenate.gov/Session/Bill/2013/0365/FloorVotes/0tb3YJRm%3DPL%3D8tmNjIyOkaLOona6hY%3D%7C14%2FPublic%2FVotes%2FBill%2F20130417%2FHouseVote%5Fh0365c2136%2EPDF
Bill http://www.flsenate.gov/Session/Bill/2013/0365/BillText/er/PDF
Bill http://www.flsenate.gov/Session/Bill/2013/0365/BillText/e1/PDF
Bill http://www.flsenate.gov/Session/Bill/2013/0365/BillText/c2/PDF
Bill http://www.flsenate.gov/Session/Bill/2013/365
Bill http://www.flsenate.gov/Session/Bill/2013/0365/BillText/c1/PDF
Bill http://www.flsenate.gov/Session/Bill/2013/0365/BillText/Filed/PDF
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