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FL H0365
Bill
Status
6/3/2013
Primary Sponsor
Larry Ahern
Click for details
AI Summary
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Amends Florida Statutes to permit Class II institutional pharmacy formularies to include biologics, biosimilars, and biosimilar interchangeables in addition to traditional medicinal drugs and proprietary preparations.
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Creates new statute 465.0252 defining pharmacist requirements for dispensing substitute biological products determined by the FDA to be biosimilar and interchangeable with prescribed biological products.
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Requires pharmacists to notify patients of biosimilar substitutions using the same method as generic drug substitutions, and prohibits substitution if the prescribing health care provider expresses written, verbal, or electronic preference against it.
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Mandates pharmacists retain written or electronic records of biosimilar substitutions for at least 2 years, and requires Class II and modified Class II institutional pharmacists to document substitutions in the institution's medical record system.
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Requires the Board of Pharmacy to maintain a current public website list of FDA-approved biological products determined to be biosimilar and interchangeable; effective date July 1, 2013.
Legislative Description
Pharmacy
Last Action
Chapter No. 2013-102
6/3/2013