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AR HB1204
Bill
Status
1/18/2017
Primary Sponsor
Stephen Magie
Click for details
AI Summary
HB1204 Summary
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Adds definitions for "biological product" (viruses, vaccines, blood products, proteins, and similar products used for disease prevention/treatment) and "interchangeable biological product" (products approved by FDA as interchangeable or therapeutically equivalent per 42 U.S.C. § 262(k)(4) or the FDA's Orange Book).
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Allows pharmacists to dispense interchangeable biological products as substitutes for prescribed biological products, subject to the same restrictions that apply to generic drug substitutions (prescriber or patient may prohibit substitution).
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Requires pharmacists to notify prescribers within 5 business days of dispensing a biological product by entering the product name and manufacturer into electronic medical records, electronic prescribing systems, pharmacy benefit management systems, or pharmacy records, or by alternative communication if electronic entry is unavailable.
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Mandates labeling requirements showing the trade name or proper name and manufacturer identity of dispensed biological products on prescription containers.
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Requires the Arkansas State Board of Pharmacy to maintain a website link to the FDA's list of all approved interchangeable biological products.
Legislative Description
To Allow Pharmacists To Make Biological Product Substitutions.
Last Action
Recommended for study in the Interim by Joint Interim Committee on PUBLIC HEALTH, WELFARE AND LABOR COMMITTEE- HOUSE
3/23/2017