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White Guide and Orange Guide Formatting Project - Pfizer

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Chapter 10: STARTERS<br />

CONTENTS<br />

Starters<br />

<strong>Orange</strong> <strong>Guide</strong> - Chapter 10: Starters<br />

Introduction ....................................................................................................................................................................2<br />

Key Points to Ensure Compliance ......................................................................................................................... 3<br />

Starter Allocation .......................................................................................................................................................... 4<br />

Starter Packaging ........................................................................................................................................................... 5<br />

Key Points: Basic Rules Regarding H<strong>and</strong>ling of Starter Packaging ................................................................... 6<br />

Inclusion of Materials with Starters ............................................................................................................................... 7<br />

Distribution of Starters to Approved Recipients .......................................................................................................... 7<br />

Hospitals, VA <strong>and</strong> DoD Institutions .................................................................................................................... 11<br />

Starters May Not Be Distributed for Research, Charitable Activities or To Defray Patients’ Pharmacy<br />

Expenses .............................................................................................................................................................. 12<br />

Managing Starters ........................................................................................................................................................ 12<br />

Starter Storage Requirements ............................................................................................................................ 12<br />

Accurately Document Receipt <strong>and</strong> Delivery of Starters .................................................................................... 13<br />

Key Points: Documenting the Receipt <strong>and</strong> Delivery of Starters ....................................................................... 14<br />

Completion of eSAFs <strong>and</strong> SAFs .......................................................................................................................... 14<br />

Reconciling Starter Inventory ............................................................................................................................. 15<br />

Reminder on Expired Starters ............................................................................................................................. 16<br />

Free Trial Vouchers: An Alternative to Starter Distribution ....................................................................................... 16<br />

Key Points for Developing a Voucher Program <strong>and</strong> Distributing Vouchers..................................................... 17<br />

FOR MORE INFORMATION ........................................................................................................................................ 17<br />

177<br />

Rev. 09/12<br />

Page 1 of 17

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