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White Guide and Orange Guide Formatting Project - Pfizer

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

more information on the distribution of starters in these government institutions, see the <strong>White</strong> <strong>Guide</strong><br />

<strong>and</strong> <strong>Orange</strong> <strong>Guide</strong> Chapters on Federal Employee Interactions <strong>and</strong> Lobbying.<br />

Sales Colleagues must learn the sample policies of any institution that they call on <strong>and</strong> follow those<br />

rules, unless they conflict with <strong>Pfizer</strong> policy or the PDMA. If there are any questions about whether<br />

a customer’s sample policies are consistent with <strong>Pfizer</strong> policies on starter distribution, Sales<br />

Colleagues should contact Starter Operations or a Regional Attorney before leaving starters with<br />

that customer.<br />

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

Pharmacy Expenses<br />

Starters may not be used for clinical trials or other research activities; nor may they be provided to non-<br />

profit organizations for missions or other charitable activities or to HCPs for distribution to patients as a<br />

means of mitigating their medication costs. A request for medication or other clinical supplies to<br />

support legitimate scientific investigations must be referred to the relevant Medical team for<br />

consideration as an Investigator-Initiated Research (IIR) grant. (For more information on scientific<br />

research, see the <strong>White</strong> <strong>Guide</strong> <strong>and</strong> <strong>Orange</strong> <strong>Guide</strong> Chapters on Clinical Research <strong>and</strong> Investigator-<br />

Initiated Research.) HCPs seeking to assist their patients in mitigating their medication costs can be<br />

referred to <strong>Pfizer</strong> Helpful Answers. (For more information, see the Patient Assistance Program<br />

Chapter.)<br />

Requests for medication from charities or from healthcare providers for charitable missions should be<br />

directed to the <strong>Pfizer</strong> Corporate Responsibility department.<br />

Managing Starters<br />

As required by law <strong>and</strong> <strong>Pfizer</strong> policy, Sales Colleagues must adhere to strict requirements regarding<br />

documentation of their receipt <strong>and</strong> delivery of starters <strong>and</strong> management of their starter inventory.<br />

Starter Storage Requirements<br />

Starters must be stored securely <strong>and</strong> under temperature-controlled conditions in accordance with the<br />

product’s labeling to maintain their integrity, stability <strong>and</strong> efficacy. They are to be stored away from<br />

188<br />

Rev. 09/12<br />

Page 12 of 17

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