White Guide and Orange Guide Formatting Project - Pfizer

Key Points to Ensure Compliance
Orange Guide - Chapter 10: Starters
It is illegal to sell, purchase, or trade, or offer to sell, purchase or trade, starters. Starters may
be provided only to licensed healthcare professionals eligible to receive starters and only if
they are expected to distribute them for free on-label use by their patients.
The amount of starters allocated by each brand team must be based on the expected on-label
use of the product. Starters must not be provided to HCPs in quantities that may appear to be
intended as an inducement to use Pfizer products (i.e., a kickback). Providing starters in
quantities or dosages based on off-label use is not permitted.
Starters may be packaged separately or in kits that may include PhRMA Code compliant
educational items. All of the patient and provider materials packaged with starters must be
reviewed and approved by the applicable Review Committee (RC) prior to distribution.
Individual starter units cannot be altered in any way either before or after they are delivered
to an HCP.
Only licensed HCPs authorized by their states’ laws to receive and prescribe medications may
sign a request for starters. Pfizer policy requires Sales Colleagues to personally witness the
signature on every starter request.
Sales Colleagues using an iCUE tablet are required to utilize the electronic Starter Activity
Form (eSAF) on the tablet for every starter transaction. A paper Starter Activity Form (SAF)
may not be used except in the very limited circumstances described in this Chapter.
All starter transactions must be documented completely and accurately at the time of the
transaction. (Those limited transactions that utilize paper SAFs must be entered into iCUE as
soon as possible after the call is made.)
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