Following are links to regulations, example forms, and policy and procedures that can be used in establishing the protocols for your patient assistance program. In navigating a very complex process of medication procurement and distribution it is paramount that a program is knowledgeable of state, federal, and other regulatory requirements for these programs.
Medication Storage Guidelines
If your PAP will make use of sample, then ensuring adherence to regulatory standards is required. Individual state board of pharmacy regulations can be accessed at the NABP State Boards of Pharmacy site.
Tracking and Monitoring Forms
This tool provides an example spreadsheet to help establish the necessary record keeping for managing a PAP.
Policies and Procedures
This document provides an example of policies and procedures necessary in operating a PAP. Including issues of defining access and who should perform the financial assessment on the patient.