A protocol shall: Be: Written; and Condition or disease-state specific; and Contain the following: The condition that the protocol is designed to manage; A list of medications that may be used under the auspices of the protocol; Monitoring parameters including laboratory tests for the: Condition; and Medication employed; A list of circumstances requiring contact with the authorized prescriber or authorized prescribers who are a party to the prescriber-pharmacist agreement; A statement prohibiting substitution of a chemically dissimilar drug product by the pharmacist for the product prescribed by the authorized prescriber unless permitted in the therapy management contract; A list of circumstances under which the pharmacist may alter doses, modify the treatment regimen, or switch the agent under the terms of the therapy management contract; Information to be documented; A listing of provisions within the protocol that may be customized within a therapy management contract; and An action plan for situations when the pharmacist encounters a situation that is not addressed in the protocol. A protocol may authorize: The modification, continuation, and discontinuation of drug therapy; The ordering of laboratory tests; Other patient care management measures related to monitoring or improving the outcomes of drug or device therapy; and For protocols by a licensed physician and licensed pharmacist, the initiation of drug therapy under written, disease-state specific protocols. A protocol may not authorize acts that exceed the scope of practice of the parties to the prescriber-pharmacist agreement. Technical modifications to the protocol shall be registered with the Board of Pharmacy within 30 days of the technical modification.