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identify, quarantine and investigate suspect product and notify the  \nU. S. Food and Drug Administration (FDA) and trading partners of illegitimate product by dispensers . This template is a sample only and we recommend using your company’s letterhead to create a Standard Operating Procedure (SOP) template.  \n2 Scope  \nThis document shall cover the procedure fo r ensuring compliance fo r all FDA classif ied human prescription drugs, that are not defined as exempt per section [582(a)(24)(B)] of the Drug Supply Chain Security Act. This process applies to all pharmacy and dispensing personnel responsible for taking  \npossession of new product and dispensing finished product to patients .  \nCencora does not make any exemption status determination for anything classified as a Human Prescription Drug and defers to the position of the manufacturer on their products DSCSA exemption  \nstatus .  \nContents of Document  \n1 Purpose............................................................................................................................ 1  \n2 Scope............................................................................................................................... 1  \n3 Acronyms and terms......................................................................................................... 2  \n4 Roles and Responsibilities ................................................................................................ 3  \n5 Procedure – Identify Suspect or Illegitimate Product and Request for verification ................ 3  \n5.1 General Requirements ................................................................................................3  \n5.2 Suspect or Illegitimate Product Investigation ............................................................... 3  \n5.3 Request for Verification Process................................................................................. 4  \n5.4 Product Identifier System of Record ........................................................................... 4  \n6 References....................................................................................................................... 5  \n6.1 Law and Guidance ..................................................................................................... 5  \n7 Submission and Revision History ...................................................................................... 5  \n8 Approval........................................................................................................................... 5  \nDisclaimer: This document is provided for guidance only. Please contact a qualified professional consultant to  \naddresses your individual or business needs. In no eventshall Cencora (formerly AmerisourceBergen) or its  \nsubsidiaries be liable for any damages.  \n3 Acronyms and terms  \nThe following are acronyms associated with this document:  \n\n| Acronym | Definition |\n| --- | --- |\n| DSCSA | Drug Supply Chain Security Act |\n| RX | Human Prescription Drug |\n\nThe following are terms associated with this document:  \n\n| Terms | Definition |\n| --- | --- |\n| DSCSA Exempt Products | Those products and transactions that are exempt from the obligations of DSCSA compliance (DSCSA Section [582(a)(24)(B)]) |\n| Illegitimate Product | The term “illegitimate product” means a product for which credible evidence shows that the product:\u003Cbr>• Is counterfeit, diverted or stolen.\u003Cbr>• Is intentionally adulterated such that the product would result in\u003Cbr>• serious adverse health consequences or death to humans .\u003Cbr>• Is the subject of a fraudulent transaction.\u003Cbr>• Appears otherwise unfit for distribution such that the product would be reasonably likely to result in serious adverse health conseque","cbCaicyHxDCJd10p","https://ap.wps.com/l/cbCaicyHxDCJd10p","pdf",225904,7,"English","# Purpose\n# Scope\n# Acronyms and terms\n## Acronyms\n## Terms\n# Roles and Responsibilities\n# Procedure – Identify Suspect or Illegitimate Product and Request for verification\n## General Requirements\n## Suspect or Illegitimate Product Investigation\n## Request for Verification Process\n## Product Identifier System of Record\n# References\n## Law and Guidance\n# Submission and Revision History\n# Approval","[{\"question\":\"What is the purpose of this SOP template?\",\"answer\":\"It provides minimum requirements and processes to identify, quarantine, and investigate suspect product and to notify the U.S. Food and Drug Administration (FDA) and trading partners of illegitimate product by dispensers.\"},{\"question\":\"Who does the scope apply to under this document?\",\"answer\":\"It applies to all pharmacy and dispensing personnel responsible for taking possession of new product and dispensing finished product to patients, for FDA-classified human prescription drugs that are not DSCSA-exempt under section [582(a)(24)(B)].\"},{\"question\":\"What does the document require regarding product verification and identifiers?\",\"answer\":\"It describes how to request verification, including determining whether the product identifier on a package or homogeneous case matches the standardized numerical identifier, lot number, and expiration date assigned by the manufacturer or repackager, and references the product identifier system of record.\"}]","Template Standard Operating Procedure (SOP) - Identify, Quarantine, Investigate Suspect or Illegitimate Product and Notify FDA | PDF",1789194931]