ABSTRACT

The US Food and Drug Administration (FDA) is developing a new framework to provide patients with quality, up-to-date prescription product information that will promote the safe use of prescribed medication. The primary goal is to provide patient-oriented information for each prescription product. The efforts of FDA is to ensure that patients receive essential prescription medication information, the concept of creating easy-to-read medication guides has gained prominence, To tackle this issue, FDA proposing to require a new type of Medication Guide called Patient Medication Information for prescription drugs and certain biological products (both brand name and generic) used, dispensed, or administered on an patient, A Medication Guide is a type of patient labeling found in the 21 CFR 208 prescription drug labeling that has been approved by the FDA. The FDA provides informational materials in the form of paper leaflets known as Patient Package Inserts (PPI), Medication Guides (MG), and Instructions for Use (IFU) thatare packaged with many prescription drugs. Creating effective easy-to-read medication guides requires collaboration between healthcare professionals, pharmacists and patient. Keywords: FDA, Patient Medication Information, Medication Guidance, 21 CFR 208
Publication date: 01/08/2025

https://ijbpas.com/pdf/2025/August/MS_IJBPAS_2025_9356.pdf

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https://doi.org/10.31032/IJBPAS/2025/14.8.9356