RX TO OTC SWITCH – FDA Authors: Likitha A , PATIL M, ABHISHEK B V AND GOUDANAVAR PS
ABSTRACT
Over-the-counter (OTC) medications are those that can be purchased by consumers without a
prescription from a medical professional. The "prescription-to-OTC switch" movement refers to a
recent development in which pharmaceuticals that were previously only available with a prescription
are now offered as over-the-counter (OTC) items. They are frequently used to treat common illness
symptoms that don't always need to be monitored closely by a doctor. If the prescription version of the
drug's post-marketing safety data confirms its efficacy, safety, and ease of use, it may be possible to
"switch" the product from its initial prescription marketing to an over-the-counter one. This refer as a
"Prescription-to-OTC Switch." It is evident that the lower pricing has reduced profits, nonetheless, this
is an minor cost to incurto keep the required market share until the drug's patent expires. In the end, the
consumer gains as the new product is more affordable. Safety comprehension, Self-selection and de-
selection Compliance as the core issue Kinds of security and effectiveness and real-world Utilize
information that can utilized to bolster the switch application, there is no "one-size-fits-all" strategy. In
the end, the consumer gains since the new product is more affordable & ensure patient safety.
Keywords: Efficacy, OTC drugs, Rx-To-OTC, Safety Publication date: 01/12/2025 https://ijbpas.com/pdf/2025/December/MS_IJBPAS_2025_9684.pdfDownload PDFhttps://doi.org/10.31032/IJBPAS/2025/14.12.9684