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Why is My Medication Available Both by Prescription and Over-The-Counter?

Did you ever wonder why certain medications are available both by prescription (Rx Only) and Over-The-Counter (OTC)? It just doesn’t seem to make sense until you look deeper into the individual products.

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The FDA allows prescription products to move from prescription to Over-The- Counter status if the medication is effective and safe without prescriber supervision. Some high-profile medications like Flonase®, Miralax®, Nexium®, Pepcid®, and Zantac® have moved to OTC status in the past, and in some cases, still have prescription versions available.

So why, then, if a medication moves Over-The-Counter would it also still be available by prescription?

The answer lies as to whether or not the FDA has determined there to be any “meaningful differences” between the Rx and OTC versions. The FDA determines “meaningful differences” based on comparing things like the indication, strength, route of administration, dosage form, and/or patient population the medication treats. If some or all of these things are different between the 2 products, then both may be allowed to remain on the market under their respective classifications. If it is determined there is no “meaningful” difference between the products, then the OTC version of the product will stay, while the prescription versions will be removed from the market. In most cases, once the medication is truly only available as an OTC product, health plans will not cover it unless subject to other guidelines within the plan (e.g. ACA/HCR or special programs).

Thanks for stopping by and see you next month at Ron’s Clinical Corner.

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