How an active ingredient becomes OTC or prescription?

When FDA determines if an active ingredient should be OTC or prescription, they do so based on what?

Do they count it prescription because that active is very effective or because it has serious side effects? 

For example: Tretinoin is prescription drug, is it so and not OTC because it is very effective or because it has serious side effects?

Or salicylic acid is OTC, is it so and not a prescription drug because it is not so effective or because it doesn't have serious side effects? 


  • PharmaPharma Member, Pharmacist
    It usually depends on many factors, not just side effects, such as indication (a drug for a serious illness which requires a doctor and not the patient to make the diagnosis is likely to be a presctiption drug), duration of therapy, therapeutic index/safety, potential for abuse/addiction/precursor chemical and so on...
    At least in theory, a drug which isn't effective doesn't get approval as a drug.
    And then there's also lots of lobbying and other non-scientific factors such as personal opinions/interpretations of the people working at the responsible agencies which results in the, sometimes marked, differences even between countries with similar regulatory frameworks (not approved in one, prescription in another, and OTC in a third).
  • PhilGeisPhilGeis Member, Professional formulator
    IN US - drugs get to the market by the New drug Approval (NDA) takes >5 years, ANDA - generic drugs or the OTC process.
    Actives per se are not approved - they have to be in a drug product context. A new drug with a new active would most likely need to satisfy NDA process and show safety and efficacy to obtain approval for prescription/Rx application.  But the NDA could be designed to generate  OTC sale - but that's rare.  Some OTC drugs started out as Rx and were "switched" to OTC. 

    The OTC process was set up in '72 to control thousands+ of drugs/patent medicines sold over the counter. Slowly weeded out a lot of bogus stuff that couldn't show safety and efficacy - e.g. Preparation H once used "yeast extract" as its active. More recently and after 40 years of discussion Agency is finally moving against "antimicrobial soaps".


  • @Pharma @PhilGeis thanks 

    Here from long time ago people were using viagra commonly without consulting doctor but according to Google search it needs prescription in US. Recently i see that a lot of people here use oral Isotretinoin for their skin smoothness which alsi need prescription in US. I wanted to know if it is ok to use drugs like this without consulting doctor or there is any serious side effects with using these drugs without consulting doctor and maybe for long term. 
  • PharmaPharma Member, Pharmacist
    Oral isotretinoin is highly likely to cause severe mental and/or physical damage to the kid if taken during and even several months prior to pregnancy. Also, it's not advised to take it as man if you're planning on 'making' a baby.
    Viagra can cause blood pressure issues or mask prostate hyperplasia (which may ultimately lead to prostate cancer which is potentially lethal if untreated).
    Bottom line is, it's seldom a good idea to take prescription drugs without consulting a doctor.
  • PhilGeisPhilGeis Member, Professional formulator
    To Pharma's excellent point - some will recall thalidomide.  Used to control nausea during pregnancy, it caused significant birth defects.  FDA had not approved it so less tragedy in US.  It was a factor in development of current NDA process that identifies specific safety endpoints(esp teratology) that must be satisfied before approval .
  • @Pharma @PhilGeis thanks a lot. 
  • Thanks for the info, @PhilGeis
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