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  • 1.  Rx only symbol

    Posted 07-Apr-2020 10:54
    Hello all,

    I know that we need to have Rx only symbol on the labels and IFU per US FDA compliance perspective. However, would it be possible to list Rx symbol for OUS (Outside of USA) market?


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    Regards,
    Shikha 
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  • 2.  RE: Rx only symbol

    Posted 08-Apr-2020 05:18
    Shikha,

    Most regulatory agencies view if you use other symbols, i.e. from other jurisdictions or even internal developed symbols, these can be used as long as they are clearly described and defined in a glossary of the Instructions for Use (IFU).  When I work with companies, I always strongly recommend having a glossary of symbols in the IFU already because some regions and healthcare professionals are not familiar symbols and there are new symbols coming out.  Also symbols like the "hourglass" should be defined within context of the device, i.e. expiration date versus shelf life (which to me means two different things).  While we have ISO 15223-1 standard, there are some new symbols and not all healthcare professionals know about ISO 15223 standard, so a glossary is helpful.  Also a note the concept of "prescription" and "Over the Counter" or OTC are not clearly defined in other regulatory jurisdictions, so should use caution using the symbol as well - maybe when defining could indicate prescribed by a healthcare professional or professional use only.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: Rx only symbol

    Posted 09-Apr-2020 20:11

    Labels, labeling, and symbols is fraught with convolutions.

    In the US, 801.109(b)(1) requires that, "The label of the device, other than surgical instruments, bears: The symbol statement "Rx only" or "℞ only" or the statement "Caution: Federal law restricts this device to sale by or on the order of a ___", the blank to be filled with the word "physician", "dentist", "veterinarian", or with the descriptive designation of any other practitioner licensed by the law of the State in which the practitioner practices to use or order the use of the device".

    The section does not mention the IFU, but it could be inferred from 801.109(c).

    In particular, the regulation says this is a "symbol statement", not as symbol.

    801.15(c)(1)(i) has the regulation for the use of symbols. 801.15(c)(1)(i)(F) allows the use of the symbol statement "Rx only" or "℞ only".

    Other jurisdictions allow the use of symbols in certain circumstances. Generally, the region accepts a symbol in ISO 15223-1:2016, but there may be specific requirements. See, for example, EU-MDR Annex I(23.1)(h).

    ISO 15223-1:2016 does not include the symbol.

    Determine the regulatory requirements for symbols in each regulatory region in which you market.



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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
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    Original Message


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