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  3. Disclosure requirements: PI & Safety Information, Federal schedule, study parameters, reference lists
  4. 97 - Is there a current practice to use a symbol "PR" to designate a prescription drug, like in trade-marks where the symbols "TM" or (R) are used ? And if so, what are the rules of use for such symbol?
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97 - Is there a current practice to use a symbol "PR" to designate a prescription drug, like in trade-marks where the symbols "TM" or (R) are used ? And if so, what are the rules of use for such symbol?

Scheduled Pinned Locked Moved Disclosure requirements: PI & Safety Information, Federal schedule, study parameters, reference lists
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  • Jennifer CarrollJ Offline
    Jennifer CarrollJ Offline
    Jennifer Carroll
    wrote on last edited by
    #1

    As per PAAB Code 2.2, the federal drug schedule (e.g. Pr for prescription products) in addition to the brand and generic names of the product must appear in juxtaposition as least once in both the advertising copy and prescribing information.

    G 1 Reply Last reply
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    • Jennifer CarrollJ Jennifer Carroll

      As per PAAB Code 2.2, the federal drug schedule (e.g. Pr for prescription products) in addition to the brand and generic names of the product must appear in juxtaposition as least once in both the advertising copy and prescribing information.

      G Offline
      G Offline
      GMC
      wrote on last edited by
      #2

      @jennifer-carroll Can you provide clarity. If this appears in the logo, does that suffice? Does it need to appear in first mention either in text or if the logo is at the top of the APS? Can you clarify what you mean by it needing to be in the safety information.

      Jennifer CarrollJ 1 Reply Last reply
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      • G GMC

        @jennifer-carroll Can you provide clarity. If this appears in the logo, does that suffice? Does it need to appear in first mention either in text or if the logo is at the top of the APS? Can you clarify what you mean by it needing to be in the safety information.

        Jennifer CarrollJ Offline
        Jennifer CarrollJ Offline
        Jennifer Carroll
        wrote on last edited by
        #3

        Hey @gmc

        Yes, inclusion in the logo qualifies. The answer above is based on an older version of the code. The current code section 2.2 states: In all APS for pharmaceutical products, the brand or trade name, the non-proprietary or generic name and the Federal drug schedule of the product must appear in juxtaposition at least once within advertising copy and must be in good contrast and be legible.

        It can appear anywhere in the piece as long as it appears at least once.

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