Regulatory Open Forum

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  • 1.  Triple Antibiotic Ointment

    Posted 05-Jan-2017 15:43
    We want to manufacture and OTC triple antibiotic ointment, besides being registered as a drug manufacturer is there any other licesing needed to manufacture this?
    Thanks


  • 2.  RE: Triple Antibiotic Ointment

    Posted 06-Jan-2017 08:25

    Hi Susan.

    I would also strongly recommend that you determine if you need any state licensing from wherever your company is based as well as wherever your manufacturing facility is located.  I know in NY we needed to get a license from the State Board of Pharmacy in order to be allowed to produce the OTC products and in CA we also have to register and upkeep our information with the CA Department of Public Health.

    ------------------------------
    Victor Mencarelli
    Director - Regulatory Affairs
    Hain Celestial Group
    United States

    Original Message


  • 3.  RE: Triple Antibiotic Ointment

    Posted 06-Jan-2017 09:06

    I would echo the state drug manufacturing registration.

    Otherwise, in terms of FDA compliance completing the three-step registration (establishment registration, NDC <g class="gr_ gr_52 gr-alert gr_spell gr_disable_anim_appear ContextualSpelling ins-del multiReplace" id="52" data-gr-id="52">relabeler</g> request, and drug listing) along with a verification that the product (formulation and labeling) complies with the relevant monograph you should be set to go. I find with clients they are often already registered but either <g class="gr_ gr_200 gr-alert gr_gramm gr_disable_anim_appear Grammar multiReplace" id="200" data-gr-id="200">overlook</g> the monograph or forget to list. 

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    Marc Sanchez
    Regulatory (FDA/USDA) Attorney and Consultant/Adjunct Professor
    FDA Atty Law Firm (CIHCC, LLC)
    Washington D.C.
    United States

    Original Message


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