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  • 1.  FDA Registration for Distributor

    Posted 12-Jul-2017 11:21
    Dear Team,

    We are a repackager and relabeler pharma company. We have added a warehouse which will be used for receiving and distribution. Can you please advise if a FDA Registration is required? Any reference is much appreciate it!

    Thanks,
    Trish

    ------------------------------
    Trisha Nguyen
    ------------------------------


  • 2.  RE: FDA Registration for Distributor

    Posted 13-Jul-2017 20:52
    Yes, check below reference:

    Features of 21 CFR 207

    Mandatory electronic submission of registration and listing information (rather than submission of information on paper forms) provides: 

    • Greater clarity that registration and listing obligations rest with persons who physically manufacture, repack, or relabel drugs (and not with persons who merely act as distributors or formulators, for example);

    Drug Registration and Listing System (DRLS and eDRLS)
    Fda remove preview
    Drug Registration and Listing System (DRLS and eDRLS)
    Section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) requires firms that manufacture, prepare, propagate, compound, or process drugs in the U.S. or that are offered for import into the U.S. to register with the FDA.
    View this on Fda >


    ------------------------------
    Gaurang Bhavsar, MS, RAC
    Scientist-II, R&D and RA
    Sunrise Pharmaceutical, Inc.
    Rahway, NJ 07065
    USA
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    Original Message


  • 3.  RE: FDA Registration for Distributor

    Posted 14-Jul-2017 20:27
    Trisha,
    Is the new warehouse on the same campus as the old repackage/relabeling facility?

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    Michael Nilo
    Network Regulatory Partners
    Nilo Medical Consulting Group
    Portland OR
    United States
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    Original Message


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