Regulatory Open Forum

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  • 1.  Product Shipment

    This message was posted by a user wishing to remain anonymous
    Posted 02-Mar-2021 08:46
    This message was posted by a user wishing to remain anonymous

    Hello RAPS, 

    There is a line in my organization's Product Shipping SOP which states, "Shipments may not be sent to Residential or FedEx hold locations per FDA regulations." We do not wish to ship to personal residences; however, we cannot find any specific reference in the CFR or Guidances that state we should not or must not ship to residential addresses. Or, that we must limit shipping to healthcare facilities.  

    Can anyone point us to where this 'legacy' line in our SOP may have come from? That is, the specific CFR or Guidance?

    Thank you!


  • 2.  RE: Product Shipment

    Posted 03-Mar-2021 08:34
    Good Day,

    We have shipped to residential addresses for over 30 years.  However, our products do not require a prescription.  We also currently sell them via our website as our products are used for home healthcare so those ship to individuals in their homes.  I have never seen any reference to shipping locations in the CFR especially calling out a freight carriers hold location. 

    Additionally we have small distributors/sales person who work out of their home so their office is a residential address where they need to receive product.

    If you chose not to ship to either of those locations then you should state just that as a corporate decision, not a regulation.

    Best regards,

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    D Michelle Williams
    VP - Operations
    United States
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    Original Message


  • 3.  RE: Product Shipment

    Posted 03-Mar-2021 08:43
    It really depends on the kind of product you are talking about and what it means to ship to a residential address. Distributors ship to residential addresses all the time - consider mail-order pharmacy services. So, I don't think there is any regulation or guidance that would universally prohibit it.

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    Glen Park PharmD
    Vice President, Regulatory Affairs and Quality Assurance
    New York NY
    United States
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    Original Message


  • 4.  RE: Product Shipment

    Posted 03-Mar-2021 11:56
    Edited by Narayan Rao 03-Mar-2021 11:57
     It's not against the law for a properly licensed pharmaceutical company or a licensed pharmacist/retailer to mail a prescription medication to the recipient residences as long as the recipient has a valid prescription from a doctor. In recent years, companies like online pharmacies and mail-order pharmacies have begun offering prescription services through the mail. As long as these companies are licensed and operating legally, they can mail drugs to people's residences with a valid prescription. Additionally, mailing Rx drug depends on the state regulations as well therefore you also need to look at USPS/Fedex websites for specific State regulations!

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    GRSAOnline
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    Original Message


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