Hello Anon,
Depending on the pill organiser, this could be Product Code NXB or NXQ (dispenser or reminder; I would use NXB personally) which are both Class I, 510(k) Exempt. In addition, these two product codes are also GMP Exempt so really only need to maintain applicable records and complaint records. In answer to the first question, it depends on who is considered the "legal manufacturer" because the product manufacturing should follow basic GMP, complaint recording, and overall good quality of product. If purchasing from a supplier this would entail supplier controls and mostly centred around aesthetics of the product (colour, clean edges, opening easily, closing securely). To answer the second question, because it is still considered a medical device, the legal manufacturer would list the product with the FDA on the FURLS database. Personally, I do not see any issue with putting the drug name on the pill case and giving away. Just having the drug name on the case is a form of advertising, as long as there are no other claims or statements being made about the drug. Typically if the drug name is on a "give away" it should have the Brand (marketing) Name and Generic (common) Name listed, but probably others can provide information on proper considerations for this.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 25-Aug-2021 16:46
From: Anonymous Member
Subject: weekly pill organizer
This message was posted by a user wishing to remain anonymous
I hope to ask if anyone has experience manufacturing weekly pill organizer or pill case? Here are some of the questions I have:
- For a pharmaceutical company who have no medical device experience - what should the pharmaceutical company look for when purchasing the finished pill cases from the suppliers?
- What would be required to put a marketed prescription drug name on the pill case and give away to customers?