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Anticaries products are treated as drugs in the USA - what does this mean for manufacturing?
So, as above, I understand that anticaries products, such as fluoridated toothpaste are treated as drugs in the USA (but not elsewhere in the world). For manufacturing purposes, does this mean the toothpaste must be manufactured in a GMP registered facility audited to PIC/S 14 standards - or does the manufacturing site need to be registered with the FDA?
If Registered with FDA, I assume we would need to be audited?
And what documentation do we require to register the finished product?
Apologies - I have tried searching the FDA website, but either my search terms are wrong or I am looking in the wrong place.
Thanks in advance.
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1 Reply
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https://www.fda.gov/drugs/human-drug-compounding/compounding-laws-and-policies
https://www.fda.gov/drugs/human-drug-compounding/section-503a-federal-food-drug-and-cosmetic-act
https://www.fda.gov/drugs/human-drug-compounding/text-compounding-quality-act
https://www.fda.gov/drugs/human-drug-compounding/information-outsourcing-facilities
https://www.fda.gov/drugs/human-drug-compounding/compounding-oversight-and-compliance-actions
don’t know if these help.
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