• General

  Anticaries products are treated as drugs in the USA - what does this mean for manufacturing?

  Posted by Herbnerd on April 13, 2021 at 7:43 pm

  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.

  Pattsi replied 3 years, 7 months ago 2 Members · 1 Reply

  • fluo
  • regulatory
  • toothpaste
  • us-regulations
• 1 Reply

• 

  Pattsi

  Member

  April 14, 2021 at 10:21 am

  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

  https://www.fda.gov/drugs/human-drug-compounding/questions-and-answers-related-guidance-entities-considering-whether-register-outsourcing-facilities

  don’t know if these help.

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