Home Cosmetic Science Talk Formulating General OTC drugs Monographs

  • OTC drugs Monographs

    Posted by vitalys on August 27, 2014 at 11:53 am

    Dear friends,

    FDA has published a wide spectrum of OTC drugs Monographs. What if I make/manufacture a product according one of this Monographs and follow the rules and all details ( for instance the Keratolytic product against the calluses based on the only possible ingredient for this type of products and claim) - Should I register it with FDA? Or can I make it without any approvals as a regular Cosmetics if I follow the FDA monograph’s rules and conditions? Thank you for all input and suggestions you may have.

    vitalys replied 9 years, 10 months ago 3 Members · 10 Replies
  • 10 Replies
  • DavidW

    Member
    August 30, 2014 at 8:20 am

    If you are making an OTC product, you are supposed to register it (the fact that you are a manufacturer making that product).

  • vitalys

    Member
    September 1, 2014 at 12:03 am

    Thank you David for clarification. FDA says that when you begin to manufacture OTC product according the monograph you don’t need their approval. Now, it makes sense.

  • DavidW

    Member
    September 3, 2014 at 11:01 am

    That is correct Vitalys.  You do not need their approval.  But, the manufacturer of an OTC product is supposed to register with the FDA that they are manufacturing that particular OTC product. 

  • Bobzchemist

    Member
    September 3, 2014 at 11:32 am

    Also, the FDA registration process is very confusing and difficult to navigate without help. It may be more cost-effective to hire a consultant to register you than it would be to learn how to register.

  • DavidW

    Member
    September 3, 2014 at 10:08 pm

    Bob is correct.  What used to take 10 minutes to fill out a form and mail in just to register as a manufacturer turned into a month long process for us about 6 months ago when we needed to renew our registration.

  • vitalys

    Member
    September 4, 2014 at 1:02 am

    David, Bobzchemist, Thank you for your thoughts. Indeed, it looks like we have to ask for help with some consultant to register. Despite of tons of information at FDA website, all the data is too ambiguous and really confusing. Though I couldn’t find any pricing for their services at all and I guess it’s enormously high.
    It’s still unclear - should I register as a manufacturer in a case when I order the product at some contract manufacturer.

  • Bobzchemist

    Member
    September 4, 2014 at 9:38 am

    @vitalys,

    One of the benefits of using a contract manufacturer is that you DON’T have to register. What you do have to do is have yourself listed on the primary packaging as a distributor or as a filler. Your contact info has to be on the package.
  • DavidW

    Member
    September 4, 2014 at 10:23 pm

    Or, you can register the product if you are the owner of the product in case in the future you switch manufacturers your product is still registered and the new one doesn’t have to do it. 

    If you email me at work I can send you info for someone who does it at a reasonable price.  I think ti was a few hundred dollars.

  • Bobzchemist

    Member
    September 5, 2014 at 11:57 am

    @vitalys,

    One of the benefits of using a contract manufacturer is that you DON’T have to register. What you do have to do is have yourself listed on the primary packaging as a distributor or as a filler. Your contact info has to be on the package.
  • vitalys

    Member
    September 6, 2014 at 3:15 am

    Bobzchemist, David, that’s some kind of insights and many things has become absolutely clear for me - those details are so important to know. Thank you for your help!

    David I do appreciate your help with share the information you’ve got - I will e-mail you shortly. Again, thank you

    Cheers :)

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