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  • 1.  OTC Drug Annual Product Review

    This message was posted by a user wishing to remain anonymous
    Posted 24-Jul-2017 09:35
    This message was posted by a user wishing to remain anonymous

    ​​Hello fellow regulatory colleagues!

    My company discontinued a product four (4) years ago.  I am wondering how long we need to conduct a Quality Annual Product Review (APR) for products that have been discontinued.  I thought that the requirement was three (3) years; however, I am unable to locate a CFR or guidance document reference to this requirement.  Does anyone know where I can find this answer?

    Thanks in advance!


  • 2.  RE: OTC Drug Annual Product Review

    Posted 25-Jul-2017 08:19
    ​While I don't know about any specific notation in the annual report requirements I can tell you that the FDA's regulations only require the following (depending on the expiration date requirements or if there is an exception to expiration dating on the products):

    Reserve samples shall be retained for 3 years after distribution of the last lot bearing a particular active ingredient if the product is exempt from expiration dating;

    Reserve samples shall be retained for 1 year after expiration of the lot if the product is required to bear an expiration date.

    See 21CFR211.170(b) and 21CFR211.170(b)(1).

    ------------------------------
    Victor Mencarelli
    Director - Regulatory Affairs
    Hain Celestial Group
    United States
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    Original Message


  • 3.  RE: OTC Drug Annual Product Review

    Posted 25-Jul-2017 11:25
    As per 21 CFR 211.180 

    Any production, control, or distribution record that is required to be maintained in compliance with this part and is specifically associated with a batch of a drug product shall be retained for at least 1 year after the expiration date of the batch or, in the case of certain OTC drug products lacking expiration dating because they meet the criteria for exemption under 211.137, 3 years after distribution of the batch.





    This part also mentions about the requirements for annual product review. 211.180 (e)

    So it would safe to assume that if you're one year past the expiration date of the last batch you would not need to do it any further. 

    Hope this helps. 


    ------------------------------
    Mehul Govani RAC
    Regulatory Affairs Manager
    PL Developments
    Westbury NY
    United States
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    Original Message


  • 4.  RE: OTC Drug Annual Product Review

    Posted 26-Jul-2017 08:11
    What is the intent of the Annual Product Review (APR) process?

    If the intent is to determine if any changes are required to manufacturing specifications or controls, and the product is no longer being manufactured, then the output of the APR provides no additional value. There are other systems to monitor quality of product in distribution, and action can be taken as a result of the output of those systems - i.e. complaint handling. The APR does not provide additional value above these systems.

    Any objections to completing one for the last year in which product was manufactured, and stating that the product has been discontinued and no more APRs will be completed?


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    Joshua Lust
    Global Regulatory Affairs Manager
    Ranir LLC
    Grand Rapids MI
    United States
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    Original Message


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