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  • 1.  Combination Product Expiration Dating

    Posted 05-Jul-2016 19:29

    I’m a device guy, but my question is about Part 211 expiration dating in the context of a device/drug combination product. The regulation allows a CGMP operating system based on QSR with some sections from Part 211. One of them is §211.137 Expiration Dating which includes, §211,137(h), “Pending consideration of a proposed exemption, published in the Federal Register of September 29, 1978, the requirements in this section shall not be enforced for human OTC drug products if their labeling does not bear dosage limitations and they are stable for at least 3 years as supported by appropriate stability data”.

    Can somebody give a simple explanation of a label that does “not bear dosage limitations”, the purpose of the regulatory discretion, and (since it has been waiting since 1978) the current status?

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    Dan O'Leary
    Swanzey NH
    United States
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  • 2.  RE: Combination Product Expiration Dating

    Posted 06-Jul-2016 08:10

    Hi Dan!

    I can provide you with 2 quick items that meet the statement of "do not bear dosage limitations" - the sunscreen monograph and the skin protectant monograph.  Each of these monographs contains a statement that you can apply as often as necessary.  So in other words - no limitation on how much to apply or any limitations on the number of applications per unit of time.

    Think of this sort of situation - many skin protectants have the active ingredient petrolatum. There is no reason to believe that this active ingredient would degrade significantly over time.  Additionally, there is no reason to limit the number of times that someone can reasonably use the active ingredient since it simply forms a barrier coating to protect the skin's moisture levels.  So provided that the active ingredient stability (and all other essentials aspects of the formulation's stability) remain intact for 3 years or more (with proof via standard stability protocols for drugs) then the product would have the 3 year minimum shelf life to avoid actually having an expiration date listed on the package (I believe in the original labeling rule that established this section of 21 CFR that the FDA determined that it was highly unlikely that an OTC would not be used within a 3 year period but I don't have the reference for that one - sorry) and the skin protectant monograph allows for unlimited application amounts and frequency, so you don't require an expiration date.

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    Victor Mencarelli
    Sr. Manager - Regulatory Affairs
    Hain Celestial Group
    United States

    Original Message


  • 3.  RE: Combination Product Expiration Dating

    Posted 06-Jul-2016 09:14
    Dan,

    This is supplemental to Victor's comments.

    As for the purpose of regulatory discretion, it is believed that "the advantages of expiration dating to the consumer may not be worth the added cost."

    As for current regulatory status (expiration dating exemption for OTC drugs with 3 yrs or longer stability with no dosing limitations), it is still "pending consideration."

    Regarding proposed final rule for labeling and effectiveness testing for OTC sunscreen products , you may refer to Docket No. FDA-1978-N-0018 as it refers to the expiration date exemption issues. 

    Thank you.  

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    Phone (Toll-Free): 1-(800) 321-8567



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