Regulatory Open Forum

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  • 1.  What does "alcohol free" mean for non-ingestible drugs?

    This message was posted by a user wishing to remain anonymous
    Posted 19-Jul-2023 13:53
    This message was posted by a user wishing to remain anonymous

    21 CFR Part 328.50 (e) mentions that "for a product to state in its labeling that it is "alcohol free," it must contain no alcohol (0 percent)." However, this regulation applies to ingestible drugs. When it comes to non-ingestible drugs, is there any guiding document or industry best practice establishing a threshold for what percentage of alcohol (as residual solvents, impurity etc.) may be present in the product, if any, that would allow "alcohol free" claims on labeling? Can ICH Q3C Section 4.3, 50 mg per day or less (corresponding to 5000 ppm or 0.5%) be an acceptable threshold? 



  • 2.  RE: What does "alcohol free" mean for non-ingestible drugs?

    This message was posted by a user wishing to remain anonymous
    Posted 20-Jul-2023 09:07
    This message was posted by a user wishing to remain anonymous

    The same regulation applies to all products labeling wishing to claim "alcohol free". Alcohol free = 0 % no exceptions!