Regulatory Open Forum

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  • 1.  OTC manufacturing

    Posted 22-Nov-2016 08:18
    I work for a small contract manufacturer and the desire is to produce OTC products.
    I am doing a gap analysis to compare 211 requirements to 111.
    Any insight would be helpful.
    Sue
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    Susan Jackson
    SPRING LAKE NJ
    United States
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  • 2.  RE: OTC manufacturing

    Posted 23-Nov-2016 07:15

    Hi Susan,

    21CFR111 is targeted at dietary supplements (not part of over-the-counter) because the FDA interprets OTC to be those products regulated by the FDA OTC monograph system, NDA (new drug application), or ANDA (abbreviated new drug application). All OTC drug products are governed under 21CFR 210 and 211. 

    However, if it is an OTC cosmetic product that your firm seeks to manufacture your firm is not required to follow cGMP.

    Therefore, please clarify your request to receive the most accurate recommendations. 

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    Timothy Kline, Ph.D., RAC
    Senior Associate Regulatory Affairs

    Original Message


  • 3.  RE: OTC manufacturing

    Posted 23-Nov-2016 08:48

    Susan:  Might need some clarification here.  While dietary supplements are sold over-the-counter, when I hear folks talk about manufacturing OTC products, I think of drugs since we commonly classify them into the two categories of Rx or OTC.  And as I'm sure you know, the drug GMPs in 21 CFR 210/211 apply equally to both Rx and OTC.  21 CFR Part 111 is GMPs for dietary supplements.  So are you asking about drug vs dietary supplement GMPs? 

     

    Chris

     

    Christopher Smith, CQE, RAC

    President, Coastal Pharmaceutical Consultants, Inc. ®

    7950 Old River Road, Burgaw, NC 28425 USA

    910-259-8877 (land)

    910-789-1232 (mobile)

    chrissmith@coastalpharmaconsultants.com

     




    Original Message