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Analysis of Volatile and Oxidation Sensitive Compounds Using a Cold Inlet System and Electron Impact Mass Spectrometry
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The Practice of Compounding, Associated Compounding Regulations, and the Impact on Dermatologists

James Quertermous, Seemal Desai, Julie Harper

    Journal of Drugs in Dermatology : JDD
    |July 14, 2018
    PubMed

    Insights

    The 2013 Drug Quality and Security Act (DQSA) increased oversight of drug compounding following a meningitis outbreak. However, these regulations have limited physicians

    Area of Science:

    • Pharmaceutical Sciences
    • Regulatory Affairs
    • Dermatology Practice

    Background:

    • A 2012 fungal meningitis outbreak linked to contaminated compounded medications highlighted safety concerns.
    • The New England Compounding Center incident led to significant regulatory changes in drug compounding.

    Purpose of the Study:

    • To provide an overview of compounding restrictions following the DQSA.
    • To review current federal and state regulations impacting drug compounding.
    • To discuss the potential effects of new policies on dermatology and offer a practical algorithm for dermatologists.

    Main Methods:

    • Review of federal and state regulations and guidelines concerning medication compounding.
    • Analysis of the impact of the Drug Quality and Security Act (DQSA) of 2013.
    • Discussion of proposed policy changes and their implications for dermatological practice.

    Main Results:

    • The DQSA of 2013 enhanced oversight of compounding pharmacies and established 503(b) outsourcing facilities.
    • Federal and state policies, influenced by the DQSA, have restricted physicians' ability to perform in-office compounding.

    Conclusions:

    • Recent regulations have significantly altered the landscape of medication compounding.
    • Dermatologists face limitations in performing in-office compounding due to evolving policies.
    • Guidance is needed for dermatologists to navigate compounding regulations effectively.

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