pure protect alcohol fda approved


Who should test pharmaceutical alcohol for use in drug products?

    Repackers and others who distribute and prepare ethanol or isopropyl alcohol API for use in drug products should test pharmaceutical alcohol that are used, sold for use, or intended for use in drug products.

What is the FDA's policy on alcohol-based hand sanitizer?

    In response to the demand for alcohol-based hand sanitizers during the COVID-19 public health emergency, FDA issued temporary policies for the manufacture of alcohol-based hand sanitizer products and ethanol for use in alcohol-based hand sanitizer.

Is isopropyl alcohol a drug?

    Bulk or repackaged ethanol or isopropyl alcohol intended as an excipient or other component of a drug product is a drug as defined by section 201(g)(1) the FD&C Act (21 U.S.C. 321(g)(1)).

Are compounded drug products adulterated under Section 501(b) of the FD&C Act?

    Thus, compounded drug products containing ethanol with more than 200 ppm methanol may be considered adulterated under section 501(b) of the FD&C Act and would not qualify for the relevant exemptions in section 503A(a) or 503B(a) because they do not comply with the standards in the applicable USP monograph.
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