Policy for testing of alcohol (ethanol) and isopropyl alcohol for methanol: guidance for industry
- Collection:
- Health Policy and Services Research
- Contributor(s):
- Center for Drug Evaluation and Research (U.S.), issuing body. Center for Biologics Evaluation and Research (U.S.), issuing body. Center for Veterinary Medicine (U.S.), issuing body.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, October 2023
- Language(s):
- English
- Format:
- Text
- Subject(s):
- 2-Propanol -- analysis Drug Compounding -- standards Drug Contamination -- prevention & control Drug Industry Ethanol -- analysis Government Regulation Methanol -- poisoning United States
- Genre(s):
- Guideline Technical Report
- Abstract:
- This guidance is intended to alert pharmaceutical manufacturers and pharmacists in State-licensed pharmacies or Federal facilities who engage in drug compounding to the potential public health hazard of alcohol (ethyl alcohol or ethanol) or isopropyl alcohol contaminated with or substituted with methanol. During the Coronavirus Disease 2019 (COVID-19) public health emergency (PHE), the Food and Drug Administration (FDA) became aware of reports of fatal methanol poisoning of consumers who ingested alcohol-based hand sanitizer products that were manufactured with methanol or methanol-contaminated ethanol. FDA has also received numerous reports of dermal toxicity associated with such products. FDA also is concerned that other drug products containing ethanol or isopropyl alcohol (pharmaceutical alcohol), which are widely used ingredients in a variety of drug products, could be similarly vulnerable to methanol contamination. For example, certain inhalation products, mouthwashes, cough and cold products, and many topical drug products include pharmaceutical alcohol. As the COVID-19 pandemic increased the demand for hand sanitizer products, the demand for pharmaceutical alcohol as the active ingredient of those products also increased. In the past, increased stress on supply chains has made ingredients more vulnerable to economically motivated adulteration. For these reasons, the policy outlined in this guidance applies to pharmaceutical alcohol used as an active or inactive ingredient in a drug product regardless of whether the drug product is a hand sanitizer product. This policy will help pharmaceutical manufacturers and pharmacists who engage in drug compounding avoid using pharmaceutical alcohol contaminated with or substituted with methanol in drug products. This guidance replaces the guidance for industry Policy for Testing Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the Public Health Emergency (COVID-19) published in January 2021. In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (9 pages))
- NLM Unique ID:
- 9918732188506676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918732188506676