첨부파일은 미국 FDA에서 발표한 공중 보건 긴급 상황(COVID-19)동안 산업계를 위한 알코올 기반 손 소독제 제품 관련 임시 정책입니다.

FDA에서는 공중 보건 비상 사태를 해결하기 위해 본 지침을 발행했고, 사전 공개 의견없이 시행되고 있습니다. 

또한 공중 보건 응급 상황(코로나 바이러스)이 끝나는 시점에서 FDA에 의해 선언 된 이 집행 재량 정책을 중단하고 이 지침을 철회 할 계획이라고 합니다. 

참고하시기 바랍니다.

<가이던스 제목> Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/temporary-policy-manufacture-alcohol-incorporation-alcohol-based-hand-sanitizer-products-during

================================================================================================

참고로, 변성알콜 관련하여, 미국 FDA로부터 받은 이메일 회신 내용을 아래와 같이 공유하여 드립니다.

Hand sanitizers (and other drugs) imported into the United States must comply with all the applicable requirements under the Federal Food, Drug, and Cosmetic Act and the pertinent regulations found in Title 21 of the Code of Federal Regulations (21 CFR).  However, FDA has described in three recent guidances that FDA does not intend to take action on the manufacture of hand sanitizers, and ethanol used as an active pharmaceutical ingredient in hand sanitizers, that are introduced into U.S. commerce, provided certain circumstances are present.

For example, as described in the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19), foreign manufacturers whose drugs, including over-the-counter drugs, are imported into the United States are required to register with FDA and submit a listing of drugs in commercial distribution, before the drugs are imported (as required by section 510 of the FD&C Act and 21 CFR Part 207). See Electronic Drug Registration and Listing Instructions for information and instructions on the electronic submission process.

One of the conditions outlined in the guidance is that the alcohol (ethanol) is denatured either by the alcohol producer or at the point of production of the finished hand sanitizer product.  Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20 and 21 provide a number of formulas for denaturing alcohol.

 Formulas acceptable for use in hand sanitizers include:

a.            Formula 40A or 40B with or without the tert-butyl alcohol

b.            Formula 3C (isopropyl alcohol)

Denatured alcohol contains specific additives that render the product less appealing to drink. There are a number of adverse events every year resulting from intentional or unintentional ingestion of hand sanitizer, which is a particular concern for young children. Adding an ingestion deterrent is a measure to mitigate a health risk. 

The agency does not intend to take enforcement action against hand sanitizers made with imported ethanol, so long as it meets the specifications outlined in our guidance, Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19). 

Please check with the U.S. Tax and Trade Bureau for any tax or importation restrictions.