Happi Staff03.30.20
The Food & Drug Adminstration has released a Q&A for consumers about hand sanitizers and COVID-19. In addition, the agency noted that consumers should not be making their own products in light of the product being hard to find.
FDA tells consumers that if “made incorrectly, hand sanitizer can be ineffective – or worse. For example, there have been reports of skin burns from homemade hand sanitizer.”
FDA also notes that “adding alcohol to non-alcohol hand sanitizer is unlikely to result in an effective product. And using disinfectant sprays or wipes on your skin may cause skin and eye irritation. Disinfectant sprays and wipes are intended to clean surfaces, not people or animals.”
The FDA notes that it “is helping increase the availability of hand sanitizers by working with companies and pharmacies to address this supply shortage.”
Further, the agency said consumers should call their doctor if they experience a serious reaction to hand sanitize, and that health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting program.
Following is FDA’s Q&A for consumers:
Q. Is hand sanitizer effective against COVID-19?
A. The best way to prevent the spread of infections and decrease the risk of getting sick is by washing your hands with plain soap and water, advises the Centers for Disease Control and Prevention (CDC). Washing hands often with soap and water for at least 20 seconds is essential, especially after going to the bathroom; before eating; and after coughing, sneezing, or blowing one’s nose. If soap and water are not available, CDC recommends consumers use an alcohol-based hand sanitizer that contains at least 60% alcohol.
Q. Where can I buy hand sanitizer? If I can’t find it in the store, can I make my own?
A. Many retail stores and pharmacies sell hand sanitizers. However, we understand that many stores have run out of hand sanitizers and they may be difficult to find. To help increase the availability of hand sanitizers, FDA has issued guidance for the temporary preparation of alcohol-based hand sanitizers by some companies and pharmacies during the public health emergency posed by COVID-19. See Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry, the Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency, and Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19).
FDA recommends that consumers do not make their own hand sanitizer. If made incorrectly, hand sanitizer can be ineffective, and there have been reports of skin burns from homemade hand sanitizer. The agency lacks verifiable information on the methods being used to prepare hand sanitizer at home and whether they are safe for use on human skin.
Q. Is the FDA taking measures to increase the supply of hand sanitizers?
A. Yes. FDA has recently developed multiple guidance documents for the temporary preparation of hand sanitizers by pharmacies and other companies during the public health emergency posed by COVID-19. The guidance documents describe circumstances under which the agency does not intend to take action when these companies prepare alcohol-based hand sanitizers for consumer use and for use as health care personnel hand rubs for the duration of the public health emergency. FDA has also issued guidance for the temporary manufacture of alcohol by alcohol producers to use as the active ingredient in hand sanitizer products.
Q. What do I do if I get a rash or other reaction to hand sanitizer?
A. Call your doctor if you experience a serious reaction to hand sanitizer. FDA encourages consumers and health care professionals to report adverse events experienced with the use of hand sanitizers to FDA’s MedWatch Adverse Event Reporting program:
A. Always follow the instructions on household cleaners. Do not use disinfectant sprays or wipes on your skin because they may cause skin and eye irritation. Disinfectant sprays or wipes are not intended for use on humans or animals. Disinfectant sprays or wipes are intended for use on hard, non-porous surfaces.
View the current list of products that meet EPA’s criteria for use against SARS-CoV-2, the cause of COVID-19. See Coronavirus Disease 2019 (COVID-19) Frequently Asked Questions for more information.
Q. If I add alcohol to non-alcohol hand sanitizer, will this be better to prevent COVID-19?
A. No. Addition of alcohol to an existing non-alcohol hand sanitizer is unlikely to result in an effective product. FDA has also issued guidance for the temporary preparation of certain alcohol-based hand sanitizer products by firms during the COVID-19 public health emergency. These temporary policies do not extend to non-alcohol based products at this time.
Q. Does the FDA regulate all hand sanitizers? Do hand sanitizers come with product information on their labeling?
A. Hand sanitizers are over-the-counter (OTC) drugs regulated by FDA.
Hand sanitizers that meet FDA’s OTC drug review conditions or that are manufactured under the conditions in FDA’s temporary policy will include a “Drug Facts” label similar to the ones found at the end of the guidance: Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19). Consumers should assure they are following the warnings and precautions described on this label, particularly regarding use in children. The Drug Facts label will also describe the ingredients in the product.
To address the supply shortage of hand sanitizers, FDA has recently developed multiple guidance documents for the temporary preparation of hand sanitizers by pharmacies and other companies during the public health emergency posed by COVID-19. The guidance documents describe circumstances under which the agency does not intend to take action when these companies prepare alcohol-based hand sanitizers for consumer use and for use as health care personnel hand rubs for the duration of the public health emergency.
Q. Do hand sanitizers have an expiration date? Are they still effective after the expiration date?
A. OTC drug products generally must list an expiration date unless they have data showing that they are stable for more than 3 years. FDA does not have information on the stability or effectiveness of drug products past their expiration date (See 21 CFR 211.137). Hand sanitizer produced under the temporary policies for hand sanitizer production and compounding may not have an expiration date listed because they are expected to be used during this public health emergency.
More info here.
FDA tells consumers that if “made incorrectly, hand sanitizer can be ineffective – or worse. For example, there have been reports of skin burns from homemade hand sanitizer.”
FDA also notes that “adding alcohol to non-alcohol hand sanitizer is unlikely to result in an effective product. And using disinfectant sprays or wipes on your skin may cause skin and eye irritation. Disinfectant sprays and wipes are intended to clean surfaces, not people or animals.”
The FDA notes that it “is helping increase the availability of hand sanitizers by working with companies and pharmacies to address this supply shortage.”
Further, the agency said consumers should call their doctor if they experience a serious reaction to hand sanitize, and that health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting program.
Following is FDA’s Q&A for consumers:
Q. Is hand sanitizer effective against COVID-19?
A. The best way to prevent the spread of infections and decrease the risk of getting sick is by washing your hands with plain soap and water, advises the Centers for Disease Control and Prevention (CDC). Washing hands often with soap and water for at least 20 seconds is essential, especially after going to the bathroom; before eating; and after coughing, sneezing, or blowing one’s nose. If soap and water are not available, CDC recommends consumers use an alcohol-based hand sanitizer that contains at least 60% alcohol.
Q. Where can I buy hand sanitizer? If I can’t find it in the store, can I make my own?
A. Many retail stores and pharmacies sell hand sanitizers. However, we understand that many stores have run out of hand sanitizers and they may be difficult to find. To help increase the availability of hand sanitizers, FDA has issued guidance for the temporary preparation of alcohol-based hand sanitizers by some companies and pharmacies during the public health emergency posed by COVID-19. See Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry, the Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency, and Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19).
FDA recommends that consumers do not make their own hand sanitizer. If made incorrectly, hand sanitizer can be ineffective, and there have been reports of skin burns from homemade hand sanitizer. The agency lacks verifiable information on the methods being used to prepare hand sanitizer at home and whether they are safe for use on human skin.
Q. Is the FDA taking measures to increase the supply of hand sanitizers?
A. Yes. FDA has recently developed multiple guidance documents for the temporary preparation of hand sanitizers by pharmacies and other companies during the public health emergency posed by COVID-19. The guidance documents describe circumstances under which the agency does not intend to take action when these companies prepare alcohol-based hand sanitizers for consumer use and for use as health care personnel hand rubs for the duration of the public health emergency. FDA has also issued guidance for the temporary manufacture of alcohol by alcohol producers to use as the active ingredient in hand sanitizer products.
Q. What do I do if I get a rash or other reaction to hand sanitizer?
A. Call your doctor if you experience a serious reaction to hand sanitizer. FDA encourages consumers and health care professionals to report adverse events experienced with the use of hand sanitizers to FDA’s MedWatch Adverse Event Reporting program:
- Complete and submit the report online; or
- Download and complete the form, then submit it via fax at 1-800-FDA-0178.
- Include as much information as you can about the product that caused the reaction, including the product name, the manufacturer, and the lot number (if available).
A. Always follow the instructions on household cleaners. Do not use disinfectant sprays or wipes on your skin because they may cause skin and eye irritation. Disinfectant sprays or wipes are not intended for use on humans or animals. Disinfectant sprays or wipes are intended for use on hard, non-porous surfaces.
View the current list of products that meet EPA’s criteria for use against SARS-CoV-2, the cause of COVID-19. See Coronavirus Disease 2019 (COVID-19) Frequently Asked Questions for more information.
Q. If I add alcohol to non-alcohol hand sanitizer, will this be better to prevent COVID-19?
A. No. Addition of alcohol to an existing non-alcohol hand sanitizer is unlikely to result in an effective product. FDA has also issued guidance for the temporary preparation of certain alcohol-based hand sanitizer products by firms during the COVID-19 public health emergency. These temporary policies do not extend to non-alcohol based products at this time.
Q. Does the FDA regulate all hand sanitizers? Do hand sanitizers come with product information on their labeling?
A. Hand sanitizers are over-the-counter (OTC) drugs regulated by FDA.
Hand sanitizers that meet FDA’s OTC drug review conditions or that are manufactured under the conditions in FDA’s temporary policy will include a “Drug Facts” label similar to the ones found at the end of the guidance: Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19). Consumers should assure they are following the warnings and precautions described on this label, particularly regarding use in children. The Drug Facts label will also describe the ingredients in the product.
To address the supply shortage of hand sanitizers, FDA has recently developed multiple guidance documents for the temporary preparation of hand sanitizers by pharmacies and other companies during the public health emergency posed by COVID-19. The guidance documents describe circumstances under which the agency does not intend to take action when these companies prepare alcohol-based hand sanitizers for consumer use and for use as health care personnel hand rubs for the duration of the public health emergency.
Q. Do hand sanitizers have an expiration date? Are they still effective after the expiration date?
A. OTC drug products generally must list an expiration date unless they have data showing that they are stable for more than 3 years. FDA does not have information on the stability or effectiveness of drug products past their expiration date (See 21 CFR 211.137). Hand sanitizer produced under the temporary policies for hand sanitizer production and compounding may not have an expiration date listed because they are expected to be used during this public health emergency.
More info here.
