COVID-19 FDA Sanitizer Production Guidance

FDA Guidance

Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)Guidance for Industry

March 2020 Updated April 15, 2020.

 

U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER)

 

The Food and Drug Administration (FDA or Agency) plays a critical role in protecting the United States from emerging infectious diseases, such as the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support continuity and response efforts to this pandemic. FDA is issuing this guidance in response to a number of queries from entities that are not currently licensed or registered drug manufacturers that would like to prepare alcohol-based hand sanitizers, either for public distribution or for their own internal use. The Agency is issuing this guidance to communicate its policy for the temporary preparation of certain alcohol-based hand sanitizer products by firms that register as over-the-counter (OTC) drug manufacturers to prepare alcohol-based hand sanitizers under the circumstances described in this guidance (“firms”) for the duration of the public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020.2 At such time when the public health emergency is over, as declared by the Secretary, FDA intends to discontinue this enforcement discretion policy and withdraw this guidance.

Given this public health emergency, this guidance is being implemented without prior public comment because the FDA has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C)(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. § 371(h)(1)(C)(i)) and 21 CFR § 10.115(g)(2)). This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency’s good guidance practices.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.

We understand that some consumers and health care professionals are currently experiencing difficulties accessing alcohol-based hand sanitizers. We are also aware of reports that some consumers are producing hand sanitizers for personal use in their homes; the Agency lacks verifiable information on the methods being used to prepare such products and whether they are safe for use on human skin. In response to the demand for alcohol-based sanitizers, certain entities that are not currently regulated by FDA as drug manufacturers have requested guidance on the preparation and distribution of hand sanitizer products for the public’s use. Because of the public health emergency posed by COVID-19, FDA does not intend to take action against firms6 that prepare alcohol-based hand sanitizers for consumer use and for use as health care personnel hand rubs7 for the duration of the public health emergency declared by the Secretary of HHS on January 31, 2020, provided the following circumstances are present: 1.The hand sanitizer is manufactured using only the following ingredients in the preparation of the product a.(Select one of two options) (1)Alcohol (ethanol) that is not less than 94.9% ethanol by volume8; OR (2)United States Pharmacopeia (USP grade) Isopropyl Alcohol9b.Glycerin (glycerol) USP or Food Chemical Codex (FCC) (also known as “food grade”)

Contains Nonbinding Recommendations4c.Hydrogen peroxide10d.Sterile water (e.g., by boiling, distillation, or other process that results in water that meets the specifications for Purified Water USP). Water should be used as quickly as possible after it is rendered sterile or purified.Additional Considerations for Ingredients in Preparation of the Product:Alcohol (ethanol) used for hand sanitizer is derived from distillation or fermentation processes typically used for consumable goods. Alcohol derived from synthetic processes is used only if it meets USP or FCC grade. Ethanol produced in facilities normally producing fuel or technical grade may be considered for use if the ethanol is produced from fermentation and distillation as would be typically used for consumable goods, and no other additives or other chemicals have been added to the ethanol. Further, special caution should be taken to ensure any other chemicals on site are not introduced into the ethanol either intentionally or via cross contamination. Because of the potential for the presence of potentially harmful impurities due to the processing approach, fuel or technical grade ethanol should only be used if it meets USP or FCC grade requirements and the ethanol has been screened for any other potentially harmful impurities not specified in the USP or FCC requirements.11Ingredients that are described as only meeting American Chemical Society (ACS) grade standards should generally not be used in hand sanitizers. The chemical standards that have been established by ACS for reagents are not designed to determine the suitability of a chemical for human use. For example, the ACS monographs for ethanol and glycerin do not include any impurity specifications. Where an ingredient is described as meeting both ACS grade and the other standard(s) cited in this section (e.g., USP or FCC grade), use of that ingredient is consistent with this policy.122.The alcohol (ethanol) is denatured either by the alcohol producer or at the point of production of the finished hand sanitizer product.13 Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20 and 21 provide a number of formulas for denaturing alcohol. Formulas for use in hand sanitizers include:14a.Formula 40A or 40B with or without the tert-butyl alcohol b.Formula 3C (isopropyl alcohol15) Denaturing is critical because there have been reports of adverse events, including deaths, from unintentional ingestion of hand sanitizer, particularly in young children.16 The alcohol should be denatured at either (1) the point of production by the alcohol production firm or (2) the point of manufacture or compounding of the hand sanitizer. Attachment I provides more information on the formulas used to denature alcohol before it is used in alcohol-based hand sanitizers. It reproduces Appendix C from FDA guidance for industry Temporary Policy for Manufacture of Alcohol for Incorporation into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19).” 3.The hand sanitizer is manufactured according to the following formula consistent with World Health Organization (WHO) recommendations:17 a.Alcohol (ethanol) (formulated to 80%, volume/volume (v/v)) in an aqueous solution; or Isopropyl Alcohol (formulated to 75%, v/v) in an aqueous solution.18 ,19b.Glycerin (glycerol) (1.45% v/v).20c.Hydrogen peroxide (0.125% v/v).21 d.Sterile distilled water or boiled cold water.The firm does not add other active or inactive ingredients, such as ingredients to improve the smell or taste, due to the risk of accidental ingestion in children. Different or additional ingredients may impact the quality and potency of the product.4.The firm pays particular attention to ensure the ethanol or isopropyl alcohol active ingredient is correct and the correct amount of the active ingredient is used. A simple record should be used to document key steps and controls to assure each batch matches the formula developed for the drug product.5.The hand sanitizer is prepared under sanitary conditions and equipment utilized is well maintained and fit for this purpose.226.The firm uses the most accurate method of analysis available at the site for verification of alcohol content in samples of the finished drug product before each batch is released for distribution. Methods can include gas chromatography (GC), alcohol meter, hydrometer, or other chemical analysis of at least equivalent accuracy. The sample tested can be performed on in-process material before filling into the final containers to be distributed.7.The hand sanitizer product is produced as an aqueous solution and not as a gel, foam, or aerosol spray.23 The firm packages the finished hand sanitizer product in packaging appropriate for liquid drug products that will seal sufficiently to prevent evaporation of the alcohol or IPA.24 Manual pump sprays that seal sufficiently to prevent evaporation are consistent with this policy.

8.The hand sanitizer is labeled consistent with the attached labeling in Appendix A(Labeling for Ethanol Formulation Consumer Use), Appendix B (Labeling for Isopropyl Alcohol Formulation Consumer Use), Appendix C (Labeling for Ethanol Formulation Health Care Personnel Hand R ub Use), or Appendix D (Labeling for Isopropyl Alcohol Formulation Health Care Personnel Hand R ub Use).25,269.Firms register their facility and list these products in the FDA Drug Registration and Listing System (DRLS, https://www.fda.gov/drugs/guidance-compliance-regulatory-information/drug-registration-and-listing-system-drls-and-edrls). Upon completion ofregistration and listing, firms receive automatic confirmation from the FDA and do not need to wait for a further communication from FDA before they begin to manufacture and distribute these products. FDA relies on registration and listing information to help manage drug shortages, monitor safety issues that may arise with product distributed to the public, and manage product recalls, among other important FDA public safety activities. Our help desk is standing by to assist with facilitating this process and can be contacted by sending an email to:edrls@fda.hhs.gov. This policy does not extend to other types of products, such as: products (1) that use different active ingredients; (2) whose potency falls above or below the formulation described above; (3) that are marketed with claims that do not conform to the “Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products,” Proposed Rule, 59 FR 31402 (June 17, 1994) (e.g., pathogen-specific disease claims): (4) that are surgical hand rubs or patient antiseptic skin preparations; or (5) whose labeling is false or misleading in any particular.Firms w ill need to have a way to accept adverse event reports for any products they manufacture, and submit adverse event reports to FDA (for more information, please see FDA’s guidance on adverse event reporting requirements, https://www.fda.gov/media/77193/download).27FDA 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

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