FDA, TTB Announce Emergency Policies to Increase the Domestic Supply of Hand Sanitizer

FDA Measures

Hand sanitizers are regulated by the FDA as over-the-counter (OTC) drugs, so their composition, manufacturing, labeling, and importation are tightly regulated. Recognizing the “increased demand for alcohol-based hand sanitizers during the COVID-19 pandemic” and reports of “consumers attempting to make hand sanitizers for personal use,” last week, FDA issued two immediately-in-effect guidance documents to allow hand sanitizer to be produced by entities other than traditional drug manufacturers. 

Hand Sanitizers Produced by Compounding Pharmacies

The first policy allows hand sanitizer to be produced by compounders – i.e., pharmacists in State-licensed pharmacies or Federal facilities (regulated under Section 503A of the Federal Food, Drug, and Cosmetic Act (FDCA)) and “outsourcing” compounding facilities (regulated under Section 503B of the FDCA).

Generally, “compounding” is defined by FDA as “a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient.” Unlike FDA-approved drugs, compounded drugs are not subject to FDA premarket review for safety, effectiveness, or quality, and the facilities in which compounded drugs are produced are not subject to premarket inspection or the same manufacturing requirements that apply to drug manufacturing facilities. 

Under the FDCA, compounders are generally prohibited from producing drugs that are “essentially copies” of commercially available drugs like hand sanitizers. But in its emergency guidance, “Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency,” FDA announced that, for the duration of the current public health emergency, the agency will not take action against compounders that prepare alcohol-based hand sanitizers for consumer use and for use as health care personnel hand rubs provided that all the following conditions are met:

• The hand sanitizer is compounded using only the following United States Pharmacopoeia (USP) grade ingredients consistent with World Health Organization (WHO) recommendations: 
  • Isopropyl Alcohol (75%, v/v) in an aqueous solution OR Alcohol (ethanol) (80%, volume/volume (v/v)) in an aqueous solution that has been denatured in accordance with the TTB’s regulations;
  • Glycerol (1.45% v/v);
  • Hydrogen peroxide (0.125% v/v); and
  • Sterile distilled water or boiled cold water. 

FDA explains that no other active or inactive ingredients (e.g., emollients, scents, etc.) are permitted, as “[d]ifferent or additional ingredients may impact the quality and potency of the product.

• The compounder “pays particular attention” to ensure that the correct type and amount of the active ingredient (noted above) is used.
• The hand sanitizer is prepared under conditions routinely used by the compounder to compound similar nonsterile drugs (e.g., USP Chapter 795 for compounding performed under 503A of the FDCA and Current Good Manufacturing Practices for compounding performed by outsourcing facilities under 503B). 
• The labeling of the hand sanitizer complies with the labeling requirements set forth in the guidance document’s appendices, does not contain any pathogen-specific disease claims, and is not otherwise false or misleading. 

Hand Sanitizers Produced by Other Manufacturers

Several days after the FDA issued its guidance allowing compounders to produce certain hand sanitizers, FDA issued a second guidance allowing other types of entities to produce alcohol-based hand sanitizers for consumer use and for use as health care personnel hand rubs. In its “Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19),” FDA explained that the agency will not take action against companies that manufacture these products provided that all of the following conditions are met:

• The hand sanitizer is manufactured only with the following USP grade ingredients consistent with WHO recommendations: 
  • Isopropyl Alcohol (75%, v/v) in an aqueous solution OR Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution that has been denatured in accordance with the TTB’s regulations;
  • Glycerol (1.45% v/v);
  • Hydrogen peroxide (0.125% v/v); and
  • Sterile distilled water or boiled cold water.

No other active or inactive ingredients are permitted.

• Similar to the agency’s policy for compounders, the manufacturing establishment must “pa[y] particular attention” to ensure that the correct type and amount of active ingredient is correct and the correct amount of the active ingredient is used. But the guidance for other manufacturing establishments also notes that manufacturers must use a “simple record … to document key steps and controls to assure each batch matches the formula developed for the drug product.”
• The hand sanitizer is prepared under sanitary conditions and “equipment utilized is well maintained and fit for this purpose.”
• The manufacturer 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,” e.g., gas chromatography, alcoholmeter, hydrometer, “or other chemical analysis of at least equivalent accuracy.”
• The labeling of the hand sanitizer complies with the labeling requirements set forth in the guidance document’s appendices, does not contain any pathogen-specific disease claims, and is not otherwise false or misleading. 
• The manufacturers comply with FDA’s drug registration and listing requirements (i.e., the facilities are registered with FDA as drug manufacturing establishments and the hand sanitizers listed with FDA). 

TTB Measures

Hand sanitizers that use ethanol as an active ingredient are also regulated by the TTB. Under TTB regulations, ethanol-based hand sanitizer is a regulated “article,” which is defined as any substance or preparation that is manufactured with spirits that have been rendered unsuitable for beverage use, referred to as “denatured spirits” in TTB regulations. The production of distilled spirits and the process of “denaturing” the spirits must occur at TTB licensed distilled spirits plants (DSPs) or alcohol fuel plants (AFP).

In addition to these licensing requirements, TTB approval is required before denatured spirits can be used in the manufacture of regulated articles such as hand sanitizer. The TTB’s recent guidance waives this approval requirement for the production of ethanol-based hand sanitizers. As a result, any existing DSP or AFP can immediately commence production of hand sanitizer or distilled spirits (ethanol) for use in hand sanitizer without having to obtain authorization first.

Companies should keep the following key points in mind:

• Manufacture of hand sanitizer products must be consistent with WHO guidance.
• Denatured alcohol must be produced in accordance with TTB-approved formulas set forth in 27 CFR Part 21, Subpart D. Only certain formulas are approved for use for hand sanitizers, including formulas: 1, 3-A, 3-C, 23-A, 23-H, 30, 37, 38-B, 39-B, 40, 40-A, 40-B, 40-C.
• Transportation of distilled spirits and denatured alcohol requires approval from the TTB, so if ethanol or denatured alcohol will be transported between facilities, TTB approval is required.
• The sale of undenatured distilled spirits (i.e., spirits still suitable for beverage use), are generally subject to federal excise tax. The tax obligation is waived only after the spirits are denatured.