Last week, the U.S. Food and Drug Administration (FDA) took yet another step to encourage production of basic medical supplies in the battle against COVID-19. On Friday, March 20, FDA published two new guidance documents communicating its policy on the manufacture of certain alcohol-based hand sanitizers. Recognizing the significant supply disruptions for hand sanitizers, and that compounders and manufacturers are better equipped than ordinary consumers to formulate safe and effective hand sanitizer products, FDA is providing flexibility in manufacturing such products during the COVID-19 public health emergency.
Guidance for Compounders
The first of the two guidance documents—Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency—is specifically directed at pharmacists in state-licensed pharmacies or federal facilities and registered outsourcing facilities (referred to collectively as "compounders"). This guidance covers the formulation of hand sanitizer for both consumer and healthcare professional use, replacing a previous version initially released on March 14 that only covered a formulation for consumer use.
The guidance explains that FDA will exercise enforcement discretion for compounders that prepare alcohol-based hand sanitizers for consumer use and for use as healthcare personnel hand rubs for the duration of the public health emergency, as long as the following specific requirements are followed:
- The hand sanitizer contains the
following USP grade ingredients, consistent with WHO
recommendations, and no additional active or inactive ingredients:
- Alcohol, which may be either ethanol (80% v/v) in an aqueous solution denatured according to the Alcohol and Tobacco Tax and Trade Bureau regulations (27 CFR part 20) or isopropyl alcohol (75% v/v) in an aqueous solution
- Glycerol (1.45% v/v for ethanol, but for isopropyl alcohol, 0.725% may be more effective)
- Hydrogen peroxide (0.125% v/v)
- Sterile distilled water or boiled cold water
- Extra caution is exercised to ensure that the active ingredient is correct, and that the correct amount of the active ingredient is used
- The hand sanitizer is prepared under the same conditions as similar nonsterile drugs compounded by the compounder, including current Good Manufacturing Practices or USP <795> (as applicable) and proper sanitary conditions
- The hand sanitizer is labeled
according to one of the four appendices provided in the guidance:
- Appendix A (Labeling for Ethyl Alcohol Formulation Consumer Use)
- Appendix B (Labeling for Isopropyl Alcohol Formulation Consumer Use)
- Appendix C (Labeling for Ethyl Alcohol Formulation Health Care Personnel Handrub Use)
- Appendix D (Labeling for Isopropyl Alcohol Formulation Health Care Personnel Handrub Use)
Additionally, the hand sanitizers must not make pathogen-specific disease claims or include false or misleading advertising and promotion.
Guidance for Entities Not Currently Licensed as Drug Manufacturers
FDA set forth those same formulation and labeling requirements for firms that are not licensed drug manufacturers in a second guidance, Temporary Policy for Preparation of Certain Alcohol Based Hand Sanitizer Products During the Public Health Emergency (COVID-19). The guidance provides that FDA will not take enforcement action against entities that prepare alcohol-based hand sanitizers for consumer use and for use as healthcare personnel hand rubs for the duration of the public health emergency. In addition to the requirements set forth for compounding pharmacists, these firms must also:
- Document the controls and steps taken to assure consistency with the prescribed formula;
- Test samples to ensure that the alcohol content of the finished product is verified prior to distribution; and
- Register their facility and list their hand sanitizer products in FDA's Drug Registration and Listing System (DRLS). Firms may begin manufacturing hand sanitizer immediately after receiving the automatic registration confirmation from FDA.
Like the compounded hand sanitizers, the manufactured hand sanitizers must not make pathogen-specific disease claims or include false or misleading advertising and promotion.
FDA has slightly modified the requirements for firms that are not licensed drug manufacturers and therefore may not be familiar with drug manufacturing protocols. For example, those firms may use either U.S. Pharmacopeia (USP)-grade or Food Chemical Codex-grade ethanol, whereas compounding pharmacists must use USP-grade ethanol. Also, non-drug manufacturers must merely manufacture the product under sanitary conditions and ensure their equipment is fit for that purpose, while compounders must comply with FDA's current good manufacturing practices or USP chapter 795's standard for compounding nonsterile preparations. With these compromises come additional oversight: unlike compounders, firms must develop a process for accepting adverse event reports related to the products they manufacture and must submit those reports to FDA.
This is yet another FDA move to bolster the medical product supply chain to meet public need and soaring demand, consistent with the Administration's recent focus on essential prevention products like N95 respirators and test kits. Last week, FDA announced that it would allow states to approve their own COVID-19 test kits and testing laboratories and allowed some of those kits to be marketed before an emergency use application was expressly approved. The Department of Health and Human Services also rallied drug and device manufacturers to develop coronavirus vaccines and therapies by issuing a PREP Act declaration, waiving tort liability for those novel products.
With store shelves empty, various how-tos and instructions for DIY hand sanitizer are circulating the Internet, encouraging average consumers to concoct their own hand sanitizer products. To ensure safety and efficacy, allowing pharmacists to compound and sell their own sanitizing solutions makes sense. But even more significant is the effort to enlist new participants to the medical drug and device market. The new guidance will encourage firms with existing relevant capability to retool their production lines for hand sanitizers. This is a huge opportunity for certain industries. Cosmetics companies and alcohol breweries and distilleries—whose usual businesses will be hit hard by the recent stay-home and business closure orders around the country—are particularly suited for the task.
Producers should note that this move is consistent with FDA's recent policy to decentralize and defer regulatory scrutiny in the interest of getting low-risk, prevention-focused products into consumer hands. While it may be relaxing traditional pre-market requirements that can be costly and time consuming, FDA is still keeping watch over these goods. It has provided pharmacists and manufacturers with a formula for the disinfectant, some quality control guidelines, and the precise labeling that should accompany the sanitizers. Deviations from these terms will likely result in FDA intervention.
The Administration is keeping an even closer eye on non-medical firms that decide to manufacture sanitizer products. Unlike compounding pharmacists, these firms must register their facilities with FDA, list their sanitizing products, and implement additional quality control measures. They must also set up adverse event reporting: a post-market safety measure commonly used in the drug and device industry to ensure that products are safe even after obtaining FDA approval.
We will continue to monitor and report on further FDA guidance and implications for the product industry.
Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.
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