The FDA has temporarily allowed for some firms to manufacture alcohol-based hand sanitizer, with limited guidance, in response to the shortage during the coronavirus pandemic. This is short second part follow up on my blog post The Dirty Truth About Hand Sanitizers in order to keep the information up to date. I’ve grabbed some of the key elements of this temporary measure and put them in one post. I’ve also included the links so that you can read what the FDA has stated in full.
Here is the press release from the FDA: Coronavirus (COVID-19) Update: FDA provides guidance on production of alcohol-based hand sanitizer to help boost supply, protect public health.
Key points from the FDA press release:
- “There have been reports of some consumers attempting to make hand sanitizers for personal use. The agency lacks information on the methods being used to prepare such products and whether they are safe for use on human skin.”
- “Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency, is in effect for the temporary compounding of certain alcohol-based hand sanitizers by pharmacists in state-licensed pharmacies or federal facilities and registered outsourcing facilities. Compounding is generally 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 tailor-made medication.”
- “The FDA’s guidance documents apply only to handrub products prepared using the United States Pharmacopoeia or Food Chemical Codex grade ingredients specifically described in the guidance, consistent with World Health Organization recommendations.” from Coronavirus (COVID-19) Update: FDA provides guidance on production of alcohol-based hand sanitizer to help boost supply, protect public health.
Key points from Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)
“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 firms7 that 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 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 United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations.
a. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20; or Isopropyl Alcohol (75%, v/v) in an aqueous solution.9
b. Glycerol (1.45% v/v).10
c. Hydrogen peroxide (0.125% v/v).
d. Sterile distilled water or boiled cold water.
The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.
2. 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.
3. The hand sanitizer is prepared under sanitary conditions and equipment utilized is well maintained and fit for this purpose.
4. 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), alcoholmeter, 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.
5. The hand sanitizer is labeled consistent with the attached labeling in 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), or Appendix D (Labeling for Isopropyl Alcohol Formulation Health Care Personnel Handrub Use). This can be found starting on page 8 of this document.
6. Firms register their facility and list these products in the FDA Drug Registration and Listing System (DRLS). Upon completion of registration 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.
Be aware that anyone making or selling DIY hand sanitizer would have to meet all of the standards set by this temporary FDA measure.
Regarding Selling Bulk Hand Sanitizer packaged outside of the registered facility.
Many have asked about repackaging bulk hand sanitizer from a registered facility. I have asked other experts and the consensus is that anything repackaged would be out of compliance with National Drug Code (NDC).
“The NDC, or National Drug Code, is a unique 10-digit or 11-digit, 3-segment number, and a universal product identifier for human drugs in the United States.
The 3 segments of the NDC identify:
- the labeler
- the product
- the commercial package size
The first set of numbers in the NDC identifies the labeler (manufacturer, repackager, or distributer). The second set of numbers is the product code, which identifies the specific strength, dosage form (i.e, capsule, tablet, liquid) and formulation of a drug for a specific company. Finally, the third set is the package code, which identifies package sizes and types. The labeler code is assigned by the U.S. Food and Drug Administration (FDA), while the product and package code are assigned by the company. For billing or other purposes, an NDC may also be arranged in an 11-digit format.” from National Code Index Explained.