By: Kevin Nolan, Senior Consultant, Strategic Compliance
The FDA is moving quickly to implement temporary Guidance to provide flexibility to those pharmacies and compounding centers to produce sanitizing solutions required to meet institutional and consumer demands. However, the current enforcement environment and regulatory actions against compounders may impact their ability to meet this demand, as they are focused on manufacturing critically needed drug products and/or are remediating current Regulatory enforcement activities (DOJ Consent Decree, etc.) that have impacted production and future viability of these firms.
The current COVID-19 healthcare impact and demand for surgical supplies, PPEs and sanitizing solutions has overrun the capacity of the domestic and global manufacturing capacity. There is a current need and demand for household and clinical access to sanitizing solutions that can be easily deployed and are familiar to the public with respect to packaging and portability. Recently in the virtual, printed and televised press, numerous companies have been augmenting their production processes and product workstreams to produce alcohol-based hand sanitizers. The manufacturers vary from local distilleries1 to larger pharmaceutical compounding centers with additional capacity.
The varied and diverse nature of these manufacturers, their facility controls and capabilities to consistency produce a product that will meet a standard of manufacturing. This was likely the impetus for the FDA to create and implement a temporary Guidance deployed without a commentary period.
The following talking points provide a high-level synopsis of the temporary Guidance:
Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) March 2020
- The Agency’s policy is applicable to pharmacists in State-licensed pharmacies or Federal facilities and registered outsourcing facilities (compounders).
- It will remain for the duration of the public health emergency declared by the Secretary of Health and Human Services on January 31, 2020.
- After which, FDA intends to discontinue this enforcement discretion policy and withdraw this guidance.
- Centers for Disease Control and Prevention (CDC) recommends consumers use an alcohol-based hand sanitizer that contains at least 60 percent (%) alcohol (also referred to as ethanol or ethyl alcohol).
- 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) recommendations2
- 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.
- Glycerol (1.45% v/v)
- Hydrogen peroxide (0.125% v/v)
- 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.
- A simple record should be used 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 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.
- The hand sanitizer is labeled consistent with the attached labeling in Appendices of the Guidance
- 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 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. \
- Firms will 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).
1. “Hand Sanitizer From Craft Distillery Could Be Useful Trend”; https://www.forbes.com/sites/larryolmsted/2020/03/17/hand-sanitizer-from-craft-distillery-could-be-useful-trend/#56a5c46a18d8
2. https://www.gpo.gov/fdsys/pkg/FR-1994-06-17/html/94-14503.htm. WHO’s recommendations, titled “Guide to Local Production: WHO-recommended Handrub Formulations,” are available at https://www.who.int/gpsc/5may/Guide_to_Local_Production.pdf.