On March 20, 2020 FDA issued a new guidance on the manufacture of alcohol-based hand sanitizers. This guidance indicates that the FDA is going to use enforcement discretion and allow non-traditional drug firms to make alcohol-based hand sanitizers provided they can meet the following minimum requirements:
- The hand sanitizer must be made from alcohol (USP or FCC grade) and be formulated in accordance with the designated 80% denatured alcohol-aqueous v/v solution for ethanol or 75% v/v/ for isopropyl alcohol solution.
- Other ingredients in the overall formulation beyond the alcohol API) are limited to: Glycerol (1.45% v/v), Hydrogen Peroxide (0.125% v/v) and the balance is composed of sterile distilled water or boiled cold water [to be used to QS to volume].
- No other active ingredients can be added, used or substituted.
- A batch record for the production of each batch needs to be generated and maintained in enough detail to determine that it was formulated properly, traces raw materials by lot number and captures weights/volume measures and any calculations.
- The manufacturing facility and equipment need to be sanitary, maintained and fit for the intended use.
- Finished product testing needs to be conducted using a method appropriate to determine the alcohol content of each batch prior to release.
- The FDA approved hand sanitizer label and drug facts panel is used (as referenced in the FDA Guidance – Appendix A, B, C, D).
- The manufacturing facility must register with FDA CDER and drug list the hand sanitizer products in the DRLS (Drug Registration and Listing System).
- There must be a means of receiving and accepting adverse event reports (AER) for reporting under the FDA’s MedWatch process. (Often these AERs come in initially as a general product complaint so a means of performing assessment a triage of complaints is likely a necessary tool as well.)
Please note that this guidance and the exceptions outlined will only remain in effect as long as the Department of Health and Human Services emergency declaration (of 31 January 2020) remains in effect.
For more information on GMP requirements for OTCs and an overview of FDA enforcement actions I encourage you to view this complimentary on-demand webinar.
Please let me know if you need any assistance or help with registration, listing or setting up for the limited GMP requirements to meet the intent of this guidance.
EAS Memo on FDA Hand Sanitizer Manufacturing Guidnace for COVID-19 Response.
Senior Director for Pharmaceutical and Device Consulting Services