UPDATED GUIDANCE FOR DSP PRODUCTION OF HAND SANITIZER AND SANITARY SPRAY: FDA & INSURANCE UPDATES
March 20th, 2020
The COVID-19 pandemic continues to rapidly evolve. ACSA leadership has been working this week with multiple Federal government agencies to ensure we have the most up-to-date guidance on the production of hand sanitizer. Today, the FDA released guidance for production of hand sanitizer for the industry. Additionally, we have detailed suggestions on insurance and liability. We will continue to brief you on this issue.
A summary follows, and the complete document is available here: Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)Guidance for Industry
Per the guidance, the FDA does not intend to take action against firms that prepare alcohol-based hand sanitizers for consumer use and for use as health care personnel hand runs for the duration of the public health emergency provided the following are adhered to:
Hand sanitizer is manufactured using United States Pharmacopoeia (USP) grade ingredients in the preparation of the product consistent with WHO recommendations:
- Alcohol (ethanol) – 80% volume/volume in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations or Isopropyl Alcohol (75% v/v) in an aqueous solution
- Glycerol (1.45% v/v)
- Hydrogen peroxide (.125 % v/v)
- Sterile distilled water or boiled water
- Firm doesn’t add other active or inactive ingredients
-Make sure that you are keeping a record to document key steps and controls to assure each batch matches the formula developed for the product. Make sure you label consistent with Appendix A in the guidance document.
-You will need to register in the FDA Drug Registration and Listing System at this link.
Any SPL authoring software may be used to create registration and listing SPL files. The FDA website offer two SPL authoring tools — CDER Direct and Xforms. One of the simplest ways to submit SPLs is through the use of CDER Direct, a free tool from the FDA. You can create an account athttps://direct.fda.gov. After you sign up for an account and it is confirmed, you can begin creating and sending SPL submissions to the FDA.
FDA recommendation is to follow this sequence of steps:
- Obtain a DUNS number if you do not have one here.
- Create a CDERDirect account here.
- Register the establishment if you are a manufacturer or performing manufacturing processes
- Electronic Code of Federal Regulations Link
- Request a labeler code (Labeler codes are only used for generatingNational Drug Code (NDC) numbers for drugs)
- List the product
Here is a link to the instructions page.On the page you will find guidance on how to register your establishment, request a labeler code and list a drug product.
You will need to have a way to accept adverse event reports for manufactured products.
NOTE: ACSA is putting together guidelines on how to meet the adverse effects reporting requirements and it will be posted as soon as possible.
Please check with your insurance provider about coverage for potential liability. You may or may not need additional coverage. Each provider will likely have a range of requirements and they will vary for every DSP and every specific case. Following are some that we have seen:
Labels are part of the product: Manufacturers cannot state a hand sanitizer kills specific viruses or bacteria without testing verification and FDA approval.
- Child-resistant closures must be used to make the product less accessible to children.
- Product labels and containers should be reviewed by an attorney familiar with FDA requirements and regulations.
- Remove all ignition sources in the immediate area of any ethanol production and distribution such as non-classified standard electrical appliances such as lights, radios, and extension cords.
- Avoid plastic intermediate bulk containers for flammable liquid storage. Metal bulk containers are safer.
- To reduce the risk of static discharge ignition, bonding and grounding measures should be implemented on all flammable liquids stored and distributed in metallic containers.
- Ensure fire protection systems are maintained and active. Keep Class B fire extinguishers readily available.
For questions or additional info please contact firstname.lastname@example.org.
March 20th, 2020