The COVID-19 pandemic has precipitated an unprecedented public health situation in the United States of America, disrupting supply chains and creating shortages of products aimed at preventing infection. As a result, the FDA & EPA have made changes and exemptions to existing regulations in order to assist companies in getting these vital products to market. This update specifically takes into consideration handwashes, personal protective equipment (PPE), and hard surface disinfectants.
These products are regulated as Over The Counter (OTC) drugs if they meet the Antiseptic Monograph and do not require FDA pre-approval and as a New Drug Application (NDA) when they do not meet the Monograph, which would require FDA preapproval. (1)
Additionally, Manufacturers of such products are required to register with the FDA, comply with 21 CFR 210 and 211 for GMPs and list their products on their Manufacturing registration.
COVID-19 Update: Anti-septic handwashes that meet the monograph in the USA do not require pre-approval.
Note: FDA has issued guidance on March 20 [see here: https://www.fda.gov/media/136289/download ] that would permit companies that do not meet 21 CFR 210 and 211 to manufacture antiseptic handwashes that meet the guide and would practice enforcement discretion if it meets the formula below:
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:
- 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
- Glycerol (1.45% v/v).
- Hydrogen peroxide (0.125% v/v).
- Sterile distilled water or boiled cold water
Note: Other antiseptic handwash products that do not align with the above formula would have to meet the current Antiseptic Monograph and drug establishment registration and listing process or would need to be assessed on a case-by-case basis to determine if they qualify for any of the FDA expedited drug review pathways
Personal Protective Equipment
PPE is regulated by the FDA as a medical device (2)
COVID-19 Update: The FDA is considering an expedited review of manufacturing site changes or premarket submissions for any manufacturers of looking to increase the availability of these products to the U.S. market. These products (along with their product codes) are as follows:
- Surgical masks (FXX)
- Surgical mask with antimicrobial/antiviral agent (OUK)
- Pediatric/child facemask (OXZ)
- Surgical gowns (FYA)
- Isolation gowns & surgical apparel accessories (FYC, LYU, OEA)
- Surgical suits (FXO)
These manufactures can reach out to the FDA at any time using the following email: email@example.com
Hard Surface Disinfectants
These products are regulated by the Environmental Protection Agency (EPA) in the U.S. and must obtain an EPA Registration Number (EPA Reg. No.) (3)
COVID-19 Update: Products that are already registered with the EPA as a surface disinfectant and do not require a review of new efficacy data could be eligible to apply for an Emerging Viral Pathogen Claims for SARS-CoV-2 (pathogen causing the disease COVID-19) claim. Applications can be fast-tracked to be added to the EPA list of disinfectants that meet the criteria for use against SARS-CoV-2. For more information on how to submit your claim visit: https://www.epa.gov/pesticide-registration/emerging-viral-pathogen-claims-sars-cov-2-submission-information-registrants
Visit dicentra for more info.