COVID-19: Compounding Hand Sanitizer

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The chart below includes NASPA’s compilation of state actions affecting compounding hand sanitizer. This is a work in progress.

The following are other relevant links:

Return to COVID-19: Information from the States

State Date Guidance
Alabama
Alaska
Arizona 3/14/2020 References FDA policy and USP guidance for compounding hand sanitizer.
Arkansas 3/18/2020 References USP guidance for compounding hand sanitizer.
California 3/16/2020 References FDA policy for compounding hand sanitizer.
Colorado
Connecticut 3/15/2020 Any pharmacy compounding such products shall be licensed pursuant to Chapter 400j of the Connecticut General Statutes.
The pharmacist compounding such product, shall follow processes in compliance with the United States Pharmacopeia Chapter 795 and maintain records for all of their compounding.
The pharmacist must use a formula from a reputable source that creates a product that is greater than 60 percent alcohol as recommended by the Center for Disease Control and Prevention.
The pharmacist must follow all federal and state labeling requirements.
Prior to selling any product pursuant to this statute, the pharmacist shall obtain contact information for the purchaser sufficient to permit the pharmacist to initiate a recall if necessary.
The purchaser’s contact information and the lot number of the compounded product shall be recorded on a log sheet.
All records required by this order shall be made available to the Department of Consumer Protection upon request and are required to be maintained for three years.
Delaware
District of Columbia 3/23/2020
Florida
Georgia 3/16/2020 References FDA policy for compounding hand sanitizer.
The Board takes the position that compounding of hand sanitizer gel is permitted given that the components are all over-the-counter products. Labels will need to comply with FDA requirements.
Hawaii
Idaho 3/25/2020 References FDA policy for compounding hand sanitizer.
Illinois
Iowa
Kansas 3/31/2020 References FDA policy and USP and WHO guidance for compounding hand sanitizer.
Kentucky 3/16/2020 References FDA policy and USP and WHO guidance for compounding hand sanitizer.
Louisiana 3/14/2020 References FDA policy for compounding hand sanitizer.
Maine 3/18/2020 References FDA policy and USP guidance for compounding hand sanitizer.
The pharmacy must label each container of hand sanitizer in accordance with USP, including ingredients, beyond use date, lot number, directions for use, etc. Specific patient information is not required on the label for compounded OTC hand sanitizer.
The compounded OTC hand sanitizer must be labeled with the statement “for external use only.”
The pharmacy may not sell compounded OTC hand sanitizer to other retail establishments and may only be sold to end users.
Maryland 3/19/2020 References FDA policy for compounding hand sanitizer.
Massachusetts 4/3/2020 Revisions were made to hand sanitizer policy and can be found at https://www.mass.gov/doc/hand-sanitizer-compounding-revised-4-3-2020/download
References FDA policy for compounding hand sanitizer.
The pharmacy and pharmacist must comply with USP <795>, including beyond-use-dates and compounding records.
The pharmacy must label each container of hand sanitizer in accordance with USP <795>, including ingredients, beyond use date, lot number, directions for use, etc. Specific patient information is not required on the label for compounded OTC hand sanitizer.
The compounded OTC hand sanitizer must be labeled with the statement “for external use only.”
The pharmacy may not sell compounded OTC hand sanitizer to other retail establishments and may only be sold to end users.
The general public may visit a participating pharmacy on a walk-in basis and purchase compounded OTC hand sanitizer, and it may be sold in the front store.
The Board expects pharmacies and pharmacists to price products fairly, to use judgment to avoid bulk sales that may result in hoarding or resale, and to uphold the integrity of the profession during this emergency.
Michigan
Minnesota 3/23/2020 References FDA policy for compounding hand sanitizer.
Mississippi 3/23/2020 ​​References FDA policy for compounding hand sanitizer.
Pharmacies may sell such product to other pharmacies in-state for resale during the duration of the Governor’s Declaration of Emergency.​​​
Missouri 3/16/2020 References FDA policy for compounding hand sanitizer.
A compounding log should be maintained as required by 20 CSR 2220-2.400.
The pharmacy may note “OTC Use” where the prescription number would normally be recorded on the log.
Unless notified otherwise, this exception will continue for the duration of the public health emergency declared by the Secretary of Health and Human Services on January 31, 2020. Once the emergency ends, pharmacies will be required to have a patient specific prescription and comply with all applicable FDA requirements.
Montana 3/16/2020 References FDA policy for compounding hand sanitizer.
Nebraska
Nevada 4/1/2020 References FDA policy for compounding hand sanitizer. Temporarily authorizes the compounding and sale of certain alcohol-based hand sanitizer products by Nevada-licensed pharmacies and outsourcing facilities (referred to collectively as compounders).
New Hampshire
3/23/2020 References FDA policy for compounding hand sanitizer. Requires pharmacy to comply with USP <795> when compounding hand sanitizer. Allows selling hand sanitizer to end users but prohibits sale to other retail establishments.
New Jersey
New Mexico
New York
North Carolina 3/18/2020 References FDA policy for compounding hand sanitizer.
Ohio 3/14/2020 References FDA policy for compounding hand sanitizer.
Oklahoma
Oregon 3/23/2020 References FDA policy for compounding hand sanitizer.
Permitted for OTC-sales and for patient-specific prescriptions
Pennsylvania
Rhode Island
South Carolina
South Dakota
3/18/2020 References FDA policy for compounding hand sanitizer.
Tennessee 3/25/2020 References USP guidance for compounding hand sanitizer
Texas 3/20/2020 References FDA policy for compounding hand sanitizer.
Utah 3/16/2020 References FDA policy for compounding hand sanitizer.
Vermont 3/23/2020 References FDA policy for compounding hand sanitizer.
Virginia 3/24/2020 Pharmacists may compound, in accordance with USP <795> standards, hand sanitizer containing at least 60% isopropyl or ethyl alcohol for sale to the general public at a reasonable price without obtaining a prescription to authorize the compounding. The pharmacist must ensure the product is labled to identify the ingredients, appropriate BUD, and directions for safe use.
Washington
West Virginia 3/14/2020 References FDA policy for compounding hand sanitizer.
Wisconsin
Wyoming 3/25/2020 References FDA policy and WHO, USP, and CDC guidance for compounding hand sanitizer.
In addition to this guidance, pharmacists that compound non-sterile products must follow Chapter 13 of the Board’s Rules and Regulations.
The pharmacist must ensure the product is labeled to identify the ingredients, appropriate BUD, and directions for safe use.

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