MARCH 14, 2020 - At the urging of the Alliance for Pharmacy Compounding and others, FDA has announced it will take no enforcement action against compounders who prepare alcohol-based hand sanitizers during the current public health emergency.
The guidance for industry document, titled " Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products," was released Saturday morning.
"Because of the public health emergency posed by COVID-19," it reads, "FDA does not intend to take action against compounders that prepare alcohol-based hand sanitizers for consumer use for the duration of the public health emergency declared by the Secretary of HHS on January 31, 2020" provided certain conditions, also outlined in the document, are met.
The GFI does not address the issue of whether a patient-specific prescription is not required. On Saturday afternoon, in response to APC's request for clarification on that point, an FDA official indicated that a prescription would not be required.
Working with APC, U.S. Representative Buddy Carter (GA-1), a pharmacist, had reached out last week to ask FDA to allow compounders to help meet consumer demand during the current shortage of FDA-approved hand sanitizers. The agency was quick in responding.
"We're grateful to FDA for acknowledging this need and issuing this guidance, which will allow compounders to serve their communities in this time of shortage," said Shawn Hodges of Kennesaw, Georgia, president of the Alliance for Pharmacy Compounding. "We also appreciate Congressman Carter, who worked with us over the past week to elevate this issue on FDA's radar. It's a commonsense response to a serious need. We continue to urge FDA to allow compounding of other over-the-counter products in current shortage as a result of the COVID-19 threat. Compounders are well qualified and eager to do much more to help in this crisis if FDA will empower us."
Compounders are urged to read the FDA guidance document carefully and to check with their state board of pharmacy to assure compliance with state laws and regulations.