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Carter Secures Increased Production of Hand Sanitizers Through Compounding

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Washington, March 23, 2020 | comments
Congressman Earl L. "Buddy" Carter (R-Ga.) has successfully worked with the U.S. Food and Drug Administration (FDA) to increase production of over-the-counter hand sanitizers during the coronavirus pandemic with the use of compounding pharmacies. 

Currently, there are prohibitions on pharmacies compounding anything that is “essentially a copy” of a commercially available drug product, including hand sanitizers. After working with Carter, the FDA has announced compounding pharmacies will be permitted to make over-the-counter hand sanitizers to help meet public demand during the pandemic. 

"In the First District, and across the nation, Americans are reporting that they are having trouble finding hand sanitizers," said Carter. "During these times, we must use every tool we have to meet the health demands of our citizens. We should certainly allow compounding pharmacies to step in and help fill this void for the health and safety of all Americans."

"PCCA thanks Congressman Carter and the FDA for their efforts to bolster access to hand sanitizer during the ongoing public health crisis," said Jim Smith, PCCA President. "We look forward to working with the Congressman, the FDA and other stakeholders to ensure the public has access to all medications and necessary supplies."

“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 Buddy Carter working 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 essential over-the-counter products in shortage as a result of the COVID-19 threat.”

Background:

The ingredients in hand sanitizers (isopropyl alcohol, aloe, a thickening agent and essential oils) can be made by compounding pharmacists.  However, the federal Food, Drug and Cosmetic Act and state pharmacy laws and regulations require an over-the-counter manufacturer license and/or a patient specific prescription for compounding, even for hand sanitizer. Additionally, there are prohibitions on pharmacies compounding anything that is “essentially a copy” of a commercially available drug product.  

While these laws and regulations are well-intended, the FDA can and does use enforcement discretion when FDA approved or commercially available products are not available to meet patient needs. The FDA has now used this authority to allow compounding pharmacists to produce hand sanitizers to address the public need during the coronavirus pandemic. 
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