U.S. Rep. Buddy Carter (R-GA) on March 23 announced that he successfully worked with the U.S. Food and Drug Administration (FDA) to permit compounding pharmacies to produce over-the-counter hand sanitizers that will help meet increased demand during the COVID-19 pandemic.
A compounding pharmacy is one that makes drugs prescribed by doctors for specific patients with needs that can’t be met by commercially available drugs, according to WebMD.
“In the First District, and across the nation, Americans are reporting that they are having trouble finding hand sanitizers,” Rep. Carter said. “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.”
Currently, there are prohibitions on pharmacies compounding anything that is “essentially a copy” of a commercially available drug product, including hand sanitizers, according to information provided by Rep. Carter’s office.
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 earlier this month used this authority to allow compounding pharmacists to produce hand sanitizers beginning on March 23.
Professional Compounding Centers of America (PCCA) and the Alliance for Pharmacy Compounding thanked Rep. Carter and the FDA for their efforts to bolster access to hand sanitizer during the ongoing public health crisis.