Should Congress amend the FD&C Act to ensure access to compounded medications?
This bill would change the Federal Food, Drug, and Cosmetic Act to codify FDA policies for compounding medications for urgent hospital needs. This would allow pharmacies to produce compounded medications when conventionally manufactured medications are not available to patients and hospitals. This bill would allow for hospitals and pharmacies to have easier access to certain compounded medications in particular urgent situations.
Sponsor: Rep. Diana Harshbarger (Republican, Tennessee, District 1)
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Opponents say
• "On behalf of The Partnership for Safe Medicines (PSM), we write to express our strong opposition to H.R. 5316, the Drug Shortage Compounding Patient Access Act. While we recognize the importance of addressing drug shortages and ensuring patient access to necessary medications, this legislation undermines critical patient safety protections established by Congress in the wake of tragedies caused by poorly regulated compounded medicine." Source: The Partnership for Safe Medicines (Open Letter)
Proponents say
• "As a pharmacist, I know the devastating impact drug shortages can have on patients, families, and hospitals. This legislation ensures when conventionally manufactured drugs aren’t available, American compounding pharmacies have clear authorities and flexibilities to step in, guided by a specified FDA process. By modernizing how shortages are addressed, we can protect patients, strengthen our health security, and reduce our dependence on unstable foreign supply chains." Source: Rep. Diana Harshbarger (Republican, Tennessee, District 1) Office of Rep. Harshbarger
• "The United States currently has over 200 drugs in shortage, representing a threat to public health and safety. By allowing compounding pharmacies to address this crisis by compounding drugs in shortage and improving the process by which FDA establishes the drug shortage list, we will strengthen our nation’s health and security without relying on hostile foreign nations for essential medications." Source: Rep. Buddy Carter (Republican, Georgia, District 1) Office of Rep. Harshbarger
