VetOnIt clinical notes
Veterinary compounding: quality risk and shifting FDA guidance
Dr. Lauren Forsythe on why compounded preparations can miss their labeled strength, when bulk drug substances come into play, and how FDA compounding guidance has changed.
Updated · VetOnIt
Quality is not guaranteed
Compounded preparations can miss their labeled strength. In a 2021 study of compounded oral antiviral liquids from nine 503A pharmacies, few samples were within the accepted potency range and neither strength tested was reliable. [1]
Approved products first, bulk substances with care
When an approved product can be used as the starting material, it should be used to prepare the compound; only when it cannot should the risks and benefits of compounding from bulk drug substances be weighed. [1]
AMDUCA does not address compounding from bulk drug substances, so FDA has relied on compliance policy guides and guidance-for-industry documents that reflect its current thinking and have changed over time. [1]
Draft guidance for industry #230, released in 2015, was withdrawn in November 2017; draft guidance #256 followed at the end of 2019. [1]
Draft guidance #256 was finalized in 2022 and took effect in 2023. It is the current FDA guidance on when bulk drug substances can be used for compounding. [1]
Related lectures
On-demand lecture
Complete Compounding Guidance: Balancing Benefits, Managing Risks, and Choosing the Right Pharmacy
View on-demand lecture →References
- Complete Compounding Guidance: Balancing Benefits, Managing Risks, and Choosing the Right Pharmacy (lecture recording, Dec 11 2025) VetOnIt lecture transcriptLecture source retained by VetOnIt.