(10/29) of FDA-sampled compounded products failed ≥1 standard quality test performed, including potency testing in 9 of 10 sampled compounds8
Compounding drugs in the absence of Current Good Manufacturing Practice (CGMP) regulations can increase the potential for preparation errors5
Modifying drugs may alter safety and efficacy4,6
Pharmacy-compounded products are not clinically tested for safety and efficacy, nor is bioequivalence testing conducted as is required for generic drugs5
Crushing or splitting can alter the dose administered and may lead to undesirable effects7
Section 503A of the Federal Food, Drug, and Cosmetic Act and the enacted Drug Quality and Security Act restrict the compounding of any drug products that are essentially copies of a commercially available drug product.9
