Pew Comments on FDA Draft Guidance for Compounded Drug Ingredients

What Ingredients Can Be Used in Compounded Drugs

When patients have medical needs that cannot be met by commercially available medicines that have been approved by the Food and Drug Administration, they can instead take compounded drugs, medications made by physicians or pharmacists. Neither FDA nor state authorities evaluate these drugs for safety or efficacy before they are administered to patients, but compounders cannot use just any chemicals to create a drug. Rather, there are criteria under federal law for determining which active drug ingredients—known as bulk drug substances— can be used to compound drugs.