FDA issues draft guidance on compounding drugs

The US Food and Drug Administration has issued two draft guidance documents describing how the FDA would implement provisions of federal law that restrict compounding human drug products that are essentially copies of commercially available or approved drug products. The draft guidance documents apply to pharmacies, physicians, federal facilities, and outsourcing facilities.

Compounded drug products pose a higher risk to patients than FDA-approved drug products because FDA does not evaluate them for safety, effectiveness, and quality before being used. In addition, some compounders are not required to comply with current Good Manufacturing Practice (cGMP) requirements. Taking poor quality compounded drugs has resulted in serious adverse events, including infections and death, in many patients, the agency said.

Compounded drug products may benefit certain patients whose medical needs cannot be met by a commercially available or an FDA-approved drug product. For example, compounded products may help a patient who has an allergy to a certain dye and needs a medication to be made without that dye, an elderly patient who cannot swallow a pill and needs a medicine in a liquid form that is not otherwise available, or a child who cannot take an adult-strength pill and needs a drug in a strength that is lower than that of the approved drug product.