	Background

		Drug Compounding by Pharmacies

Traditionally, a drug is compounded, through the process of mixing,  combining, or altering ingredients, to create a customized drug tailored to  the medical needs of an individual patient upon receipt of a prescription. See appendix II for details about  these developments and how they have affected FDA’s authority to  oversee drug compounding. States and National Organizations Have Taken Various Actions to Strengthen Oversight of Drug Compounding

The four states we reviewed—California, Connecticut, Florida, and  Iowa—have each recently taken actions, such as working with national  pharmacy organizations, to improve their oversight of drug compounding. In addition, national pharmacy organizations have undertaken efforts to  help states oversee drug compounding. For example, national  pharmacy organizations have developed standards for compounded  drugs that could be adopted by states. Matter for Congressional Consideration

To help ensure appropriate oversight of the safety of products from the  entities that prepare and distribute compounded drugs that have a high  potential to adversely affect public health, Congress should consider  clarifying FDA’s authority to regulate entities that compound drugs. Recommendations for Executive Action

We recommend that the Secretary of Health and Human Services direct  the Commissioner of the FDA to  take steps to consistently collect reliable and timely information in  FDA’s existing databases on inspections and enforcement actions  associated with compounded drugs, and  clearly differentiate in FDA’s database, those manufacturers of FDA- approved drugs that FDA inspects for compliance with good  manufacturing practices from those entities compounding drugs that  are not FDA-approved and that FDA does not routinely inspect. HHS’s comments also support the Matter for Congressional  Consideration that Congress should consider clarifying FDA’s authority to  oversee entities that compound drugs.
Why GAO Did This Study

Drug compounding is the process by which a pharmacist combines, mixes, or alters ingredients to create a drug tailored to the medical needs of an individual. An outbreak of fungal meningitis in 2012 linked to contaminated compounded drugs has raised concerns about state and federal oversight of drug compounding. GAO was asked to update its 2003 testimony on drug compounding. Specifically, this report addresses (1) the status of FDA's authority to oversee drug compounding, and the gaps, if any, between state and federal authority; (2) how FDA has used its data and authority to oversee drug compounding; and (3) the actions taken or planned by states or national pharmacy organizations to improve oversight of drug compounding. GAO reviewed relevant statutes and guidance; reviewed FDA data; and interviewed officials from FDA, national pharmacy organizations, and four states with varied geography, population, and pharmacy regulations.

What GAO Recommends

To help ensure that the entities that compound drugs have appropriate oversight, Congress should consider clarifying FDAs authority to oversee drug compounding. In addition, FDA should ensure its databases collect reliable and timely data on inspections associated with compounded drugs, and differentiate drug compounders from manufacturers. HHS's comments support the need to clarify FDA's authority, and stated that the information in its inspection database could be improved and that it would consider whether it can differentiate compounding pharmacies from manufacturers.