2003 United States General Accounting Office(GOA) Study: What Will the Next GOA Look Like?

Below is a portion of the statement of Janet Heinrich: Director, Health Care--Public Health Issues, about the GAO study conduct in 2003 regarding compounding pharmacies:

My testimony today is based in part on discussions with the National Association of Boards of Pharmacy (NABP), as well as a review we conducted of four states: Missouri, North Carolina, Vermont, and Wyoming. We selected these states based on their geographic location and variation in compounding regulations. Two of the states came to our attention as having taken unique steps with regard to oversight of compounded drugs, and the other two had each adopted new regulations on drug compounding. For each of the four states, we reviewed state statutes and regulations, interviewed officials from the state board of pharmacy, and reviewed relevant documents such as pharmacy inspection forms. In addition to examining state-level actions, we examined national industry efforts by interviewing officials from the American Pharmacists Association, the International Academy of Compounding Pharmacists, the American Society of Health-System Pharmacists, the National Association of Chain Drug Stores, and Professional Compounding Centers of America, which provides training to pharmacists and also sells bulk ingredients for drug compounding. We also contacted and obtained information from the United States Pharmacopeia (USP), which is a nonprofit agency that develops standards for pharmaceuticals. Finally, to examine federal authority and enforcement power, we reviewed federal statutes, FDA compliance policy guides, court decisions, and other relevant documents, and interviewed FDA officials and industry experts. We conducted our work from August 2003 to October 2003 in accordance with generally accepted government auditing standards. In summary, efforts at the state level and among pharmacy organizations at the national level have been taken or are under way to potentially strengthen state oversight of drug compounding. Actions among the four states we reviewed included adopting new statutes and regulations about compounding, such as requirements for facilities and equipment, and conducting more extensive testing of compounded drugs. For example, the pharmacy board in Missouri is starting a program of random testing of compounded drugs for safety, quality, and potency. At the national level, industry organizations are working on standards for compounded drugs that could be adopted by the states in their laws and regulations, thereby helping to ensure that pharmacies consistently produce safe, high-quality compounded drugs. While these actions may help improve oversight, the ability of states to oversee and ensure the quality and safety of compounded drugs may be affected by state- specific factors such as the resources available for inspections and enforcement. For example, in three of the four states we reviewed, pharmacy board officials indicated that resource limitations affected their ability to conduct routine inspections.

It will be interesting to see how the study recently ordered by Congress compares to this 2003 study.  To view the entire statement of  Heinrich click here.  To view the 2003 GOA study click here