United States Government Publishing Office publisher pbl distributor dst United States Government Accountability Office author aut Government Organization text government publication eng GAOREPORTS Legislative Agency Publications gao legislative 2010-08-12 U.S. Government Printing Office 2003-10-23 monographic deposited born digital 17 p. GA 1.13:GAO-04-195T https://www.govinfo.gov/app/details/GAOREPORTS-GAO-04-195T P0b002ee180375049 f:d04195t DGPO 2010-08-12 2011-03-28 GAOREPORTS-GAO-04-195T machine generated eng fdlp REPORT GAOREPORTS-GAO-04-195T GAO-04-195T Food and drug law Quality assurance Quality control Safety regulation Pharmaceutical industry Drugs Safety standards Federal/state relations Missouri North Carolina Vermont Wyoming Testimony A08757 Drug compounding--the process of mixing, combining, or altering ingredients--is an important part of the practice of pharmacy because there is a need for medications tailored to individual patient needs. Several recent compounding cases that resulted in serious illness and deaths have raised concern about oversight to ensure the safety and quality of compounded drugs. These concerns have raised questions about what states--which regulate the practice of pharmacy--and the Food and Drug Administration (FDA) are doing to oversee drug compounding. GAO was asked to examine (1) the actions taken or proposed by states and national pharmacy organizations that may affect state oversight of drug compounding, and (2) federal authority and enforcement power regarding compounded drugs. This testimony is based on discussions with the National Association of Boards of Pharmacy (NABP) and a GAO review of four states: Missouri, North Carolina, Vermont, and Wyoming. GAO also interviewed and reviewed documents from pharmacist organizations, FDA, and others involved in the practice of pharmacy or drug compounding. https://www.govinfo.gov/content/pkg/GAOREPORTS-GAO-04-195T/html/GAOREPORTS-GAO-04-195T.htm https://www.govinfo.gov/content/pkg/GAOREPORTS-GAO-04-195T/pdf/GAOREPORTS-GAO-04-195T.pdf GAO-04-195T https://www.govinfo.gov/app/details/GAOREPORTS-GAO-04-195T Testimony GAO-04-195T; Prescription Drugs: State and Federal Oversight of Drug Compounding by Pharmacies; Food and drug law Quality assurance Quality control Safety regulation Pharmaceutical industry Drugs Safety standards Federal/state relations Missouri North Carolina Vermont Wyoming Volume 111 Page 2296 111 Stat. 2296 Public Law 105-115