Compounded Drugs

Compounded Drugs

Date: May 23, 2013
Creator: Glassgold, Judith M.
Description: This report provides background information on compounded drugs (CDs) and nontraditional compounding pharmacies relevant to policy discussions. This includes an overview of the 2012 fungal meningitis outbreak; recent recalls of compounded drugs; definitions of traditional compounding and nontraditional compounding; information on the CDs produced and by whom; information on the demand for nontraditional compounding, including the role of shortages of sterile injectable drugs, hospital outsourcing, and patient and provider demand; and information on adverse events involving compounded drugs.
Contributing Partner: UNT Libraries Government Documents Department
The Food and Drug Administration Safety and Innovation Act (P.L. 112-144)

The Food and Drug Administration Safety and Innovation Act (P.L. 112-144)

Date: August 21, 2012
Creator: Thaul, Susan; Bagalman, Erin; Corby-Edwards, Amalia K.; Glassgold, Judith M.; Johnson, Judith A.; Lister, Sarah A. et al.
Description: This report provides a brief policy background narrative and an overview of provisions for each title of the Food and Drug Administration Safety and Innovation Act (FDASIA), P.L. 112-144. The legislation amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to expand the authority of the Food and Drug Administration (FDA) in performing its human drug, biological product, and medical device responsibilities.
Contributing Partner: UNT Libraries Government Documents Department