This is a 35 page report. Below is the table of content. The report can be viewed here
Contents
Introduction ...................................................................................................................................... 1
Background ...................................................................................................................................... 2
Health Concerns Involving CDs ................................................................................................ 3
Background ......................................................................................................................... 3
Adverse Event Reporting .................................................................................................... 5
Traditional Compounding .......................................................................................................... 8
Non-Traditional Compounding ............................................................................................... 10
Existing Regulatory Oversight ....................................................................................................... 11
Federal Authorities .................................................................................................................. 11
State Authorities ...................................................................................................................... 12
Industry Self-Regulation ......................................................................................................... 13
Growth of Non-Traditional Compounding .................................................................................... 14
Hospital Compounding and Outsourcing ................................................................................ 15
The Role of Drug Shortages in CD Demand ........................................................................... 16
Shortages of Generic Injectable Drugs .............................................................................. 16
Shortages of CDs ............................................................................................................... 18
Other Sources of Demand for Compounded Products ............................................................ 19
Pharmacist Business Development ................................................................................... 19
Provider Demand............................................................................................................... 20
Issues for Consideration................................................................................................................. 20
Adverse Event Reporting and Labeling ................................................................................... 21
The Federal Role in Oversight................................................................................................. 22