Congressional Research Service Report Judith M. Glassgold Specialist in Health Policy June 3, 2013

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