Table V.2: The Number of States That Reported Obtaining Information Related to Drug Compounding from FDA’s Website, and How These States Rated the Helpfulness of This Information | |||||||
---|---|---|---|---|---|---|---|
Information on the Food and Drug Administration’s (FDA) website | Number of states that reported obtaining the information (%) | How states that reported obtaining the information rated the helpfulness of the information | |||||
Yes | No | No response | Very or moderately helpful | Slightly or not at all helpful | Don't know | No response | |
List of FDA-registered outsourcing facilities | 38 (76) | 10 (20) | 2 (4) | 32 | 3 | 0 | 3 |
Names of compounding pharmacies that were inspected by FDA | 33 (66) | 15 (30) | 2 (4) | 29 | 3 | 0 | 1 |
FDA Form 483 inspection observation reports to determine violations found during inspections of compounding pharmacies | 35 (70) | 13 (26) | 2 (4) | 25 | 7 | 1 | 2 |
FDA Form 483 inspection observation reports to determine violations found during inspections of FDA-registered outsourcing facilities | 33 (66) | 15 (30) | 2 (4) | 23 | 6 | 1 | 3 |
FDA warning letters issued to compounding pharmacies | 35 (70) | 13 (26) | 2 (4) | 27 | 6 | 1 | 1 |
FDA warning letters issued to FDA-registered outsourcing facilities | 32 (64) | 16 (32) | 2 (4) | 26 | 4 | 1 | 1 |
Information on recalls of compounded drugs | 36 (72) | 12 (24) | 2 (4) | 30 | 3 | 1 | 2 |
Source: GAO survey of state pharmacy regulatory bodies, survey question 29. | GAO-17-363SP |
Note: GAO surveyed the state pharmacy regulatory bodies in the 50 states, the District of Columbia, Guam, Puerto Rico, and the U.S. Virgin Islands, and all but 4 completed the survey. |