Table V.6: States Reporting Challenges in Communication or Other Interactions with FDA | |||||
---|---|---|---|---|---|
Significance of challenges in communication or other interactions with FDA reported by 15 states reporting challenges | |||||
Number of states | |||||
Types of communication or interactions with the Food and Drug Administration (FDA) that posed a challenge | Very challenging | Moderately challenging | Slightly challenging | Not at all challenging | Not applicable |
Getting FDA to respond to our requests for information | 7 | 7 | 1 | 0 | 0 |
Scheduling an individual meeting with FDA | 2 | 2 | 5 | 3 | 3 |
Getting FDA to provide responses to our questions related to oversight of drug compounding | 4 | 6 | 3 | 0 | 2 |
Getting notification of pharmacy inspections conducted by FDA in our state | 2 | 4 | 2 | 6 | 1 |
Getting complete information from FDA in Form 483 inspection observation reports on pharmacy inspections conducted by FDA in our state | 5 | 2 | 3 | 3 | 2 |
Getting FDA approval of our requests for joint inspections of licensed or registered pharmacies in our statea | 2 | 1 | 3 | 1 | 7 |
Getting notification from FDA when FDA determines a licensed or registered pharmacy in our state is acting contrary to section 503A of the Federal Food, Drug, and Cosmetic Act | 5 | 3 | 0 | 3 | 4 |
Getting notification from FDA of FDA enforcement actions taken against licensed or registered pharmacies in our state | 3 | 5 | 0 | 3 | 4 |
Source: GAO survey of state pharmacy regulatory bodies, survey question 33. | GAO-17-363SP |
Notes: 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. |
aOne of the 15 states did not indicate a significance of the challenge related to this type of communication or interaction with FDA. |