Table VII.2: The Number of States Reporting Hearing Concerns Regarding FDA’s Implementation of Section 503A of the Federal Food, Drug, and Cosmetic Act, as of January 1, 2016 | ||||
---|---|---|---|---|
Number of states (%) | ||||
Area of concern | Yes | No | Don't know | No response |
Availability of compounded drugs for office use | 30 (60)a | 14 (28) | 4 (8) | 2 (4) |
Access to certain compounded drugs for patients with a medical need for these drugs | 23 (46)b | 19 (38) | 6 (12) | 2 (4) |
Issues related to the practice of compounding performed by physicians or other nonpharmacist health care practitioners | 21 (42)c | 19 (38) | 8 (16) | 2 (4) |
Source: GAO survey of state pharmacy regulatory bodies, survey question 47. | 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. |
aStates reported that concerns about the availability of compounded drugs for office use came from a variety of individuals and entities, including patients, physicians, pharmacists, and hospitals. |
bMost of the states that commented about access to compounded drugs for patients with a medical need reported that these concerns came from physicians and pharmacists. |
cStates reported that concerns about compounding by physicians and other nonpharmacist health care practitioners came from pharmacists, physicians, members of the public, and other entities, such as the state nursing commission in one state and the state medical board in another state. |