OCT 31, 2019
Help Deliver Important Compounding Data for Joint FDA-Academic Survey
The Academy is supporting a joint Food and Drug Administration-University of Maryland effort to better understand how compounded drugs containing certain bulk drug substances are used in clinical practice. The University of Maryland Center of Excellence in Regulatory Science and Innovation is surveying ophthalmologists on the FDA’s 503B Bulks List.
You can participate in this effort by providing information on one or more of the 19 bulk substances used clinically in ophthalmology practices and potentially help improve access to these drugs.
The Academy helped identify the substances for the survey as those likely to be used by specialists like you. The results from this survey will help provide policymakers with valuable information. By sharing your expertise through this survey, we can ensure these substances are placed on the 503B Bulks List and protect their utilization by outsourcing facilities for compounding ophthalmic drugs.
Each survey has nine substances, with questions specific to the substances for you opt to provide data. You are not required to complete the survey for each substance listed.
- Alpha lipoic acid (ALA)
- Dexamethasone acetate
- Prednisolone acetate
- Triamcinolone acetate
- Vitamin A acetate
- Amphotericin B
- Brilliant blue
- Cyclosporine A
- Edetate disodium (EDTA)
- Riboflavin-5’-phosphate sodium
Survey responses are anonymous. The University of Maryland will not collect contact information from respondents.
Contact the Academy with any questions at 202.737.6662 or email Scott Haber, the Academy’s manager for federal affairs and public health, at email@example.com.