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Help ASCRS Secure Access to Important Bulk Drug Substances Used for Compounding Ophthalmic Drugs in 503B Outsourcing Facilities by Completing Survey

The University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), in collaboration with the FDA, is conducting research to better understand how compounded drugs containing bulk drug substances are used in clinical practice. This research will be used by the FDA to determine the clinical need to compound with a bulk substance. If the FDA determines there is a clinical need for the substance, then it will place it on the 503B Bulks List, which is an approved list of drugs that outsourcing facilities may use to compound. If a bulk substance does not appear on the 503B Bulks List, then outsourcing facilities will no longer be able to compound using that substance.

UM has identified 18 substances that appear to have a clinical use in ophthalmology. Each survey has nine substances, with questions specific to the substances you select.  The table below outlines the substances that are included on each survey.

Survey 1

Survey 2

Alpha lipoic acid (ALA)

Amphotericin B

Dexamethasone acetate

Brilliant blue

Hydroxocobalamin

Cyclopentolate

Inositol

Cyclosporine A

Methylcobalamin/mecobalamin

Dapiprazole

Prednisolone acetate

Edetate disodium (EDTA)

Taurine

Phenylephrine

Triamcinolone acetate

Proparacaine

Vitamin A acetate

Testosterone

We strongly encourage your participation in this survey, as the FDA will use this data to determine what bulk substances outsourcing facilities may use to compound which will ultimately impact patient and physician access. All responses are anonymous.

To access the surveys please use the links below:

Survey 1: https://umaryland.az1.qualtrics.com/jfe/form/SV_d6AjCPz7GHurU1f

Survey 2: https://umaryland.az1.qualtrics.com/jfe/form/SV_2rR4beLFrOBjjbD

As a reminder, ASCRS has been working with the ophthalmic community to nominate bulks substances to the 503B Bulks List to ensure physicians have access to these important drugs. If you have any questions or comments, please reach out to Jillian Winans, regulatory affairs specialist, at jwinans@ascrs.org or 703-591-2220.

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