ASCRS is preparing to participate in an FDA listening session next month, along with other medical and insurer organizations, to discuss the agency’s implementation of compounding provisions in the Drug Quality and Security Act (DQSA). ASCRS is providing comments on several aspects of the FDA’s implementation of the DQSA and its impact on the availability of compounded drug products for both our members and the patients they treat. Specifically, we will express the following:
- Opposition to the final guidance, “Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act,” as it restricts timely access to compounded medications for patients with an emergent condition for whom that may cause significant ocular damage. We will continue to urge the FDA to allow physicians to obtain limited quantities of compounded drugs to treat critical conditions without a patient-specific prescription from a 503A traditional compounder;
- Opposition to the FDA final guidance, “Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act,” which will severely impact patient care and safety, as it is not possible to compound many ophthalmic medications using bulk drug substances that are components of FDA-approved drugs. We, along with our colleagues in the ophthalmic community, are in the process of nominating bulk substances required for compounding ophthalmic drugs and urge the FDA to recognize the necessity of bulk drug substances for ophthalmic needs by approving our nominations for inclusion on the 503B bulks list; and
- Limit the use of guidance documents, often still in draft form, because of the uncertainty of whether the described policies will be enforced.
ASCRS will submit a written statement prior to the meeting. We will keep you updated.