ASRS, DQSA Coalition Urge FDA to Close Critical Gaps in Patient Access to Compounded Drugs
On Monday, the ASRS met with Julie Dohm, J.D., Ph.D., Senior Science Advisor for Compounding, at the Federal Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CEDR), along with a coalition of organizations representing patients, physicians, pharmacists, and other healthcare providers united in a mission to preserve patient safety and access to compounded medications.
ASRS provided FDA a list of compounded medications not available from compounding pharmacies registered under Section 503B and explained how the FDA requirement for a patient specific prescription prior to obtaining these medications from 503A pharmacies leaves retina specialists without sufficient stock of important antibiotics, including those administered in emergencies. We pointed out the irony that despite enactment of the Drug Quality and Security Act (DQSA) five years ago, which aimed to improve the safety and availability of compounded drugs, retina specialists face increased difficulty obtaining ophthalmic medications and patients are unable to receive the prompt emergency care for fungal eye infections that they received before the DQSA.
ASRS urged the FDA to allow physicians to administer critically necessary compounded drugs to patients when those drugs are not available from 503B facilities. ASRS, the American Society of Cataract and Refractive Surgeons (ASCRS), and the American Academy of Ophthalmology (AAO) will follow up with a letter to the agency providing a joint list of compounded drugs ophthalmologists cannot obtain from 503B facilities and request an exemption to the prescription requirement.
Please help us provide the FDA with a comprehensive list by sending information on compounded drugs you are unable to obtain from a 503B pharmacy to
members@asrs.org
. Please include concentration, dosage, route of administration and indications for each drug.