From the American Academy of Ophthalmology

Congress is considering the need for tighter regulations on compounding pharmacies in conjunction with its investigation into the cause of the deadly fungal meningitis outbreak linked to the New England Compounding Center. Hearings last week by the U.S. House Committee on Energy and Commerce and the U.S. Senate Committee on Health, Education, Labor and Pensions, focused on actions by federal and state regulators and their oversight of compounding pharmacies. Fifteen states are implementing new regulations or stepping up enforcement of existing regulations on compounding pharmacies, including: Colorado, Georgia, Hawaii, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, New Mexico, New York, Ohio, Pennsylvania, Rhode Island and Tennessee. The states require an individual patient prescription for every compounded medication order. This limits an ophthalmologist’s ability to purchase bulk quantities of commonly used compounded ophthalmic drugs, including Avastin, intravitreal antibiotics and Betadine 5 percent.

The Academy is working with the American Society of Retina Specialists to keep the focus on improved patient safety, rather than distribution regulations that have the potential to limit drug availability. The ophthalmology groups assert that the need is for tighter regulations to ensure sterile conditions in compounding pharmacies.

For more information, contact Catherine G. Cohen, Academy vice president for governmental affairs, at cgcohen@aaodc.org or 202.737.6662