WASHINGTON – As legislation to toughen oversight of compounding pharmaceuticals goes to the Senate floor for further debate, ophthalmologists are warning Congress of the unintended consequences of proposed provisions to the bill that require a named prescription for many uses of compounded drugs. While it is largely supportive of the higher safety standards bill S. 959 (the Pharmaceutical Compounding Quality and Accountability Act) would impose on compounding pharmacies and manufacturers, the American Academy of Ophthalmology is seeking exemptions from sections 503A(d)(4) for biological products and 503A(d)(3) for marketed drugs to allow for continued office use of safe, sterile compounded ophthalmic drugs without a specific patient designation. The Academy points out that there is no evidence to suggest that labeling a drug with a patient's name increases the safety of the repackaging process.
"Safe, sterile compounded medications have long been essential tools available to ophthalmologists for urgent treatment of eye diseases and conditions, benefitting millions of patients," said David W. Parke II, M.D., CEO of the American Academy of Ophthalmology. "The American Academy of Ophthalmology shares the concerns of Congress regarding the need to ensure that these products are compounded in the most sterile and safest manner possible in order to protect public health. As part of that process, however, the Academy urges the continued availability of these sight-saving medications without requiring patient-specific prescriptions, as time is often a critical element in preventing irreversible blindness. The Academy believes that compounding can be done in a safe and efficacious manner and support Congress in ensuring the safe availability of these medications for eye physicians and surgeons and the patients they serve."
About the American Academy of Ophthalmology
The American Academy of Ophthalmology, headquartered in San Francisco, is the world's largest association of eye physicians and surgeons — Eye M.D.s — with more than 32,000 members worldwide. Eye health care is provided by the three "O's" – ophthalmologists, optometrists, and opticians. It is the ophthalmologist, or Eye M.D., who has the education and training to treat it all: eye diseases, infections and injuries, and perform eye surgery. For more information, visit www.aao.org. The Academy's EyeSmart® program educates the public about the importance of eye health and empowers them to preserve healthy vision. EyeSmart provides the most trusted and medically accurate information about eye diseases, conditions and injuries. OjosSanos™ is the Spanish-language version of the program. Visit www.geteyesmart.org or www.ojossanos.org to learn more.