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KNOW THE POTENTIAL RISKS OF COMPOUNDED PRODUCTS

The high quality standards in OMIDRIA meet your high standards

Unlike FDA-approved treatments, compounded intracameral medicines are not clinically evaluated for efficacy and safety1-3

The U.S. Department of Health and Human Services (HHS) and the FDA recommend the use of an FDA-approved product when it is commercially available over the use of a compounded drug1-3

Learn more about guidance from the FDA

Without evaluation and testing, compounded products pose the risk of quality issues as well as contamination1-6

Complications can be associated with the quality of the product, dose miscalculation, or incorrect preparation on the part of the pharmacy1-6

Compounded products carry potential liability risks for physicians and accreditation risks for surgical facilities3,7

REFERENCES: 1. US Department of Health and Human Services. Memorandum of understanding addressing certain distributions of compounded human drug products between the State Board of Pharmacy or other appropriate state agency and the Food and Drug Administration; availability. Fed Regist. 2020;85(208):68074 - 68082. 2. US Department of Health and Human Services, US Food and Drug Administration. Compounded drug products that are essentially copies of a commercially available drug product under section 503A of the federal Food, Drug, and Cosmetic Act: guidance for industry. Published January 2018. Accessed September 15, 2021. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/compounded-drug-products-are-essentially-copies-commercially-available-drug-product-under-section 3. Gudeman J, Jozwiakowski M, Chollet J, Randell M. Potential risks of pharmacy compounding. Drugs R D. 2013;13:1-8. 4. Osher RH, Ahmed IIK, Demopulos GA. OMS302 (phenylephrine and ketorolac injection) 1%/0.3% to maintain intraoperative pupil size and to prevent postoperative ocular pain in cataract surgery with intraocular lens replacement. Expert Rev Ophthalmol. 2015;10(2):91-103. 5. The Pew Charitable Trusts. U.S. illnesses and deaths associated with compounded or repackaged medications, 2001-19. Published March 2, 2020. Accessed September 16, 2021. https://www.pewtrusts.org/en/research-and-analysis/data-visualizations/2020/us-illnesses-and-deaths-associated-with-compounded-or-repackaged-medications-2001-19 6. Eyewire News. Ophthalmic societies call on FDA to keep moxifloxacin on bulk substance list. Published September 17, 2020. Accessed September 16, 2021. https://eyewire.news/articles/ophthalmic-societies-call-on-fda-to-keep-moxifloxacin-on-bulk-substance-list/ 7. Sellers S, Utian WH. Pharmacy compounding primer for physicians: prescriber beware. Drugs. 2012;72(16):2043-2050.

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