Serious ocular infections resulting from the use of contaminated ophthalmic solutions are becoming increasingly prevalent. This situation may be directly attributed to the astounding fact that in the United States, until recently,1 no section of the Federal Food, Drug, and Cosmetic Act was interpreted as requiring manufacturers and dispensers of eye medicaments to prepare sterile solutions fortified with adequate preservatives.2 Recognition of this health and economic hazard is growing. At present the Federal Food and Drug Administration, the United States Pharmacopeia, the National Formulary, and the American Medical Association are all working toward a common goal: proper safeguards for ophthalmic drugs. The A. M. A. Council on Pharmacy and Chemistry has required sterility of commercially prepared ophthalmic solutions as a prerequisite for Council approval for some time. Objections have been raised in regard to the feasibility of certain aspects of legislation concerning this problem; these objections served to
Theodore FH, Feinstein RR. PREPARATION AND MAINTENANCE OF STERILE OPHTHALMIC SOLUTIONS. JAMA. 1953;152(17):1631–1633. doi:10.1001/jama.1953.63690170013013
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