Ophthalmic preparations are sterile products that may contain one or more pharmaceutical ingredient (s) administered topically, or by subconjunctival or intraocular (e.g. intravitreal and intracameral) injection in the form of solution, suspension, or ointment. Ophthalmic formulations also require that the pH, buffer capacity, viscosity, and tonicity is carefully controlled. These may include anesthetics, antibiotics, antioxidants, antivirals, cataract therapies, corticosteroids, decongestants, miotics, lubricants, and macular degeneration and nutritional support formulas.
Strict adherence to aseptic technique and proper sterilization procedures are crucial in the preparation of ophthalmic products. All extemporaneous compounding of ophthalmic products must be prepared in the proper sterile environment, with adherence to USP <797> standards and performance of necessary sterility testing to ensure quality and safety of products.