Medical Necessity

All formulations manufactured and dispensed from an FDA-Registered Outsourcing Facility must be accompanied with a clinical need. Cost by itself IS NOT considered a clinical need to prescribe or purchase a compound formulation. By agreeing to these terms, you are confirming the purchase of the formulation(s) include one or more of the following clincal need(s):

 

Pred-Moxi-Nepaf (prednisolone acetate 1%, moxifloxacin 0.5% and nepafenac 0.1%)

  • No commercial formulation available.
  • Patient has physical and/or mental difficulty with multiple drop regimen.
  • Patients cannot tolerate preservatives. Need to reduce exposure to preservatives by 67% or more.
  • Reduce the risk of endophthalmitis
  • Protect against inflammation. 
  • Protect against cystoid macular edema.

Pred-Moxi-Brom (prednisolone acetate 1%, moxifloxacin 0.5% and bromfenac 0.075%)

  • No commercial formulation available.
  • Patients have trouble administering multiple drops.
  • Patients cannot tolerate preservatives. Need to reduce exposure to preservatives by 67% or more.
  • Reduce the risk of endophthalmitis
  • Protect against inflammation. 
  • Protect against cystoid macular edema.

Pred-Brom (prednisolone acetate 1% and bromfenac 0.075%)*

  • Patients have trouble administering multiple drops.
  • Need to reduce exposure to preservatives.
  • Reduce the risk of endophthalmitis.
  • Protect against inflammation. 
  • Protect against cystoid macular edema.
  • No commercial formulation available.

Pred-Acetate 1% PF

  • Need to reduce patients exposure to preservatives.
  • No commercial preservative free drops available.
  • Protect against inflammation.
  • Protect against cystoid macular edema.

Tri-Moxi (triamcinolone acetonide 15mg and moxifloxacin hydrochloride 1mg/mL)

  • No commercial injectable formulation available.
  • Reduce the risk of endophthalmitis. 
  • Protect against inflammation.
  • Protect against cystoid macular edema.
  • Patient has physical or mental difficulty with administering topical drop regimen.
  • Minimizing the number of times entering the eye to deliver medication to one administration.

Dex-Moxi® (dexamethasone 1mg and moxifloxacin 5mg/mL)

  • No commercial injectable formulation available.
  • Reduce the risk of endophthalmitis. 
  • Protect against inflammation.
  • Protect against cystoid macular edema.
  • Patient has physical or mental difficulty with administering topical drop regimen.
  • Minimizing the number of times entering the eye to deliver medication to one administration.

Dex-Moxi-Ketor® (dexamethasone 1mg, moxifloxacin 0.5mg and ketorolac 0.4mg/mL)

  • No commercial injectable formulation available.
  • Reduce the risk of endophthalmitis. 
  • Protect against inflammation.
  • Protect against cystoid macular edema.
  • Patient has physical or mental difficulty with administering topical drop regimen.
  • Minimizing the number of times entering the eye to deliver medication to one administration.

Moxifloxacin injectable 0.5% (moxifloxacin 5mg/mL)

  • No commercial injectable formulation available.
  • Reduce the risk of endophthalmitis. 
  • Patient has physical or mental difficulty with administering topical drop regimen.

Moxifloxacin injectable 0.1% (moxifloxacin 1mg/mL)

  • No commercial injectable formulation available.
  • Reduce the risk of endophthalmitis. 
  • Patient has physical or mental difficulty with administering topical drop regimen.

Phenyl-Lido injectable (phenylephrine 1.5% and lidocaine 1%)

  • Combined drops necessary for appropriate dilation.
  • Single injection into eye vs. multiple injections.
  • Needed as a combined drop for intra-operative floppy iris syndrome (IFIS)
  • No combined commercially available product.
  • Minimizing the number of times entering the eye to deliver medication to one administration.

Epi-Lido (Lidocaine 0.75% and epinephrine in BSS 0.025%)

  • Combined drops necessary for appropriate dilation.
  • Single injection into eye vs. multiple injections.
  • Needed as a combined drop for intra-operative floppy iris syndrome (IFIS)
  • No combined commercially available product.
  • Minimizing the number of times entering the eye to deliver medication to one administration.

Klarity-C Drops® Cyclosporine 0.1% (Cyclosporine 0.1% ophthalmic emulsion)

  • Need higher strength in emulsion to improve efficacy and minimize irritation.
  • No commercially available product at this strength.
  • Need to reduce patient exposure to preservatives.

Mydriatic 2 (Tropicamide 1% and phenylephrine 2.5%)

  • Combined drops necessary for appropriate dilation.
  • No combined commercially available product.

Mydriatic 4 (Tropicamide 1%, proparacaine 0.5%, phenylephrine 2.5% and ketorolac 0.5%)

  • Combined drops necessary for appropriate dilation.
  • No combined commercially available product.