LEADING OFF: O.D.s Discuss Choosing a Compounding Pharmacy

A compounding pharmacy provides corticosteroids, antibiotics, NSAIDs, autologous serum, cyclosporine, preservative-free glaucoma drops and atropine, among other ophthalmic drugs. While compounded drugs do not require FDA approval, each ingredient in their formulations is FDA-approved. In addition, compounders that are designated as 503B (or outsourcing facilities) are subject to current good manufacturing practice requirements and are inspected by the FDA and must meet other conditions, such as reporting adverse events to the FDA (see for more information).

Here, three optometrists offer criteria for choosing a compounding pharmacy.

  • Formulations/medication availability. “Ask the senior pharmacist whether your requested formulations can be made and whether they’ll be available through that specific pharmacy, so you can get it when you need it, and you don’t have to worry about possible contamination via delivery from another pharmacy,” explains Mitch Ibach, O.D.
  • Knowledgeable pharmacists. Consult with the senior pharmacist by inquiring about formulations and asking specific questions related to those formulations, explains Agustin Gonzalez, O.D.
  • Stringent protocols. “Strict adherence to manufacturing guidelines and clearly written procedures and protocols for each ophthalmic product are key for assuring patient safety,” explains Ahmad M. Fahmy, O.D. “Mathematical calculations must be reviewed by more than one pharmacist. This becomes more critical in ophthalmic preparations, which require more dilution. A decimal error may have serious consequences ...”
  • Patient ease of use. This includes insurance acceptance, reasonable pricing and medication delivery, says Dr. Gonzalez, whose compounding pharmacy can provide a spray bottle for the cycloplegic drugs prescribed for his pediatric patients.
  • Cleanliness. “Ask whether you can visit the compounding pharmacy and get a tour of the facility to corroborate everything you’ve been told, while also making sure the facility is clean and well organized,” says Dr. Fahmy.

Dr. Ibach adds to ask colleagues about their experiences. OM