Your Compounding Questions Answered
Q: There’s a shortage of 8.5% sodium bicarbonate; it is hindering preparation of liquid dose forms of proton pump inhibitors. I also cannot obtain diclofenac gel for my patients. Is compounding an alternative?
A:The current drug shortages have created inconvenience at the least and deadly situations at the worst. The shortages provide an excellent opportunity for compounding pharmacists to assist patient therapy in a very visible, critical way. They also provide an opportunity to review the role of extemporaneous compounding vs manufacturing in drug therapy.
Pharmacists should consult Code of Federal Regulations [21CFR] for current FDA rules about compounding and refer to Compliance Policy Guide 460.200, which is used by inspectors to determine whether to employ “enforcement discretion” during an inspection. (Note that state boards of pharmacy have Memoranda of Agreement with the FDA for inspection purposes.) CPG 460.200 provides excellent guidance in 9 points describing pharmacist actions that could lead to the FDA not using enforcement discretion. This means it would regard the pharmacist as manufacturer and subject to 21CFR§210 and §211, the stringent regulations for manufacturing facilities.
When a shortage exists or patient health needs are urgent (greater than time to delivery of commercially manufactured product), the CPG is clear: compound extemporaneously, referring to USP monographs <795> and <797> for excellence and elegance.
Sodium Bicarbonate 8.5%
This solution is sterile, which is not necessary for oral dosing. You could compound the solution extemporaneously using nonsterile Sodium Bicarbonate USP. An an alternative—presuming that commercially manufactured solutions or granules for suspension are unavailable, inadequate (eg, dose volume excessive for neonatal intensive care unit patient), or cannot be tolerated by the patient (eg, allergy to an ingredient)—high-pH vehicles, such as SyrSpend SF Alka (Fagron), can be obtained from compounding vehicle suppliers.
Several gel vehicles for extemporaneous compounding are available, as is the bulk active ingredient powder. Standard weighing and trituration techniques should produce an acceptable temporary substitute. Remember to reduce all powders to a fine, uniform consistency with a ceramic or Wedgwood mortar and pestle before levigating for elegance (if the final preparation is “gritty,” this step was skipped or could have been more thorough).
Mr. Erickson is director of professional affairs and director of professional services at Gallipot, a Fagron company.