Earlier this year I discussed changes that we saw in the extemporaneous compounding section of the APF25. A big one was the adjustment to the expiry dates section. The new amendment limited pharmacies to using an exact stability study only and took away the option of using your professional judgement and other reliable literature. From community pharmacies up to our big compounding-only guys, this has affected a multitude of their formulations, namely capsules which, in some cases, went from 6 months expiry to 28 days overnight. Since the change, a number of independent pharmacists appealed to the PSA regarding the limitations of this decision and have now seen results!
This week, the PSA has amended the section on expiry dates which now includes an update regarding capsules. The amended version now includes a statement that “The expiry date of compounded capsules or powders is 6 months or less from the date the medicine is compounded, provided the ingredients are stable in air and not hygroscopic or deliquescent.” This has given a bit of room for pharmacists to again use their professional judgement. This is not a simple green light to assign 6 months to all capsules, but it does give pharmacists the ability to make an informed decision based on evidence available to them. In previous versions, the pharmacist was able to make an informed decision on expiry dates using “reliable literature”. This included United States Pharmacopoeia and peer-reviewed journals which the pharmacist could then use to come to a decision using the nature of the drug and dosage form, the potential for microbial growth, final containers used, storage conditions and duration of treatment.
Using their knowledge and research, pharmacists should then assign an expiry which ensures the compounded products remain safe, suitable and efficacious throughout the patient’s treatment. When reviewing your evidence, be sure to consider the characteristics of the ingredients, containers and storage conditions. A couple of things to remember when assessing stability of capsules;
- Not all powders work well together – check your ingredients, including your excipients, don’t effect stability
- Capsules are designed to dissolve when wet and are often affected by humidity
- How long should the dispensed amount last? Are you actually giving the patient 6 months of treatment, if not, why is the expiry 6 months? Longer expiry ≠ Better product.
Hopefully this is a sign of things to come – training and trusting our pharmacists to make evidence-based decisions using ALL the information provided to them.