Recently the Pharmaceutical Society of Australia (PSA) has changed the expiry date for compounded capsules from 180 days to 30 days in the newly released APF 25. For the last 25+ years that we have been compounding it has always been 180 days and now has suddenly reduced to 30 days with what seems to be little justification for the change. The 180 day expiry was in line with USP 795 in the USA which was developed by a panel of experts along with input from those in the industry with experience and expertise which respectfully is a process that does not seem to occur with PSA in Australia.
What scientific basis was used to establish this new expiry date? When a API with an expiry date of several years is mixed with an inert filler how does this drastically reduce its expiry date to 30 days? How is the chemical stability of the API so significantly compromised by an inert filler? The reason inert fillers are used is because they are inert and thus do not interact with the API.
The consequences of these new changes appear to not have been fully considered by those who made the decision or they simply do not care? It is common practice to compound up to a three month supply of capsules prescribed by the doctor for their patients on ongoing treatment. By reducing supply to 30 days will significantly increase the cost per dose of the medication to the patient as any discount offered when purchasing larger quantities can no longer be offered as labor costs savings due to making larger batches will be lost. In addition for those patients who have their medication posted to them will now have to pay monthly postage fees instead of quarterly which will increase shipping costs.
All the scripts with a quantity of 100 capsules will need to be sent back to the doctor to amend the script or have a new script supplied which means delays for the patient when re-ordering not to mention the extra expenses and delays. This inconveniences the doctor, the patient and the pharmacist for no good justifiable reason. The compounding pharmacist is the one on the receiving end of all of the complaints and abuse as a result of these changes which is outside of our control.
We cannot help but being cynical about the motive behind this decision. The authorities seem to have taken an aggressive attitude against compounders lately and such a decision by PSA to further restrict the practice of compounding seems to be aligned with their ongoing agenda.
If these changes effect you we suggest you write a letter of complaint to the PSA and express your concern otherwise nothing will change.
Their contact email address is: