Over the last several months, MEDISCA Australia along with other industry leaders have been actively putting forward to the Australian Pharmaceutical Formulary & Handbook (APF), scientific rationale for longer expiry dates for compounded preparations. Medisca is now pleased to see the efforts of the compounding community come to fruition.
In January 2021, the APF published revised standards where, in the absence of an APF formulary or stability study, compounding pharmacies are restricted to applying up to 28-day expiry dates on all compounded dosage forms, including capsules and powders that have historically received up to 6 months dating. A 28-day expiry date restriction on capsules and powders has the potential to drastically impact compounding pharmacy workflow efficiencies, cost to prepare medications, and most importantly, patient access to much needed personalised medications.
“Upon receiving the news of the change in capsule dating, we quickly ramped up efforts alongside fellow industry leaders and compounding pharmacies to express our concerns to the APF. Not only did the APF listen to us, they acted for us and, ultimately, the patients compounding pharmacy serves,” said Andrew Harb, General Manager for Medisca Australia and Emerging Markets. “The efforts of the last several months demonstrated what it means to be a community – and I and the Medisca team could not be prouder to be a part of it.”
After months of discussions and deliberations, effective as of 10 August 2021, the APF has revised the expiry date of compounded capsules and powders from up to 28 days to up to 6 months. This dating is applicable to capsules and powders that contain ingredients that are stable in air and not hygroscopic or deliquescent. This expiry date guidance is also applicable in the absence of an APF formula or stability study.
For additional support on how to assign an expiry date and access to a databank of stability-indicating studies for extended expiry dating visit: www.medisca.com.au/expiry-date
MEDISCA is the leader in providing turnkey solutions to the pharmaceutical compounding industry and allied health care professionals worldwide. Through its global partners, LP3 Network and MEDISCA Network, MEDISCA is committed to being a complete resource for prescribers, pharmacists and pharmacy technicians engaged in personalized medicine by offering educational trainings, products, and support. Founded in 1989, the company has locations in Canada, the United States and Australia, optimizing its service to the international market. For more information about MEDISCA, please visit www.medisca.com and follow us on Twitter at @medisca.