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 a global corporation with locations throughout North America, Australia, and Europe, that contributes to healthcare by leveraging strong partnerships that deliver customized solutions with an unwavering commitment to quality and innovation. Backed by 30+ years and a strong foundation in pharmaceutical compounding supply, Medisca is a business-to-business company that delivers comprehensive offerings by providing value, consistency, responsiveness, and loyalty. As Partners in Wellness, Medisca offers an unfailing devotion to improving lives across a multitude of needs and people. For more information visit www.medisca.com and follow us on LinkedIn, Facebook, Twitter, and YouTube.