Have you ever opened up a box of prescription medicine and found that sheet of paper filled with tiny text? Did you throw it away? Consumer Medicine Information (CMI) leaflets are often seen as the “terms and conditions” you get with prescription medicines, full of technobabble. However, Consumer Medicine Information leaflets are filled with essential…
Counterfeit medicines — fake drugs and falsified medicines — are endangering lives. How large is the problem of substandard medications and falsified pharmaceuticals? What are the global statistics of counterfeit medications entering countries across the globe? And how many fake medicines are entering Australia’s pharmaceutical supply chains? Once primarily seen in low-income regions, the phenomenon…
Compounding pharmacies are in the FDA’s headlights again, with another pharmacy receiving a warning letter after an inspection, these inspections normal have findings relating to poor design of pharmacy clean rooms, i.e. CFR 211.42. Highlighted below within the text are the top 10 ranking 2014/15 FDA warning letters trends, full list here. The Warning Letter included:…
In its first major revision since the original release in 2000, ISO 14644-2 was updated and approved as an International Standard in October 2015 and published in December 2015. This blog aims to provide a brief overview of the changes, but more importantly, how the changes affect the current PIC/S Guide to GMP for Medicinal…
As you may have heard in recent reports from the US, the deaths of 7 people and the illness of a further 91 from fungal meningitis have been traced to a batch of steroidal spinal injections prepared by a New England compounding company. This article from The New York Times, discusses the incident, the background…
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