Here’s the fact – In Australia it isn’t.
As it stands, USP(797) is entirely self-assessed – that is, the rules are handed to the pharmacist, and it is up to them to enforce them, with no referee to check their progress. Breaking the most basic rule of Good manufacturing Practice (GMP): You don’t check your own work as you are biased.
If you read the previous reports and information about some of the problems arising in compounding in the last few years (found here), it becomes clear that this is a major issue. There is something you should know:
These compounders were also under self-assessment.
Egregious oversights and cheating the system were responsible for some terrible events in pharmaceutical compounding history – systemic failures that were allowed to happen under self-assessed USP(797) lead to permanent injuries and even deaths.
At ACPHARM we believe that independent auditing of our systems is the best option. We believe that if you are doing everything right, then what could go wrong with another check? That is why we were the first pharmacy in Australia sign up for PCAB Accreditation – a completely independent review of our processes and production. Find out about PCAB here.
What does this mean for you?
If you place your order with ACPHARM, you can be sure that:
- We comply to the regulations – fully and completely.
- Our products are tested for sterility.
- Our facility is tested daily, weekly and monthly for sterility.
- The product is tested for potency.
- The formula is tested for stability.
When you have your prescription compounded at ACPHARM, you know that you are getting a medicine that is tailor-made for you and meets all the requirements for sterility and stability/potency in our injectable products.
When you send your prescriptions to ACPHARM, you have the comfort of knowing our processes are independently verified to comply with the standards enforced to keep you safe while meeting your proper therapeutic outcome.