UPDATE USP 797 2023
The update to USP 797 which took effect in NOVEMBER 2023 will significantly effect supply and add further costs to your sterile medications.
Significant Changes that effect supply include:
- New limits set on expiry dates which in most cases are shorter than before even if chemically stable for longer periods. With sterility and endoxtoxin testing we are only allowed to put an expiry date of 45 days in the fridge or 30 days at room temperature if not autoclaved. If the product is stable enough to be autoclaved then it can be increased to 60 days in the fridge and 45 days at room temperature. Without any endotoxin and sterility testing we are limited to 4 days in the fridge and 1 day at room temperature or if autoclaved limited to 28 days in the fridge and 14 days at room temperature.
- Endotoxin tests are now required for all injectable medications. In previous versions of USP 797 endotoxin testing was only required if batches exceeded 25 units but now are required even if only supplying a single unit. This will add significant costs as endotoxin tests cost $150 per test.
If you receive a sterile product with an expiry date that exceeds 4 days at room temperature, 10 days in the fridge or 45 days in the freezer then it requires a sterility test and endotoxin test which add significant costs to your medication.
Previously we could supply larger quantities up to 3 month supply to make it more cost effective but if we do so now it is considered an over supply by the authorities and we are in breach of regulations.
It appears many compounders are not complying with these new changes with very few testing as required and assigning longer used by dates than allowed.
OLD USP Guidelines
Since 1st Feb 2018 sterile compounding guidelines took effect in Australia. The guidelines, although a welcomed change to finally get some direction in regards to sterile compounding which were previously absent, and hopefully improve standards across the industry. However it did create problems with supplies by introducing significant delays and increased costs. The main reason for this is that Australian Compounders now follow USP 797 standards, which is a quality standard used in the US, however batching in anticipation of a sale is allowed in the US but not in Australia which makes certain aspects of it almost unworkable when applied here.
Australian Compounding Regulations and Guidelines forbid us to prepare products in anticipation of a sale so we can only compound your order once we receive a prescription for it. We cannot make a small batch to have available to you when you present your prescription.
Once compounded a sterile product can only be assigned an used by date of 24hrs at room temperature, 3 days in the fridge or 45 days in the freezer. This is not practical in many situations as the majority of patents need ongoing treatment so in order to extend the used by date beyond these limitations a sterility test is required which takes 14 days before it can be released for sale. A sterility test is required every time you order if you require a used by date beyond 24hrs. Sterility testing not only adds significant delay but also adds significant costs to the product as most third party testing facilities charge at least $300 per test. To reduce the cost per order it would be ideal to do a sterility test on a batch of the same product as they do in the USA otherwise if we add the $300 testing charge to each order its becomes prohibitively expensive. The only way to do this as the laws stand is to add further delays by waiting for several orders of the same product to accumulate before they are made and tested as a single batch as we cannot make a batch in anticipation of a sale.
If we were able to have the regulations changed to match those in many states in the USA we would be allowed to prepare a 14 day supply in advance. This would allow a single batch to be compounded every 14 days and tested which would eliminate any delays with supply and also allow small batches to be made and tested together thus reducing the cost per item and thus saving you money. A safe and sensible option. To date the Pharmacy Board does not allow this practice.
If your sterile injections have expiry date beyond the limits set out above and you receive them within a few days after ordering them then they have not been sterility tested. We hear from our patients this occurs too often by other compounders who either do not test or batch manufacture in anticipation of a sale, both of which are not allowed.
Hopefully one day common sense will fall upon our regulators and allow us to make small batches in anticipation of a sale to avoid delays in supply and help ease the cost of compounded medicines which means dealing with less complaints about delays that are out of our control.
