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Why was USP(797) Updated?

All pharmacopeial standards are regularly updated – some more regularly than others.

USP 797 has been in place for many decades for US-based Compounding Pharmacists, however, it is always self-assessed.

In 2012, New England Compounding Center – based in Massachusetts, USA – engaged in bulk compounding of a sterile suspension. Owing to widespread negligence and poor practice, more than 800 people contracted fungal meningitis, 64 of whom died.

Things had to change in order to prevent such a crisis from reoccurring.

This event already had world-wide pharmacy regulators – particularly in those markets where there is an already-established compounding industry – seeking public consultations and preparing investigatory papers looking into the options for further regulation of the Sterile Compounding Pharmacy Industry.

Since that time, Australian regulators have been scrambling to make their changes, with decisions being delayed and deferred for many months.

That was until February, 2018.

In February, while the industry expected yet another deferral, the Pharmacy Board of Australia (PBA) held their ground, and stated that all pharmacies producing compounded sterile products had to do so according to USP 797 or TGA Therapeutic Goods Act.

All of a sudden, Sterile Compounding Pharmacies:

  • Had to separate areas used for sterile and non-sterile compounding.
  • Need a Master formulation record, a compounding record, Standard Operating Procedures (SOP’s) and Material Safety Data Sheets (MSDS) File.
  • Are required to verify compounding accuracy via analytical testing.
  • Are required to verify sterility via microbial testing.
  • Are required to maintain and test the quality of their airflow.
  • Are required to train and routinely perform competency evaluations of staff.
  • Are required to perform stability testing on their formulas to assign Beyond Use Dates
  • Are required to routinely assess the packaging and freight of sterile preparations in order to maintain integrity of the product.
  • Must put into place a formal QA program to meet all of these and other conditions of operating correctly under USP 797.

How does the Pharmacy Board ensure that adherence to these conditions are independently verified?

They don’t.

  Under current regulations, pharmacies only need to self-assess their adherence to the rules.

Read HERE to find out why independent audit of adherence to USP(797) is so important.