PCAB Accreditation

 – and why it is important for patients, prescribers, and the compounding industry.

 In keeping with our position as an industry leader in Australia, ACPHARM has recently become the first Australian sterile compounding pharmacy to undergo independent auditing for global PCAB (USP797) Accreditation.

Why is  this  such an important step? It shows that an Australian pharmacy is able to not only comply with USP(797) (click HERE to learn about USP 797), but that an Australian pharmacy is able to do so at the next level, under independent audit conditions – find out why that is important here.

Who Benefits from PCAB Accreditation?

Patients: who can be assured that their medicines are compounded correctly, per the regulatory requirements EVERY TIME with validated processes.

Prescribers: who can rest easy knowing that prescriptions the prescribe are dispensed from ACPHARM are of the highest quality standard, as set down in the USP regulations.

Clinical Trial Sponsors: receive a level of GMP previously not available from a compounding pharmacy and who know that products from ACPHARM are consistent and that results will be reproducible for scale up or further trials.

The accreditation process

 ACPHARM has worked tirelessly since November 2018 to make the deadline for our independent audit.  We have invested across the board – and found ourselves fortunate to be commencing from a position of already-high standards.

Our independent audit assessed all mandatory requirements:

  • Stability of products Sterility of products
  • Ongoing documentation of potency, stability and sterility
  • Environmental monitoring systems
  • Essential Product recall and adverse Event recording
  • Staff training

What does this mean for the compounding industry?

 We believe that, by demonstrating that it is possible for an Australian compounding pharmacy to pass a PCAB audit, ACPHARM has paved the way to make an independent audit the preferable option over self-assessment, industry-wide.  Patient safety and therapeutic outcomes are simply something about which there should be no compromise. All patient misadventure related to sterile compounded products in Australia have occurred under USP(797) with self-audit.

What does this mean for ACPHARM and our patients?

ACPHARM is leading the way to keep our patients safe, by allowing independent assessors to scrutinize and audit our practices – thus ensuring the maximum  patient safety and positive medical outcomes. ACPHARM patients and prescribers alike can rest easy knowing that their compounded products are as dispensed as prescribed.

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 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 stability and potency for ALL of 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.

What is USP 797?

Why was USP 797 Updated?

Why is this mandatory in Australia?

How is this Independently Verified?

What is PCAB?