Safety of compounded medications: Separating the myths from the facts

Occasionally we hear a story from overseas, usually the U.S., about a compounding pharmacy supplying unsafe and dangerous medicine to patients. The picture painted is one of a careless compounder (usually unshaven with a comically shifty look in his eyes)  brewing up concoctions of variable standards in an unhygienic and poorly controlled back room.

The situation at National Custom Compounding, and most reputable compounding pharmacies in Australia is vastly different. To begin, National Custom Compounding operates in line with a range of internationally recognised standards. We operate in highly specialised facilities, only use high quality ingredients from government-approved suppliers and we voluntarily conduct regular independent testing to ensure quality and safety remain consistently high.

Our Quality Assurance Plan is a long and exhausting read, outlining the extensive steps and procedures we follow each and every time we compound a medication for a client. We’ll spare you the drudgery of plodding through the mighty tome by giving you the highlight reel of our safety and quality control measures:

Specialised Facilities – Our purpose-built laboratories are equipped with powder containment hoods with HEPA filters and each room has its own air supply through individual air-conditioning units. This ensures medicines are not contaminated with other medicines being prepared in the area, or with things like dust and pollen from outside. All equipment is maintained and calibrated according to (very high) USP standards.

Cleaning – All technical equipment is cleaned and disinfected prior to, and after use, or to a pre-determined schedule recommended by the manufacturer. The filters are replaced every 6 months (or sooner if necessary) and the system is serviced and maintained every 3 months.

Testing for quality and consistency: We conduct independent laboratory testing of our compounds so we can be sure we’re producing medicine of the highest quality and purity. We also run stability tests which enable us to supply patients with accurate expiry dates and storage information.

High Grade Ingredients – The pharmaceutical ingredients we use in our products are of the highest standard available in Australia. We only use ingredients sourced from trustworthy and reputable compounding suppliers who have a long and respected track record. These suppliers include Bella-Corp, Medisca and PCCA.

Regulations –  We operate in line with QCPP (Quality Care Pharmacy Practice) which is an ISO AS 85000:2011 (internationally recognised standard). The program is administered by the Pharmacy Guild of Australia and audited bi-annually by Ernest Young. We are accredited with the Accreditation Commission for Health Care (ACHC) and we also comply with the standards set by USP 795, 797 and 800 (United States Pharmacopeia), the Pharmacy Board of Australia, PSA (Pharmaceutical Society of Australia) Compounding Guidelines, QCPP, complex compounding standards and QCPP operational guidelines.

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