The world’s leading authority on safety in drug manufacturing, United States Pharmacopeia (USP), has announced that this year they will be updating their standards for the compounding of medications in traditional compounding pharmacies.
Specialist pharmacist Matthew Bellgrove from National Custom Compounding welcomed the news saying it would help to build trust in the sector.
“Anything that’s designed to improve the standard of safety and quality in compounded medicine, or any medicine for that matter, is welcome as far as I’m concerned,” Matthew said, “The more we can do to protect the safety of the public and build consumer-confidence in our industry, the better.”
USP is based in the United States, however it’s standards are recognised as best practice worldwide and many Australian compounding pharmacies, including National Custom Compounding, maintain and calibrate their equipment and organise their documentation, according to them.
The not-for-profit organisation says the review is part of its continual program of improvement and is designed to ensure their standards align with recent advances in scientific knowledge and clinical practice.
Matthew said standards like USP’s were fundamental in protecting public health and he agreed it was essential they kept pace with developments in the pharmacological industry.
“Traditional compounded medication is an essential piece of the healthcare model in this country however strict controls need to be in place to maintain a very high standard of safety,” Matthew said, “These standards help to prevent harm that could come from poor quality ingredients, variable strength of ingredients, chemical, microbial or physical contaminants and bacterial endotoxins.”
“Whatever we need to do to ensure our medication is completely safe and of high quality, we’ll do.”
“For example, to comply with current USP standards we’ve constructed three purpose-built rooms at our laboratory – one for hormones only, one for vitamins and nutritional supplements only and one for dermatological preparations only. This has been put in place to prevent potentially harmful cross-contamination of ingredients. Each room is also equipped with a powder containment hood with appropriately maintained HEPA filters and has its own air supply through individual air-conditioning units.
The standards currently being reviewed by USP include:
- Reducing the risk of contamination, infection or incorrect dosing of compounded sterile as well as nonsterile drugs. This includes facilities, equipment, components, documentation, quality controls and training.
- Guidelines for assigning beyond-use dates to nonsterile preparations.
- Sterile preparations and the roles and responsibilities of compounding personnel, training, facilities, environmental monitoring, storage and testing.
The new standards are expected to be released by USP in December 2019.
For more information on USP guidelines for the compounding of medication contact National Custom Compounding on 1300 731 755 or [email protected].