New Guidelines on Compounding of Medicines
Based on the News Updates on the Pharmacy Board of Australia’s website (http://www.pharmacyboard.gov.au/News/2015-03-02-media-release.aspx), The Pharmacy Board of Australia has released (on 2 March 2015) new guidelines and other tools for registered pharmacists who compound medicines.
These guidelines will apply to all pharmacists holding general, provisional or limited registration. It is aimed to provide guidance to pharmacists in relation to the compounding of medicines to ensure product quality, safety and efficacy (i.e. community compounding pharmacies and hospital pharmacies are included).
In the guidelines, pharmacists are reminded that the medicines they compound are not exempted from meeting the quality standard set out in the Therapeutic Goods Act 1989 (Cth). Failure to practice in accordance with these requirements may give rise to actions by one or more responsible authorities.
How will the new guidelines affect compounding pharmacies and how can ams Laboratories help with their new microbiological testing needs?
Non-sterile Pharmaceutical Products Testing
ams Laboratories performs non-sterile pharmaceutical products testing to meet the requirements of Therapeutic Goods Administration’s (TGA) guidelines. The TGA follows the Therapeutic Goods Order no. 77 (TGO 77) Microbiological Standards for Medicines when regulating non-sterile pharmaceutical products.
Sterile Products Testing
ams Laboratories provides a range of comprehensive Sterile Product Testing services. These tests include but are not limited to those shown below:
These guidelines will apply to all pharmacists holding general, provisional or limited registration. It is aimed to provide guidance to pharmacists in relation to the compounding of medicines to ensure product quality, safety and efficacy (i.e. community compounding pharmacies and hospital pharmacies are included).
In the guidelines, pharmacists are reminded that the medicines they compound are not exempted from meeting the quality standard set out in the Therapeutic Goods Act 1989 (Cth). Failure to practice in accordance with these requirements may give rise to actions by one or more responsible authorities.
How will the new guidelines affect compounding pharmacies and how can ams Laboratories help with their new microbiological testing needs?
Non-sterile Pharmaceutical Products Testing
ams Laboratories performs non-sterile pharmaceutical products testing to meet the requirements of Therapeutic Goods Administration’s (TGA) guidelines. The TGA follows the Therapeutic Goods Order no. 77 (TGO 77) Microbiological Standards for Medicines when regulating non-sterile pharmaceutical products.
Sterile Products Testing
ams Laboratories provides a range of comprehensive Sterile Product Testing services. These tests include but are not limited to those shown below:
- Sterility Test
- Endotoxin Test
- Sub-visible Particle Count
- Mycoplasma Detection
- Extraneous Viral Agents Test
- Seal Integrity Test
- Media Fill Studies
- Cytotoxicity Studies
Facility and working environment
- Facility Qualification
- Environmental Monitoring
- Isolate Identifications
- Disinfectant Qualification Studies
Compounded medicines will have to meet the quality standards set out in the Therapeutic Goods Act 1989 (Cth). The required specifications for compounded medicines include relevant standards of the British Pharmacopoeia (BP), European Pharmacopoeia (EP) or United States Pharmacopeia (USP), including relevant standards on microbiological quality of non-sterile pharmaceutical preparations. It is the pharmacist’s responsibility to ensure that compounded medicines comply with the relevant standards.
The facility and working environment and equipment specifications detailed in the relevant practice standards and guidelines listed in the new guidelines must be met for the type of compounding carried out.
To find out how we will be able to assist you, feel free to contact us.
The facility and working environment and equipment specifications detailed in the relevant practice standards and guidelines listed in the new guidelines must be met for the type of compounding carried out.
To find out how we will be able to assist you, feel free to contact us.