Unit of competency Outline

Date retreived
23/07/2026 6:00 AM AWST

Whilst all efforts are made to provide accurate and timely information from the relevant source/documentation, please be aware that the information supplied may not be the most current version. The accuracy of the detail has not been confirmed by the Department and therefore should not be relied upon without first confirming the contents.

Conduct small scale compounding and labelling of pharmaceutical products

Conduct small scale compounding and labelling of pharmaceutical products

Unit of competency
National Code
HLTPHA005
State Code
AUZ95
TGA Status
Replaced
DTWD Status
Replaced
Current Release Number
1.00
Current Release Date
06/08/2015
View on TGA
State Implementation and Classification
Approved Date
22/01/2016
Field of Education
060501 - Pharmacy
Original Release Date
22/01/2016
Nominal Hours
50
Description
This unit describes the skills and knowledge required to complete small scale compounding of non-sterile pharmaceutical products from predetermined formulae, including extemporaneous dispensing.This unit applies to pharmacy assistants and technicians working under the supervision of a pharmacist.The skills in this unit must be applied in accordance with Commonwealth and State/Territory legislation, Australian/New Zealand standards and industry codes of practice.
Notes
Elements and Performance Criteria
1. Source informationon formula
  • 1.1 Select appropriate formula and master batch sheet for product, based on correct interpretation of the medication order or prescription
  • 1.2 Confirm suitability of chosen master work sheet and availability of resources
  • 1.3 Obtain authority of pharmacist to proceed
2. Prepare for production process
  • 2.1 Comply with dress code, safety and personal hygiene procedures prior to entering the work area
  • 2.2 Clean work area and equipment correctly
  • 2.3 Confirm inventory levels of raw materials and disposable equipment
  • 2.4 Prepare a work sheet referenced from amaster work sheet
  • 2.5 Verify that batch/work sheets are clearly written in logical order with clear directions and contains all the required information
  • 2.6 Assign product batch number
  • 2.7 Generate the product labels referenced from the master label detailed on the master work sheet
  • 2.8 Check and note the number of labels generated
  • 2.9 Submit work sheet and labels to pharmacist for approval
  • 2.10 Check and set up compounding requirements and equipment
3. Obtain equipment and supplies
  • 3.1 Acquire materials listed on the work sheet according to stock levels and stock requisitioning procedures
  • 3.2 Check raw materials to ensure they have been released from quarantine for use by authorised persons
  • 3.3 Verify raw materials against batch work sheet and record raw material batch numbers and expiry dates
  • 3.4 Weigh or measure raw materials in designated area
  • 3.5 Obtain required authorisation or checks at designated points according to work sheet
4. Compound products
  • 4.1 Allocate approved raw materials to equipment according to batch work sheet
  • 4.2 Compound product according to method on work sheet
  • 4.3 Monitor and adjust compounding to comply with work sheet specifications
  • 4.4 Perform verification procedures, inspect finished product for deviations and report to authorised person
  • 4.5 Pack compounded product as specified on the work sheet, and following approval from an authorised person
  • 4.6 Label containers/units according to labelling specifications on the work sheet
  • 4.7 Obtain required authorisation or checks at designated points
5. Complete production process
  • 5.1 Reconcile number of labels printed with number used and report discrepancies to the pharmacist
  • 5.2 Place product in quarantinearea under appropriate storage conditions
  • 5.3 Clean machinery and manufacturing area and dispose of disposable equipment safely
  • 5.4 Complete all required documentation and forward to an authorised person
  • 5.5 Report all discrepancies to an authorised person
  • 5.6 Obtain final approval from the pharmacist before releasing packed medicines to storage areas
6. Participate in quality control
  • 6.1 Pack and label a retention sample and/or quality control sample if specified on the work sheet
  • 6.2 Submit product sample and relevant documentation to quality control, where specified
  • 6.3 Record and file product quality control assay results
7. Store and transport released product
  • 7.1 Store products according to work sheet documentation
  • 7.2 Obtain released product(s) from quarantine store
  • 7.3 Pack released product(s) into delivery containers which will maintain the required ambient conditions for the product
  • 7.4 Deliver product to destination
  • 7.5 Advise receipting area personnel of specific storage requirements
  • 7.6 Complete and file records and/or work sheets
No information
No information
Replaces
State Code National Code Title Type
WD259 HLTPH408A Conduct small scale compounding and labelling of pharmaceutical products Unit of competency
Replaced By
State Code National Code Title Type
OEI49 HLTPHA014 Conduct small-scale compounding and labelling of pharmaceutical products Unit of competency
State Code National Code Title Type
AWL9 HLT47115 Certificate IV in Hospital/Health Services Pharmacy Support Qualification