№ files_lp_4_process_2_91823
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Guidance document detailing the legal authorities, storage, record-keeping, and compliance requirements for pharmacists under the Medicines and Poisons Regulations 2016.
Year:
2016
Region:
Australia / Western Australia
Subject:
Pharmacy practice, Medicines regulation
Document type:
Regulatory guidance
Institution:
Department of Health, Western Australia
Author:
Medicines and Poisons Regulation Branch
Target audience:
Registered pharmacists
Scope of authority:
Purchase, possess, administer, supply, dispense, prescribe medicines
Storage requirements:
Locked storage for S4 and purpose-built safes for S8 medicines
Record-keeping:
Clinical and transaction records retention (S4 – 2 years, S8 – 5 years)
Compliance monitoring:
Routine audits and regulatory enforcement
Contact information:
[email protected], (08) 9222 6883
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2026
Region / city:
Victoria, Australia
Subject:
Pharmaceutical regulations
Document type:
Legislative guideline
Institution:
Medicines and Poisons Regulation
Author:
Medicines and Poisons Regulation
Target audience:
Pharmacists
Period of validity:
Ongoing
Approval date:
2017
Date of changes:
None specified
Year:
2025-2026
Region / city:
Australia
Subject:
Fines and penalties related to the administration of the Drugs, Poisons and Controlled Substances Act 1981
Document type:
Official publication
Organ / institution:
Minister for Health
Author:
Not specified
Target audience:
General public
Period of validity:
2025-2026
Approval date:
Not specified
Amendment date:
Not specified
Year:
2021
Region / City:
Victoria, Australia
Theme:
Medicine regulation, poisons schedules
Document type:
Official regulatory guidance
Organization / Institution:
Medicines and Poisons Regulation
Author:
Medicines and Poisons Regulation
Target audience:
Health practitioners, pharmacists, medical professionals
Period of validity:
Indefinite
Date of approval:
2017
Date of changes:
Not specified
Year:
2023
Region:
Victoria, Australia
Subject:
Regulation of drugs, poisons, and controlled substances
Document type:
Legal code
Legislative basis:
Drugs, Poisons and Controlled Substances Act 1981, Sections 12 and 12E
Author:
Mary-Anne Thomas, Minister for Health
Date of publication:
23 January 2023
Effective date:
1 February 2023
Website:
https://www.health.vic.gov.au/drugs-and-poisons/poisons-code
Jurisdiction:
Australian Capital Territory
Instrument number:
NI2021-161
Type of instrument:
Notifiable instrument
Legislation:
Medicines, Poisons and Therapeutic Goods Regulation 2008
Relevant Act:
Medicines, Poisons and Therapeutic Goods Act 2008
Made under:
Section 575 (Controlled medicines prescribing standards)
Date made:
31 March 2021
Commencement:
Day after notification day
Revokes:
Medicines, Poisons and Therapeutic Goods (Category Approval) Determination 2021 (No 1) – NI2021-39
Issuing authority:
Chief Health Officer
Name of signatory:
Dr Kerryn Coleman
Administering body:
Health Protection Service
Subject matter:
Prescribing of controlled medicines
Geographical scope:
Australian Capital Territory
Contact:
[email protected]
Note:
; 5124 9700
Year:
2021
Region / City:
Australian Capital Territory
Topic:
Medicines, poisons, therapeutic goods regulation
Document Type:
Regulation
Authority / Institution:
Australian Government
Author:
Australian Capital Territory Government
Target Audience:
Health professionals, regulators, and relevant stakeholders
Period of Effect:
Ongoing
Approval Date:
2021
Amendment Date:
N/A
Year:
2018
Region / City:
Australian Capital Territory
Topic:
Controlled Medicines Prescribing Standards
Document Type:
Regulatory Instrument
Authority / Organization:
Chief Health Officer
Author:
Dr Paul Kelly
Target Audience:
Prescribers of controlled medicines
Period of validity:
Ongoing
Approval Date:
26 September 2018
Date of Changes:
N/A
Year:
2020
Region / City:
Australian Capital Territory
Topic:
Health Regulation
Document Type:
Amendment Regulation
Authority:
Australian Government
Author:
Australian Government
Target Audience:
Medical Radiation Practitioners, Healthcare Professionals
Period of Effect:
From the day after notification
Approval Date:
Not specified
Amendment Date:
2020
Changes:
Amendment to the Medicines, Poisons and Therapeutic Goods Regulation 2008
Description:
The document outlines the amendment to the Medicines, Poisons and Therapeutic Goods Regulation 2008, authorising medical radiation practitioners to deal with scheduled medicines within their professional scope of practice.
Year:
2025
Region / City:
Australian Capital Territory
Topic:
Medicines and Poisons Regulation
Document Type:
Legislation
Authority:
Australian Government
Author:
Australian Capital Territory Government
Target Audience:
Health professionals, regulatory authorities, medical practitioners
Effective Period:
From 2025 onwards
Approval Date:
2025
Amendment Date:
2025
Contextual Description:
Legislative text outlining amendments to the Medicines, Poisons and Therapeutic Goods Regulation 2008 in the Australian Capital Territory, specifically regarding controlled medicines and emergency medical supplies.
Year:
1964
Region / city:
Western Australia
Theme:
Pharmacy regulations, poisons management
Document type:
Application form
Authority / institution:
Department of Health, Western Australia
Author:
Pharmaceutical Services Branch
Target audience:
Pharmacy licence applicants
Effective period:
Ongoing
Approval date:
Not specified
Amendment date:
Not specified
Year:
2014
Region / City:
Australia
Topic:
Medicines and Poisons Regulations
Document Type:
Application Form
Organization / Institution:
Department of Health
Author:
Unknown
Target Audience:
Individuals and entities applying for a Schedule 2 Retail Licence
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2016
Region / City:
Western Australia, AU
Topic:
Health / Hospital practice / Medication management
Document Type:
Regulatory guidance / Professional practice document
Institution:
Department of Health, Western Australia
Target Audience:
Anaesthetic technicians, hospital staff
Scope of Practice:
Administration, possession, and storage of S4 and S8 medicines under direction of anaesthetist
Record Keeping:
Clinical records retention for S4 (2 years) and S8 (5 years), monthly inventory for S8 medicines
Compliance:
Routine audit assessments and adherence to Medicines and Poisons Regulations 2016
Contact Information:
Medicines and Poisons Regulation Branch, [email protected]
Note:
, (08) 9222 6883
Jurisdiction:
Western Australia
Legislation:
Medicines and Poisons Regulations 2016
Regulatory Authority:
Department of Health
Professional Regulator:
Nursing and Midwifery Board of Australia
Subject:
Authority to obtain, possess, administer, supply and prescribe medicines
Applicable Professions:
Nurse Practitioner; Registered Nurse; Enrolled Nurse; Endorsed Midwife; Midwife
Medicine Schedules:
Schedule 4 (S4); Schedule 8 (S8)
Scope of Application:
Lawful professional practice within defined scope and conditions
Requirements:
Storage, recording, inventory control, and compliance assessment obligations
Record Retention Period:
Minimum 2 years for S4 medicines; minimum 5 years for S8 medicines
Compliance Measures:
Audit assessments and regulatory enforcement provisions
Contact Body:
Medicines and Poisons Regulation Branch
Year:
2024
Jurisdiction:
Australia
Subject:
Regulation of poisons and controlled substances
Document type:
Legal instrument
Issuing authority:
Department of Health and Aged Care
Author:
Sarah Syme, Assistant Secretary Regulatory Engagement Branch
Effective date:
27 September 2024
Amendments:
Not indicated
Scope:
Human and veterinary medicines, hazardous substances
Classification system:
Schedules 1–10, Appendices A–L
Target audience:
Healthcare professionals, pharmacists, regulatory bodies
Year:
2023
Country:
Australia
Topic:
Opioid dependence treatment
Document type:
Information overview
Program:
ODT Community Pharmacy Program
Administering body:
Pharmacy Programs Administrator
Related scheme:
Pharmaceutical Benefits Scheme
Legislative framework:
National Health (Highly specialised drugs program) Special Arrangement 2021
Target audience:
Community pharmacists and hospital pharmacists
Effective date:
1 July 2023
Funding period:
2023–24 to 2026–27
Medicines covered:
Methadone, buprenorphine, buprenorphine with naloxone
Regulatory classification:
Schedule 8 controlled drugs
Source type:
Government health program guidance
Year:
2022/2023
Region / City:
LaSE
Topic:
Trainee Pharmacist Education, Community Pharmacy
Document Type:
Workbook
Organization:
Health Education England (HEE)
Author:
Health Education England (HEE)
Target Audience:
Trainee Pharmacists
Period of Action:
Foundation Training Year 2022/2023
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2021
Region / city:
Victoria, Australia
Theme:
Pharmacist regulations
Document type:
Legislative guideline
Agency / institution:
Medicines and Poisons Regulation (MPR)
Author:
Medicines and Poisons Regulation (MPR)
Target audience:
Health practitioners, pharmacists
Period of validity:
Ongoing
Approval date:
2017
Date of amendments:
2021
Context:
This document provides guidelines for pharmacists regarding the dispensing, administration, and supply of Schedule 4 and 8 medicines in Victoria, Australia, as outlined in the Drugs Poisons and Controlled Substances Act 1981 and related regulations.
Year:
2026
Region / city:
Victoria, Australia
Subject:
Pharmaceutical regulations
Document type:
Legislative guideline
Institution:
Medicines and Poisons Regulation
Author:
Medicines and Poisons Regulation
Target audience:
Pharmacists
Period of validity:
Ongoing
Approval date:
2017
Date of changes:
None specified
Year:
2007
Region / City:
USA
Subject:
Pharmacy Management, Outpatient Care
Document Type:
User Manual
Organization / Institution:
Department of Veterans Affairs (VA)
Author:
Department of Veterans Affairs
Target Audience:
Pharmacists, Healthcare Providers
Period of Validity:
Ongoing Updates
Approval Date:
December 2007
Date of Last Revision:
June 2020
Note:
Context
Year:
2025
Region / City:
Powys
Topic:
Pharmacist responsibilities in transcribing and amending inpatient medication charts
Document Type:
Protocol
Organization:
Powys Teaching Health Board
Author:
Clinical Pharmacist
Target Audience:
Pharmacists employed by Powys Teaching Health Board
Period of Validity:
2025–2028
Approval Date:
14/02/2025
Review Date:
23/02/2028
Date of Changes:
February 2025
Version:
2
Approval Body:
Head of Community Services Pharmacy
Scope:
Powys Teaching Health Board pharmacists
Impact Assessment:
No impact
Training Requirements:
Medicines management team to provide training
Risk Assessment:
No risks identified
Context:
A protocol outlining the procedures for transcribing and amending inpatient medication charts by pharmacists at Powys Teaching Health Board.