Scheduled Substances
Management Procedure
(Poisons and Therapeutic Goods)
Version
TRIM file number
Short description
Relevant to
Approved by
Responsible officer
Responsible office
Date introduced
Date(s) modified
Next scheduled review date
Related University documents
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Key words
Scheduled Substances Procedure
Version 1.0 /Version date 12/2011
1.0
11/55869
Procedure for managing Scheduled Substances
(Poisons and Therapeutic Goods) safely in the
Faculty of Science.
All employees, researchers and students
Manager, University Laboratories
Faculty of Science
01, December, 2011
December, 2013
Waste Guidelines
Waste Procedure
Chemical Labelling Procedure
Chemical Storage Guidelines
S8 Checklist
Commonwealth:
Therapeutic Goods Act 1989
Poisons List
NSW legislation
OHS Act 2000 & Regulation 2001
Poisons and Therapeutic Goods Act 1966 &
Regulation 2008
Animal Research Act 1985
Stock medicines Act 1989
Pesticides Act 1999 & Regulation 2009
procedure, chemical, hazardous, scheduled, substance,
storage, pharmaceutical, disposal
Page 1 of 17
1.0
PURPOSE
In accordance with the CSU Occupational Health and Safety Policy, the CSU Risk Management
Policy and the Occupational Health and Safety Act 2000, the Faculty of Science shall provide a safe
and healthy environment for staff, students, visitors and contractors. Central to this is staff,
students, visitors and contractors understanding their duty of care responsibilities and the
specialised risks associated with Faculty of Science Facilities.
This procedure outlines the requirements for the compliant purchase, use, storage and disposal of
scheduled substances for the purpose of analysis, research or instruction according to the Poisons
and Therapeutic Goods Act 1966 and Regulation 2008. Further information can be sourced from
the NSW Pharmaceutical Services Branch.
2.0
SCOPE
This procedure applies to all activities, including but not limited to teaching and research which
involve the use of scheduled substances in the Faculty of Science.
3.0
DEFINITIONS
Authorised person
The person who has written authority from the Pharmaceutical Services Branch, NSW Department
of Health (PSB) to possess and use S8 substances for research and teaching activities at or on
behalf of Charles Sturt University.
Approved person
The person who has the authority from the Head of School to manage the purchase, possession,
use, storage and disposal of scheduled substances.
Competent person
As defined in the NSW OHS Regulation 2001:
“A person who has acquired through training, qualifications or experience, or a combination of
them, the knowledge and skills to carry out a task”
Poisons Standard
The legal title of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP)
Poisons List 2011
A list published by NSW Department of Health based on which the Poisons and Therapeutic Goods
Act and Regulation apply. It is based on the Standard for the Uniform Scheduling of Medicines and
Poisons (SUSMP)
Pharmaceutical Services Branch (PSB)
The section of NSW Health responsible for the administration of the Poisons and Therapeutic
Goods Act and Regulation 2008
Scheduled substances
As listed in the Poisons and Therapeutic Goods Act and Regulations
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4.0
PROCEDURE
4.1
Risk assess the hazard(s)
Before procuring a scheduled substance, try to:
•
•
•
•
4.2
Eliminate the risk if possible by substitution with a less potent substitute
Aim to minimise the purchase and use of the substance
Review the processes to minimise exposure to employees
Include storage and waste disposal of the substance or its by-products in the
risk assessment
Requirements
In order to use scheduled substances for teaching or research activities the ‘Approved
Person’ must:
•
•
•
•
•
•
•
•
•
•
•
4.3
Use the substance in accordance with legislative regulations and CSU’s
Faculty of Science procedures
Have the appropriate approvals to purchase
Store the substance in the original packaging
Store the substance in accordance with legal requirements
Complete a risk assessment for the use, handling, storage and disposal of
the substance
Implement Standard Operating Procedures for the use, handling, storage and
disposal of the substance
Notify other members of staff and students of the inherent risks and dangers
of the substance
Record the substance name and quantity on a manifest (or drug register
where required)
Retain manifests or registers as required
Obtain an SDS (previously an MSDS) prior to procurement
Dispose of substances in accordance with legislative requirements, through
the CSU Chemsal contractor or other professional body as required.
Authority and Approval
4.3.1
Authority
The possession and use of S8 drugs of addiction is an offence without written
authority from the Pharmaceutical Services Branch of the NSW Department
of Health (PSB). Authority given by the PSB is not transferable. Staff,
researchers and students intending to undertake activities using S8 drugs of
addiction must obtain written approval from the PSB.
The Dean of the Faculty of Science is the office bearer through which all
official correspondence with the PBS is conducted. The Faculty of Science
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requires all teaching and research staff intending to undertake activities using
S8 drugs of addiction, to obtain written authorisation through this process.
An application to use S8 drugs of addiction in teaching or research activities
must be made through the Head of School or Centre Director to the Dean.
Applications will include a research approval and a risk assessment (see the
Risk Assessment Procedure).
The Dean is responsible for maintaining a CSU S8 Authority Register listing
Authorised Managers and their School or Centre.
An Authorised Manager has the option to approve, in writing, a competent
person working under their supervision to use S8 drugs of addiction for
teaching or research activities. Approval paperwork is to be maintained by
the individual, in facility records (with the risk assessment) and in the Faculty
Office.
The Head of School or Centre Director must maintain written records for all
competent personnel working with S8 drugs of addiction under the
supervision of Authorised Managers.
4.3.2
Approval
All teaching and research staff (including those professionally authorised)
wanting to use scheduled substances for teaching or research activities, must
first obtain written approval from their Head of School for the procurement,
use and storage of all scheduled substances.
The Head of School must notify the Faculty of all ‘Authorised Personnel’ and
‘Approved Personnel’ in regards scheduled substances management.
•
•
•
•
4.4
Authorised Personnel (S8 drugs of addiction) as per Pharmaceutical
Services Branch (PSB)
Approved Personnel (S4 restricted substances)
Any person working with S4 or S8 substances under the above
authority
Personnel approved to purchase S2, S3, S4, S7, S8 substances
Information, Training and Supervision for Authorised Managers
Once PSB approval has been received, the Dean will outline for the Authorised
Manager the legislative requirements for S8 drugs of addictions management,
including the requirements for secure storage, handling and record keeping. The
Authorised Manager is responsible for ensuring all identified risks have been
controlled.
Authorised Managers are responsible for providing supervision and training and
ensuring the legislative compliance of persons working with S8 drugs under their
authority.
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4.5
Procurement
The Head of School may approve an appropriately qualified delegate to place orders
for any scheduled substance. All orders and invoices must state the supply “shall only
be made to the Approved Person at an official University address”. Risk assessments
and manifests must be kept up to date and reflect usage.
Schools are required to keep the following records and ensure a copy is forwarded to
the Faculty Office:
•
•
•
4.6
Approval to procure
Purchase order
An up-to-date manifest of all Scheduled Drugs
Registers
The S8 drugs of addiction register must be kept at the same location where the S8
drugs of addiction are stored. The Authorised Manager may delegate the keeping of
the S8 drug register to a competent person who is responsible for maintaining register.
This delegation of duty must be in writing and the person’s name must be recorded in
the register. A copy of this delegation acknowledgement shall be forwarded to the
Head of School or Centre Director and the Facility Manager (keep with risk
assessment).
4.6.1
Register Format
The register must:
•
•
•
•
Contain consecutively numbered pages
Be bound so that the pages cannot be removed or replaced without
trace
Contain provision on each page for the inclusion of the particulars
required to be entered in the book
Must list each preparation of a S8 drug and each strength and form on
a separate page of the register
Table: Schedule 8 Drug Register
DATE
NAME & ADDRESS
OF PERSON
SUPPLIED OR
FROM WHOM
RECEIVED
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QTY
IN
QTY
OUT
BALANCE
NAME OF
AUTHORITY
SIGNATURE OF
PERSON
PRESCRIBING,
SUPPLING OR
ADMINISTERING
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4.6.2
Data Entry into the S8 Drug Register
The person who receives, administers or uses the S8 drug is responsible for
entering the details of the drug into the register.
Entries must:
• Be done on the day the person receives (from the supplier) the drug,
uses it or administers a quantity of the drug
• Written indelibly in English
• Include no false or misleading information
• Be legible, complete and with appropriate detail
• Be true and correct
Entries must contain:
• The name, form and strength on the appropriate page of the relevant
drug register
• The quantity of the drug remaining after the transaction takes place
• The date and signature of the person by whom the entry is made
• The name and address of the person to, from, or by whom the drug
was manufactured, received, supplied, administered or used
• In the case of a drug that has been used by a person who is in charge
of a laboratory, or is an analyst, the purpose for which the drug was
used
The entries must include when applicable:
• The name and address of the patient or
• If the treatment is for an animal, the species of animal and the name
and address of the animal’s owner.
• In the case of a drug supplied or administered on prescription:
o The prescription reference number, and
o the name of the authorised practitioner by whom the
prescription was issued
• In the case of a drug administered to an animal, the name of the
veterinary practitioner by whom, or under whose direct personal
supervision, the drug was administered
• In the case of a drug administered by a person authorized to do so by
an authority, details of the circumstances requiring administration.
4.6.3
Maintenance of an S8 Register
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•
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The balance in the register should also coincide with the stock on
hand. Any mistake in the register must be corrected by making a
footnote, dating and initialling the mistake.
Altering or deleting an entry, removing a page, or re writing
information is not permitted.
Multiple alterations to entries must be reported to the Head of School
or Centre Director.
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•
•
Opening and closing balance should be verified and signed.
Balances should be checked for the page and carried forward to the
new page. Verifying figures with a second authorised person is
preferable.
4.6.4
Retention of an S8 Register
Drug and prescription registers must be kept for at least 2 years from the
date:
• the last entry was made
• any S8 drug was received, administered or used
The register must be stored on the University’s document record system
(TRIM).
4.6.5
Inspection of Registers
Drug registers shall be made available for inspection on demand by the PSB,
the police or any other authorised CSU representative (eg) Manager
University Laboratories, OHS representative.
All drugs and registers must be maintained in a secure manner. Any
suspected loss or theft must be reported.
4.6.6
Loss or Destruction of Registers
In the event of a suspected loss or destruction of a register, the person
responsible for keeping the register must immediately notify the Authorised
Manager, the Facility Manager and the Head of School or Centre Director.
The Dean must immediately contact the PSB in writing and detail the
circumstances.
The person responsible for the register must then count the quantity of drugs
of addiction held and make an accurate inventory of all drug particulars in a
new register.
4.7
Inventory of S8 drugs of addiction
The competent person responsible for maintaining the S8 drug store and register
must:
• Every March and September (or at an additional time as directed by the PSB)
make a full and accurate inventory of all S8 drugs
• Endorse the relevant drug register, immediately under the last entry for each
S8 drug, with the quantity of each S8 drug actually held and the date on
which the inventory was made (i.e. write the words ‘balance on hand’ against
the actual quantity held)
• Sign each entry in the drug register
• Submit the register to Head of School or Centre Director
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Two additional circumstances where inventory entries must be made:
•
•
A person who is to assume the control of the drug store and register for a
period of a month or longer, must immediately make an inventory and
endorse all the registers under their control as per steps above
the loss or destruction of drugs (refer 4.6.1 and 4.6.2)
When stocktaking, check sealed packs are intact and record the quantity as per the
label. Opened liquid volumes should be estimated against their labeled volume, and
can only be totally accounted for when emptied. The word ‘estimated’ should be
documented when making the entry in the register, and once a liquid container is
empty, any discrepancy in the entry should be noted. If the discrepancy is over that
designated through the risk assessment process (see Risk Assessment Procedure)
the discrepancy must be reported (refer 4.11).
When there is no apparent loss of drugs, but concern exists of possible or admitted
misappropriation of drugs by staff or students (refer to 4.11).
S8 drug registers will be audited every March and September. Scheduled substance
records, drug registers and records must be made available for inspection by a CSU
representative, eg Manager University Laboratories, OHS representative, or inspection
by compliance authorities upon request.
4.8
Labelling
All scheduled substances must be labelled in accordance with legislative
requirements, as outlined on the TGA website. All Schedule substances shall be
stored in their original packaging. Signal words placed at the top of the main label are
specific to each schedule as indicated in Table 2. The only other word allowed on the
top of the main label is Australian Dangerous Goods Code class labels (such as a red
diamond for flammable liquid).
Table: 2
S2
S3
S4
S5
S6
S7
S8
S9
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PHARMACY MEDICINE
PHARMACIST MEDICINE ONLY
PRESCRIPTION ONLY MEDICINE
PRESCRIPTION ANIMAL REMEDY
(RESTRICTED SUBSTANCE)
CAUTION
POISON
DANGEROUS POISON
DRUG OF ADDICTION
PROHIBITED SUBSTANCE
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4.9
Prescription
Any prescribing must comply with legislative requirements and be recorded in a
prescription register.
4.10
Storage
Scheduled substances must be stored in a secure room or location where access is
restricted to approved only Faculty of Science staff, or approved and inducted
postgraduate students.
General storage requirements also include:
• Apart from food intended for consumption by humans or animals, and
• In such a way that, if its container breaks or leaks, the poison cannot mix with
or contaminate any food intended for consumption by humans or animals.
• With the SDS’s retained in the workplace in close proximity to where the
substance is stored.
Specific storage requirements for scheduled substances:
Schedule 4 substances shall be stored in a locked cabinet, securely attached to part of
the premises in a restricted access room.
Schedule 6 substances must be:
• Stored in a place to which access is restricted
• Stored at least 1.2 metres above the floor and at least 1.2 metres from any
step, stairway, ramp etc to which the public have access (out of reach of young
children) unless it is:
o stored in a storeroom or other area to which there is restricted access
o packed in containers with child-resistant closures
o packed in containers with a capacity of 5 litres (or 5 kilograms) or
more
o a hair dye contained in a container which has a capacity of 50
millilitres or less
o a cockroach bait enclosed in a welded plastics labyrinth; or
o a therapeutic substance for internal use in animal
Schedule 8 drugs of addiction must be:
• Stored apart from all other goods (other than cash or documents)
• Stored in a separate room, safe, cupboard or other receptacle securely
attached to a part of the premises and kept securely locked when not in
immediate use
• The room containing the safe or cupboard must also have restricted access,
appropriate signage and must be locked when authorised staff are not present
4.11
Loss or Theft
Any suspected or actual loss or theft of an S4 or S4D or S8 substance must be
reported by the Head of School, or their nominee to:
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•
•
•
•
4.12
HR via an incident report
To the Dean of the Faculty of Science
The Pharmaceutical Services Branch of NSW Department of Health
In the case of a robbery report theft to the police
Disposal
It is an offence to dispose of any poison or restricted substance that may be a public
risk. Any disposal of scheduled substances (or their derivatives) must be carried out
legally and in accordance with the Waste Procedure and Waste Guidelines.
If necessary, discuss with the Chemical Safety Committee or Technical Area
Committees the most viable option for disposal. Disposal of Scheduled Poisons shall
be arranged through a licensed hazardous waste contractor and recorded in the
manifest.
S4 substances which have specific requirements for disposal must be handled by
Approved Personnel and documented in the register
S8 drugs of addiction must not be wilfully destroyed, except under the personal
supervision of a PSB officer or a police officer. The disposal of S8 drugs should be
arranged by the Authorised Manager through contacting the Duty Pharmaceutical
Advisor at the PSB to make collection arrangements. The officer will make the
relevant entries in the drugs register.
Injectable steroids used by veterinarians i.e. anabolic and androgenic steroids are
required to be disposed of in accordance with legislative requirements.
4.13
Monitoring Compliance
Monitoring of S8 drugs of addiction shall be done using the S8 Drug Checklist. It shall
be completed by the Authorised Manager at inventory compliance times (see 4.7). A
copy of the checklist shall be sent to the Head of School or Centre Director and stored
with the facilities records.
4.14
Out-of-date stock
The Poisons and Therapeutic Goods Act prohibits the supply of any prescription
medicine or over the counter medicine including those for veterinary use, after the
expiry date shown on the label.
NOTE: The Faculty of Science prohibits staff, researchers and students from making
or accepting gifts of such medicines for any purpose.
4.15
Ethics Approval
Where scheduled drugs are to be used on humans, animals or in materials of
biological origin, staff must seek approval from the relevant Ethics and/or Biosafety
Committee. Appropriate approvals, authorities and risk assessments must be
completed prior to procurement.
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4.16
Overview of Schedules
There are eight schedules used for classifying substances according to the Poisons
and Therapeutic Goods Act 1966 and Regulation 2008. They are Schedule 2 – 9,
Schedule 1 is not used. These schedules classify substances requiring similar
regulatory controls over their availability. Where preparations contain two or more
poisons, the provisions of all schedules apply. Where all provisions cannot be
complied with, the more restrictive schedule applies.
Schedule 2 - Pharmacy medicine
Schedule 3 - Pharmacist only medicine
Schedule 3 - Pseudoephedrine
Pseudoephedrine can be either a Schedule 3 or Schedule 4 substance and requires
additional management due to the potential for abuse.
Records of purchase (source, quantities, date) use and disposal must be maintained.
Records must clearly account for all purchases and use, and be kept for at least two
years. Suitable consolidated records which can account for all purchases and use are
acceptable.
Schedule 4 - ‘Prescription only medicine’ or ‘Prescription Animal Remedy’
(restricted substances)
These are supplied only by a medical practitioner, authorised nurse, dentist or
veterinary surgeon or from a pharmacist on the advice of afore mentioned.
Unauthorised possession is an offence.
The Head of School shall appoint Approved Person(s) to manage S4 substances and
is responsible for maintaining records of all Approved Personnel (S4 substances) and
all persons working with S4 restricted substances under their authority. The Head of
School may delegate an appropriately qualified person the approval to place an order
for S4 substances. The order and invoice(s) must state that the supply is only to the
Approved Person at an official University address. Risk assessments and manifests
must be kept up to date and reflect usage.
The University requires all records for S4 substances be kept in a suitable format or
register and made available to the Head of School or Manager of University
Laboratories as requested.
Schedule 4 - Prescribed Restricted Substances Appendix D (S4D) of the Poisons
and Therapeutic Goods Regulation 2008
Appendix D lists substances liable to be abused and include:
• Amylobarbitone and pentobarbitone injections
• Anabolic/androgenic steroidal agents (may not prescribe injectable forms)
• Benzodiazepines such as diazepam
• Ephedrine
• All forms of phenobarbitone and methylphenobarbitone
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S4D substances must be stored apart from all other substances (except Schedule 8
drugs) in a separate sturdy cupboard, preferably a metal safe, which is securely
attached to a wall or floor and kept locked when not in immediate use. The key to the
S4D cabinet must be kept separate from all other keys, except an S8 cupboard key.
Note: Ketamine and the oral forms of the short acting barbiturates such as
amylobarbitone and pentobarbitone previously in Appendix D are now Schedule 8, as
is flunitrazepam.
Injectable Steroids – Additional requirements for veterinary use (S4)
Stock Medicines Act 1989 (Primary Industries website), also impose controls on
injectable steroids i.e. anabolic and androgenic steroids. Order No. 1998/1
776.6
KB ‘Injectable Steroids (Anabolic and Other Products)’, restricts all supply of injectable
anabolic steroids or testosterone by veterinary surgeons.
• Veterinary surgeons are not permitted to supply injectable steroids to anyone
(except another veterinary surgeon), nor to return them to the supplier.
•
Injectable steroids are not permitted to be prescribed by veterinary surgeons.
•
The veterinary surgeon (or a person acting under their direct supervision) must
administer an injectable steroid. An exception to this exists for sheep
testosterone product under conditions specified in the legislation.
•
Injectable steroids must be securely stored and in addition, if being transported
in a vehicle, the vehicle must also be locked when not occupied.
•
Detailed records for use of injectable steroids must be maintained, clearly
identifying the animal/client, date and amount used for each product
purchased. Records of purchase (source, quantities, date) must also be
maintained (records must be similar to those for S8’s). Records must clearly
account for all purchases, use and disposal and kept for at least two years.
Suitable consolidated records which can account for all purchases and use are
acceptable.
•
Injectable anabolic steroids - for the purposes of the Stock Medicines Act it is
permissible to use the S8 drug register as a record.
•
Records of stock on hand must be established immediately, and all records of
purchase or use made within 24 hours of the use.
•
Authorised inspectors under the Stock Medicines Act may request access to all
such records. Suitable consolidated records which account for all purchases
and use must be produced within a reasonable time.
•
Any loss or theft greater than 50ml must be reported to Veterinary Officer Biological and Chemical Risk Management listed on the DPI website.
•
Unwanted products may only be disposed of as approved by Veterinary Officer
- Biological and Chemical Risk Management listed on the DPI website.
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Sheep testosterone (S4)
A number of exemptions and conditions apply to veterinary surgeons supplying
injectable testosterone for use in sheep. A record of the purchase, supply and use
must be maintained in a book similar to the S8 Drug Register with separate records for
all purchases and supplies. Batch numbers of products must be recorded.
Pentobarbitone sodium (S4)
As specified in legislation, pentobarbitone sodium (used for the destruction of animals)
can only be handled by an Authorised Person. Pentobarbitone sodium must be kept
separately from all other goods in a safe or cupboard as per the requirements for S8
storage, and managed with a register as per S8 (refer 4.6).
As with S4 and S8 management, the records must be retained for a period of not less
than 2 years from the date on which the last use, supply or prescription of the stock
medicine occurred.
Veterinary Prostaglandins S4 drugs
Prostaglandins (PG’s) are hormone like chemicals essential for physiological
functions. There are a range of prostaglandins which have been synthesised in the
laboratory for use in humans and animals and are scheduled as S4 drugs.
Staff and students must be aware of the risks of prostaglandins prior to exposure.
Only trained staff should handle PG’s and safe working procedures and the use of
PPE and hand washing is mandatory.
Examples of names are; Prosolvin, Lutalyse, Estrumate and Juramate. These drugs
are rapidly absorbed through the skin, eyes, nose and mouth and human exposure or
potential contact with them is seen as a risk. Possible risks are; convulsions,
bronchospasm, impaired liver function, jaundice, gastrointestinal bleeding, increased
menstrual bleeding, abortions.
Due to potentially adverse health effects, any person with conditions such as asthma,
bronchial or respiratory concerns shall not handle the drugs. Pregnant women must
not be exposed to these drugs through handling or administering. Persons who suffer
from functional impairment of the heart, liver, kidneys or diabetes or epilepsy should
not be exposed to these drugs.
Prostaglandins must be managed as if they were classified as a scheduled 8.
Research Drug Thalidomide (S4)
Thalidomide is specifically mentioned in the regulations and any procurement and
research must be done in accordance with the legislative requirements with approval
from the Head of the Commonwealth Department of Health.
Schedule 5 ‘Caution’ Poisons
Commonly available, domestic poisons which can dangerous if not handled correctly.
They require caution in handling storage and use.
No licence, authority or qualification required of seller.
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Schedule 5 poisons must be kept apart from food.
Schedule 6 - Poison
For use in agriculture, horticulture, veterinary and industrial processes, they are also
used for the destruction of pests.
Sale - No licence, authority or qualification required of seller.
Schedule 7 - Dangerous Poison
Substances of exceptional danger of harm at low exposure which require special
precautions for their manufacture or use
They include such poisons as: arsenic, cyanides, fluoro acetamide, fluoroacetic acid,
thallium, strychnine, hydrocyanic acid, pesticides that must not be repackaged, and
those substances included in Appendix C of the Poisons Standard, substances which
are extremely dangerous and whose use or supply is prohibited when intended for
therapeutic use.
Certain Schedule 7 substances can only be supplied and used under an authority. The
University is generally exempt when they are purchased by the laboratory manager.
However the Head of School must give documented approval to purchase. Risk
assessments and manifests must be kept up to date to reflect usage or requirements
of Scheduled Poisons.
Schedule 8 - Drugs of Addiction
These are controlled drugs, available for use, but have restrictions on the
manufacture, supply, distribution and possession. This is to reduce abuse and misuse
as well as physical or psychological dependence. It is an offence for an unauthorised
person to possess them.
Each entry in the drug register shall be consecutive and the register endorsed
immediately under the last entry. The Authorised Person shall sign each entry in the
drug register.
Schedule 9 - Prohibited Substance
The manufacture, supply, distribution and possession of any scheduled 9 substance is
prohibited i.e. illicit or illegal drug. Approval must be obtained from the Commonwealth
and State Governments to use for scientific or medical research or for analytical
purposes.
5.0
REFERENCES and related University Documents
Veterinary Practice OHS Guide
NSW Health Pharmaceutical Services Publications:
Guide to Poisons and Therapeutic Goods Legislation for Pharmacists TG 79/28
Guide to Poisons and Therapeutic Goods Legislation for Veterinary Practitioners TG 74/12
Poisons List TG147/91
http://www.health.nsw.gov.au/resources/publichealth/pharmaceutical/poisons_list_alpha_pdf.asp
Poisons Standard (the SUSMP) http://www.tga.gov.au/industry/scheduling-poisons-standard.htm#electronic
Guide to Labelling Drugs and Poisons
Scheduled Substances Procedure
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Risk Assessment Procedure
Scheduled 8 Drugs Checklist
6.0
APPENDICES
Poisons and Therapeutic Goods Regulation 2008 [2008-392] Appendix D Prescribed restricted
substances
Table of amendments
Version
number
0.2
1.0
Date
240810
241111
Author and Position
Short description of amendment
Charles Svenson – Manager
University Laboratories
Draft
Initial version and Incorporating S8 drug management
procedure
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APPENDIX 1
Poisons and Therapeutic Goods Regulation 2008 [2008-392]
Status Information
Currency of version
Current version for 7 October 2011 to date (accessed 16 November 2011 at 09:32).
Appendix D Prescribed restricted substances
(Clause 61)
Substance
Alprazolam
Amylobarbitone when included in Schedule 4 of the Poisons List
Anabolic and androgenic steroidal agents included in Schedule 4 of the Poisons List, except
when referred to elsewhere in this Appendix
Androisoxazole
Barbiturates included in Schedule 4 of the Poisons List, except when referred to elsewhere
in this Appendix
Benzodiazepine derivatives included in Schedule 4 of the Poisons List, except when
referred to elsewhere in this Appendix
Benzphetamine
Bolandiol
Bolasterone
Boldenone
Bolmantalate
Bromazepam
Calusterone
Cathine
Chlorandrostenolone
Chlordiazepoxide
Chloroxydienone
Chloroxymesterone
Clobazam
Clonazepam
Clorazepate
Clostebol
Dextropropoxyphene when included in Schedule 4 of the Poisons List
Diazepam
Diethylpropion
Dihydrolone
Dimethandrostanolone
Dimethazine
Doxapram
Drostanolone
Ephedrine
Scheduled Substances Procedure
Version 1.0 /Version date 12/2011
Prescribed quantity
0.25 gram
50.0 grams
5.0 grams
5.0 grams
50.0 grams
0.5 gram
5.0 grams
5.0 grams
5.0 grams
2.5 grams
5.0 grams
5.0 grams
30.0 grams
5.0 grams
5.0 grams
5.0 grams
5.0 grams
5.0 grams
2.5 grams
0.5 gram
3.0 grams
2.0 grams
15.0 grams
2.5 grams
5.0 grams
5.0 grams
5.0 grams
5.0 grams
2.0 grams
2.0 grams
5.0 grams
Page 15 of 17
Ethchlorvynol
Ethinamate
Ethyldienolone
Ethyloestrenol
Fencamfamin
Fenproporex
Fluoxymesterone
Flurazepam
Formebolone
Formyldienolone
Furazabol
Glutethimide
Hydroxystenozol
Lorazepam
Mazindol
Medazepam
Mefenorex
Meprobamate
Mesabolone
Mestanolone
Mesterolone
Methandienone
Methandriol
Methenolone
Methylandrostanolone
Methylclostebol
Methylphenobarbitone
Methyltestosterone
Methyltrienolone
Methyprylone
Mibolerone
Midazolam
Nalbuphine
Nandrolone
Nitrazepam
Norandrostenolone
Norbolethone
Norethandrolone
Normethandrone
Oxabolone
Oxandrolone
Oxazepam
Oxymesterone
Oxymetholone
Paraldehyde
Pentobarbitone when included in Schedule 4 of the Poisons List
Phenobarbitone
Scheduled Substances Procedure
Version 1.0 /Version date 12/2011
50.0 grams
50.0 grams
5.0 grams
1.0 gram
1.0 gram
1.0 gram
2.0 grams
10.0 grams
1.0 gram
1.0 gram
0.5 gram
50.0 grams
5.0 grams
1.0 gram
0.5 gram
2.5 grams
5.0 grams
100.0 grams
5.0 grams
5.0 grams
10.0 grams
1.0 gram
20.0 grams
2.0 grams
5.0 grams
5.0 grams
50.0 grams
20.0 grams
5.0 grams
40.0 grams
0.01 gram
0.5 gram
0.5 gram
1.0 gram
1.0 gram
1.0 gram
5.0 grams
4.0 grams
0.5 gram
0.5 gram
1.0 gram
10.0 grams
4.0 grams
40.0 grams
250 millilitres
50.0 grams
50.0 grams
Page 16 of 17
Phentermine
Pipradrol
Prasterone
Prazepam
Propylhexedrine
Pseudoephedrine when included in Schedule 4 of the Poisons List
Pyrovalerone
Quinbolone
Silandrone
Stanolone
Stanozolol
Stenbolone
Temazepam
Testolactone
Testosterone except when included in Schedule 6 of the Poisons List
Thiomesterone
Trenbolone except when included in Schedule 6 of the Poisons List
Trestolone
Triazolam
Zolazepam
Scheduled Substances Procedure
Version 1.0 /Version date 12/2011
10.0 grams
1.0 gram
1.0 gram
2.5 grams
5.0 grams
20.0 grams
1.0 gram
3.0 grams
5.0 grams
10.0 grams
2.0 grams
5.0 grams
5.0 grams
100.0 grams
20.0 grams
5.0 grams
5.0 grams
5.0 grams
0.05 gram
2.5 grams
Page 17 of 17