NSW Health

Electronic prescribing

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The Australian Government, in collaboration with states and territories, has accelerated the delivery
of electronic prescribing to help protect people most at-risk from COVID-19. Electronic prescribing,
where available in the community, will provide patients with a choice to receive either an electronic or
a paper prescription from their prescriber. Visit the Electronic Prescriptions
[https://www.digitalhealth.gov.au/get-started-with-digital-health/electronic-prescriptions] website
for more information.

An exemption [https://www.health.nsw.gov.au/pharmaceutical/Documents/exemption-
eprescriptions-sep20.pdf] from the NSW Poisons and Therapeutic Goods Regulation has been
granted to allow electronic prescriptions to be legally issued and dispensed in NSW.

On this page
1. Information for software vendors
2. Information for prescribers
3. Information for community pharmacists

Information for software vendors

To participate in electronic prescribing, software vendors are required to meet the requirements in the
Electronic Prescribing Conformance Profile developed by the Australian Digital Health Agency
(ADHA). The ADHA publishes information for vendors on the Electronic Prescribing Conformance
Process [https://developer.digitalhealth.gov.au/resources/articles/electronic-prescribing-
conformance-process] .

NSW requirements

For an electronic prescription to be legally valid in NSW, all systems participating in the prescribing,
transmission and dispensing of the prescription must be listed on the ADHA Electronic Prescribing
Conformance Register [https://www.digitalhealth.gov.au/about-us/policies-privacy-and-
reporting/registers] with a Conformance ID. Such a prescription is then termed a 'Conformant
Electronic Prescription'.

Specifications identified in the Electronic Prescribing Participating Software Conformance Profile

[https://developer.digitalhealth.gov.au/specifications/ehealth-foundations/ep-3733-2022] as having
a jurisdictional requirement are provided below and must be met.

PRES-13

Electronic prescriptions are accepted in all circumstances where systems are conformant (i.e. each
participating system has a Conformance ID) and the prescription contains all required details (see
PRES-17).

PRES-17
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For an electronic prescription to be legally valid for dispensing in NSW it must contain the details
listed below. This list incorporates prescription requirements under the Poisons and Therapeutic
Goods Regulation 2008. (Where possible, Reference IDs from the Conformance Profile are listed).

Conformance ID of the system used to create the prescription (PRES-83)

Healthcare Provider Identifier – Organisation (HPI-O) of the practice or organisation from which
the prescription is issued (PRES-18)
Healthcare Provider Identifier – Individual (HPI-I) of the prescriber (PRES-83) (see Note 1)
unique prescription number for the prescription (PRES-83)
prescriber name, practice address and telephone number
date (and time) of issue
patient’s full name (first name and last name)
patient's address (PRES-18) (or email address or mobile phone number but only in specific
circumstances - see Note 2)
patient’s date of birth (PRES-18)
name, strength and form (if not readily apparent) and quantity of the medicine (PRES-18)
adequate directions for use (including route of administration if not readily apparent) (PRES-18)
number of repeat supplies authorised, if any (PRES-18)
interval between any repeats (PRES-18) (see Note 3)
the NSW authorisation reference number (PRES-18A) (see Note 4)
prescriber specialist qualification (PRES-18) (see Note 5)
annotation with the words “issued under clause 37 of the NSW Poisons and Therapeutic Goods
Regulation” or similar (see Note 5)

Notes

1. See the Electronic Prescribing Participating Software Conformance Profile

[https://developer.digitalhealth.gov.au/specifications/ehealth-foundations/ep-3733-2022] for
requirements for Open PDS and Direct PDS.
2. In the case where the prescription is for azithromycin for the treatment of chlamydia in the
partner of the presenting patient, email address or mobile phone number of the partner is
accepted as an alternative to the physical address.
3. The interval between any repeats must be stated for medicines in Schedule 8 (S8) of the Poisons
Standard [https://www.tga.gov.au/publication/poisons-standard-susmp] ('controlled drugs' or
'drugs of addiction') and Schedule 4 medicines listed in Appendix B of the Poisons and
Therapeutic Goods Regulation 2008 (S4B) (e.g. anabolic/androgenic steroids).
The interval between each repeat supply must be clearly specified (e.g. stated as number of
days).
4. The NSW authorisation reference number (known as the 'NSW Authority number') is distinct
from, and independent of, the 'authority code' associated with an Authority PBS prescription for3/9
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restricted medicines.

The NSW Authority number is issued by the NSW Ministry of Health and is alphanumeric in
format, and may be prefixed with a text string of letters/characters, including 'AU', 'CNS', 's28c',
'CL', 'RA', and 'PG(T)'. Examples are AU123456789, RA998. 
a Type A drug of addiction (see clause 122 of the Poisons and Therapeutic Goods Regulation
2008), i.e. Schedule 8 psychostimulants and pharmacist-compounded Schedule 8 medicines
a Schedule 4 (S4) medicine listed in clause 37 of the Poisons and Therapeutic Goods
Regulation 2008 (e.g. clomiphene, isotretinoin) (or as specified in Note 5)

5. For S4 medicines listed in clause 37 of the Poisons and Therapeutic Goods Regulation 2008 (e.g.
clomiphene, isotretinoin) the prescription must include either:
the prescriber’s specialist qualification (abbreviation is acceptable and could be up to 12
alphabetical characters) AND the text “issued under clause 37 of the Poisons and
Therapeutic Goods Regulation 2008” or words to that effect, OR
the NSW Authority number (see Note 4).
Some requirements for paper prescriptions do not apply to Conformant Electronic Prescriptions.

Prescribers of Conformant Electronic Prescriptions do not need to comply with the following paper
prescription requirements:

handwriting and hand signature on the prescription

underlining and initialing of any dose that could be regarded as dangerous or unusual
for S8 medicines, the quantity to be dispensed written in words as well as figures.

Pharmacists dispensing Conformant Electronic Prescriptions are exempted from the following paper
prescription requirements:

endorse in ink:
the date of dispensing
the pharmacy address
the prescription reference number
the word 'CANCELLED' where no valid repeat supplies remain

keep S4B and S8 prescriptions in hardcopy

store S4B and S8 hardcopy prescriptions separately

PRES-23

Under the Poisons and Therapeutic Goods Regulation 2008, a person issuing a prescription for a
Schedule 4 medicine listed in Appendix D of the Poisons and Therapeutic Goods Regulation 2008
[https://www.health.nsw.gov.au/pharmaceutical/Pages/sch4d.aspx] (S4D) or a S8 medicine must
keep a record of it for a period of at least two (2) years.

Medical records otherwise must be kept as required under the Health Practitioner Regulation
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National Law. They should be retained in a retrievable format and readable state for their minimum
required retention period.

PRES-24

All NSW required details (see PRES-17) shall be displayed.

Electronic prescriptions should be displayed in a similar manner to paper prescriptions.

DISP-4

While there is no requirement for each dispenser to login for each dispense transaction, the
pharmacist authorising a dispense event must ensure their identity is recorded against each dispense
event, for example, by entering their initials before each dispense event.

DISP-33

The NSW Poisons and Therapeutic Goods Regulation 2008 has no mandatory requirement to record
receipt of supply in the dispensing system.

For opioid substitution therapy, the pharmacist may record that the dose has been received by the
patient.

DISP-34

All records must be retrievable in human readable format immediately by any pharmacist in charge at
any time at the premises where the prescription was dispensed and retained for two (2) years from
the date of dispensing.

DISP-36

The dispense record must contain:

details of the prescription (see PRES-17)

the date (and time) on which the prescription was dispensed
the name (first name and last name) of the pharmacist who dispensed the prescription (that is,
the pharmacist who personally dispensed the prescription)
the pharmacy name and address

All dispense records must be retrievable in human readable format immediately by any pharmacist in
charge at any time at the premises where the prescription was dispensed and retained for two (2)
years from the date of dispensing.

DISP-51

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Records (prescribing and dispensing) must be searchable, filterable and retrievable by categories
including by patient, by prescriber, by drug, by legal category (at least S8, S4B, S4D, and S4, and
optionally S3, S2, and unscheduled).

DISP-50

PRES-17 provides a list of prescription details required to be displayed to the dispensing pharmacist.

MI-10

Records must be immediately retrievable in human readable format at the premises and retained for
two (2) years.

MI-10A

Records (prescribing and dispensing) must be searchable, filterable and retrievable by categories
including by patient, by prescriber, by drug, by legal category (at least S8, S4B, S4D, and S4, and
optionally S3, S2, and unscheduled).

Frequently asked questions

How do I get my software approved for use in NSW?

A separate approval from NSW Health is not required where a system conforms under the Electronic
Prescribing Conformance Assessment Scheme and has been listed on the Electronic Prescribing
Register of Conformance with a Conformance ID.

Send enquiries to MOH-PharmaceuticalServices@health.nsw.gov.au [mailto:MOH-

PharmaceuticalServices@health.nsw.gov.au] .

Information for prescribers

Electronic prescribing is permitted for both PBS and non-PBS prescriptions in the community where
all systems participating in the prescribing, transmission and dispensing of the prescription conform
under the national Electronic Prescribing Conformance Assessment Scheme
[https://developer.digitalhealth.gov.au/electronic-prescribing/conformance-process] . If your
prescribing system is conformant it will be listed on the Electronic Prescribing Register of
Conformance [https://www.digitalhealth.gov.au/about-us/policies-privacy-and-reporting/registers]
with a Conformance ID. Your software vendor can also provide you with your system's Conformance ID
if it has one.

Prescribers must ensure that the electronic prescription created by their prescribing system contains
all the required details (see PRES-17 above). The requirements in NSW are the same as those for
paper prescriptions with a small number of exceptions. While not required for a paper prescription,
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patient date of birth is required for an electronic prescription. Prescribers of conformant electronic
prescriptions do not need to comply with the following paper prescription requirements:

handwriting and hand signature on the prescription

underlining and initialing of any dose that could be regarded as dangerous or unusual
for Schedule 8 (S8) medicines, the quantity to be dispensed written in words as well as figures

If a prescribing system does not have a designated field for a required detail (e.g. NSW Authority
number, which is required for certain S8 medicine prescriptions), a prescriber must ensure the detail
is entered into the system so it will be displayed to the dispensing pharmacist. A pharmacist can
dispense an electronic prescription only if all required prescription information is displayed. Contact
your software vendor if you have any concerns or queries about how to enter details in your
prescribing system.

Electronic prescriptions are not valid for veterinary practitioners.

For more information on electronic prescribing visit the Australian Digital Health Agency's Electronic
Prescribing - For Prescribers [https://www.digitalhealth.gov.au/healthcare-providers/initiatives-and-
programs/electronic-prescribing/for-prescribers] .

Information for community pharmacists

When dispensing an electronic prescription, community pharmacists (both the pharmacy proprietor
and the dispensing pharmacist) must ensure that all of the systems participating in the prescribing,
transmission and dispensing of the prescription conform under the national Electronic Prescribing
Conformance Assessment Scheme [https://developer.digitalhealth.gov.au/electronic-
prescribing/conformance-process] and that the electronic prescription has the details required for it
to be legally valid in NSW (see PRES-17 above). Pharmacists should be particularly vigilant that the
on-screen display shows repeat intervals and the NSW authorisation reference number ('NSW
Authority number') where they are required (see PRES-17 above).

A pharmacist should not assume that dispensing a prescription is legal merely because the
prescription has been digitally transferred.

Key things to note

Under electronic prescribing, a prescriber gives a paper token or sends a digital token (also
known as ‘Evidence of Prescription’) to the patient or his/her authorised agent. The prescriber
does not send it directly to a pharmacy, unless the patient or his/her authorised agent has
requested this to be done for one or more of his/her prescriptions. The prescriber should
document the request.
The paper or digital token presented to the pharmacy is not a legal prescription. It is used by the
pharmacist to ‘unlock’ the legal prescription so it can be dispensed.
A prescription that is created, transmitted or dispensed from a system that is not listed on the
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Electronic Prescribing Conformance Register [https://www.digitalhealth.gov.au/about-
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us/policies-privacy-and-reporting/registers] with a Conformance ID is not legally valid for

dispensing.

Requirements for electronic prescriptions

The requirements for electronic prescriptions are the same as those for paper prescriptions with a
small number of exceptions. Patient date of birth is required for electronic prescriptions. Prescribers
do not need to hand write or hand sign the prescription, nor underline or initial any dose that could be
regarded as dangerous or unusual, nor for S8 medicines, write the quantity to be dispensed in words
and figures.

Pharmacists who dispense conformant electronic prescriptions are exempted from the requirement
to:

endorse in ink:
the date of dispensing
the pharmacy address
the prescription reference number
the word 'CANCELLED' where no valid repeat supplies remain

keep S4B and S8 prescriptions in hardcopy

store S4B and S8 hardcopy prescriptions separately

Pharmacists are exempted from these requirements because conformant systems record the date of
dispensing, the pharmacy address and the prescription reference number, and securely transmit and
retain details of prescriptions which are easily searchable. Repeats of conformant electronic
prescriptions for S4B and S8 medicines, therefore, do not have to be dispensed at the same pharmacy
which dispensed the original prescription. A patient can take the new token for their repeat
prescription to a different pharmacy if they choose so.

When dispensing electronic prescriptions, pharmacists should be particularly vigilant that the on-
screen display shows repeat intervals where required. A prescription for a S4B or S8 medicine with
repeat/s specified must show an interval for repeats. If no repeat interval appears, directions for any
repeat supplies are invalid and no repeats can be dispensed. The pharmacist may only dispense a
single supply. The prescription should be electronically cancelled to prevent a new token from being
issued.

Pharmacists should also be vigilant that the NSW Authority number is displayed where it is required
(see PRES-17 above). The Authority number must be displayed for a prescription for:

a S8 psychostimulant (e.g. dexamfetamine, lisdexamfetamine, methylphenidate)

a pharmacist-compounded S8 medicine
a S4 medicine listed in clause 37 of the Poisons and Therapeutic Goods Regulation 2008 (e.g.
clomiphene, isotretinoin), unless the prescriber belongs to an authorised specialist group. In this
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specialist qualification and the words “issued under clause 37 of the Poisons Regulation” or
words to that effect.

Electronic prescriptions are not valid for veterinary practitioners.

Prescriber and patient identity for Schedule 8 prescriptions

The Electronic Prescribing Conformance Assessment Scheme
[https://developer.digitalhealth.gov.au/electronic-prescribing/conformance-process] has safeguards
to ensure the dispensing pharmacist can be confident in the identity of the prescriber issuing the
conformant electronic prescription.

For conformant electronic prescriptions for S8 medicines that include all required details, a
pharmacist does not need to contact the prescriber to verify the prescription where the pharmacist
does not know the patient. If a pharmacist has doubt about the identity of the prescriber or any other
aspect of the prescription or the patient’s treatment he/she should contact the prescriber directly.

Validity of tokens
Pharmacists must be confident the token presented by the patient or his/her authorised agent has not
been fraudulently obtained or altered. Where the pharmacist has concerns, the same steps as used
for paper prescriptions are appropriate, including sighting the patient’s or agent’s identification
document/s (e.g. photo driver licence) and/or contacting the prescriber. If the token for a S8 or S4D
prescription has been altered or fraudulently obtained, the electronic prescription should be
cancelled to make the token invalid and unable to be used by any person. The Police should be
informed immediately.

For more information on electronic prescribing visit the Australian Digital Health Agency's Electronic
Prescribing - For Dispensers [https://www.digitalhealth.gov.au/get-started-with-digital-
health/electronic-prescriptions/for-dispensers] .

Current as at: Thursday 30 March 2023

Contact page owner: Pharmaceutical Services

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 NSW Health

How to apply to prescribe or supply Schedule 8 and

unregistered cannabis medicines

On this page
1. Applying to prescribe or supply Schedule 8 cannabis medicines
2. Applying to the TGA
3. Applying to NSW Health
4. Pathways for prescribing or supplying Schedule 8 cannabis medicines

Applying to prescribe or supply Schedule 8 cannabis medicines

To prescribe or supply a Schedule 8 cannabis medicine in NSW, the prescriber must:

be a registered practitioner who may lawfully prescribe the medicine

be approved by the Australian Government to import and/or supply that particular product, if it is
unregistered, under the Commonwealth’s:
Special Access Scheme Category (for a particular patient)
Authorised Prescriber scheme (by medical practitioners for a particular group of patients)
Clinical Trial schemes (for a particular group of patients)

obtain informed consent from the patient, or carer, for the use of a product that has not been
assessed for quality, safety and efficacy, if the product is unregistered or the use is not an
approved indication
establish whether the patient is being prescribed or supplied any other Schedule 8 medicine by
other prescribers, and if so, manage as clinically appropriate. The prescriber must determine if
the patient is drug dependent involving either dependence to Schedule 8 medicines or other
prohibited drugs (including but not limited to heroin, methylamphetamine or cocaine) and make
application to NSW Health.

Applying to the TGA

The TGA has an online system to apply for authorisation to prescribe or supply unregistered cannabis
medicines under the Special Access Scheme (SAS). This online system is available on the TGA’s
website [https://www.tga.gov.au/special-access-scheme-and-authorised-prescriber-online-system] .

Prescribers are encouraged to use the TGA’s online system for SAS applications.

Applying to NSW Health

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6/20/23, 12:22 AM How to apply to prescribe or supply Schedule 8 and unregistered cannabis medicines - Cannabis medicines

The Poisons and Therapeutic Goods Act 1966 sets the controls on the prescribing and supply of
Schedule 8 cannabis medicines in NSW. To prescribe or supply a Schedule 8 cannabis medicine, an
application to NSW Health is required in certain circumstances. These are where:

1. prescribing or supplying is for a drug dependent person, or

[A drug dependent person means a person who has acquired an overpowering desire for the
continued administration of a drug of addiction (Schedule 8) or a prohibited drug (including but
not limited to heroin, methylamphetamine or cocaine) as a result of repeated administration of
that drug. Any person who has been treated under the Opioid Treatment Program is a drug
dependent person.]
2. prescribing or supplying for a clinical trial (if it is an unregistered cannabis medicine), or
3. prescribing or supplying is for a child aged under 16 years
[Treatment involving the administration of a Schedule 8 cannabis medicine to a child aged under
16 years requires an exemption under the Children and Young Persons (Care and Protection) Act
1998. This exemption is sought by a medical practitioner by application to NSW Health.]

Prescribers are encouraged to use the TGA’s online system for SAS applications to NSW to prescribe
or supply unregistered Schedule 8 cannabis medicines as this provides a streamlined application
pathway. This online system is available on the TGA’s website [https://www.tga.gov.au/special-
access-scheme-and-authorised-prescriber-online-system] .

A medical practitioner must submit an application directly to NSW Health:

to prescribe or supply an unregistered cannabis medicine for a drug dependent patient or a

patient under 16 years of age if they are an Authorised Prescriber
[https://www.tga.gov.au/form/authorised-prescribers]
to prescribe or supply a registered cannabis medicine for a drug dependent patient or a patient
under 16 years of age.

The form Application for Authority to Prescribe or Supply a Schedule 8 Cannabis Medicine for
Human Therapeutic Use [https://www.health.nsw.gov.au/pharmaceutical/Documents/cannabis-
appln.pdf] is to be used in these circumstances.

A NSW Authority is not required in the following circumstances:

to continue treatment with a Schedule 8 cannabis medicine for a patient in hospital, if the patient
was subject of an authority immediately prior to hospital admission
to continue treatment with a Schedule 8 cannabis medicine for a patient in community, if the
patient is subject of an authority, and the medical or nurse practitioner is practising at the same
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premises that the holder of the authority was practising at when the authority was issued.
6/20/23, 12:22 AM How to apply to prescribe or supply Schedule 8 and unregistered cannabis medicines - Cannabis medicines

A NSW Authority to prescribe or supply an unregistered cannabis medicine for the purpose of a
clinical trial is required in all circumstances.

To apply for a NSW Authority to prescribe or supply an unregistered Schedule 8 cannabis medicine
for the purpose of a clinical trial, the form Application for Authority to Prescribe or Supply a
Substance for the Purpose of Human Research
[https://www.health.nsw.gov.au/pharmaceutical/Documents/human-research.pdf] is to be used.

Information about clinical trials is available on National Health and Medical Research Council -
Australian clinical trials [https://www.australianclinicaltrials.gov.au/] .

For further information on prescribing or supplying cannabis medicines, please contact

Pharmaceutical Regulatory Unit by email at MOH-PharmaceuticalServices@health.nsw.gov.au
[mailto:MOH-PharmaceuticalServices@health.nsw.gov.au] or on (02) 9391 9944.
Information about prescribing or supplying extemporaneously compounded Schedule 8 medicines
or unregistered Schedule 8 medicines
[https://www.health.nsw.gov.au/pharmaceutical/Pages/unregistered-s8s.aspx] other than cannabis
medicines is available.

Pathways for prescribing or supplying Schedule 8 cannabis medicines

Pathways for registered and unregistered Schedule 8 cannabis medicines
under the Special Access Scheme (SAS)

[https://www.health.nsw.gov.au/pharmaceutical/Documents/pathway-reg-sas-s8cannabis.pdf]
Alternative text: Pathways for registered and unregistered Schedule 8 cannabis medicines under
the Special Access Scheme
[https://www.health.nsw.gov.au/pharmaceutical/cannabismedicines/Pages/pathway-reg-sas-
https://www.health.nsw.gov.au/pharmaceutical/cannabismedicines/Pages/how-to-apply.aspx 3/4
s8cannabis-alt.aspx] .
6/20/23, 12:22 AM How to apply to prescribe or supply Schedule 8 and unregistered cannabis medicines - Cannabis medicines

Authorised Prescriber and Clinical Trial pathways for Schedule 8 cannabis

medicines

[https://www.health.nsw.gov.au/pharmaceutical/Documents/pathway-ap-trial-s8cannabis.pdf]
Alternative text: Authorised Prescriber and Clinical Trial pathways for Schedule 8 cannabis
medicines [https://www.health.nsw.gov.au/pharmaceutical/cannabismedicines/Pages/pathway-ap-
trial-s8cannabis-alt.aspx] .

More information

For more information, visit prescribing compounded medicines

[https://www.health.nsw.gov.au/pharmaceutical/Pages/unregistered-s8s.aspx] .

Resources
Fact sheet for medical practitioners - Legal access to cannabis based medicines
[https://www.health.nsw.gov.au/pharmaceutical/Factsheets/cannabis.pdf] .

Related Links
Approvals for authority to prescribe or supply Schedule 8 cannabis medicines
[https://www.health.nsw.gov.au/pharmaceutical/Pages/authority-cannabis.aspx]

Current as at: Thursday 22 December 2022

Contact page owner: Pharmaceutical Services

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 NSW Health

Schedule 4 Appendix D drugs - Prescribed restricted

substances

Appendix D of the Poisons and Therapeutic Goods Regulation 2008 (Regulation) lists Schedule 4
substances (prescription-only medicines) that have common therapeutic uses, but are also liable to
abuse, misuse and diversion, warranting more stringent controls on possession and supply. These
substances are referred to under the Regulation as prescribed restricted substances, and are also
more commonly referred to as Schedule 4 Appendix D (S4D) medicines.

Refer to List of substances in Appendix D of the Poisons and Therapeutic Goods Regulation 2008.

Possession of a S4D medicine is prohibited unless authorised, such as in the lawful practice of a
person’s profession as a medical practitioner, pharmacist, dentist or veterinary practitioner. A person
for whom the S4D medicine has been lawfully prescribed or supplied, or their carer, may also be in
possession of the medicine. A licensed wholesaler may possess and supply S4D medicines to
authorised entities in accordance with the conditions attached to the licence. A carrier may also be in
possession of a S4D medicine for the purpose of delivering it to the addressee.

Appendix D of the Regulation (NSW Appendix D) is not the same as Appendix D of the National
Poisons Standard [https://www.tga.gov.au/publication/poisons-standard-susmp] (National Appendix
D), noting:

NSW does not automatically adopt the National Appendix D

To date, NSW has included all entries in section 5 of the National Appendix D in the NSW
Appendix D
NSW Appendix D is independently compiled in NSW, irrespective of the substance’s inclusion in
the National Appendix D
NSW Appendix D includes substances considered to be high risk warranting more stringent
controls, and includes substances other than those in the National Appendix D
NSW adopts the Schedules of the National Poisons Standard, however Appendix D of the
National Poisons Standard is not included in the Schedules

Storage
Medicines in Appendix D of the Regulation in a hospital ward or nursing home must be stored apart
from all other goods (other than drugs of addiction) 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.

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6/20/23, 12:13 AM Schedule 4 Appendix D drugs - Prescribed restricted substances - Pharmaceutical services

For further information on storage of refrigerated S4D medicines in NSW public health facilities see
section 5.4.4 of the NSW PD2022_032 Medication Handling
[https://www1.health.nsw.gov.au/pds/Pages/doc.aspx?dn=PD2022_032] .

Prescribers
Prescribing S4D medicines is the same as prescribing any other Schedule 4 medicine. Care should be
taken to monitor for overuse or misuse. Of note is that the prescription will only be valid for six
months, rather than twelve months.

Record keeping
There are specific record keeping requirements under the Regulation, however most of these details
are regularly being recorded and kept in prescribing software.

An authorised practitioner who prescribes a S4D medicine must make a record of the following
particulars:

1. the name, strength and quantity of the substance prescribed and the date on which it was
prescribed
2. if the substance is intended for the treatment of a person, the name and address of the person to
be treated
3. if the substance is intended for the treatment of an animal, the species of animal and the name
and address of the animal’s owner
4. the maximum number of times the substance may be supplied on the prescription
5. in the case of a prescription for a special restricted substance (some barbiturates and anabolic
and androgenic steroidal agents), the intervals at which the substance may be supplied on the
prescription
6. the directions for use, as shown on the prescription

The record must be kept at the surgery, hospital or office of the prescriber.

Disclosure by patient

Prescribers should note that patients who ask to be prescribed or supplied a S4D medicine must
disclose the quantity of that and any other S4D medicine with which they have been prescribed or
supplied, within the last two months. Prescribers should ask patients about such previous supplies
and note the response in their records.

Community pharmacists
There are more stringent requirements on dispensing S4D medicines on prescription, and supply
without a prescription, than other Schedule 4 medicines. A subset of S4D medicines are subject to
further requirements on dispensing. These medicines are listed in Appendix B of the Regulation and
are known as S4B medicines or 'special restricted substances'.
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Prescription validity

A prescription for a S4D medicine is valid to be dispensed only up to six months from the date it is
written and it cannot be dispensed once it is out-of-date. For example, if a patient presents a
prescription for tramadol on 17 April 2020, and the prescription is dated 16 October 2019 (more than
six months old), then the pharmacist cannot dispense the prescription as it is out-of-date.

Forged or fraudulently obtained prescriptions

Immediately on being requested to supply a S4D medicine on a paper prescription that appears to
have been forged or fraudulently obtained, or if the prescription appears to have been altered
otherwise than by the authorised practitioner by whom it was issued, a pharmacist must retain the
prescription and report the request to a police officer.

Lost or stolen S4D medicines

The loss or theft of S4D medicines must be reported to the NSW Ministry of Health. See the NSW
Health webpage on Notifying the loss or theft of drugs under Poisons and Therapeutic Goods
legislation [https://www.health.nsw.gov.au/pharmaceutical/Pages/lost-stolen-drugs.aspx] .

Doctors bag orders

A pharmacist may supply an authorised practitioner with any Schedule 4, including a S4D, medicine
for emergency use, but only on a written order signed and dated by the authorised practitioner.

Emergency supply on the direction of an authorised practitioner

A pharmacist may supply a patient with a Schedule 4, including a S4D, medicine if an authorised
practitioner directs the supply either face-to-face, by telephone, by email or by fax. The authorised
practitioner must then make out a prescription immediately and send it within 24 hours of giving the
direction to the pharmacist. If the pharmacist does not receive this prescription within seven days, a
report must be made to the NSW Ministry of Health by emailing MOH-
Pharmaceuticalservices@health.nsw.gov.au [mailto:MOH-
Pharmaceuticalservices@health.nsw.gov.au] .

Emergency supply without the direction of an authorised practitioner

There is no provision under the Regulation to supply an S4D medicine to a patient without a
prescription. The patient will need to obtain a valid prescription by an authorised prescriber.

Special restricted substances (S4B medicines)

Special restricted substances are S4D substances that are also listed in Appendix B and are
commonly referred to as S4B medicines. They include some barbiturates and anabolic and
androgenic steroidal agents. S4B medicines have more stringent dispensing requirements than other
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S4D medicines. For details see Schedule 4 Appendix B drugs - Special restricted substances
[https://www.health.nsw.gov.au/pharmaceutical/Pages/sch4b.aspx] .

Lost or stolen S4D medicines

A person authorised to be in possession of a S4D medicine (for example medical practitioner,
pharmacist, dentist, nurse, nurse practitioner, ambulance officer, veterinary practitioner,
pharmaceutical wholesaler) must report the loss or theft of a S4D medicine to the NSW Ministry of
Health. See the NSW Health webpage on Notifying the loss or theft of drugs under Poisons and
Therapeutic Goods legislation [https://www.health.nsw.gov.au/pharmaceutical/Pages/lost-stolen-
drugs.aspx] .

List of substances in Appendix D of the Poisons and Therapeutic Goods

Regulation 2008
Anabolic and androgenic steroidal agents, barbiturates and benzodiazepines that are not listed
individually are included in their classes. Salts, derivatives, preparations and admixtures of the
substances listed are controlled in the same way as the substances themselves.

Generic name

Amobarbital (amylobarbitone) [1]

Anabolic and androgenic steroidal agents [2]
Androisoxazole
AOD-9604 (CAS No. 221231-10-3)
Barbiturates [2]
Benzodiazepine derivatives [2]
Benzphetamine
Bolandiol
Bolasterone
Boldenone
Bolmantalate
Bromazepam
Calusterone
Cathine
Chlorandrostenolone
Chlordiazepoxide
Chloroxydienone
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Chloroxymesterone
CJC-1295 (CAS No. 863288-34-0)
Clobazam
Clonazepam
Clorazepate
Clostebol
Darbepoetin
Dextropropoxyphene [1]
Diazepam
Diethylpropion
Dihydrolone
Dimethandrostanolone
Dimethazine
Doxapram
Drostanolone
Enobosarm
Ephedrine
Epoetins
Erythropoietins [3]
Ethchlorvynol
Ethinamate
Ethyldienolone
Ethyloestrenol
Fencamfamin
Fenproporex
Fibroblast growth factors
Fluoxymesterone
Flurazepam
Follistatin
Formebolone
Formyldienolone
Furazabol
Glutethimide
Growth hormone releasing hormones (GHRH) [5]
Growth hormone releasing peptides (GHRP) [5]
Growth hormone releasing peptides-6 (GHRP-6)
Growth hormone secretagogues [5]
Hexarelin
Hydroxystenozol
Ibutamoren
Insulin-like growth factors
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Ipamorelin
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 [1]
Perampanel for human use
Phenobarbitone
Phentermine
Pipradrol
Pralmorelin ((growth hormone releasing peptide-2) (GHRP-2))
Prasterone
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Prazepam
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Pregabalin
Propylhexedrine
Pseudoephedrine [1]
Pyrovalerone
Quetiapine
Quinbolone
Selective androgen receptor modulators
Silandrone
Somatropin (human growth hormone)
Stanolone
Stanozolol
Stenabolic (SR9009) and other synthetic rev-erb agonists
Stenbolone
TB-500
Temazepam
Testolactone
Testosterone[4]
Tianeptine
Thiomesterone
Thymosin beta 4 (thymosin β4)
Tramadol
Trenbolone [6]
Trestolone
Triazolam
Zolazepam
Zolpidem
Zopiclone

References
1. when included in Schedule 4 of the Poisons List*
2. included in Schedule 4 of the Poisons List*, except when referred to elsewhere in this Appendix
3. except when referred to elsewhere in this Appendix
4. except when included in Schedule 6 of the Poisons List*
5. including those separately specified in Schedule 4
6. except when included in Schedule 5 of the Poisons List

*For information on the NSW Poisons List see Legislation

[https://www.health.nsw.gov.au/pharmaceutical/Pages/legislation.aspx] .

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Current as at: Tuesday 21 March 2023
Contact page owner: Pharmaceutical Services

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 NSW Health

Schedule 4 Appendix B drugs - Special restricted

substances

Appendix B of the Poisons and Therapeutic Goods Regulation 2008 (Regulation) lists Schedule 4
substances (prescription-only medicines) that have more stringent controls on possession and supply
because they are liable to abuse, misuse and diversion. These substances are referred to under the
Regulation as special restricted substances, and are more commonly referred to as Schedule 4
Appendix B (S4B) medicines.

S4B medicines are a subset of medicines listed in Appendix D of the Regulation (S4D medicines) and
have more stringent dispensing requirements than other S4D medicines. For more information about
S4D medicines see Schedule 4 Appendix D drugs - Prescribed restricted substances
[https://www.health.nsw.gov.au/pharmaceutical/Pages/sch4d.aspx] .

The following additional restrictions apply to prescribing and dispensing of S4B medicines:

Paper prescriptions (handwritten or computer-generated, printed prescriptions):

A prescription for a S4B medicine with repeats must have an interval for repeats, in the same
way as a prescription for a Schedule 8 (S8) medicine.
A pharmacist who supplies a S4B medicine must keep the prescription whether or not the
prescription authorises more than one supply of the substance. This means paper repeats for
a S4B medicine must be kept at the pharmacy, separately from other prescriptions (except
S8 and other S4B prescriptions), and must not be given to the patient.
If the prescriber has not clearly specified an interval for repeats on a S4B medicine paper
prescription, the pharmacist dispensing the first supply must write the word CANCELLED in
ink across the prescription. Directions for any repeat supplies are invalid and no repeats can
be dispensed.

Paper form of the National Residential Medication Chart/chart equivalents:

The prescriber must issue a separate paper-based prescription (as above) for a S4B medicine
with an interval for repeats as well as writing the order to administer the medicine on the
medication chart. The paper-based prescription must be kept at the pharmacy separate to
other prescriptions (except S8 and other S4B prescriptions).

Electronic prescriptions [https://www.health.nsw.gov.au/pharmaceutical/Pages/electronic-

prescribing.aspx] from conformant electronic prescribing systems (other than for electronic
forms of medication chart prescriptions on an approved National Residential Medication
Chart/chart equivalent):

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An electronic prescription for a S4B medicine with repeats must have an interval for repeats,
in the same way as a prescription for a S8 medicine. This includes all electronic prescriptions
in the community. The prescriber must ensure the instruction is entered. If no repeat intervals
appear on the electronic prescription, directions for any repeat supplies are invalid and no
repeats can be dispensed. The pharmacist may only dispense a single supply. The
prescription should be electronically cancelled to prevent a new token from being issued.
Conformant systems retain details of dispensed prescriptions therefore there is no need for a
pharmacist to keep any paper copies of dispensed S4B medicine prescriptions.

List of substances in Appendix B of the Poisons and Therapeutic Goods

Regulation 2008
Anabolic and androgenic steroidal agents that are not listed individually are included in their classes.
The substances are listed by generic name. Some may have more than one medicine brand name.

Amylobarbital (amylobarbitone) [1]

Anabolic and androgenic steroidal agents [2]
Drostanolone
Ethyloestrenol
Fluoxymesterone
Mesterolone
Methandienone
Methandriol
Methenolone
Methylandrostanolone
Methyltestosterone
Mibolerone
Nandrolone
Norethandrolone
Oxandrolone
Oxymesterone
Oxymetholone in preparations for therapeutic use
Pentobarbitone [1]
Stanolone
Stanozolol
Testosterone [3]

References

1. when included in Schedule 4 of the Poisons List* (i.e. when for injection)
2. included in Schedule 4 of the Poisons List*, except when referred to elsewhere in the Appendix
3. except when included in Schedule 6 of the Poisons List* (i.e. when in implants for animals)
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*For infomation on the NSW Poisons List refer to Legislation

[https://www.health.nsw.gov.au/pharmaceutical/Pages/legislation.aspx] .

Current as at: Thursday 16 June 2022

Contact page owner: Pharmaceutical Services

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