The Controlled Substances Act 1984 and the Controlled Substances (Poisons) Regulations 2011 regulate the prescription, supply, and administration of drugs and poisons in South Australia. This legislation is administered by the Drugs of Dependence Unit, SA Health. The following is a non-exhaustive guide to the major legal obligations only. Reference should be made to the legislation for further information. Pharmacists are expected to be familiar and comply with the below information.
The Act provides pharmacists with certain privileges not available to the general public. In exchange for these privileges, it expects pharmacists to be aware of the requirements of the Act, to act lawfully and act responsibly at all times. These privileges may be withdrawn by order of the Minister responsible for the Act if a conviction is obtained or an opinion is formed that the pharmacist has acted irresponsibly in handling prescription drugs (Section 57 of the Act).
See also: Legal requirements when prescribing or supplying drugs of dependence
See the Controlled Substances Act 1984 Pharmacists' obligations (PDF 236KB) for a downloadable copy.
See below information on general controls and prescription drug controls
Schedule 2 / Pharmacy Medicine – Pharmacy and Medicine Sellers – Pharmacist advice should be available.
Schedule 3 / Pharmacist Only Medicine – Pharmacy only – Expert advice is required on use of the drug - Pharmacist advice is required and a Pharmacist must take part in the sale
Schedule 4 / Prescription Only Medicine – Professional diagnosis and monitoring is required – prescribed or supplied by a Medical Practitioner, Dentist or Veterinary Surgeon, Dispensed by pharmacist on prescription.
Schedule 6 / Poison – Substances with a moderate potential for causing harm, the extent of which can be reduced through the use of distinctive packaging with strong warnings and safety directions on the label.
Schedule 7 / Dangerous Poison – Substances with a high potential for causing harm at low exposure and which require special precautions during manufacture, handling or use.
Schedule 8 / Controlled Drug or Drug of Dependence – As for Schedule 4 but because of their high abuse potential, additional security, records and accountability is required.
"Prescription drugs" refers to Schedule 4 and Schedule 8 drugs.
"Controlled Drugs" are drugs of dependence and other drugs that have no medical use and a high abuse potential.
For further information refer to the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP).
Section 13,14,15,18, and 31
Pharmacists may manufacture, produce, pack, sell or supply scheduled poisons where such activity is part of ordinary pharmacy practice. Mass production is considered to be manufacturing and requires a licence.
Regulation 40
Section 14,15,18, and 31
Pharmacists are authorised to sell or supply all classes of drugs and poisons but must be satisfied the supply is lawful.
Regulation 13
A Pharmacist must personally (not through an assistant) give oral directions, supplemented where practicable with written directions, for the safe and proper use of a schedule 3 medicine to the person who is being supplied the medicine.
Certain S3 medicines must be labelled according to the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) (Regulation 26). These medicines are:
For further information refer to Project STOP.
Regulation 14
Pharmacists must not sell or supply pseudoephedrine (either as Schedule 3 or Schedule 4) unless the person presenting for the supply provides a specified form of photo-identification or his or her birth certificate. Accepted forms of photo-identification include a current:
The records of sale or supply must be made in an electronic form that is accessible via the internet to the Chief Executive of the Department for Health and Wellbeing and the Commissioner of Police.
Section 16
Regulation 12 and 21
Schedule 7 poisons must not be sold to a person under 18 years of age, a person not known to the pharmacist (unless evidence of identity is produced) or for domestic or garden use.
A record of the sale must be kept including the intended use of the poison and the licence number is applicable.
Regulation 8A
The Controlled Substances (Controlled Drugs, Precursors and Plants) Regulations 2000 permits a pharmacist to supply needles, syringes and advice regarding their safe use to drug users.
Section 24
Regulation 26
Prescribed medicines (medicines listed in Schedule 1 to Therapeutic Goods Order No. 80) must be provided in child resistant packaging or containers except where the pharmacist believes that the person would suffer undue hardship through difficulty in opening a container that complies with that Order.
Section 24
Regulation 26
All poisons must be labelled with the original manufacturers label or labelled with the name (trade and approved), form and strength of the medicine, directions for safe use including route of administration, name of patient, date dispensed, reference number linking to the prescription record if dispensed, name and address of pharmacy.
Drugs for patient use must be labelled according to the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP). Warning labels such as a drowsiness warning label may also be required.
Section 25
Regulation 27, Code of Practice for the Storage and Transport of Drugs of Dependence
S4 drugs must be stored to prevent public access.
No poison can be stored:
Schedule 8 drugs must be stored to prevent unauthorised access, for instance generally in a locked safe or vault.
Minimum specifications depend on the number of doses stored. The standard 10mm steel pharmacy safe is sufficient if 500 or less doses, or 1000 or less doses if there is 24 hour alarm monitoring.
Larger quantities, or where there is less monitoring, require greater security.
For further information refer to the Code of Practice for the Storage and Transport of Drugs of Dependence
Section 25
Regulation 28 and 239
Schedule 8 drugs must be transported in a manner consistent with the Code of Practice for the Storage and Transport of Drugs of Dependence.
Using Australia Post to transport Schedule 8 drugs is prohibited, unless the particular distribution program is exempted under the Crimes Act 1914 . Where it is necessary to transport Schedule 8 drugs, for example to remote locations, this must be arranged through a courier service and comply with relevant provisions of the Code of Practice for the Storage and Transport of Drugs of Dependence.
Schedule 8 drugs must maintain a drug of dependence register and record all transactions. (Regulation 41)
All records must be kept a minimum of two years from date of last entry on the record. (Regulation 49)
For applications to include a new electronic drug register to the approved list – please refer to Application for Electronic Drug Registers.
Approved electronic registers available:
*Previously Methsof Pty Ltd
A pharmacist may not advertise a Schedule 3, 4 or 8 medicine except where the following applies:
An employer may be held responsible for the actions of an employee.
Section 18
Regulation 35 and 37
Regulation 21
Pharmacists are permitted to supply Schedule 4 drugs on receipt of a written order to:
For drugs of dependence
Regulation 40
Section 18
Regulation 18
Regulation 33 and 34
Prescriptions for Schedule 4 and Schedule 8 drugs must be legible, written in ink and include the following**:
** This does not apply to a medical practitioner who writes a medication chart prescription for an Schedule 4 medicine that may be supplied under the Medication Charts Program (when that Program comes into operation). Refer to the National Health (Residential Medication Chart) Determination.
For drugs of dependence (Schedule 8 drugs), prescriptions must also include:
Prescriptions are valid for a period of 12 months from the date of prescribing and 6 months in the case Schedule 8 drugs.
Regulation 35
Only valid prescriptions may be dispensed.
The pharmacist must:
In the case of a drug of dependence:
Regulation 35 (12)
Regulation 21
Regulation 33
A prescriber may, where there is a good reason, give a prescription by telephone, facsimile, or other electronic means.
The same information as required for a written prescription must be provided. Unless the prescription was faxed and endorsed with the name of the single pharmacy to dispense the prescription, the prescriber must forward a written prescription as confirmation as soon as practical or if a drug of dependence, within 24 hours.
These drugs of dependence may be used in opioid pharmacotherapy (Medication Assisted Treatment for Opioid Dependence Program) with supervised administration of doses and, when appropriate, limited take-away doses. All requirements covering drugs of dependence, including prescription records, labelling of dispensed doses for patient self-administration, storage, drug register and monthly prescription returns apply as for other drugs of dependence.
Regulation 40
A drug of dependence may be supplied on receipt of an order where the pharmacist is satisfied the person ordering is lawfully authorised to possess the drug, (this includes patients, medical practitioners, dentists, veterinary surgeons and licence holders).
If the person is not known to the pharmacist he or she must provide satisfactory identification before the drug is supplied, and provide the pharmacist with a signed and dated receipt for the drug.
Schedule 8 drugs pharmacists must maintain a drug of dependence register and record all drug transactions.
All records must be retained, protected and available for inspection for a period of two years from date of last entry on the record (regulation 35).
The supply must be recorded with the following details and the pharmacist must sign the record:
Cancelled orders (unless supplying to a health service) must be forwarded to Drugs of Dependence Unit each month with the prescription returns.
Regulation 35 and 40
A drug of dependence must not be supplied without prior receipt of a lawful order or prescription (written, verbal, fax or by other permitted electronic transmission)
A Schedule 4 drug may be supplied to a person by a pharmacist without an order or prescription provided
Destruction and disposal must be witnessed by another appropriate person (ie. pharmacist, registered health practitioner, an authorised officer, police officer, registered veterinary surgeon or a person who has been authorised in writing by the Chief Executive of the SA Ambulance Service to administer drugs of dependence). A record including the full names and signatures of the person and the witness to the destruction, name, strength and amount of drug; and the date and time of destruction must be made immediately after the drug is destroyed.
Drugs must be rendered unusable (damage that is so severe that the drug is unrecoverable), disposed of in an environmentally responsible way and so there is no risk to the public of them being reused or diverted.
Destruction and disposal of drugs of dependence must not pose a risk to public health or safety (Regulation 48).
The Pharmacy Regulation Authority SA (PRASA) may be able provide practical advice about how to destroy and dispose of specific prescription drugs (PDF 1.2MB) at your pharmacy.
It is an offence for a person to obtain or attempt to obtain a prescription drug by fraud or have in his or her possession or utter a forged document to obtain a prescription drug. (Section 30)
Pharmacists should take all reasonable actions to ensure they are treating a genuine medical condition and treatment does not contribute to the induction of drug dependence, maintenance of drug dependence without a proper treatment plan or add to the pool of drugs available for illicit drug trafficking.
Supply without due diligence may be considered to be "irresponsible" and result in the serving of an Order which effectively removes privileges granted to a pharmacist to handle prescription drugs. (Section 57)
Pharmacists may contact the Drugs of Dependence Unit if suspicious of a person seeking prescription drugs. Unit officers, acting for the Minister for Mental Health and Substance Abuse, are empowered to provide information regarding medical history to a Medical Practitioner where an opinion is formed the person is drug dependent and acting illegally. The Minister also publishes a "Privileged Circular" periodically listing those major drug seekers at the time with the aim to restrict or stop further supplies of drugs to those persons. (Section 58)
For more information, see the Forged prescription notifications page.
Regulation 19
Clomiphene, cyclofenil, follitropin-alpha, follitropin-beta, luteinisinghormone, or urofollitrophinmay only be supplied if prescribed or ordered by a specialist in endocrinology, obstetrics and gynaecology or a medical practitioner providing services to a fertility unit, an endocrinology unit, or an obstetric and gynaecological unit in a teaching hospital.
Acitretin, bexarotene and etretinate (for human use) and isotretinoin (for human internal use) and may only be supplied if prescribed or ordered by a specialist in dermatology, oncology or haematology (or a medical registrar working under such a specialist), or such other specialist individually authorised by the Minister.
Tretinoin (for human internal use) may only be supplied if prescribed or ordered by a specialist in oncology or haematology (or a medical registrar working under such a specialist) or such other specialist individually authorised by the Minister.
Thalidomide or lenalidomide for human use may only be supplied if prescribed or ordered by a specialist in oncology or haematology (or a medical registrar working under such a specialist), or a medical practitioner individually authorised by the Minister.
Ambrisentan, bosentan, and sitaxentan may only be prescribed or ordered by a relevant specialist (or a medical registrar working under such a specialist) or a medical practitioner individually authorised by the Minister.
Prescribers must be authorised by the Secretary of the Commonwealth Department of Health and Ageing to prescribe or order dronabinol (contact the TGA). Authority to prescribe will not be granted by the South Australian Minister for Mental Health and Substance Abuse unless the applying prescriber can demonstrate he or she is in possession of a Commonwealth authority.
Convictions against the Act, or where the Minister forms an opinion a prescription drug (Schedule 4 or Schedule 8) has been prescribed, supplied, or administered in an "irresponsible manner", may result in a Prohibition Order that effectively removes the ability of a pharmacist to handle these drugs. Other courses of action may include prosecution and or reporting the alleged conduct to the Australian Health Practitioner Regulation Agency.
Pharmacists are encouraged to telephone the Drugs of Dependence Unit to discuss cases where guidance or advice is required.
