Part 3—Application of Part 4 of Act (general offences)
9—Manufacture, production and packing (section 13 of Act)
Section 13 of the Act applies to all S1 poisons, S2 poisons, S3 poisons and S7 poisons.
10—Exemption from section 13 of Act
The holder of a licence under the Commonwealth Act to manufacture goods is exempt from the requirement to hold a licence under section 13 of the Act in respect of the manufacture of those goods.
11—Sale by wholesale (section 14 of Act)
Section 14 of the Act applies to all S1 poisons, S2 poisons, S3 poisons and S7 poisons.
12—Sale or supply to end user (section 15 of Act)
(1) Section 15 of the Act applies to all S1 poisons, S2 poisons, S3 poisons and S7 poisons.
(2) A council, council subsidiary or health service facility is exempt from section 15 of the Act in respect of the supply by the council, council subsidiary or health service facility of adrenaline for administration to a person as part of an immunisation program delivered by the council, council subsidiary or health service facility.
13—Directions to be given for safe and proper use of S3 poisons sold by retail etc
(1) Subject to subregulation (2), a person who sells by retail or supplies an S3 poison must personally (not through an assistant) give oral directions, supplemented wherever practicable with written directions, for the safe and proper use of the poison to the person purchasing or being supplied with the poison.
(2) An interpreter may be used to assist in the giving of oral directions if the person purchasing or being supplied with the poison is not sufficiently familiar with the English language.
14—Special provisions relating to sale or supply of pseudoephedrine
(1) A person must not sell or supply pseudoephedrine unless a prescribed identification document or a birth certificate is produced by the person to whom the pseudoephedrine is to be sold or supplied.
(2) A person who sells or supplies pseudoephedrine must make and keep a record of the following information:
(a) the name and address of the person to whom the pseudoephedrine is being sold or supplied;
(b) the form of prescribed identification document produced by the person to whom the pseudoephedrine is being sold or supplied;
(c) the unique identification number (if any) on the prescribed identification document produced;
(d) the date of the sale or supply;
(e) the directions given for the safe and proper use of the pseudoephedrine;
(f) the trade name or the approved name of the pseudoephedrine being sold or supplied, or, if it does not have either a trade name or approved name, its ingredients and the form, strength and quantity sold or supplied;
(g) a unique identifier enabling those records to be linked with the pseudoephedrine sold or supplied.
(3) Subregulations (1) and (2) do not apply in relation to—
(a) the sale of pseudoephedrine by wholesale; or
(b) the sale or supply of pseudoephedrine in the course of professional practice by—
(i) a pharmacist in a hospital; or
(ii) a registered health practitioner other than a pharmacist; or
(iii) a veterinary surgeon.
(4) A person who makes a record under subregulation (2) must keep it in an electronic form that is accessible via the internet by the Chief Executive and the Commissioner of Police.
(5) In this regulation—
Australian student identification card means a card issued by an Australian educational institution to identify a person studying at the institution;
birth certificate of a person means a certified copy of, or extract from, a register of births kept under an Australian law, or under the law of the country in which the person was born;
driver's licence means—
(a) a driver's licence issued under the Motor Vehicles Act 1959; or
(b) an interstate licence, interstate learner's permit or foreign licence within the meaning of that Act;
prescribed identification document means a current—
(a) driver's licence; or
(b) firearms licence; or
(c) passport (other than an Australian passport); or
(d) proof of age card; or
(e) Australian student identification card,
that bears a photograph of the holder;
proof of age card means a proof of age card issued by the Registrar of Motor Vehicles or by a corresponding public authority of another State or a Territory of the Commonwealth.
15—Sale of certain poisons (section 16 of Act)
(1) Section 16 of the Act applies to all S7 poisons.
(2) For the purposes of section 16(4) of the Act, a person who sells S7 poisons must keep records of such matters as are specified in Part 2 Section 56(1) of the Uniform Poisons Standard.
16—Declaration of precursors (sections 17A, 17B and 17C of Act)
(1) Section 17A of the Act applies to the following poisons:
1-Chlorophenyl-2-aminopropane
3,4-Methylenedioxyphenylpropan-2-one (PMK)
1-Phenyl-2-bromopropane
1-Phenyl-1-chloro-2-methylaminopropane
1-Phenyl-2-chloropropane
1-Phenyl-2-iodopropane
1-Phenyl-2-nitropropene.
(2) Section 17B of the Act applies to the following poisons:
Part Part 3 - Controlled Substances (Poisons) Regulations 2011 - Application of Part 4 of Act (general offences) | Zoe
Chemical name
Alternative name
CAS number
Acetic anhydride
8006-80-2
Sodium bis(2-methoxyethoxy) aluminium hydride
Sodium dihydrido-bis(2-methoxyethoxy) aluminate
22722-98-1
Sodium cyanoborohydride
Sodium borocyanohydride
25895-60-7
(3) Section 17C of the Act applies to the following poisons:
Acetaldehyde
N‑Acetylanthranilic acid
Allylbenzene
Ammonium formate
Anthranilic acid
Benzaldehyde
1,3‑benzodioxole
Benzyl bromide
Benzyl chloride
5‑bromo‑1,3‑benzodioxole
Chromic acid (including salts)
Ergometrine
Ergotamine
Ethanamine
N‑Ethylephedrine
N‑Ethylpseudoephedrine
Eugenol
Formaldehyde
Formamide
Hydrobromic acid
Iodine (including iodide salts)
Isosafrole
Lithium
Lysergic acid
Magnesium
Mandelic acid
Mercuric chloride
Mercury
Methylamine
Methylammonium salts
N‑methylformamide
Nitroethane
Nitromethane
Palladium (including salts)
Phenylalanine
Piperidine
Platinum
Potassium
Propionic anhydride
Raney nickel
Sodium
Sodium borohydride
Thionyl chloride
Thorium (including salts)
Trans‑beta‑methylstyrene.
17—End user statement for precursors (sections 17B and 17C of Act)
For the purposes of sections 17B(1)(c) and 17C(1)(a) of the Act, the form of end user statement in Schedule 1 is prescribed.
17A—Regulation of prescription drugs—prescription by pharmacists of certain prescription drugs (section 18(1)(a)(iii) of Act)
(1) For the purposes of section 18(1)(a)(iii) of the Act, a pharmacist is authorised to prescribe a prescription drug (not being a drug of dependence) if—
(a) the pharmacist is included on the register of authorised pharmacists; and
(b) the drug is prescribed in accordance with the Community Pharmacist Prescribing Code.
(2) The Minister may authorise a pharmacist for the purpose of this regulation (an authorised pharmacist) if the Minister is satisfied that the pharmacist meets the criteria and requirements set out by the Community Pharmacist Prescribing Code.
(3) The Minister must cause a register of authorised pharmacists to be kept and made available to the public on a website operated by, or on behalf of, the Department.
Community Pharmacist Prescribing Code means the document of that name published by the Department, as in force from time to time.
18—Regulation of prescription drugs—administration of certain S4 drugs (section 18(1d)(a)(iii) of Act)
(1) For the purposes of section 18(1d)(a)(iii) of the Act, a dental hygienist, dental therapist, oral health therapist or podiatrist is authorised to administer any of the following S4 drugs:
Articaine
Benzocaine
Bupivacaine
Levobupivacaine
Lignocaine
Mepivacaine
Prilocaine
Ropivacaine.
(2) For the purposes of section 18(1d)(a)(iii) of the Act, an optometrist is authorised to administer any of the following S4 drugs:
Eye drops containing 0.5% or less of amethocaine
Eye drops containing 1.0% or less of atropine sulphate
Eye drops containing 1.0% or less of cyclopentolate hydrochloride
Eye drops containing 2.0% or less of homatropine hydrobromide
Eye drops containing 0.5% or less of lignocaine
Eye drops containing 0.5% or less of oxybuprocaine
Eye drops containing 2.0% or less of pilocarpine nitrate
Eye drops containing 0.5% or less of proxymetacaine
Eye drops containing 1.0% or less of tropicamide.
(3) For the purposes of section 18(1d)(a)(iii) of the Act, a registered health practitioner of a class determined by the Minister may administer a prescription drug (not being a drug of dependence) to a person if—
(a) the registered health practitioner has successfully completed a training program approved by the Minister from time to time for the purposes of this subregulation; and
(b) the drug is listed in the Vaccine Administration Code or is a drug approved by the Minister from time to time for the purposes of this subregulation; and
(c) the drug is administered as part of—
(i) an immunisation program delivered by—
(A) an incorporated hospital; or
(B) SAAS; or
(C) a council or council subsidiary; or
(ii) an immunisation program delivered by an organisation approved by the Minister for the purposes of this subregulation; and
(d) the drug is administered in accordance with—
(i) the Vaccine Administration Code; and
(ii) —
(A) in the case of a drug administered as part of the National Immunisation Program—the National Immunisation Program Schedule and the Australian Immunisation Handbook; or
(B) in any other case—requirements specified by the Minister.
(3a) For the purposes of section 18(1d)(a)(iii) of the Act, a pharmacist may administer an S4 drug that is a vaccine to a person if—
(a) the pharmacist has successfully completed an immunisation education or training program accredited for pharmacists by—
(i) Australian Pharmacy Council Ltd; or
(ii) Health Education Services Australia Pty Ltd; or
(iii) any other person or body approved by the Minister for the purposes of this subregulation; and
(b) the drug is administered in accordance with—
(i) if instructions for the administration of the drug are in the Australian Immunisation Handbook—the Australian Immunisation Handbook; or
(ii) in any other case—requirements specified by the Minister.
Australian Immunisation Handbook means The Australian Immunisation Handbook published by the Commonwealth Department of Health and Ageing, as in force from time to time;
National Immunisation Program Schedule means the National Immunisation Program Schedule published by the Commonwealth Department of Health and Ageing, as in force from time to time.
19—Regulation of prescription drugs—prescription of certain S4 drugs by medical practitioners (section 18(2) of Act)
(1) For the purposes of section 18(2) of the Act—
(a) each of the S4 drugs listed in column 1 of the table below, when used for the purpose set out in column 2, is a prescribed prescription drug; and
(b) the qualifications and requirements specified in that table alongside a drug or list of drugs in column 3 are prescribed qualifications and requirements.
Prescription drug
Use
Qualifications and requirements
Clomiphene
Cyclofenil
Follitropin alpha (recombinant human follicle stimulating hormone)
Follitropin beta (recombinant human follicle stimulating hormone)
Luteinising hormone
Urofollitrophin (follicle stimulating hormone)
(a) is registered in the specialty of endocrinology or obstetrics and gynaecology; or
(b) provides services to a fertility unit, an endocrinology unit or obstetrics and gynaecology unit of a teaching hospital in South Australia.
Acitretin
Bexarotene
Etretinate
(a) is registered in the specialty of dermatology, oncology or haematology; or
(b) is a medical registrar working under the supervision of a medical practitioner referred to in paragraph (a); or
(c) is registered in some other specialty and is authorised by the Minister to prescribe such drugs.
Isotretinoin
Human internal use
(a) is registered in the specialty of dermatology, oncology or haematology; or
(b) is a medical registrar working under the supervision of a medical practitioner referred to in paragraph (a); or
(c) is registered in some other speciality and is authorised by the Minister to prescribe such drugs.
Tretinoin
Human internal use
(a) is registered in the specialty of oncology or haematology; or
(b) is a medical registrar working under the supervision of a medical practitioner referred to in paragraph (a); or
(c) is registered in some other speciality and is authorised by the Minister to prescribe such drugs.
Lenalidomide
Pomalidomide
Thalidomide
(a) is registered in the specialty of oncology or haematology; or
(b) is a medical registrar working under the supervision of a medical practitioner referred to in paragraph (a); or
Ambrisentan
Bosentan
Macitentan
Sitaxentan
(b) is a medical registrar who is working under the supervision of a medical practitioner referred to in paragraph (a); or
Enzalutamide
(b) is a medical registrar who is working under the supervision of a medical practitioner referred to in paragraph (a); or
Riociguat
(b) is a medical registrar who is working under the supervision of a medical practitioner referred to in paragraph (a); or
(2) A medical practitioner who prescribes an S4 drug listed in the table in subregulation (1) (other than in item 1) must—
(a) inform the patient of the name of the drug and that the drug may cause birth defects; and
(b) provide the patient with written information about the drug and its potential side effects; and
(c) inform the patient of the dangers should the patient unlawfully supply the drug to another person; and
(d) if the patient is a female of child‑bearing age—
(i) ensure that the possibility of pregnancy has been excluded prior to commencement of treatment; and
(ii) inform her that she must not become pregnant during treatment or within the prescribed period after completion of treatment; and
(e) obtain written consent for the treatment from the patient.
prescribed period means—
(a) in the case of treatment with a drug listed in item 2 of the table in subregulation (1) (other than bexarotene)—24 months;
(b) in the case of treatment with bexarotene or a drug listed in item 3, 4, 5 or 8 of that table—1 month;
(c) in the case of treatment with a drug listed in item 6 or 7 of that table—3 months.
20—Regulation of prescription drugs—prescription of certain S8 poisons by medical practitioners (section 18(2) of Act)
(1) For the purposes of section 18(2) of the Act—
(a) each of the S8 poisons listed in column 1 of the table below, when used for the purpose set out in column 2, is a prescribed prescription drug; and
(b) the qualifications and requirements specified in that table alongside a drug in column 3 are prescribed qualifications and requirements.
Prescription drug
Use
Qualifications and requirements
N,α‑dimethyl‑3,4‑(methylenedioxy)phenylethylamine (MDMA)
Human use, for the treatment of post-traumatic stress disorder
A medical practitioner—
(a) who is registered in the specialty of psychiatry; and
(b) for whom an authority under section 19(5) of the Commonwealth Act that covers MDMA is in force.
Psilocybine (Psilocybin)
Human use, for the treatment of treatment-resistant depression
A medical practitioner—
(a) who is registered in the specialty of psychiatry; and
(b) for whom an authority under section 19(5) of the Commonwealth Act that covers psilocybine is in force.
(2) A medical practitioner who prescribes an S8 poison listed in the table in subregulation (1) must, within 1 business day of prescribing the poison and for the purposes of the Chief Psychiatrist performing the Chief Psychiatrist's functions under the Mental Health Act 2009, give notice to the Chief Psychiatrist—
(a) in a form determined by the Chief Psychiatrist; and
(b) containing such information as the Chief Psychiatrist may determine.
21—Exemptions from section 18 of Act
(1) A council, council subsidiary or health service facility is exempt from section 18(1c)(d) of the Act in respect of the supply of an S4 drug under an immunisation program run by the council, council subsidiary or health service facility.
(2) A pharmacist who sells or supplies an S4 drug without dispensing a prescription is exempt from section 18(1b)(a) and (1c)(a) of the Act in relation to that sale or supply if—
(a) the drug is sold or supplied to a council, council subsidiary or health service facility for use in an immunisation program delivered by the council, council subsidiary or health service facility and the pharmacist has received a written order for the drug from the council, council subsidiary or health service facility; or
(b) the drug is for use by a person who holds a licence to sell, supply or administer an S4 drug and the pharmacist has received a written order for the drug from the licensee; or
(c) the drug is sold or supplied for the mass treatment of certain animals to the owner of the animals and—
(i) the pharmacist has received a written order for the drug from a veterinary surgeon; or
(ii) —
(A) the drug is an antibiotic; and
(B) the pharmacist has received a written order for the drug from an inspector appointed under the Livestock Act 1997; and
(C) the written order is on a form approved by the Chief Inspector of Stock under that Act and has been countersigned by the Chief Inspector; or
(d) the drug is sold or supplied to a registered health practitioner or veterinary surgeon authorised to sell, supply or administer S4 drugs and the pharmacist has received a written order for the drug from that practitioner or veterinary surgeon; or
(e) the drug is authorised or required by the law of any place to be carried on board a ship and the pharmacist has received a written order for the drug from the master or medical officer of the ship; or
(f) the drug is not one listed in the table in regulation 19(1) for the purposes of section 18(2) of the Act and the pharmacist—
(i) is satisfied that—
(A) the person for whom it is to be sold or supplied is being medically treated with the drug; and
(B) the continued sale or supply of that drug is essential to the health of that person; and
(C) there is good reason for the person's inability to produce a prescription for the drug; and
(ii) sells or supplies—
(A) where the pharmacist is satisfied that the person for whom it is to be sold or supplied is affected by an emergency specified by the Minister by notice under subregulation (2a) and the sale or supply occurs during the period specified in relation to that emergency in the same notice—
• for drugs that are on the Pharmaceutical Benefits Scheme—no more than the standard Pharmaceutical Benefits maximum quantity; or
• for drugs that are not on the Pharmaceutical Benefits Scheme—the quantity that is contained in the smallest standard pack in which the drug is generally available; or
(B) in any other case—
• if the drug is a cream, ointment or liquid or one that is packaged in such a manner as to promote the safe and proper use of the drug—the smallest standard package or container made by the manufacturer; or
• if the drug is not a cream, ointment or liquid or other drug described above—no more than 3 days dosage of the drug; and
(iii) on the day on which the drug is sold or supplied, records—
(A) his or her name as the seller or supplier of the drug; and
(B) the date; and
(C) the trade name or the approved name of the drug, or, if it does not have either a trade name or approved name, its ingredients; and
(D) the name and address of the person for whom the drug is sold or supplied; and
(E) the form, strength and quantity of the drug; and
(F) the directions given for the safe and proper use of the drug, including (where appropriate) the route of administration of the drug; or
(g) the drug is a prescribed (continued dispensing) pharmaceutical benefit and the sale or supply is made in accordance with the conditions specified in the National Health (Continued Dispensing) Determination; or
(h) the drug is sold or supplied to a person in accordance with a scheme determined by the Minister from time to time for the purposes of this paragraph by notice in the Gazette.
(2a) If the Minister is satisfied that an emergency (within the meaning of the Emergency Management Act 2004) is occurring in an area of the State, the Minister may, by notice in the Gazette, specify the emergency and a period of time in relation to that emergency for the purposes of subregulation (2)(f)(ii)(A).
(2b) A notice under subregulation (2a)—
(a) may specify the emergency by reference to any factor the Minister thinks fit (including, without limitation, by a description of the circumstances of the emergency, the area within which the emergency is occurring or by any description by which the emergency is commonly known); and
(b) may, from time to time as the Minister thinks fit, be varied or substituted by a new notice or be revoked.
(3) The holder of a licence under the Commonwealth Act to manufacture goods is exempt from section 18(1e) of the Act in respect of the manufacture of those goods.
Pharmaceutical Benefits Scheme means the Pharmaceutical Benefits Scheme under the National Health Act.
22—Exemptions from section 18A of Act
(1) A registered health practitioner authorised to prescribe or supply a drug of dependence is exempt from section 18A(1) of the Act in respect of the prescription or supply of such a drug for use by a person in respect of whom a section 18A authority exists if—
(a) in the case of a person who is receiving treatment in a hospital or correctional institution—
(i) the registered health practitioner notifies the holder of the section 18A authority that the practitioner has prescribed or supplied the drug or is intending to prescribe or supply the drug in respect of that person; and
(ii) the drug is only administered to the person while in the hospital or correctional institution; and
(iii) if the drug is solely for the treatment of drug dependence—the dose administered does not exceed the dose authorised; or
(b) in the case of a person who is being discharged from a hospital following treatment in the hospital—
(i) the registered health practitioner notifies the holder of the section 18A authority that the practitioner has prescribed or supplied the drug or is intending to prescribe or supply the drug in respect of that person; and
(ii) if the drug is solely for the treatment of drug dependence—the dose prescribed does not exceed the dose authorised; or
(c) in the case of a person not referred to in paragraph (a) or (b)—
(i) the registered health practitioner prescribing or supplying the drug—
(A) notifies the holder of the section 18A authority that the practitioner has prescribed or supplied the drug or is intending to prescribe or supply the drug in respect of that person; or
(B) is a medical practitioner (including a locum for the time being substituting for such a practitioner) in the same practice as the holder of the section 18A authority; and
(ii) the registered health practitioner prescribing or supplying the drug does so with the approval of the holder of the section 18A authority; and
(iii) the registered health practitioner prescribing or supplying the drug complies with the section 18A authority relating to the person for whom the drug is prescribed or to whom the drug is supplied.
(2) A registered health practitioner authorised to prescribe or supply a drug of dependence is exempt from section 18A(1) of the Act in relation to the prescription or supply of such a drug for a person in respect of whom a section 18A authority does not exist if—
(b) the drug (not being dextromoramide or pethidine) is for use by a person whose life expectancy is reasonably believed by the registered health practitioner principally responsible for treatment of the person, to be less than 12 months and—
(i) the registered health practitioner has informed the Minister of the person's name and address, date of birth and the nature of the condition for which the drug is prescribed; and
(ii) the prescription for the drug is endorsed either "Notified Palliative Care Patient" or "NPCP"; or
(c) the drug is for use by a person who is receiving treatment in a hospital or correctional institution and the duration of treatment of the person with the drug while the person is in the hospital or correctional institution does not exceed 14 days; or
(d) the drug is for use by a person who is being discharged from a hospital following treatment in the hospital and the duration of treatment of the person with the drug after discharge does not exceed 14 days; or
(e) —
(i) the drug is prescribed or supplied by a registered health practitioner solely for the treatment of drug dependence and as part of a drug treatment service program administered by an incorporated hospital; and
(ii) an application for a section 18A authority is made in respect of the person by a registered health practitioner practising at the drug treatment service program within 5 business days of the drug being prescribed or supplied to the person.
section 18A authority means an authority granted by the Minister to a registered health practitioner under section 18A of the Act to prescribe or supply a drug of dependence.
23—Sale or supply of volatile solvents (section 19 of Act)
(1) Section 19(3) of the Act applies to—
(a) nitrous oxide; and
(b) volatile solvents that are petroleum products.
(1a) For the purposes of section 19(3) of the Act, the age prescribed is—
(a) in the case of nitrous oxide—18 years; or
(b) in the case of a volatile solvent that is a petroleum product—16 years.
(1b) A person is exempt from section 19(3) of the Act in respect of the supply of nitrous oxide to a person who is under the age of 18 years if—
(a) the first person lawfully carries on a business of selling nitrous oxide; and
(b) the second person is an employee of the first person; and
(c) the supply is in the ordinary course of business.
(1c) The Minister may, by notice in the Gazette, exempt any person from section 19(3) of the Act in respect of the sale or supply of nitrous oxide subject to such conditions (if any) as the Minister thinks fit.
(2) A person who sells or supplies a volatile solvent for use as an inhalant in medical or dental treatment is exempt from section 19 of the Act in respect of that sale or supply.
23A—Special provisions relating to retail sale of nitrous oxide
(1) A person must not sell a substance that is, or purports to be, nitrous oxide by retail between the hours of 10 pm and 5 am on the following day.
(2) A person who sells a substance that is, or purports to be, nitrous oxide from premises by retail must ensure that the substance is—
(a) stored in a part of the premises to which members of the public are not permitted access; and
(b) stored in such a way that it is not visible to members of the public at the premises.
(3) A person who sells a substance that is, or purports to be, nitrous oxide from premises by retail must display a notice that complies with the requirements in subregulation (4) in a manner and position that is likely to attract the attention of customers.
Maximum penalty: $2 500.
Expiation fee: $315.
(4) A notice displayed under subregulation (3) must comply with the following requirements:
(a) the notice must display the following words:
IT IS UNLAWFUL TO SELL OR SUPPLY NITROUS OXIDE TO PERSONS UNDER THE AGE OF 18 YEARS. PERSONS MAY BE REQUIRED TO PRODUCE EVIDENCE OF AGE WHEN MAKING A PURCHASE;
(b) the words required to be displayed must appear on the notice in legible letters or numerals not less than 15 millimetres in height and be of a colour that contrasts with the background colour of the notice.
24—Automatic vending machines (section 20 of Act)
(1) Section 20(1) of the Act does not apply to—
(a) an S5 poison that is sold or supplied by means of an automatic vending machine located at a car washing facility provided that the first aid instructions, warning statements and safety directions for the poison specified in the Uniform Poisons Standard are displayed at the facility; or
(b) the following products sold or supplied by means of an automatic vending machine:
(i) condoms with or without spermicides or viricides;
(ii) lubricants with or without spermicides or viricides; or
(c) injecting equipment sold or supplied by way of an automatic vending machine at a location and site approved by the Minister; or
(d) an unscheduled medicine sold or supplied by way of an automatic vending machine provided that—
(i) the medicine is sold or supplied in the original unopened pack supplied by the manufacturer; and
(ii) the medicine is sold or supplied in a pack that contains not more than 2 adult doses of the medicine; and
(iii) the automatic vending machine is presented and located in such a way that makes unsupervised access by children unlikely.
(2) In this regulation—
injecting equipment means—
(a) alcohol swabs, needles, syringe filters, syringes, tourniquets, water for injection or winged infusion sets; or
(b) a kit containing 1 or more of the items specified in paragraph (a);
unscheduled medicine means a medicine that is included in the Australian Register of Therapeutic Goods and is not a scheduled medicine.
25—Possession of poisons (section 22 of Act)
(1) Section 22 of the Act applies to the following poisons:
4‑aminopropiophenone
Acrolein
Arsenic as an S7 poison
Chloropicrin
Cyanides as S7 poisons
Cyanogen
DDT
Fluoroacetamide
Fluoroacetic acid
Hydrocyanic acid as an S7 poison
Methyl bromide
Mirex
Sodium fluoroacetate
Strychnine as an S7 poison
Thallium.
(2) A person is exempt from section 22 of the Act in respect of the possession of 4‑aminopropiophenone if—
(a) the 4‑aminopropiophenone is a constituent of baits designed for destroying vertebrate animals; and
(b) the concentration of 4‑aminopropiophenone in each bait does not exceed 2%; and
(c) the total amount of 4‑aminopropiophenone in the particular quantity of baits for destroying vertebrate animals does not exceed 5 kilograms; and
(d) the person—
(i) has the written approval of the Minister to acquire and possess those baits; and
(ii) acquires the baits from a supplier approved by the Minister.
(3) A person is exempt from section 22 of the Act in respect of the possession of sodium fluoroacetate if—
(a) —
(i) in the case of sodium fluoroacetate that is contained in a capsule for use with a Canid Pest Ejector designed for destroying foxes or wild dogs—the concentration of sodium fluoroacetate in each capsule does not exceed 0.8%; or
(ii) in the case of sodium fluoroacetate that is a constituent of baits designed for destroying vertebrate animals—the concentration of sodium fluoroacetate in each bait does not exceed 0.04%; or
(iii) in the case of sodium fluoroacetate that is contained in a cartridge for use with a Felixer grooming trap—the concentration of sodium fluoroacetate in each cartridge does not exceed the constituent concentration specified in the Public Chemical Registration Information System (PUBCRIS) by APVMA; and
(b) the total amount of sodium fluoroacetate present in the particular quantity of capsules, cartridges or baits does not exceed 50 grams; and
(c) the person—
(i) has the written approval of the Minister to acquire and possess those capsules, cartridges or baits; and
(ii) acquires the capsules, cartridges or baits from a supplier approved by the Minister.
(4) A person is exempt from section 22 of the Act in respect of the possession of strychnine if—
(a) the person is the owner or occupier, or an agent or employee of an owner or occupier, of land that is situated outside a township and outside Metropolitan Adelaide; and
(b) the strychnine is a constituent of baits designed for destroying mice; and
(c) the quantity of baits in the person's possession does not exceed 5 kilograms; and
(d) the amount of strychnine present in any quantity of the baits does not exceed 0.5%.
(5) A person lawfully in possession of baits containing strychnine under this regulation must not use those baits except for the purpose of destroying mice in or around storage areas on land situated outside a township and outside Metropolitan Adelaide.
(6) The Minister may exempt a person who is licensed under the Controlled Substances (Pesticides) Regulations 2017 from the requirement to hold a licence under section 22 of the Act in respect of the use of a pesticide that is a section 22 poison.
26—Packaging and labelling of poisons (section 24 of Act)
(1) For the purposes of section 24(b) of the Act, the package or container—
(a) must comply with the requirements set out in the Uniform Poisons Standard; and
(b) in the case of a package or container for an S2 poison, S3 poison, S4 poison or S8 poison, must—
(i) be impervious to, and incapable of chemical reaction with, the poison when the package or container is under conditions of temperature and pressure that are likely to be encountered in normal use; and
(ii) have sufficient strength and impermeability to prevent leakage of the poison during handling, transport and storage of the package or container under normal handling conditions; and
(iii) in the case of a package or container intended to be opened more than once—be able to be securely and readily closed and reclosed; and
(iv) in the case of a prescribed medicine—comply with the packaging requirements of Therapeutic Goods Order No 95.
(2) For the purposes of section 24(c) of the Act, a package or container in which a poison for human or animal therapeutic use is sold by retail on prescription, or is supplied on prescription—
(a) must have affixed to it a label that complies with Appendix L Clause 1 of the Uniform Poisons Standard; and
(b) must, in the case of a poison that is listed in column 1 of Appendix L Clause 2 of the Uniform Poisons Standard have affixed to it a label that contains the warning statements prescribed for that poison by Appendix F Clause 1 of that Standard; and
(c) must, in the case of a preparation for internal use by humans that contains a poison listed in Appendix K of the Uniform Poisons Standard, have affixed to it a label that contains the sedation warning statement 39, 40 or 90 as specified in Appendix F Clause 1 of that Standard.
(3) For the purposes of section 24(c) of the Act, a package or container in which a prescribed S3 poison is sold by retail, or is supplied—
(a) must have affixed to it a label that—
(i) complies with Appendix L Clause 1 of the Uniform Poisons Standard; and
(ii) in the case of pseudoephedrine—contains a unique identifier enabling that poison to be linked with the records required to be kept under regulation 14; and
(b) must, in the case of a preparation for internal use by humans that contains a poison listed in Appendix K of the Uniform Poisons Standard, have affixed to it a label that contains the sedation warning statement 39, 40 or 90 as specified in Appendix F Clause 1 of that Standard.
(4) For the purposes of section 24(c) of the Act, a package or container in which a poison designed for human or animal therapeutic use (other than a prescribed S3 poison) is sold by retail or is supplied—
(a) must have affixed to it the label appearing on the package or container for the poison as supplied by the manufacturer (being a label that complies with the Uniform Poisons Standard); or
(b) must have affixed to it—
(i) a label that complies with Appendix L Clause 1 of the Uniform Poisons Standard; and
(ii) in the case of a preparation for internal use by humans that contains a poison listed in Appendix K of that Standard—a label that contains the sedation warning statement 39, 40 or 90 as specified in Appendix F Clause 1 of that Standard.
(5) For the purposes of section 24(c) of the Act, a package or container in which a poison (other than a poison designed for human or animal therapeutic use or a prescribed S3 poison) is sold by retail or is supplied (other than on prescription) must have affixed to it a label that complies with the Uniform Poisons Standard.
(6) A registered health practitioner or veterinary surgeon who is authorised to prescribe, sell or supply a prescribed medicine is exempt from the requirement to comply with the packaging requirements of Therapeutic Goods Order No 95 in relation to the sale or supply of that prescribed medicine to a particular person if the registered health practitioner or veterinary surgeon believes that the person would suffer undue hardship through difficulty in opening a container that complies with the requirements of that Order.
(7) The Minister may grant an exemption from specified requirements of section 24(b) or (c) of the Act to a seller or supplier in respect of a particular product if the Minister is satisfied that the product is otherwise adequately packaged or labelled.
(8) The Minister may grant a seller or supplier, or a class of sellers or suppliers, an exemption from subregulation (1)(b)(iv) in relation to specified packaging requirements of Therapeutic Goods Order No 95 for a specified prescribed medicine.
(9) In this regulation—
prescribed medicine means—
(a) a medicine that contains a substance listed in Schedule 1 to Therapeutic Goods Order No 95 or a salt, ester or other derivative of such a substance; or
(b) a product that—
(i) contains a substance listed in Schedule 1 to Therapeutic Goods Order No 95 or a salt, ester or other derivative of such a substance; and
(ii) is intended solely for use in animals;
prescribed S3 poison means any of the following S3 poisons:
(a) dihydrocodeine in cough preparations;
(d) pseudoephedrine;
Therapeutic Goods Order No 95 means Therapeutic Goods Order No. 95 - Child‑resistant packaging requirements for medicines 2017 made under the Commonwealth Act on 29 November 2017, as in force from time to time.
27—Storage of poisons (section 25 of Act)
For the purposes of section 25 of the Act, the following requirements apply:
(a) a person must not store a poison in a container that—
(i) is normally used for containing food or beverages; or
(ii) is similar to a container that is normally used for containing food or beverages;
(b) a person must not store an S2 poison in premises where such a poison is sold by retail unless—
(i) it is stored in a part of the premises to which the public is not permitted access; or
(ii) if it is stored in a part of the premises to which the public is permitted access, it—
(A) is stored not less than 1.2 metres above floor level; or
(B) is enclosed in—
• a child‑resistant package; or
• a blister pack; or
• a container approved by the Minister; or
(C) is stored in a container that has a capacity of not less than 5 litres; or
(D) is stored in a container that has a gross weight of not less than 5 kilograms;
(c) a person must not store an S3 poison or S4 poison in premises where such a poison is sold by retail unless it is stored in a part of the premises to which the public is not permitted access;
(d) a person must not store an S6 poison or S7 poison in premises where such a poison is sold by retail except in accordance with the requirements of Part 2 Section 54(3) and (4) of the Uniform Poisons Standard;
(e) a person must not store a drug of dependence except in accordance with the requirements of the Code of Practice for the Storage and Transport of Drugs of Dependence, published by the Department, as in force from time to time;
(f) a person must not store pentobarbital in injectable preparations except in a locked container.
28—Consignment of poisons for transport
A person must not—
(a) consign a poison for transport unless it is packed in such a way as to avoid leakage arising from the ordinary risks of handling and transport; or
(b) consign for transport a drug of dependence except in accordance with the requirements of the Code of Practice for the Storage and Transport of Drugs of Dependence, published by the Department, as in force from time to time.
29—Transport of poisons (section 26 of Act)
For the purposes of section 26 of the Act, a person must not—
(a) transport an S2 poison, S3 poison, S4 poison or S8 poison in a vehicle in which any food, or component of food, for human or animal consumption is being transported unless that poison is carried in a part of the vehicle effectively separated from that part of the vehicle containing the food; or
(b) transport a drug of dependence except in accordance with the requirements of the Code of Practice for the Storage and Transport of Drugs of Dependence, published by the Department, as in force from time to time.
30—Prohibition on use of certain poisons for certain purposes (section 27 of Act)
(1) For the purposes of section 27 of the Act, a person must not sell, supply, purchase or use an S7 poison for a domestic purpose or domestic gardening purpose.
(2) For the purposes of section 27 of the Act, a person must not sell, supply, prescribe or use a poison listed in Schedule 10 of the Uniform Poisons Standard for the purpose or purposes indicated in relation to that poison in that Schedule (other than amygdalin for human therapeutic use).
31—Prohibition on use of certain poisons
(1) A person must not sell, supply, prescribe or use amygdalin for human therapeutic use unless—
(a) special access to amygdalin has been authorised in accordance with the requirements of sections 18 and 31A of the Commonwealth Act and regulation 12A of the Therapeutic Goods Regulations 1990 made under that Act; and
(b) permission for the importation of amygdalin (subject to special access authorisation) has been granted under regulation 5H and Schedule 8 item 12AA of the Customs (Prohibited Imports) Regulations 1956 of the Commonwealth.
(2) A person must not—
(a) prescribe, sell, supply or purchase a poison produced for the treatment of animals if the person knows, or if there are reasonable grounds for suspecting, that the poison is intended for human use; or
(b) administer to any person (including himself or herself) a poison produced for the treatment of animals; or
(c) use choramphenicol for the treatment of stock bred, raised or used for the purpose of providing a product for human consumption.
stock means—
(a) a bird or other animal; or
(b) a bee of the genus Apis or Megachile.
32—Restrictions on advertising (section 28 of Act)
(1) Section 28 of the Act applies to—
(a) all poisons listed in Schedule 10 of the Uniform Poisons Standard; and
(b) all S3 poisons other than those listed in Appendix H of the Uniform Poisons Standard; and
(c) all S4 poisons and S8 poisons; and
(d) all controlled drugs other than drugs of dependence.
(2) A person is exempt from section 28 of the Act if—
(a) the person only publishes an advertisement of a poison in a journal that is circulated predominantly among registered health practitioners, medical administrators, scientists working in medical laboratories or persons who are licensed to sell the poison by wholesale; or
(b) the person only publishes an advertisement of a poison that consists of a price list that complies with the Price Information Code of Practice published by the TGA as in force from time to time.
journal means a newsletter, magazine or other periodical, whether published for sale or for distribution without charge.