Does not include amendments by— Cl 42A(7) of this Regulation (cl 42A(7) repeals cl 42A on 30.9.2021)
(1) A dealer who supplies a poison must ensure that the poison is packaged and labelled—
(a) in accordance with the relevant provisions of the current Poisons Standard, and (b) in the case of a poison to which applies, in accordance with that Order. Therapeutic Goods Order No. 95
(1) A pharmacist must not supply a Schedule 3 substance to any person unless the pharmacist—
(a) personally hands the substance to the person, and (b) gives the person an opportunity to seek advice as to the use of the substance, including advice that the person may require in respect of the dosage, frequency of administration and general toxicity of the substance. (2) This clause does not apply to the supply of any substance—
(a) to an authorised practitioner, or (b) to any other person on the prescription of an authorised practitioner.
(1) A person must not obtain or use a Schedule 7 substance unless the person holds an authority under Part 8 to obtain or use the substance. Maximum penalty—10 penalty units. (2) A dealer must not supply a Schedule 7 substance to any other person unless—
(a) the dealer holds an authority under Part 8 to supply the substance, and (b) the person being supplied holds an authority under Part 8 to obtain the substance. Maximum penalty—10 penalty units. (3) A person being supplied with a Schedule 7 substance must surrender to the dealer the person’s authority to obtain the substance. Maximum penalty—10 penalty units.
(1) A pharmacist who supplies pseudoephedrine on prescription must record details of the supply in accordance with clause 55 as if pseudoephedrine were a restricted substance. Maximum penalty—20 penalty units or imprisonment for 3 months, or both. (1A) A pharmacist who supplies pseudoephedrine to a person without a prescription must, at the time of the supply, record the following details in an electronic form approved by the Secretary—
(a) a unique reference number for the supply, (b) the name of the person by whom the pseudoephedrine is supplied, (c) the name and address of the person to whom the pseudoephedrine is supplied, (d) the name, strength (if not readily apparent) and quantity of the pseudoephedrine supplied and the date on which it is supplied, (e) if the pharmacist does not know the identity of the person to whom the pseudoephedrine is supplied, the unique reference number of a photo identification of the person and the type of that identification. Maximum penalty—20 penalty units or imprisonment for 3 months, or both.
(1) A dealer who supplies a restricted substance must ensure that the substance is packaged and labelled—
(a) in accordance with the relevant provisions of the current Poisons Standard, and (b) in the case of a substance to which applies, in accordance with that Order. Therapeutic Goods Order No. 95
(1) Prescribed restricted substances that are kept in a hospital ward 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.
(1) The management company for a managed correctional centre must ensure that restricted substances at the managed correctional centre are stored—
(a) in a room or enclosure to which the public does not have access, and (b) apart from food intended for consumption by humans or animals, and (c) in a way that, if the container breaks or leaks, the restricted substance cannot mix with or contaminate any food intended for consumption by humans or animals. (2) The management company for a managed correctional centre must ensure that prescribed restricted substances at the managed correctional centre are stored—
(a) apart from all other goods and substances, and (b) in a separate room, safe, cupboard or other receptacle that is securely attached to a part of the premises and kept securely locked when not in immediate use. (3) The management company for a managed correctional centre must appoint, by written instrument, a pharmacist employed at the managed correctional centre as the person responsible for the storage of restricted substances at the managed correctional centre.
(1) A medical practitioner must not issue a prescription for a restricted substance otherwise than for medical treatment. (2) A nurse practitioner must not issue a prescription for a restricted substance otherwise than in the course of practising as a nurse practitioner. (3) A midwife practitioner must not issue a prescription for a restricted substance otherwise than in the course of practising as a midwife practitioner.
(1) A prescription for a restricted substance must include the following details—
(a) the date on which it is issued, (b) if the treatment is for—
(i) a patient—the name and address of the patient, or (ii) an animal—the species of animal and the name and address of the animal’s owner, or (iii) a patient’s partner and the prescription is for azithromycin for the treatment of chlamydia—the name and email address or mobile phone number of the partner, (c) the name, strength (if not readily apparent) and quantity of the substance to be supplied, (c1) the route of administration (if not readily apparent) of the substance to be supplied, (d) adequate directions for use, (e) the maximum number of times the substance may be supplied on the prescription, (f) in the case of a prescription for a special restricted substance, the intervals at which the substance may be supplied on the prescription, (g) if the prescription is issued at a hospital, the name and designation of the person by whom it is issued and the name, address and telephone number of the hospital, (h) if the prescription is issued elsewhere than at a hospital, the name and designation of the person by whom it is issued and the address and telephone number of the premises at which it is issued. (1A) As an alternative to complying with subclause (1), a medication chart prescription authorising the supply of a substance that is not a special restricted substance or a substance listed in clause 37 must include the following details—
(a) the date on which it is issued, (b) the name and address of the patient, (c) the name and form (if not readily apparent) of the substance to be supplied, (d) the strength (if not readily apparent) of the substance to be supplied, (e) the route of administration (if not readily apparent) of the substance to be supplied, (f) adequate directions for use, (g) the frequency or times at which the substance is to be administered or used, (h) the period during which the substance is to be used or administered (being a period that ends on a date that is no more than 4 months from the date of first use of the relevant chart for the resident), (i) the name and designation of the person by whom it is issued, (j) the name, address and telephone number of the relevant residential care facility. (2) The details referred to in subclause (1A)(b) and (j) can be made out by any person. (2A) The details referred to in subclause (1) or (1A)(a) or (c)–(i) must be made out—
(a) in the handwriting of the person by whom the prescription is issued, or (b) in such other manner as may be approved for the time being by the Secretary. (2B) A prescription must be signed by the person by whom it is issued (whether it complies with subclause (1) or (1A)).
(1) During the prescribed period, a medical practitioner or nurse practitioner may issue a prescription for a restricted substance by sending a prescription to a pharmacist by email or facsimile. (2) A medical practitioner or nurse practitioner who issues a prescription for a restricted substance in accordance with this clause must keep the prescription.
(1) This clause applies to the following restricted substances—
acitretin clomiphene cyclofenil dinoprost dinoprostone etretinate follitropin beta hydroxychloroquine isotretinoin for oral use luteinising hormone tretinoin for oral use urofollitrophin (human follicle stimulating hormone)
(1) A pharmacist must not supply a restricted substance on prescription unless the prescription is in the form required by Division 3. (2) This clause does not prevent a pharmacist from supplying a restricted substance on a prescription that otherwise complies with clause 35(1) merely because—
(a) the prescription fails to specify the maximum number of times the substance may be supplied, or (b) in the case of a prescription for a special restricted substance, the prescription fails to specify the intervals at which the substance may be supplied, or (c) the address shown on the prescription indicates that it has been issued by a veterinary practitioner from some other State or a Territory.
(1) A pharmacist who supplies a restricted substance on prescription must (on each occasion the substance is supplied) endorse the following particulars (in ink) on the prescription—
(a) the date on which the substance was supplied, (b) the address of the place at which the substance was supplied, (c) the prescription reference number. Maximum penalty—15 penalty units.
(1) If the Secretary is satisfied that there is a shortage of a restricted substance or class of restricted substances for supply to patients by pharmacists, the Secretary may, by order published in the Gazette (an authorisation order ), authorise any of following—
(a) the supply of the substance or class of substances (a short supply medicine ) in accordance with this clause,(b) the supply of another substance (a substitute medicine ) in accordance with this clause instead of a short supply medicine.(2) An authorisation order may be made subject to any conditions the Secretary specifies in the order, including (without limitation) conditions concerning the supply of a substitute medicine. (3) A pharmacist supplying a short supply medicine or substitute medicine is taken to supply the substance in accordance with the prescription despite anything to the contrary in the prescription dosage details if—
(a) the form of supply is one permitted by subclause (4), and (b) the supply complies with the conditions (if any) specified in the authorisation order for the medicine.
(1) A medical practitioner must not supply a restricted substance to any person otherwise than for medical treatment. (2) A nurse practitioner must not supply a restricted substance to any person otherwise than in the course of practising as a nurse practitioner. (3) A midwife practitioner must not supply a restricted substance to any person otherwise than in the course of practising as a midwife practitioner.
(1) The responsible person for a residential care facility is authorised to have possession of a restricted substance (including a prescribed restricted substance) that is approved by the Secretary for urgent use in a residential care facility.
(1A) This clause applies to the following vaccines—
(a) influenza vaccine, (b) measles-mumps-rubella combination vaccine, (c) diphtheria-tetanus-pertussis combination vaccine, (d) a SARS-CoV-2 (COVID-19) vaccine approved by the Secretary. (1B) The Secretary may impose conditions on an approval under subclause (1A)(d). Note— For example, a condition may be imposed setting the minimum or maximum age of a person to whom an approved vaccine may be administered by a pharmacist under this clause.
(1) This clause applies to the following substances—
acitretin clomiphene cyclofenil dinoprost dinoprostone etretinate follitropin beta hydroxychloroquine isotretinoin for oral use luteinising hormone tretinoin for oral use urofollitropin (human follicle stimulating hormone)
(1) A person employed at a hospital or managed correctional centre must not administer a restricted substance to a patient without a direction from an authorised practitioner. (2) A direction must be written and given in person. (3) However, a direction may be given in an emergency—
(a) by email or facsimile, or (b) orally by telephone or in another manner approved by the Secretary.
(1) This clause applies to the following restricted substances—
acitretin clomiphene cyclofenil dinoprost dinoprostone etretinate follitropin beta hydroxychloroquine isotretinoin for oral use luteinising hormone tretinoin for oral use urofollitropin (human follicle stimulating hormone)
(1) A person must not administer a relevant substance to a patient unless the person—
(a) is a nurse, and (b) is acting in accordance with a direction of a medical practitioner or nurse practitioner.
(1) A medical practitioner or nurse practitioner may give a direction to a nurse only if the practitioner has personally reviewed the patient in person or by audiovisual link.
(1) A responsible provider must ensure the administration of a relevant substance to which this Part applies that occurs as part of the responsible provider’s business is carried out in accordance with this Part.
(1) A dealer who supplies a drug of addiction must ensure that the drug is packaged and labelled—
(a) in accordance with the relevant provisions of the current Poisons Standard, and (b) in the case of a drug of addiction to which applies, in accordance with that Order. Therapeutic Goods Order No. 95
(1) The pharmacist for the time being in charge of a pharmacy must keep any drug of addiction stored apart from other substances or goods (other than cash or documents) in a separate safe. (2) Unless otherwise approved for the time being by the Secretary, such a safe must comply with the following requirements—
(a) it must be made of black mild steel plate at least 9 millimetres thick with continuous welding along all edges, (b) it must be fitted with a door made of mild steel plate at least 9 millimetres thick, the door being flush fitting with a clearance around the door of not more than 1.5 millimetres, (c) it must have a fixed locking bar, welded to the inside face of the door near the hinged edge, that engages in a rebate in the safe body when the door is closed, (d) it must be fitted with a five lever key lock (or a locking mechanism providing at least equivalent security) securely fixed to the rear face of the door, (e) if mounted on a brick or concrete wall or floor, it must be attached to the wall or floor by means of suitably sized expanding bolts through holes 9 millimetres in diameter drilled in the rear or bottom of the safe, (f) if mounted on a timber framed wall or floor, it must be attached to the wall or floor frame by means of suitably sized coach screws through holes 9 millimetres in diameter drilled in the rear or bottom of the safe, (g) if mounted on any other kind of wall or floor, it must be attached to the wall or floor in a manner approved for the time being by the Secretary.
(1) The management company for a managed correctional centre must ensure that drugs of addiction at the managed correctional centre are stored in a separate safe apart from other goods or substances. (2) Unless otherwise approved for the time being by the Secretary, the safe must comply with the requirements specified in clause 76(2)(a)–(g). (3) The management company for a managed correctional centre must ensure that—
(a) the safe is kept securely locked when not in immediate use, and (b) a key or other device that unlocks the safe is—
(i) kept on the person of an appropriate person at the managed correctional centre, or (ii) locked in a separate safe that can be unlocked only by an appropriate person, and (c) a code or combination that is required to unlock the safe is not disclosed to a person who is not an appropriate person. (4) Despite subclause (1), a drug of addiction that requires refrigeration may be kept in a refrigerator instead of a safe if the following requirements are met—
(a) the refrigerator must be in a room, part of a room or an enclosure to which the public does not have access, (b) the refrigerator, or a cupboard or receptacle in which the refrigerator is kept, must be securely attached to a part of the premises, (c) the refrigerator, or the room, cupboard or receptacle in which the refrigerator is kept, must be kept securely locked when not in immediate use, (d) a key or other device that unlocks the refrigerator, or the room, cupboard or receptacle in which the refrigerator is kept, must be—
(i) kept on the person of an appropriate person at the managed correctional centre, or (ii) locked in a safe that can be unlocked only by an appropriate person, (e) a code or combination that is required to unlock anything under this subclause must not be disclosed to a person who is not an appropriate person, (f) the refrigerator must not be used to store an item that is not a Schedule 2, 3, 4 or 8 substance or a therapeutic good.
(1) A medical practitioner must not issue a prescription for a drug of addiction otherwise than for medical treatment (including in a clinical trial). (2) A nurse practitioner must not issue a prescription for a drug of addiction otherwise than in the course of practising as a nurse practitioner. (3) A midwife practitioner must not issue a prescription for a drug of addiction otherwise than in the course of practising as a midwife practitioner.
(1) A person who issues a prescription for a drug of addiction must ensure that the prescription includes the following details—
(a) the date on which it is issued, (b) the name and address of the patient or (if the treatment is for an animal) the species of animal and the name and address of the animal’s owner, (c) the name, strength and quantity (expressed in both words and figures) of the drug to be supplied, (d) adequate directions for use, (e) the maximum number of times the drug may be supplied on the prescription, (f) the intervals at which the drug may be supplied on the prescription, (g) if the prescription is issued at a hospital, the name and designation of the person by whom it is issued and the name, address and telephone number of the hospital, (h) if the prescription is issued elsewhere than at a hospital, the name and designation of the person by whom it is issued and the address and telephone number of the premises at which it is issued, (i) if the drug of addiction is a type A drug of addiction and the person holds an authority to issue the prescription under section 29 of the Act or Part 8 of this Regulation, the reference number of the authority. (2) The details referred to in subclause (1)(a)–(f) must be made out—
(a) in the handwriting of the person by whom the prescription is issued, or (b) in such other manner as may be approved for the time being by the Secretary, and the prescription must be signed by the person by whom it is issued.
(1) In an emergency, an authorised practitioner may direct the supply of a drug of addiction, other than an unregistered drug of addiction, orally, by telephone, by electronic mail or by facsimile.
(1) A medical practitioner or nurse practitioner is authorised to issue a prescription for a drug of addiction, other than an unregistered drug of addiction, for a person without an authority under section 29 of the Act if—
(a) the medical practitioner or nurse practitioner is of the opinion that the person requires the use of the drug in the course of treatment as an in-patient in a public hospital or private health facility, and (b) the prescription is for a course of treatment for a period of not more than 14 days following the person’s admission as an in-patient.
(1) A pharmacist at a retail pharmacy who supplies any person with methadone in oral liquid form or buprenorphine on a prescription for the treatment of drug dependence must keep a record of the supply in accordance with this clause. Maximum penalty—20 penalty units.
(1A) Despite clause 85, a pharmacist must not supply methadone in oral liquid form or buprenorphine on prescription for the treatment of drug dependence unless—
(a) the methadone or buprenorphine is supplied at the premises of, and in the course of carrying on the business of, a retail pharmacy, and (b) the retail pharmacy is located on premises at which a pharmacist is approved to supply pharmaceutical benefits under section 90 of the of the Commonwealth. National Health Act 1953 Maximum penalty—20 penalty units.
(1) The owner of a pharmacy may apply in writing to the Secretary for an exemption from clause 92(1A) or (1) in relation to the pharmacy. (2) The Secretary may require the owner of the pharmacy to furnish such information as is necessary to enable the Secretary to determine the application. (3) The Secretary may, by notice in writing served on the owner of the pharmacy, grant the exemption, if the Secretary is satisfied that exceptional circumstances exist that justify the granting of the exemption, or refuse to grant the exemption.
(1) A medical practitioner or nurse practitioner is authorised to supply a drug of addiction, other than an unregistered drug of addiction, for a person without an authority under section 29 of the Act if—
(a) the medical practitioner or nurse practitioner is of the opinion that the person requires the use of the drug in the course of treatment as an in-patient in a public hospital or private health facility, and (b) the supply is for a course of treatment for a period of not more than 14 days following the person’s admission as an in-patient.
(1)
(1) The following persons are authorised to have possession of, and to supply, drugs of addiction—
(a) an authorised practitioner, (b) the chief pharmacist of, and any pharmacist employed in dispensing medicines at, any public hospital or other public institution, (c) the director of nursing of a hospital in which a pharmacist is not employed, (d) the nurse or midwife in charge of a ward in a public hospital, (e) a nurse or midwife who is approved for the time being by the Secretary for the purposes of this clause, or who belongs to a class of nurses or a class of midwives so approved, (f) any other nurse or midwife, but for the purpose only of administering doses of such drugs to individual patients in a hospital or individual inmates in a managed correctional centre, (g) a person—
(i) who is employed in the Ambulance Service of NSW as an ambulance officer or as an air ambulance flight nurse, and (ii) who is approved for the time being by the Secretary for the purposes of this clause, (h) a pharmacist at a managed correctional centre, but for the purpose only of supplying the drugs for use by individual inmates in the managed correctional centre. (2) The following persons are authorised to have possession of (but not to supply) drugs of addiction—
(a) a person in charge of a laboratory used for the purpose of analysis, research or instruction, who is, or who belongs to a class of persons who are, authorised for the time being by the Secretary for the purposes of this clause, (b) an analyst, (c) a person acting under the direct personal supervision of a person referred to in paragraph (a) or (b).
(1) The following persons are authorised to have possession of ampoules of morphine sulphate in a quantity not exceeding 30 ampoules, each of 1 millilitre or less, at a concentration of 30 milligrams or less of morphine sulfate per millilitre—
(a) the director of nursing of a private health facility, (b) the responsible person for a residential care facility, (c) a registered nurse at a residential care facility, but for the purpose only of administering doses of such drugs to individual residents of the residential care facility. (2) The director of nursing of a private health facility is authorised to have possession of no more than 5 ampoules, each of 2 millilitres or less, of pethidine hydrochloride, at a concentration of 50 milligrams or less of pethidine hydrochloride per millilitre. (3) Order of Secretary—specified facilities The Secretary may, by order in writing, authorise the possession of a drug of addiction specified in subclause (1) or (2), in a quantity that exceeds the limit specified in subclause (1) or (2), by the following persons—
(a) in the case of morphine sulphate—
(i) the director of nursing of a specified private health facility, or (ii) the responsible person for a specified residential care facility, (b) in the case of pethidine hydrochloride—the director of nursing of a specified private health facility. (4) Order of Secretary—specified classes of facilities The Secretary may, by order published in the Gazette, authorise the possession of a drug of addiction specified in subclause (1) or (2), in a quantity that exceeds the limit specified in subclause (1) or (2), by the following persons—
(a) in the case of morphine sulphate—
(i) the director of nursing of a specified class of private health facilities, or (ii) the responsible person for a specified class of residential care facilities, (b) in the case of pethidine hydrochloride—the director of nursing of a specified class of private health facilities.
(1) The master of a ship is authorised to have possession of drugs of addiction that are required by law to be carried on the ship. (2) A pharmacist may supply drugs of addiction to the master of a ship if the pharmacist is authorised to do so by an authority under Part 8.
(1) The nurse or midwife in charge of a hospital ward must keep a register of the drugs of addiction kept in the ward. (2) The responsible person for a residential care facility must keep a register of the drugs of addiction kept in the residential care facility. (3) The responsible person for a managed correctional centre must keep a register of drugs of addiction kept in the managed correctional centre.
(1) On the day on which a person receives, supplies or administers a drug of addiction in a ward, residential care facility or managed correctional centre, the person must enter the following details in the register—
(a) the quantity of the drug received, supplied or administered, (b) the time of day when the drug was received, supplied or administered, (c) in the case of a drug that is supplied or administered to a patient—
(i) the name of the patient to whom the drug was supplied or administered, and (ii) the name of the person by whom the supply or administration of the drug was prescribed or directed, (d) the quantity of drugs of addiction of that kind held in the ward, residential care facility or managed correctional centre after the transaction takes place, (e) any other details approved by the Secretary. (2) The entry must be dated and signed by the person by whom it is made and countersigned—
(a) in the case of an entry relating to the receipt of a drug of addiction, by a person who witnessed its receipt, or (b) in the case of an entry relating to the supply or administration of a drug of addiction—
(i) by the person who supervised or directed its supply or administration, or (ii) by a person who witnessed its supply or administration.
(1) The person responsible for maintaining a drug register at any place—
(a) must, during the prescribed periods, make an accurate inventory of all drugs of addiction at that place, and (b) must endorse the relevant drug register, immediately under the last entry for each drug of addiction, with the quantity of each drug of addiction actually held and the date on which the inventory was made, and (c) must sign each entry.
(1) A person employed at a hospital or managed correctional centre must not administer a drug of addiction to a patient without a direction from an authorised practitioner. (2) A direction must be written and given in person. (3) However, a direction may be given in an emergency—
(a) by email or facsimile, or (b) orally by telephone or in another manner approved by the Secretary.
(1) For the purposes of Division 1 of Part 2 of the — Drug Misuse and Trafficking Act 1985
(a) a medical practitioner is authorised to self-administer a drug of addiction, but only if the medical practitioner does so for the purposes of medical treatment, and (b) a dentist is authorised to self-administer a drug of addiction, but only if the dentist does so for the purposes of dental treatment.
(1) A retail pharmacist who is engaged in the supply of restricted substances or drugs of addiction to any of the following—
(a) a private health facility, (b) a residential care facility, (c) a patient in a private health facility, (d) a patient in a residential care facility that is a nursing home, is, subject to subclauses (2) and (3), authorised to destroy any unwanted drug of addiction on the premises of that private health facility or residential care facility.
(1) The management company for a managed correctional centre may arrange for unusable or unwanted drugs of addiction at the managed correctional centre to be destroyed by a responsible person in the presence of another person who is—
(a) a pharmacist, or (b) a medical practitioner, or (c) a nurse practitioner, or (d) a dentist. (2) A responsible person who destroys a drug of addiction under this clause must make a record of the destruction in the managed correctional centre’s drug register that includes the following—
(a) the date of the destruction, (b) the responsible person’s name, signature and registration number under the , Health Practitioner Regulation National Law (NSW) (c) the name, signature and registration number under the of the person who witnessed the destruction, Health Practitioner Regulation National Law (NSW) (d) the quantity of the drug of addiction destroyed.
(1) Each person specified in Appendix C is authorised to possess and use the substances specified in relation to that person in that Appendix subject to any conditions or qualifications that may be specified. Note— Section 11(1) of the Act creates an offence if the holder of a wholesaler’s licence or wholesaler’s authority supplies any Schedule 1, 2, 3 or 7 substance or any restricted substance to a person other than an authorised person. An authorised person includes a person who is authorised by or under the Act to use, or have possession of, the substance concerned.
(1) Any person may apply to the Secretary for a licence to supply by wholesale any poisons or restricted substances.
(1) Any person may apply to the Secretary for a licence to manufacture drugs of addiction at, or to supply drugs of addiction from, any premises.
(1) After considering an application under this Division, the Secretary may issue the licence for which the application is made or may refuse the application. (2) In particular, the Secretary may refuse an application if of the opinion that the applicant is not a fit and proper person to hold the licence for which the application is made.
(Clauses 7, 26, 69 and 146) Note— Although this Appendix refers to labels “on” a container, the information required by this Appendix may be shown by tags, brands, marks or statements in writing on the container itself (rather than on something affixed or attached to the container). See the definition of Label in section 4(1) of the Act.
(Clause 129) Note— Clause 129 provides that each person who is authorised by this Appendix to possess and use a substance is also authorised to be supplied with the substance, whether by wholesale or otherwise, by the holder of a wholesaler’s licence or wholesaler’s authority.