You are using a version of the website built for webcrawlers and people whose devices cannot use javascript.
Some functionality will not be available.
Warning: This page is an archive.
General administrative information and links are not current and should not be used.
Contents (2008 - 392)
Poisons and Therapeutic Goods Regulation 2008
Current version for 1 July 2017 to date (accessed 19 November 2017 at 10:25)
Part 4 Division 4
Division 4 Supply
Subdivision 1 Supply on prescription
85   Pharmacists may supply drugs of addiction on prescription
(1)  A pharmacist may supply a drug of addiction on prescription if the prescription is in the form required by Division 3.
(2)  This clause does not prevent a pharmacist from supplying a drug of addiction on prescription merely because:
(a)  the prescription fails to specify the maximum number of times the drug may be supplied, or
(b)  the prescription fails to specify the intervals at which the drug may be supplied.
(3)  A pharmacist must not supply a drug of addiction on a prescription referred to in subclause (2) if it appears to the pharmacist that the drug has previously been supplied on the prescription, regardless of how many times the prescription purports to authorise the supply of the drug.
(4)  The Director-General may, by order in writing, exempt any person or drug, or any class of persons or drugs, from any or all of the requirements of this clause.
(5)  Such an exemption may be given unconditionally or subject to conditions.
Maximum penalty: 20 penalty units.
86   Certain prescriptions not to be filled
(1)  A pharmacist must not supply a drug of addiction on prescription:
(a)  if the prescription is marked “CANCELLED”, or
(b)  if the drug has already been supplied on the prescription the maximum number of times indicated by the prescription, or
(c)  if the interval of time that has elapsed since the drug was last supplied on the prescription is less than that indicated by the prescription as the minimum interval that must elapse between successive supplies of the drug, or
(d)  if the prescription is illegible or defaced, or
(e)  if the prescription is dated more than 6 months before the date on which the supply is being requested, or
(f)  if the prescription appears to have been forged or fraudulently obtained, or
(g)  if the prescription appears to have been altered otherwise than by the authorised practitioner by whom it was issued, or
(h)  if notice of an order prohibiting the person by whom the prescription was issued from issuing such a prescription has been published in the Gazette, unless the prescription contains a direction for the supply of the drug more than once and it appears that the drug has been supplied on the basis of the prescription at least once before the notice was published.
(2)  Immediately on being requested to supply a drug of addiction in any of the circumstances referred to in subclause (1) (f), (g) or (h), a pharmacist must retain the prescription and cause notice of the request to be given to a police officer.
Maximum penalty: 15 penalty units.
(3)  A pharmacist must not supply a drug of addiction on a prescription that includes:
(a)  more than one preparation containing a drug of addiction, or
(b)  both a preparation containing a drug of addiction and another preparation.
Maximum penalty: 20 penalty units.
87   Prescriptions require verification
(1)  A pharmacist must not supply a drug of addiction on prescription unless he or she:
(a)  is familiar with the handwriting of the person who issued the prescription, or
(b)  knows the person for whom the drug is prescribed, or
(c)  has verified that the person who is purported to have issued the prescription has actually issued the prescription.
(2)  This clause does not prevent a pharmacist who is otherwise authorised to supply drugs of addiction from supplying a drug of addiction on prescription in a quantity sufficient for no more than 2 days’ treatment.
Maximum penalty: 20 penalty units.
88   Prescriptions to be endorsed
(1)  A person who supplies a drug of addiction on prescription must (on each occasion the drug is supplied) endorse the following particulars (in ink) on the prescription:
(a)  the date on which the drug was supplied,
(b)  the address of the place at which the drug was supplied,
(c)  the prescription reference number.
Maximum penalty: 20 penalty units.
(2)  A person who supplies a drug of addiction on prescription must endorse (in ink) across the prescription the word “CANCELLED”:
(a)  if the maximum number of times the prescription is to be dispensed is not clearly specified, or
(b)  if the intervals at which the drug may be supplied are not clearly specified, or
(c)  if the prescription has reached the last occasion on which it can be supplied according to the maximum number of times specified on it.
Maximum penalty: 20 penalty units.
(3)  The Director-General may, by order in writing, exempt any person or drug of addiction, or any class of persons or drugs of addiction, from any or all of the requirements of this clause.
(4)  Such an exemption may be given unconditionally or subject to conditions.
89   Prescriptions and orders to be kept
(1)  A pharmacist who supplies a drug of addiction on prescription, or by order under clause 97 or 103, must keep the prescription or order, whether or not the prescription or order authorises more than one supply of the drug.
Maximum penalty: 20 penalty units.
(2)  A pharmacist must keep prescriptions or orders for drugs of addiction separate from other prescriptions (other than prescriptions for special restricted substances).
Maximum penalty: 20 penalty units.
(3)  The Director-General may, by order in writing, exempt any person or drug of addiction, or any class of persons or drugs of addiction, from any or all of the requirements of this clause.
(4)  Such an exemption may be given unconditionally or subject to conditions.
90   Supply by pharmacists of amphetamines and nabiximols
(1)  This clause applies to the following substances:
amphetamine
dexamphetamine
lisdexamfetamine
methylamphetamine
methylphenidate
nabiximols
phendimetrazine
phenmetrazine
(2)  A pharmacist must not supply such a substance on prescription unless the reference number of the authority to issue the prescription (whether given under section 29 of the Act or Part 8 of this Regulation) is shown on the prescription.
Maximum penalty: 20 penalty units.
91   Records to be kept by pharmacists of methadone or buprenorphine prescriptions
(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.
(2)  A record under this clause must contain the following particulars:
(a)  the name of the person to whom the supply was made,
(b)  the number of the prescription on which the supply was made,
(c)  the name of the person who gave the prescription,
(d)  the amount of methadone in oral liquid form or buprenorphine supplied,
(e)  the date on which the supply occurred,
(f)  if the whole or part of the methadone in oral liquid form or buprenorphine was supplied for consumption on a different day to that on which it was supplied, the day or days on which it is to be consumed and the amount to be consumed on that day or on each of those days.
(3)  Records made under this clause in relation to a particular pharmacy are to be made in writing in a book in which all such records for the pharmacy are kept.
(4)  The Director-General may from time to time approve the keeping of records under this clause in any other form.
(5)  A record made under this clause must be kept for at least 2 years from the date on which it is made.
92   Supply by pharmacists of liquid methadone or buprenorphine
(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 National Health Act 1953 of the Commonwealth.
Maximum penalty: 20 penalty units.
(1)  A pharmacist at a retail pharmacy must not, on any particular day, supply any person with methadone in oral liquid form or buprenorphine on a prescription for the treatment of drug dependence if that supply would result in more than 50 persons having been supplied with methadone in oral liquid form or buprenorphine on prescription at that pharmacy on that day.
Maximum penalty: 20 penalty units.
(2)  For the purposes of subclause (1), if an amount of methadone in oral liquid form or buprenorphine is supplied for consumption on a day other than the day on which it is supplied, the supply of that amount is taken to have occurred on the day on which the amount is to be consumed.
(3)  A person is not to be counted for the purposes of subclause (1) if the person is supplied with an amount of methadone in oral liquid form or buprenorphine that is intended to last the person for at least one week and the person is supplied at that pharmacy with either of those drugs no more than once in any 7 day period.
(4)  Subclause (1) does not apply to the supply of methadone in oral liquid form or buprenorphine at a pharmacy in accordance with:
(a)  an exemption granted under clause 93, or
(b)  a licence issued under Division 3 of Part 8.
93   Exemptions relating to methadone or buprenorphine supply at pharmacies
(1)  The owner of a pharmacy may apply in writing to the Director-General for an exemption from clause 92 (1A) or (1) in relation to the pharmacy.
(2)  The Director-General may require the owner of the pharmacy to furnish such information as is necessary to enable the Director-General to determine the application.
(3)  The Director-General may, by notice in writing served on the owner of the pharmacy, grant the exemption, if the Director-General is satisfied that exceptional circumstances exist that justify the granting of the exemption, or refuse to grant the exemption.
(4)  An exemption is subject to such conditions as may be specified in the notice referred to in subclause (3) and to such further conditions as the Director-General may from time to time notify in writing to the holder of the exemption.
(5)  The Director-General may from time to time vary or revoke any condition of an exemption by notice in writing served on the holder of the exemption.
(6)  An exemption remains in force until:
(a)  the expiry date (if any) specified in the exemption, or
(b)  it is surrendered or cancelled,
whichever occurs first.
(7)  The Director-General may suspend or cancel an exemption by notice in writing served on the holder of the exemption.
(8)  An exemption has no effect during any period of suspension.
(9)  For the removal of doubt, an exemption is not a licence or authority for the purposes of this Regulation.
94   Exceptions to section 28—supply
(1)  A medical practitioner or nurse practitioner is authorised to supply a 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.
(2)  A medical practitioner or nurse practitioner is authorised to supply methadone or buprenorphine to a person without an authority under section 29 of the Act if:
(a)  in the case of a medical practitioner, the medical practitioner is approved as a prescriber of drugs of addiction under section 28A of the Act and in the case of a nurse practitioner, the nurse practitioner is authorised by the Director-General for the purposes of this clause, and
(b)  the person is an inmate in a correctional centre (within the meaning of the Crimes (Administration of Sentences) Act 1999), and
(c)  the methadone or buprenorphine is supplied in oral dosage form for use by the person as a course of treatment while an inmate, and
(d)  immediately before the person became an inmate, a medical practitioner or nurse practitioner had an authority under section 29 of the Act to prescribe methadone or buprenorphine for the person, or supply methadone or buprenorphine to the person, and
(e)  the methadone or buprenorphine is supplied for the purpose of continuing the treatment that the person was receiving or was about to receive immediately before the person became an inmate.
(3)  A medical practitioner or nurse practitioner is authorised to supply a drug of addiction to a person without an authority under section 29 of the Act if:
(a)  the person is the subject of such an authority, and
(b)  the medical practitioner or nurse practitioner is practising at the same premises that the holder of the authority was practising at when the authority was issued, and
(c)  the supply is in accordance with any conditions to which that authority is subject.
94A   Supply of liquid methadone or buprenorphine by pharmacists—transitional provision
Clause 92 (1A) (as inserted by the Poisons and Therapeutic Goods Amendment (Supply by Pharmacists) Regulation 2013) does not operate to prevent a pharmacist who, before that insertion, supplied liquid methadone or buprenorphine on prescription for the treatment of drug dependence from continuing to supply methadone or buprenorphine after that insertion at the premises at which those drugs were provided by the pharmacist before that insertion.
Subdivision 2 Supply without prescription
95   Supply and receipt of drugs of addiction generally
(1)  A person who is authorised to supply drugs of addiction (whether by this Division or by an authority or licence under Part 8) may supply a drug of addiction to an authorised person, being:
(a)  any person who is authorised to have possession of such a drug of addiction, or
(b)  any other person if the other person is in possession of a certificate, signed by a person so authorised, to the effect that the other person is authorised to obtain the drug of addiction on behalf of the person so authorised.
(2)  A supplier may supply drugs of addiction under this clause on the basis of a written order signed by an authorised person or on the basis of an order received from an authorised person by telephone, electronic mail or facsimile.
(3)  A person who orders and receives a drug of addiction must notify the supplier of the receipt of the drug within 24 hours after that receipt.
(4)  The notice under subclause (3) must be in writing and must be dated and signed by an authorised person.
(5)  If a supplier, who supplies a drug of addiction on the basis of an order, does not receive written notice of the order under subclause (3) within 7 days after the drug is supplied, the supplier must report that fact to the Director-General.
(6)  A person who supplies a drug of addiction in accordance with this clause must:
(a)  keep and cancel the relevant order, and
(b)  keep the written notice under subclause (3) and (if the drug is supplied as referred to in subclause (1) (b)) the relevant certificate.
Maximum penalty: 20 penalty units.
96   Emergency supply by pharmacists
(1)  A pharmacist may supply a person with a drug of addiction in accordance with a direction given under clause 81.
(2)  A pharmacist who supplies a drug of addiction in accordance with this clause:
(a)  must keep and cancel the prescription that is subsequently sent in confirmation of the direction, or
(b)  if such a prescription is not received within 7 days after the drug is supplied, must report that fact to the Director-General.
Maximum penalty: 20 penalty units.
97   Supply by pharmacists for emergency purposes
A pharmacist may supply an authorised practitioner with a drug of addiction for emergency use, but only on a written order signed and dated by the authorised practitioner.
98   Supply of amphetamines and nabiximols
(1)  This clause applies to the following substances:
amphetamine
dexamphetamine
lisdexamfetamine
methylamphetamine
methylphenidate
nabiximols
phendimetrazine
phenmetrazine
(2)  A medical practitioner does not require an authority under section 29 of the Act to supply dexamphetamine, lisdexamfetamine or methylphenidate to a person for the purpose of testing the suitability of the person to undergo a course of medical treatment involving the use of such a substance so long as the medical practitioner holds an authority under Part 8 to supply such a substance.
(3)  A nurse practitioner, midwife practitioner, dentist or veterinary practitioner is not authorised to supply any substance to which this clause applies.
(4)  This clause does not prevent a veterinary practitioner from supplying methylphenidate in solid dosage form to a person for the treatment of an animal.
Subdivision 3 Supply in hospitals
99   Supply by pharmacists
(1)  A pharmacist employed at a hospital may supply a drug of addiction from the pharmacy department of the hospital:
(a)  on a prescription issued in accordance with Division 3, or
(b)  on the authorisation (whether in writing, by electronic mail, by facsimile or by any other form of electronic communication approved by the Director-General) of an authorised practitioner (other than a veterinary practitioner), where that authorisation is entered on a patient’s medication chart, or
(c)  on the requisition (whether in writing, by electronic mail, by facsimile or by any other form of electronic communication approved by the Director-General) of an authorised practitioner (other than a veterinary practitioner) or of the nurse or midwife in charge of the ward in which the drug is to be used or stored.
(2)  The person delivering a drug of addiction to a ward from the pharmacy department of the hospital must obtain a receipt, dated and signed, from the person to whom the drug is delivered.
Maximum penalty: 20 penalty units.
Subdivision 4 Manufacture, possession and supply generally
100   Unauthorised manufacture and supply of drugs of addiction prohibited
(1)  A person must not manufacture or supply a drug of addiction unless the person is authorised to do so by this Division or by an authority or licence under Part 8.
(2)  This Division does not authorise a person to manufacture or supply drugs of addiction in contravention of any prohibition or restriction to which the person is otherwise subject.
Maximum penalty: 20 penalty units.
101   Possession and supply of drugs of addiction
(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 Director-General 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,
(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 Director-General for the purposes of this clause.
(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 Director-General 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).
(3)  This clause authorises a person referred to in subclause (1) or (2) to have possession of, or to supply, drugs of addiction for the purpose only of the lawful practice of the person’s profession or occupation.
(4)    (Repealed)
(5)  This clause does not authorise a nurse practitioner, midwife practitioner, dentist or veterinary practitioner to have possession of, or to supply, any of the following substances:
amphetamine
dexamphetamine
lisdexamfetamine
methylamphetamine
methylphenidate (other than methylphenidate in solid dosage form, in the case of a veterinary practitioner)
nabiximols
phendimetrazine
phenmetrazine
102   Possession and manufacture of drugs of addiction by retail pharmacists
(1)  A retail pharmacist is authorised:
(a)  to have possession of drugs of addiction, and
(b)  to manufacture drugs of addiction and any preparation, admixture or extract of a drug of addiction,
but only if he or she does so at the premises of, and in the course of carrying on a pharmacy business.
(2)    (Repealed)
Maximum penalty: 20 penalty units.
103   Possession of drugs of addiction by directors of nursing of private health facilities and nursing homes
(1)  The director of nursing of a private health facility or nursing home is authorised to have possession of the following drugs of addiction in the following quantities:
(a)  no more than 5 ampoules, each of 1 millilitre or less, of morphine sulfate, at a concentration of 30 milligrams or less of morphine sulfate per millilitre,
(b)  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.
(1A)  The Director-General may, by order in writing, authorise the possession of a drug of addiction specified in subclause (1), by the director of nursing of a specified private health facility or nursing home, in a quantity that exceeds the limit specified in subclause (1).
(1B)  The Director-General may, by order published in the Gazette, authorise the possession of a drug of addiction specified in subclause (1), by a director of nursing of a specified class of private health facilities or nursing homes, in a quantity that exceeds the limit specified in subclause (1).
(2)  A retail pharmacist is authorised to supply a drug of addiction to the director of nursing of a private health facility or nursing home but only if the drug is supplied:
(a)  at the premises of, and in the course of carrying on the business of, the pharmacy, and
(b)  in accordance with a written order signed by the director of nursing.
(3)  The director of nursing must not sign an order for any quantity of a drug of addiction if the quantity of that drug that will be in the possession of the director of nursing as a result of the order being filled will be in excess of the maximum quantity allowed by this clause.
(4)  The director of nursing must not allow any drug of addiction in his or her possession to be used otherwise than for administration to a patient in accordance with the directions of an authorised practitioner (other than a veterinary practitioner).
(5)  This clause does not limit the power of a director of nursing to have possession of drugs of addiction, or to supply drugs of addiction to patients, in accordance with a licence under Part 8.
Maximum penalty: 20 penalty units.
104   Possession of drugs of addiction by masters of ships
(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.
(3)  A person must not supply a drug of addiction to the master of a ship unless the person receives:
(a)  a written order for the drug (in duplicate) signed by the master of the ship, and
(b)  a written statement (in duplicate) signed by the master of the ship to the effect that the drug is required by law to be carried on the ship, and
(c)  a certificate, issued by the ship’s agent in New South Wales, to the effect that the signatures appearing on the order and statement are those of the master of the ship.
(4)  A person who supplies a drug of addiction in accordance with this clause:
(a)  must keep and cancel the relevant order and statement, and
(b)  must cancel the duplicate copies of the order and statement and forward them to the Director-General, together with the certificate issued by the ship’s agent, within 24 hours.
(5)    (Repealed)
Maximum penalty: 20 penalty units.
105   (Repealed)
106   Authorities to possess and administer drugs of addiction
(1)  The following persons are authorised to have possession of drugs of addiction, but only if authorised to do so by an authority under Part 8:
(a)  a person in an isolated locality,
(b)  a person in charge of a first aid post,
(c)  a person representing an organisation established for search and rescue,
(d)  any other person the Minister may from time to time approve.
(2)  A person who is so authorised to have possession of a drug of addiction is also authorised to administer the drug to another person in an emergency.
107   Mode of delivery
(1)  A person who supplies drugs of addiction must do so personally, by registered mail or by carrier.
(2)  A person who supplies a drug of addiction personally:
(a)  must deliver it to the person being supplied at the premises of the supplier or at the premises of the person being supplied, and
(b)  must obtain a receipt, dated and signed, from the person to whom it is delivered.
(3)  A person who supplies a drug of addiction by registered mail must obtain and keep written evidence of postage of the drug.
(4)  A person who supplies a drug of addiction by carrier must obtain and keep written evidence of the consignment of the drug.
(5)  A person who supplies a drug of addiction must not deliver a drug of addiction by carrier otherwise than under an arrangement under which the carrier undertakes:
(a)  to obtain a receipt, dated and signed, from the person to whom the drug is delivered, and
(b)  to deliver the receipt to the supplier.
Maximum penalty: 20 penalty units.
108   Delivery by carrier
(1)  A carrier is authorised to be in possession of a package containing a drug of addiction, but for the purpose only of delivering it to the person to whom it is addressed.
(2)  A dealer (other than an authorised practitioner or pharmacist) who supplies a drug of addiction by post or by carrier must ensure that:
(a)  the drug is contained in a package that has at least one opaque covering, and
(b)  no other goods are contained in the package, and
(c)  the package contains a document:
(i)  listing the contents of the package, and
(ii)  bearing the words “SCHEDULE EIGHT—CHECK CAREFULLY” in bold face sans serif capital letters with a letter height of at least 12.5 millimetres, and
(d)  the outside of the package does not indicate that it contains a drug of addiction, and
(e)  the package is properly addressed to the person to whom the drug is being supplied.
(3)  This clause does not prevent a dealer from supplying a drug of addiction by means of a separately wrapped inner package within an outer package containing other goods so long as:
(a)  a document listing the contents of the inner package is contained in the inner package, and
(b)  the inner package is marked with the words “SCHEDULE EIGHT—CHECK CAREFULLY” in bold face sans serif capital letters with a letter height of at least 12.5 millimetres, and
(c)  the outside of the outer package does not indicate that it contains a drug of addiction, and
(d)  the outer package is properly addressed to the person to whom the drug is being supplied.
Maximum penalty: 20 penalty units.
109   Quantity and purpose of supply to be appropriate
An authorised practitioner or pharmacist must not supply any drug of addiction in a quantity, or for a purpose, that does not accord with the recognised therapeutic standard of what is appropriate in the circumstances.
Maximum penalty: 20 penalty units or imprisonment for 6 months, or both.