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Contents (2008 - 392)
Poisons and Therapeutic Goods Regulation 2008
Current version for 1 July 2017 to date (accessed 21 November 2017 at 06:14)
Part 4 Division 4 Subdivision 1
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.