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Contents (2008 - 392)
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Poisons and Therapeutic Goods Regulation 2008
Current version for 1 July 2017 to date (accessed 22 September 2017 at 03:34)
Part 3 Division 4
Division 4 Supply
Subdivision 1 Supply on prescription
39   Prescriptions may be filled only if in proper form
(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.
(2A)  This clause does not prevent a pharmacist from supplying a substance on a medication chart prescription that otherwise complies with clause 35 (1A) merely because the prescription fails to specify the maximum number of times that the substance may be supplied.
(3)  A pharmacist must not supply a restricted substance on a prescription referred to in subclause (2) (a) or (b) if it appears to the pharmacist that the substance has previously been supplied on the prescription, regardless of how many times the prescription purports to authorise the supply of the substance.
(4)  The Director-General may, by order in writing, exempt any person or restricted substance, or any class of persons or restricted substances, from any or all of the requirements of this clause.
(5)  Such an exemption may be given unconditionally or subject to conditions.
Maximum penalty: 15 penalty units.
40   Certain prescriptions not to be filled
(1)  A pharmacist must not supply a restricted substance on prescription:
(a)  if the prescription is marked “CANCELLED”, or
(b)  if the substance 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 substance 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 substance, or
(d)  if the prescription is illegible or defaced, or
(e)  if the prescription appears to have been forged or fraudulently obtained, or
(f)  if the prescription appears to have been altered otherwise than by the authorised practitioner by whom it was issued, or
(g)  if the prescription is dated:
(i)  in the case of a medication chart prescription—more than 4 months before the date on which the supply is requested, or
(ii)  in the case of a prescription, other than a medication chart prescription, for a prescribed restricted substance—more than 6 months before the date on which the supply is requested, or
(iii)  in any other case—more than 12 months before the date on which the supply is requested, or
(h)  in the case of a medication chart prescription—where it appears to the pharmacist that a sufficient quantity of the substance has already been supplied to the resident for the period indicated on the prescription.
(2)  Immediately on being requested to supply a prescribed restricted substance in either of the circumstances referred to in subclause (1) (e) or (f), a pharmacist must retain the prescription and cause notice of the request to be given to a police officer.
Maximum penalty: 15 penalty units.
41   Prescriptions to be endorsed
(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.
(2)  A person who supplies a substance 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 (in the case of a prescription for a special restricted substance) the intervals at which the substance 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: 15 penalty units.
(3)  The Director-General may, by order in writing, exempt any person or substance, or any class of persons or substances, from any or all of the requirements of this clause.
(4)  Such an exemption may be given unconditionally or subject to conditions.
(5)  This clause does not apply to a medication chart prescription.
42   Prescriptions for certain substances to be kept
(1)  A pharmacist who supplies a special restricted substance on prescription must keep the prescription, whether or not the prescription authorises more than one supply of the substance.
Maximum penalty: 20 penalty units.
(2)  A pharmacist must keep prescriptions for special restricted substances separate from other prescriptions (other than prescriptions for drugs of addiction).
Maximum penalty: 20 penalty units.
(3)  The Director-General may, by order in writing, exempt any person or substance, or any class of persons or substances, from any or all of the requirements of this clause.
(4)  Such an exemption may be given unconditionally or subject to conditions.
Subdivision 2 Supply without prescription
43   Supply by certain health practitioners
(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.
(4)  A dentist must not supply a restricted substance to any person otherwise than for dental treatment.
(5)  An optometrist must not supply a restricted substance to any person otherwise than in the course of practising as an optometrist.
(6)  A veterinary practitioner must not supply a restricted substance to any person otherwise than for veterinary treatment.
(7)  A podiatrist must not supply a restricted substance to any person otherwise than in the course of practising as a podiatrist.
Maximum penalty: 15 penalty units.
44   Emergency supply by pharmacists on direction of certain health practitioners
(1)  A pharmacist may supply a person with a restricted substance (including a prescribed restricted substance) in accordance with a direction given under clause 36.
(2)  A prescription that is subsequently sent in confirmation of the direction must be dealt with in accordance with clauses 41 and 42, and details of the supply must be recorded in accordance with clause 55, in the same way as if the restricted substance had been supplied on prescription.
(3)  If such a prescription is not received within 7 days after the substance is supplied, the pharmacist must report that fact to the Director-General.
Maximum penalty: 15 penalty units.
45   Emergency supply by pharmacists otherwise than on direction of health practitioner
(1)  A pharmacist may supply a person with a restricted substance (other than a prescribed restricted substance) if the pharmacist is satisfied:
(a)  that the person is undergoing treatment essential to the person’s well-being, and
(b)  that the substance has previously been prescribed for the treatment, and
(c)  that the person is in immediate need of the substance for continuation of the treatment, and
(d)  that, in the circumstances, it is not practicable for the person to obtain a prescription for the substance from an authorised practitioner.
(2)  A restricted substance may not be supplied to any person under this clause unless:
(a)  the quantity supplied is no more than that required for 3 days’ treatment, or
(b)  in the case of a liquid, aerosol, cream, ointment or anovulant tablet that is contained in a standard pack, the standard pack is the smallest standard pack in which that kind of liquid, aerosol, cream, ointment or anovulant tablet is generally available.
Maximum penalty: 15 penalty units.
45A   Supply by pharmacists in accordance with determination under National Health Act 1953 of Commonwealth
(1)  A pharmacist may supply a person with a restricted substance that is covered by the Continued Dispensing Determination under this clause if:
(a)  the supply is made in accordance with conditions that are specified in that determination, and
(b)  the supply is made in accordance with the document entitled Guidelines for the Continued Dispensing of eligible prescribed medicines by pharmacists, issued by the Pharmaceutical Society of Australia and as in force on 1 July 2012, and
(c)  the pharmacist is an approved pharmacist within the meaning of the National Health Act 1953 of the Commonwealth, and
(d)  the person is in immediate need of the substance for continuation of treatment.
(2)  In this clause, Continued Dispensing Determination means the National Health (Continued Dispensing) Determination 2012 of the Commonwealth, as in force on the commencement of the Poisons and Therapeutic Goods Amendment (Continued Dispensing) Regulation 2013.
46   Supply by pharmacists to health practitioners for emergency use
A pharmacist may supply an authorised practitioner with a restricted substance (including a prescribed restricted substance) for emergency use, but only on a written order signed and dated by the authorised practitioner.
47   Supply by pharmacists to nursing homes of stock for emergency use
(1)  The director of nursing of a nursing home is authorised to have possession of a restricted substance (including a prescribed restricted substance) that is approved by the Director-General for emergency use in that nursing home.
(2)  A retail pharmacist is authorised to supply a manufacturer’s original pack of a restricted substance (including a prescribed restricted substance) to the director of nursing of a nursing home but only if the substance 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)  A director of nursing at a nursing home must not:
(a)  sign an order under this clause for a restricted substance unless the substance is approved by the Director-General for emergency use in that nursing home, or
(b)  allow any restricted substance in his or her possession to be used otherwise than for administration to a resident of the nursing home in accordance with an authorisation by a medical practitioner, nurse practitioner, podiatrist, dentist or optometrist who prescribes substances to the nursing home’s residents.
Maximum penalty: 15 penalty units.
(4)  An approval under this clause:
(a)  is to be by order in writing, and
(b)  may apply generally or may be limited to a particular nursing home or class of nursing homes, and
(c)  may apply generally or may be limited to a particular substance or class of substance, and
(d)  may be given unconditionally or subject to conditions.
48   Supply by pharmacists of benzylpenicillin for use in animals
(1)  This clause applies to benzylpenicillin, including procaine penicillin, in preparations for use by intramuscular injection in animals.
(2)  A pharmacist may supply benzylpenicillin otherwise than on prescription to a person who satisfies the pharmacist that it is needed for the urgent treatment of an animal and that, under the circumstances, it is not practicable to obtain a prescription authorising its supply.
(3)  A pharmacist must not supply benzylpenicillin:
(a)  to any person who is under 18 years of age, or
(b)  to any person who is unknown to the pharmacist.
(4)  Subclause (3) (b) does not prevent a pharmacist from supplying benzylpenicillin to a person who is unknown to the pharmacist if it is supplied in the presence of a person who is known to the pharmacist and who satisfies the pharmacist that he or she knows the person being supplied.
48A   Supply by pharmacists of influenza vaccine
(1)  A pharmacist may supply and administer an influenza vaccine to a person who is 18 years old or older at a retail pharmacy otherwise than on prescription if:
(a)  the pharmacist has completed a training course conducted by a provider of continuing professional development who is accredited by the Australian Pharmacy Council to provide the course, being a course that complies with any standards for the accreditation of programs to support pharmacist administration of vaccines that are published by the Australian Pharmacy Council from time to time, and
(b)  the pharmacist acts in accordance with any practice standards approved by the Director-General.
(2)  A pharmacist who supplies an influenza vaccine to a person in accordance with this clause must record the following details:
(a)  the person’s name, address, date of birth and contact details,
(b)  the name and contact details of the person’s primary medical practitioner,
(c)  the brand, batch number and expiry date of the vaccine,
(d)  the part of the body to which the vaccine was administered,
(e)  the date on which the vaccine was administered,
(f)  the pharmacist’s name and contact details and his or her certificate of accreditation number,
(g)  the address of the pharmacy at which the vaccination was administered,
(h)  a unique reference number for the supply and administration.
Maximum penalty: 15 penalty units.
Subdivision 3 Supply in hospitals
49   Supply by pharmacists
A pharmacist employed at a hospital may supply a restricted substance:
(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 the nurse or midwife in charge of the ward in which the substance is to be used or stored.
50   Supply in original containers
(1)  A person who supplies a restricted substance to a patient in a hospital, or to an inmate in an institution, in accordance with section 10 (4) (c) of the Act must supply the substance, unopened, in the container in which it was received by the person.
(2)  This clause does not prevent the person from supplying an individual dose of the substance to the patient or inmate.
Maximum penalty: 15 penalty units.
Subdivision 4 Supply generally
51   Research drugs
(1)  This clause applies to thalidomide other than as registered goods.
(2)  A dealer must not supply thalidomide unless the person being supplied holds an authority under Part 8 to be supplied with thalidomide.
(3)  This clause:
(a)  does not prohibit a dealer from supplying thalidomide to a person who has the approval in writing of the Permanent Head of the Commonwealth Department of Health to import, buy, obtain or otherwise be supplied with thalidomide, and
(b)  does not prohibit a person holding an authority under Part 8 to be supplied with thalidomide from supplying thalidomide to a person under his or her general supervision, for the purpose of enabling that other person to carry out medical diagnosis, or medical or scientific research or analysis (including the conduct of clinical trials), and
(c)  does not prohibit a medical practitioner holding an authority under Part 8 to be supplied with thalidomide from supplying thalidomide to another person for the purpose of treating that other person in accordance with the authority.
(4)  A person being supplied with thalidomide (otherwise than as referred to in subclause (3) (c)) must surrender his or her authority to the dealer.
(5)  A dealer must keep any authority surrendered to the dealer under this clause.
Maximum penalty: 15 penalty units.
52   Authority required to supply certain restricted substances
(1)  This clause applies to the following substances:
acitretin
clomiphene
cyclofenil
dinoprost
dinoprostone
etretinate
follitropin beta
isotretinoin for oral use
luteinising hormone
tretinoin for oral use
urofollitropin (human follicle stimulating hormone)
(2)  A person must not supply a substance to which this clause applies unless the person holds an authority under Part 8 to supply the substance.
(3)  This clause does not apply to the supply of a substance:
(a)  by wholesale, or
(b)  by a veterinary practitioner, or
(c)  by a pharmacist on the prescription of:
(i)  a medical practitioner holding an authority under Part 8 to prescribe the substance, or
(ii)  a veterinary practitioner, or
(d)  by a person who is authorised by the Permanent Head of the Commonwealth Department of Health to supply the substance.
Maximum penalty: 15 penalty units.
53   Restricted substances may be supplied by authorised persons
A person who is not an authorised practitioner may supply a restricted substance to another person if the person by whom the substance is supplied holds an authority under Part 8 to supply the substance.
54   Quantity and purpose of supply to be appropriate
An authorised practitioner or pharmacist must not supply any restricted substance 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.