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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 23 September 2017 at 08:27)
Part 4 Division 5
Division 5 Records of supply
Subdivision 1 Drug registers otherwise than for hospital wards
110   Application of Subdivision
This Subdivision applies to drugs of addiction that are kept at any place (including the pharmacy of a hospital) for the purposes of manufacture, supply, research or testing, but does not apply to drugs of addiction that are kept in a hospital ward or that are in the possession of a carrier for the purpose of their being delivered to the persons to whom they are addressed.
111   Drug registers to be kept
(1)  A person who has possession of drugs of addiction at any place must keep a separate register (a drug register) at that place.
(2)  A drug register is to be in the form of a book:
(a)  that contains consecutively numbered pages, and
(b)  that is so bound that the pages cannot be removed or replaced without trace, and
(c)  that contains provision on each page for the inclusion of the particulars required to be entered in the book.
(3)  Separate pages of the register must be used for each drug of addiction, and for each form and strength of the drug.
(4)  The Director-General may from time to time approve the keeping of a drug register in any other form.
Maximum penalty: 20 penalty units.
112   Entries in drug registers
(1)  On the day on which a person manufactures, receives, supplies, administers or uses a drug of addiction at any place, the person must enter in the drug register for that place such of the following details as are relevant to the transaction:
(a)  the quantity of the drug manufactured, received, supplied, administered or used,
(b)  the name and address of the person to, from, or by, whom the drug was manufactured, received, supplied, administered or used,
(c)  in the case of a drug that has been administered to an animal or supplied for the treatment of an animal, the species of animal and the name and address of the animal’s owner,
(d)  in the case of a drug that is supplied or administered on prescription:
(i)  the prescription reference number, and
(ii)  the name of the authorised practitioner by whom the prescription was issued,
(e)  in the case of a drug that has been administered to a patient, the name of the authorised practitioner (other than a veterinary practitioner) by whom, or under whose direct personal supervision, the drug was administered,
(f)  in the case of a drug that has been administered to an animal, the name of the veterinary practitioner by whom, or under whose direct personal supervision, the drug was administered,
(g)  in the case of a drug that has been administered by a person authorised to do so by an authority under Part 8, details of the circumstances requiring administration of the drug,
(h)  in the case of a drug that has been used by a person who is in charge of a laboratory, or is an analyst, the purpose for which the drug was used,
(i)  the quantity of drugs of addiction of that kind held at that place after the transaction takes place,
(j)  any other details approved by the Director-General.
(2)  Each entry in a drug register must be dated and signed by the person by whom it is made.
(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.
Maximum penalty: 20 penalty units or imprisonment for 6 months, or both.
113   Supply on prescription to be recorded
(1)  A pharmacist who supplies a drug of addiction on prescription must record the following details in a manner approved by the Director-General:
(a)  the details required by clause 80 (1) to be included in the prescription,
(b)  a unique reference number for the prescription,
(c)  the date on which the substance was supplied,
(d)  the name of the person by whom the substance was supplied.
Maximum penalty: 20 penalty units.
(2)  A prescription for the supply of a drug of addiction in a hospital need not be recorded so long as the chief pharmacist of the hospital keeps the prescription or a copy of the prescription.
(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 the requirements of this clause.
(4)  Such an exemption may be given unconditionally or subject to conditions.
114   Emergency supply or supply to private health facility or nursing home to be recorded
A pharmacist who supplies a drug of addiction in accordance with clause 97 or 103 must record the following details of the supply in a manner approved by the Director-General:
(a)  a unique reference number for the supply,
(b)  the name and address of the person supplied,
(c)  the name, strength and quantity of the substance,
(d)  the date on which the substance was supplied,
(e)  the name of the person by whom the substance was supplied.
Maximum penalty: 20 penalty units.
Subdivision 2 Drug registers for hospital wards
115   Application of Subdivision
This Subdivision applies to drugs of addiction that are kept in a hospital ward, but does not apply to drugs of addiction that are kept in a pharmacy at the hospital.
116   Ward registers to be kept
(1)  The nurse or midwife in charge of a hospital ward must keep a register of drugs of addiction (a ward register) in that ward.
(2)  A ward register is to be in the form of a book:
(a)  that contains consecutively numbered pages, and
(b)  that is so bound that the pages cannot be removed or replaced without trace, and
(c)  that contains provision on each page for the inclusion of the particulars required to be entered in the book.
(3)  Separate pages of the register must be used for each drug of addiction, and for each form and strength of the drug.
(4)  The Director-General may from time to time approve the keeping of a ward register in any other form.
Maximum penalty: 20 penalty units.
117   Entries in ward registers
(1)  On the day on which a person receives, supplies or administers a drug of addiction in any ward, the person must enter in the ward register such of the following details as are relevant to the transaction:
(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 after the transaction takes place,
(e)  any other details approved by the Director-General.
(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.
(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.
Maximum penalty: 20 penalty units.
Subdivision 3 Records generally
118   Periodical inventory of stock of drugs of addiction
(1)  The person responsible for maintaining a drug register (including a ward 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.
(2)  The prescribed periods for the purposes of subclause (1) (a) are:
(a)  March and September each year, or
(b)  if the Director-General determines some other periods, either generally or in specified circumstances, the periods so determined.
(3)  A person who assumes control for a period of one month or more over any place at which drugs of addiction are held must, immediately on assuming control, make an inventory and endorse the drug register as if the inventory were an inventory made under this clause.
Maximum penalty: 20 penalty units.
119   Loss or destruction of registers
Immediately after a drug register (including a ward register) is lost or destroyed, the person responsible for keeping the register:
(a)  must give written notice to the Director-General of that fact and of the circumstances of the loss or destruction, and
(b)  must make an accurate inventory of all drugs of addiction held at the premises concerned and enter, in a new drug register, the particulars of the drugs so held.
Maximum penalty: 20 penalty units.
119A   Records relating to prescriptions for residents of residential care facilities
The operator of a residential care facility in which medication charts are used must ensure that an employee of the facility makes a record in the medication chart of a resident of the facility of administration of any drug of addiction to the resident.
Maximum penalty: 20 penalty units.