Medicines, Poisons and Therapeutic Goods Regulation 2008

The following conditions apply to a person who supplies medicines by wholesale under a corresponding law:

the person must comply with, and must ensure that the person’s agents and employees comply with—

the Australian code of good wholesaling practice for medicines in schedules 2, 3, 4 and 8; and

the medicines Australia code of conduct;

Note Australian code of good wholesaling practice for medicines in schedules 2, 3, 4 and 8 and medicines Australia code of conduct—see the dictionary.

the person must not supply sample packs of a controlled medicine;

the person must not supply a medicine to someone else (the buyer) unless—

the buyer is authorised to possess the medicine; and

the supply is in accordance with section 140 (Authorisation conditions for supplying medicines on purchase orders—Act, s 44 (1) (b) and (2) (b));

the person must store medicines—

within the manufacturer’s recommended storage temperature range; and

in any other environmental condition that is necessary to preserve the medicine’s stability and therapeutic quality.

Chapter 5 Administering medicines

Part 5.1 Authorisations for health-related occupations

350 Authorisation under sch 1 for people in health-related occupations to administer medicines—Act, s 37 (1) (b) and (3) (b)

A person mentioned in schedule 1, column 2 is authorised to administer a medicine if—

administering the medicine is included in the schedule, column 3 in relation to the person; and

the administration is consistent with any restriction for the administration mentioned in the schedule, column 3.

Note For authorisation to self-administer a medicine, see s 360.

351 Authorisation conditions for administration of medicines at institutions by people in health-related occupations—Act, s 44 (1) (b) and (2) (b)

An authorisation under section 350 or section 490 to administer a medicine is subject to the following conditions:

if the medicine is administered under a standing order to a patient at an institution—the administration is recorded in the patient’s medical records;

Note Institution includes a correctional centre and a CYP detention place (see s 652).

if the medicine is a controlled medicine administered to a patient at an institution—

the medicine is not removed from a storage receptacle until immediately before its administration; and

the administration is witnessed by a prescribed administration witness or, if a prescribed administration witness is not reasonably available to witness the administration, the administration is witnessed by another person; and

Note The witness must sign the record of the administration as witness (see Act, s 53 (e)).

the administration is recorded in—

the patient’s medical records; and

the applicable controlled medicines register mentioned in section 543 (3) (Making entries in controlled medicines registers—Act, s 51 (1) (b)).

However, subsection (1) (b) does not apply in relation to a controlled medicine dispensed in a dose administration aid for—

a patient at a residential aged care facility or residential disability care facility; or

a detainee at a correctional centre; or

a young detainee at a CYP detention place.

In this section:

prescribed administration witness means a person prescribed under section 544 (Prescribed witnesses for administration of controlled medicines—Act, s 53 (a) and (b)) for the administration of a controlled medicine.