44Offence—administration or non-wholesale supply of unregistered or unlisted therapeutic goods

44 Offence—administration or non-wholesale supply of unregistered or unlisted therapeutic goods

44 Offence—administration or non-wholesale supply of unregistered or unlisted therapeutic goods

(1) A person must not administer or supply therapeutic goods for use in or on humans unless the goods are—

(a) registered goods, or

(b) listed goods, or

(c) subject to an approval, authority or exemption under the Commonwealth Therapeutic Goods Act, Chapter 3 or 4.

Maximum penalty—Tier 5 penalty.

(2) This section does not apply to the following—

(a) the supply of therapeutic goods that are medical devices, other than medical devices that contain scheduled substances,

(b) the administration or supply of therapeutic goods by a person who is a sponsor,

(c) the administration or supply of therapeutic goods by a carer of another person to the extent the goods are—

(i) a Schedule 2 or 3 substance, or

(ii) a Schedule 4 or 8 substance dispensed on a prescription by a pharmacist or supplied by an authorised practitioner for the other person,

(d) the self-administration of therapeutic goods by a person,

(e) the wholesale supply of therapeutic goods,

Note—

See the Commonwealth Therapeutic Goods Act, section 21 for an offence relating to wholesale supply of unregistered or unlisted therapeutic goods.

(f) the administration or supply of prescribed therapeutic goods in prescribed circumstances,

(g) the administration or supply of therapeutic goods if—

(i) the registration or listing has been suspended under the Commonwealth Therapeutic Goods Act, and

(ii) the Secretary under the Commonwealth Therapeutic Goods Act has not required the therapeutic goods to be recalled under that Act.

(3) In this section—

listed goods, registered goods and sponsor have the same meaning as in the Commonwealth Therapeutic Goods Act.