Therapeutic Goods Regulations 1990

The Secretary may direct that unused emergency goods or unused emergency biologicals be destroyed within the time specified in the direction if any of the following applies:

the goods or biologicals have passed their expiry date;

the goods or biologicals no longer conform to a standard that applies to the goods or biologicals;

use of the goods or biologicals poses, or would pose, a risk to public health;

storage of the goods or biologicals at their current location and any other location poses, or would pose, a risk to the public or the environment;

for unused emergency goods—within 12 months after the exemption ceases to have effect in relation to the goods, the goods have not become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):

registered goods or listed goods; or

exempt goods under section 18 of the Act; or

goods that are the subject of an approval or authority under section 19 of the Act; or

goods that are the subject of an approval under section 19A of the Act;

for unused emergency biologicals—within 12 months after the exemption ceases to have effect in relation to the biologicals, the biologicals have not become (whether in relation to an indication for which the biologicals could have been used under the exemption or in relation to a different indication):

included in the Register under Part 3‑2A of the Act; or

exempt biologicals under section 32CA of the Act; or

biologicals that are the subject of an approval or authority under section 32CK or 32CM of the Act; or

biologicals that are the subject of an approval under section 32CO of the Act;

the person who has control over the goods or biologicals requests that the goods or biologicals be destroyed.

A person directed to destroy the goods or biologicals may destroy the goods or biologicals only in a way, approved by the Secretary, that ensures that the destruction avoids or minimises harm to the public and the environment.