United States Pharmacopeia - Australian Government


You must comply with this Pharmacopeia if you intend to export medicine from Australia into the United States of America (USA).

Prior to the exportation of the medicine you must be able to show:

  • the medicine meets the regulatory requirements listed in this Pharmacopeia;
  • if the medicine is regulated as a product other than a type of medicine in the USA then it must meet the regulatory requirements for such products; and
  • evidence demonstrating the relevant authority in the USA has confirmed its willingness to accept the medicine or confirmed it would have no objection to importing the medicine.

Please consult the Contact Officer for more information and to ascertain the level of compliance (if any) that may be required.

Service type

Code of Practice

A code of practice can be either a legal requirement or non-legal requirement. Legal codes of practice are defined as a result of legislation. Non-legal codes of practice are defined by industry regulators and bodies.

Other resources

Task Business Structure Resources
Comply All United States Pharmacopeia (Opens in new window)

Act(s) name

Therapeutic Goods Act 1989 AG

Regulation(s) name

Therapeutic Goods Order No. 70C - Standards for Export Only Medicine 2014 AG

Administering agency

Department of Health

Therapeutic Goods Administration

Contact details

Contact Email, Phone and Address Details for this service in simple two column table format, header then data.


Therapeutic Goods Administration

Department of Health

Operating address: 136 Narrabundah Lane
Australian Capital Territory 2609
Mailing address: TGA, PO Box 100
Australian Capital Territory 2606
Phone: 1800 020 653
Email: info@tga.gov.au