THERAPEUTIC SUBSTANCES.
No. 73 of 1959.
An Act to amend the Therapeutic Substances Act 1953.
[Assented to 1st December, 1959.]
BE it enacted by the Queen’s Most Excellent Majesty, the Senate, and the House of Representatives of the Commonwealth of Australia, as follows:—
Short title and citation.
1.—(1.) This Act may be cited as the Therapeutic Substances Act 1959.
(2.) The Therapeutic Substances Act 1953, as amended by this Act, may be cited as the Therapeutic Substances Act 1953—1959.
Commencement.
2. This Act shall come into operation on the day on which it receives the Royal Assent.
Interpretation.
3. Section four of the Therapeutic Substances Act 1953 is amended—
(a) by omitting from sub-section (1.) the definitions of “the British Pharmaceutical Codex” and “the British Pharmacopoeia” and inserting in their stead the following definitions:—
“‘the British Pharmaceutical Codex’ means—
(a) the latest edition (being an edition that has taken effect for the purposes of
this Act, in accordance with sub-section (4.) of this section) for the time being of the book called the British Pharmaceutical Codex published by direction of the Council of the Pharmaceutical Society of Great Britain; or
(b) if that edition has been added to or amended by additions or amendments that have taken effect for the purposes of this Act, in accordance with sub-section (4.) of this section—that edition as affected by those additions or amendments;
“‘the British Pharmacopoeia’ means—
(a) the latest edition (being an edition that has taken effect for the purposes of this Act, in accordance with sub-section (5.) of this section) for the time being of the book called the British Pharmacopoeia published under the direction of the General Medical Council of the United Kingdom; or
(b) if that edition has been added to or amended by additions or amendments that have taken effect for the purposes of this Act, in accordance with sub-section (5.) of this section—that edition as affected by those additions or amendments;”; and
(b) by adding at the end thereof the following sub-sections:—
“(4.) The edition of the British Pharmaceutical Codex that was published in the year One thousand nine hundred and fifty-four, and the additions to, and amendments of, that edition contained in the Supplement to the British Pharmaceutical Codex published in the year One thousand nine hundred and fifty-seven, shall be deemed to have taken effect for the purposes of this Act before the commencement of this sub-section, and any further additions to, or amendments of, that edition, any subsequent edition of the British Pharmaceutical Codex and any additions to, or amendments of, any such subsequent edition shall take effect for the purposes of this Act upon such dates as are respectively fixed by the Minister by notices published in the Gazette.
“(5.) The edition of the British Pharmacopoeia that was published in the year One thousand nine hundred and fifty-eight shall be deemed to have taken effect for the purposes of this Act before the commencement of this sub-section, and any additions to, or amendments of, that edition, any subsequent edition of the British Pharmacopoeia and any additions to, or amendments of, any such subsequent edition shall take effect for the purposes of this Act upon such dates as are respectively fixed by the Minister by notices published in the Gazette”.
Overview
The Therapeutic Substances Act 1959 was enacted to amend the Therapeutic Substances Act 1953, addressing the need for updating the references to the British Pharmaceutical Codex and British Pharmacopoeia to reflect their latest editions. This Act was passed by the Parliament of Australia and received Royal Assent on 1st December 1959, immediately coming into operation on that date. The primary objective of this legislative amendment was to ensure that the definitions of key pharmaceutical references within the Therapeutic Substances Act 1953 are current and reflect the most recent additions or amendments, thereby facilitating the regulation of therapeutic substances with up-to-date standards.
Scope and Application
The Therapeutic Substances Act 1959 applies to the regulation and amendment of therapeutic substances within the Commonwealth of Australia. This legislation amends the Therapeutic Substances Act 1953 by updating definitions related to the British Pharmaceutical Codex and the British Pharmacopoeia, ensuring that the most current editions and any subsequent amendments are recognised and enforced. The Act encompasses all entities and individuals involved in the manufacture, supply, and sale of therapeutic substances, thereby impacting various industries including pharmaceuticals and healthcare. Geographically, its jurisdiction extends across the Commonwealth, applying uniformly throughout Australia. While the Act itself does not specify exclusions or exemptions, it allows the Minister to set effective dates for updated editions and amendments through notices published in the Gazette, thereby extending or restricting its application as necessary.
Key Provisions
The Therapeutic Substances Act 1959 (Act) makes several key amendments to the Therapeutic Substances Act 1953. Firstly, the Act provides new definitions for "the British Pharmaceutical Codex" and "the British Pharmacopoeia" in section three, replacing the previous definitions with updated ones that clarify the specific editions and any amendments that are relevant for the purposes of the Act (subsection 3(a)). It also establishes that certain editions of these works, along with any subsequent amendments, are deemed to have taken effect on specified dates as determined by the Minister through notices in the Gazette (subsection 3(4) and 3(5)).
Under the Act, entities and individuals involved in the manufacture, sale, or distribution of therapeutic substances must comply with the updated definitions and regulations as set out in the Therapeutic Substances Act 1953. This includes ensuring that any therapeutic substances they produce or distribute adhere to the standards specified in the relevant editions of the British Pharmaceutical Codex and British Pharmacopoeia, as amended by the Minister. These entities and individuals must also be aware of the dates on which any amendments to these works take effect, as specified in the Gazette.
Failure to comply with the provisions of the Therapeutic Substances Act 1953 and its amendments by the Therapeutic Substances Act 1959 may result in civil or criminal penalties. The specific penalties are not detailed in the Act itself but would be determined by the courts or relevant regulatory authorities based on the nature and severity of the breach. Generally, penalties for breaches of therapeutic substances legislation can include fines and imprisonment, with the exact penalties varying according to the specific circumstances of each case and the relevant state or territory laws.