- Q. What does 'default standard' mean in relation to medicines?
- From 1 July 2009, the definition of 'default standard' has been included in section 3 of the Therapeutic Goods Act 1989 (the Act). 'Default standard' means any of the British Pharmacopoeia (BP), European Pharmacopoeia (Ph Eur), and United States Pharmacopoeia-National Formulary (USP).
- Q. What is the definition of 'British Pharmacopoeia'?
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From 1 July 2009, an amended definition of the British Pharmacopoeia (BP) has been included in section 3 of the Act.
The definition of the BP under the Act includes the BP and its Online updates in January, April and July. These updates consist of the supplements to the European Pharmacopoeia that become effective at those times.
- Q. What is the definition of 'European Pharmacopoeia'?
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From 1 July 2009, the definition of the European Pharmacopoeia (Ph Eur) has been included in section 3 of the Act.
The English edition of the Ph Eur that came into force under the Act on 1 July 2009 was the 6th edition, as amended by the non-cumulative supplements 6.1 to 6.5 inclusive.
Thereafter, 'European Pharmacopoeia' means any additions, amendments and new editions from the effective date published by the Council of Europe or any replacement body.
- Q. What is the definition of 'United States Pharmacopeia-National Formulary'?
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From 1 July 2009, the definition of the United States Pharmacopeia-National Formulary (USP) has been included in section 3 of the Act.
The English edition of the USP that came into force under the Act on 1 July 2009 was the 32nd edition.
Thereafter, 'United States Pharmacopeia-National Formulary' means any additions, amendments and new editions from the effective date published by the United States Pharmacopeial Convention or any replacement body.
- Q. What are the current 'default standards'?
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The easiest way to determine what edition of each pharmacopoeia is current, and the publication plans for future editions, is to refer to the Internet sites of the pharmacopoeias.
The BP is published annually around August and takes effect on the following 1 January. While the BP Online gives the choice of the "as published" or "updated" versions, it is the "updated" version that is defined by the Act.
Supplements to the Ph Eur are published six months prior to coming into effect; corrections become effective at publication. In exceptional cases, monographs are introduced between supplements via publication in the PharmEuropa.
The Accelerated Revision process used by the United States Pharmacopeial Convention includes Revision Bulletins, Interim Revision Announcements, and Errata published in the Pharmacopeial Forum and on the USP website that come into effect on the dates published.
- Q. When will new editions of the pharmacopoeias be introduced?
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The following tabulation is based on information current at 18 January 2011:
Date of Effect Pharmacopoeias effective from that date 1 July 2009 BP 2009
Ph Eur (6.0 to 6.5 inclusive)
USP 32 - NF 27 (see Note below)
1 August 2009 1st Supplement of USP 32 and USP Interim Revisions 1 October 2009 USP Interim Revisions 1 December 2009 2nd Supplement of USP 32 and USP Interim Revisions 1 January 2010 BP 2010, including Online update inclusive of Supplement 6.6 of Ph Eur
Supplement 6.6 of Ph Eur
1 February 2010 USP Interim Revisions 1 April 2010 BP 2010, including Online updates inclusive of Supplement 6.7 of Ph Eur
Supplement 6.7 of Ph Eur
USP Interim Revisions
1 May 2010 (see Note below) 1 June 2010 USP Interim Revisions 1 July 2010 BP 2010, including Online updates inclusive of Supplement 6.8 of Ph Eur
Supplement 6.8 of Ph Eur
1 August 2010 (see Note below) USP Interim Revisions 1 September 2010 USP Interim Revisions 1 October 2010 USP 33-NF 28 Reissue
First Supplement to the USP 33-NF 28 Reissue
USP Interim Revisions
1 November 2010 USP Interim Revisions 1 December 2010 USP Interim Revisions 1 January 2011 BP 2011
Ph Eur 7th Edition
USP Interim Revisions
January 2011 BP 2011 including Online update inclusive of the Ph Eur 7th Edition 1 February 2011 Second Supplement to the USP 33-NF 28 Reissue
USP Interim Revisions
1 March 2011 USP Interim Revisions 1 April 2011 BP 2011 including Online updates inclusive of Supplement 7.1 of Ph Eur
Supplement 7.1 of Ph Eur
USP Interim Revisions
1 May 2011 USP 34-NF 29
USP Interim Revisions
1 July 2011 BP 2011 including Online updates inclusive of Supplement 7.2 of Ph Eur
Supplement 7.2 of Ph Eur
1 August 2011 First Supplement to the USP 34-NF 29 1 December 2011 Second Supplement to the USP 34-NF 29 Note: The United States Pharmacopeial Convention has recalled USP 33-NF 28. The previously published dates of 1 May 2010 for USP 33-NF 28 to become effective, and 1 August 2010 for the First Supplement to USP33-NF28 to become effective, were revoked. The USP 32-NF 27 and Supplements and Interim Revisions to that edition remain official, other than where updated or supplemented by USP 33-NF28 Reissue and its Supplements and Interim Revisions, until USP 34-NF 29 becomes official on 1 May 2011.
- Q. How do I find out what is being added into new editions of the pharmacopoeias?
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The preliminary pages of each edition or supplement highlight the changes introduced in that publication. See:
- the European Pharmacopoeia - the information about the changes to be introduced in the European Pharmacopoeia supplements is also relevant to the BP Online updates.
- the United States Pharmacopoeia New Official Text and Pharmacopeial Forum.
- British Pharmacopoeia 2011.
Questions & answers relating to the additional default standards legislation
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