Issue link: https://www.e-digitaleditions.com/i/1192284
Pharmaceutical Technology REGULATORY SOURCEBOOK DECEMBER 2019 21 vision bulletins (RBs), and errata, which are posted on the USP website on a regular (monthly) schedule. IRAs are first published as proposals in the forum, given a 90-day notice and comment period, then posted as official text on the USP website and incorporated into the next available official pub- lication. If circumstances require a more rapid publication of official text, a revision bulletin is posted on the USP web- site with the official date indicated. Errata are published to correct content in the USP that does not accurately ref lect the intended requirements as approved by the experts, and may address inaccuracies in chemical formulas, mathemati- cal equations relevant to analyses, or inaccurate descriptions of apparatus or materials used in analytical tests. The USP also publishes compendial notices to inform stakeholders of the changing status of monographs and general chapters, for example, to modify general chapter titles, appendix titles, or references to external resources that may be listed through- out the pharmacopoeia. These processes for accelerated re- visions do not always require publication in the forum and allow revisions to become official prior to the next edition or supplement. There is another process for USP pending mono- graphs to allow development of new or revised monographs Table II. Publication schedule for new editions/supplements (official updates). Pharmacopoeia Official publication Media type Official language (Translation) Frequency (Publication date) Notes European Pharmacopoeia (Ph. Eur.) Main Edition Online and hard copy English and French New edition every 3 years (Publish: July. Official: January) Supplements Online and hard copy English and French 8 supplements over 3-year cycle (Publish: October, January, July) British Pharmacopoeia (BP) Main Edition Online and hard copy English New edition every year. (Publish: August. Official: January.) Updates are made to the BP on-line publication (not the hard-copy version) to reflect Ph. Eur. supplements. Supplements N/A English No supplements are published United States Pharmacopeia (USP) Main Edition Online English (Spanish) New edition every year (Publish: November. Official: May) Final hardcopy publication of USP occured in November 2019. Only online publication available after that date. Supplements Online English (Spanish) 2 supplements per year (Publish: February, June) Japanese Pharmacopoeia (JP) Main Edition Hard copy Japanese (English) New edition every 5 years Free on-line PDF versions of the official JP edition and supplements are available on the health authority website in both Japanese and English. Supplements Hard copy Japanese (English) 2 supplements published in year 2 and 4 of 5-year cycle Chinese Pharmacopoeia (ChP) Main Edition Hard copy Chinese (English) New edition every 5 years Supplements Hard copy Chinese 2 supplements over 5-year cycle (No English translation) Indian Pharmacopoeia (IP) Main Edition Hard copy English New edition every 4 years Supplements Hard copy English 2 supplements (addenda) published over 4-year cycle State Pharmacopoeia of the Russian Federation (SP RF) Main Edition Online Russian New edition published but not on a regular cycle. (No English translation.) Publication of supplements unknown. Free on-line version of the official SP RF edition is available on the health authority website in Russian (only). Korean Pharmacopoeia (KP) Main Edition Hard copy Korean (English) New edition targeted every 5 years. Publication of supplements unknown. Free on-line PDF version of the official KP edition is available on the health authority website in English. Brazilian Pharmacopoeia (FBras) Main Edition Hard copy Portuguese (English) New edition published but no defined periodicity. Publication of supplements unknown. Free on-line version of FBras may be available on the health authority website in Portuguese and English