United States Pharmacopeia/National Formulary (USP/NF)

U.S. Pharmacopeia / National Formulary：Pharmacopeia

Issuance history and latest edition

They are edited and published by the United States Pharmacopeial Convention under the U.S. government. The first edition of USP was published in 1820; from 1950, one revised edition was published every 5 years, until USP25 in 2002; from 2002, one edition is published every year, and it reaches the 41^st edition by November 2017.

The first edition of NF was published in 1883; from 1980, the 15^th edition was incorporated in USP, but they were still two parts, with USP being the first part and NF being the second part, to make the first USP20-NF15 combined volume; also from 2002, one edition is published every year, and it reaches the NF36 by November 2017.

Table 4 USP Publication Schedule

Characteristics of the USP

The USP is technical provisions of the U.S. government on the pharmaceutical product quality standards and testing methods, and serves as the legal basis for pharmaceutical production, use, management, and inspection. NF mainly contains the excipient standards.

USP/NF is currently divided into three volumes. Volume 1 includes Front Matter, General Notices, General Chapters, Reagents, Monographs, Reference Tables, Dietary Supplements, NF and Combined Index, etc.; Volume 2 and Volume 3 mainly include USP General Notices and Monographs content. The pharmaceutical product list in the monographs of the USP is in the alphabetical order of the legal drug names, and each pharmaceutical product entry mostly has drug name, structure formula, molecular formula, CAS registration No., ingredients and content description, package and storage specifications, identification method, loss on drying, residue on ignition, testing method, etc. The attached USP and NF combined index can be used to consult each drug in the USP-NF.

British Pharmacopoeia (BP)

Issuance history and latest edition

BP is a formal publication of the British Pharmacopoeia Commission, and importance source of the British pharmaceutical standards. It does not only furnish readers with medicinal and drug formulation standards and formula dispensing standards, but also presents them with many clearly classified and referenceable European pharmacopoeia monographs.

BP was born in 1864, and is the official collection of standards for UK medicinal products and pharmaceutical substances. A new edition of BP is published in August every year, and takes legal effect on January 1 of next year. It covers all standards in the European Pharmacopoeia and is updated three times per year online to include the European Pharmacopoeia supplements; it includes monographs for drug substances and formulated preparation, and monographs for herbal and veterinary drugs, etc. BP is named according to BP plus year, and the latest edition is BP2018.

Characteristics of BP

BP has 6 volumes in total

The specific content of BP includes:

General notices (providing general information applicable to all texts)

General monographs (applicable to all dosage forms)

Specific monographs providing mandatory standards for

1. Active pharmaceutical ingredients; 2. Excipients; 3. Formulated preparations (licensed and unlicensed products); 4. Herbal drugs, herbal drug products and herbal medicinal products; 5. Materials for use in the manufacture of homoeopathic preparations; 6. Blood-related products; 7. Immunological products; 8. Radiopharmaceutical preparations; 9. Surgical materials

Infrared reference spectra

Appendices

Supplementary chapters (providing additional guidance)

Comprehensive index

British Pharmacopoeia (Veterinary)

European Pharmacopoeia (EP)

Issuance history and latest edition

Established in 1964, the European Pharmacopoeia Commission published the first edition of EP in 1977. From 1980 to 1996, the new and revised items and new varieties were contained in one loose-leaf publication and put together as the volumes of the second edition of EP, and those not revised were still implemented according to the first edition.

The third edition of EP combined volume was published in 1997, and one supplement was published every year thereafter; new and revised content significantly increased as the European integration and international pharmaceutical product standard coordination efforts continued to develop, and the fourth edition of EP came into force five years later in January 2002. Thereafter, one edition is published every three years, and updated through non-cumulative supplements each time upon decision of the plenary session of European Pharmacopoeia Commission, with 3 supplements every year. The current ninth edition was published in July 2016, and the latest supplement is Supplement 9.5. A table is provided on EDQM website to introduce the publication schedule and implementation date.

Table 5 EP Publication Schedule

Characteristics of EP

There have been 28 countries using the EP, including the European Community member states and other European countries, and also Turkey and Cyprus in Asia, being a very important regional pharmacopeia.

The EP is divided into two volumes, wherein, Volume 1 contains general notices, general methods, general monographs on dosage forms, and guidelines, and Volume 2 contains the pharmaceutical product standards. A characteristic of the EP is that it only contains the APIs, but no preparations. EP does not contain preparations, but the general monographs on dosage forms are very comprehensive in terms of testing methods relating to preparations, and have some characteristics. General chapter of each general monograph on dosage forms includes Definition, Production, and Test. Preparation-related items in the appendix are separately specified in the above three parts according to different content and requirements, for example, pharmaceutical product packaging container is listed under Definition; non-sterile preparation microbial limit test and non-coated tablet friability and compressive resistance test, etc. are listed under Production; other items directly detecting the pharmaceutical product quality, such as the dissolution and content uniformity, etc., are listed under Test. Some provisions under Production serve as guidelines, however, they clearly specify that manufacturers shall guarantee their products to meet the requirements thereof.

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