Composition of the USP Pharmacists Pharmacopeia (Cont'd)

We will continue to look in detail at more selected portions of the Introductory Material, as follows.

INTRODUCTORY MATERIAL

The General Notices and Requirements section (the General Notices) presents the basic assumptions, definitions, and default conditions for the interpretation and application of the United States Pharmacopeia (USP) and the National Formulary (NF).

Requirements stated in these General Notices apply to all articles recognized in the USP and NF (the "compendia") and to all general chapters unless specifically stated otherwise.

1. TITLE AND REVISION

The full title of this joint compendium is The Pharmacopeia of the United States of America and the National Formulary (USP-NF). Although the USP and NF are published together and share these General Notices, they are separate compendia. Where the terms "USP", "NF", or "USP-NF" are used without further qualification, they refer to the currently official standard.

New and revised content is added to the USP-NF periodically (see section 2.10 Official Text). Routine revisions are published three times a year, on the following dates, corresponding with three "issues":
USP-NF 2021 Issue 1: Published November 1, 2020
USP-NF 2021 Issue 2: Published February 1, 2021
USP-NF 2021 Issue 3: Published June 1, 2021

"Issues" represent dates on which new and revised content is added to the USP-NF. The USP-NF is in continuous revision, with standards having official dates that correspond to their specific revision histories.

2. OFFICIAL STATUS AND LEGAL RECOGNITION

2.10. Official Text

Official text of the USP and NF is published online at https://online.​uspnf.com

Routine revisions are published in the USP-NF and become official on the date indicated, usually six months after publication.

Accelerated Revisions, published periodically in the USP-NF, are designed to make revisions official more quickly than through the routine process for publishing standards in the USP-NF. Accelerated Revisions may also be published on the Official Text section of USP's website (www.uspnf.com/​official-text). Accelerated Revisions supersede previously published content and become official on the date indicated.

Interim Revision Announcements are Accelerated Revisions to USP and NF that contain revisions and their official dates.

Revision Bulletins are Accelerated Revisions to official text or postponements that require expedited publication. They generally are official immediately unless otherwise specified in the Revision Bulletin.

Errata are Accelerated Revisions representing corrections to items erroneously published.

Periodically, a non-official volume of associated revisions and additions to the USP-NF is published in print or other media. This volume is intended to serve as a historical reference document and is not considered official text.

2.20. Official Articles

An official article is an article that is recognized in the USP or NF. An article is deemed to be recognized and included in a compendium when a monograph for the article is published in the compendium and an official date is generally or specifically assigned to the monograph.

The title specified in a monograph is the official title for such article. Other names considered to be synonyms of the official titles may not be used as substitutes for official titles. For a biologic product licensed under the Public Health Service Act, the official title shall be the title specified in the relevant monograph plus any prefix and/or suffix designated by the FDA unless otherwise specified in the applicable monograph (USP 1-Dec-2022). For drug products that incorporate a sensor to detect that the product has been administered, the official title shall be the title specified in the relevant drug product monograph plus the words "with sensor".

Official articles include both official substances and official products.

An official substance is a drug substance, excipient, dietary ingredient, other ingredient, or component of a finished device for which the monograph title includes no indication of the nature of the finished form.

An official product is a drug product, dietary supplement, compounded preparation, or finished device for which a monograph is provided.

2.30. Legal Recognition

The USP and NF are recognized in the laws and regulations of many countries throughout the world. Regulatory authorities may enforce the standards presented in the USP and NF, but because recognition of the USP and NF may vary by country, users should understand applicable laws and regulations. In the United States under the Federal Food, Drug, and Cosmetic Act (FDCA), both the USP and NF are recognized as official compendia. A drug with a name recognized in USP-NF must comply with compendial identity standards or be deemed adulterated, misbranded, or both. See e.g., FDCA § 501(b) and 502(e)(3)(b); also U.S. Food and Drug Administration (FDA) regulations, 21 CFR § 299.5(a&b). To avoid being deemed adulterated, such drugs must also comply with compendial standards for strength, quality, and purity, unless labeled to show all respects in which the drug differs. See e.g., FDCA § 501(b) and 21 CFR § 299.5(c). In addition, to avoid being deemed misbranded, drugs recognized in the USP-NF must also be packaged and labeled in compliance with compendial standards. See FDCA § 502(g).

A dietary supplement represented as conforming to specifications in the USP will be deemed a misbranded food if it fails to so conform. See FDCA § 403(s)(2)(D).

Enforcement of USP standards is the responsibility of the FDA and other government authorities in the U.S. and elsewhere. The USP has no role in enforcement.

3. CONFORMANCE TO STANDARDS

3.10. Applicability of Standards

Standards for an article recognized in the compendia (USP-NF) are expressed in the article's monograph, applicable general chapters, and General Notices. The identity, strength, quality, and purity of an article are determined by the official tests, procedures, and acceptance criteria, and other requirements incorporated in the monograph, in applicable general chapters, or in the General Notices.

In a monograph, requirements for official articles are indicated in two ways: (1) for certain monographs, after the official title, the primarily informational portions of the text appear first, followed by the text comprising requirements, the latter section of the monograph being introduced by a double arrow symbol "; and (2) for monographs more recently redesigned, requirements appear in the official title and in any text beginning with the section titled "Definition". In either format, information that appears: (1) after the title but before the double arrow symbol; (2) after the title but before the section titled "Definition"; or (3) in or after the section titled "Auxiliary Information" is provided for informational purposes. See the Preface for information related to updates to Chemical Information.

Where conformance to any specifications represented by Chemical Information is critical to establishing identity, purity, potency, or another quality attribute of an official article, the monograph will include such specifications in the text that states requirements.

"Applicable general chapters" means general chapters numbered below 1000 or above 2000 that are made applicable to an article through reference in the General Notices, a monograph, or another applicable general chapter numbered below 1000. Where the requirements of a monograph differ from the requirements specified in these General Notices or an applicable general chapter, the monograph requirements apply and supersede the requirements of the General Notices or applicable general chapters, whether or not the monograph explicitly states the difference.

Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition

Did You Know (On School) ...

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From Out of the Past

Cattle crossing
Means go slow
That old bull
Is some cows beau!
     Burma-Shave