3. CONFORMANCE TO STANDARDS
3.10. Applicability of Standards
Standards for an article recognized in a USP compendium are expressed in the article's monograph, applicable general chapters, and General Notices. Unless specifically exempted elsewhere in a compendium, the identity, strength, quality, and purity of an article are determined by the official tests, procedures, and acceptance criteria, whether incorporated in the monograph itself, in the General Notices, or in the applicable general chapters. Early adoption of revised standards is allowed. Where revised standards for an existing article have been published as final approved official text (as approved in section 2.10) but are not yet official (six months after publication, unless otherwise specified; see official date, section 2.20) compliance with the revised standard shall not preclude a finding or indication of conformance with USP official standards, unless USP specifies otherwise by prohibiting early adoption in a particular standard.
The standards in the relevant monograph, general chapter(s), and General Notices apply at all times in the life of the article from production to expiration. The manufacturer's specifications, and good manufacturing practices generally (including, e.g., Quality by Design initiatives), are developed and followed to ensure that the article will comply with compendial standards until its expiration date, when stored as directed. Thus, any official article is expected to meet the compendial standards if tested, and any official article actually tested as directed in the relevant monograph must meet such standards to demonstrate compliance.
At times, compendial standards take on the character of statistical procedures, with multiple units involved and perhaps a sequential procedural design to allow the user to determine that the tested article meets or does not meet the standard. The similarity to statistical procedures may seem to suggest an intent to make inference to some larger group of units, but in all cases, statements about whether the compendial standard is met apply only to the units tested. Repeats, replicates, statistical rejection of outliers, or extrapolations of results to larger populations, as well as the necessity and appropriate frequency of batch testing, are neither specified nor proscribed by the compendia. Frequency of testing and sampling are left to the preferences or direction of those performing compliance testing, and other users of USPNF, including manufacturers, buyers, or regulatory authorities.
Official products are prepared according to recognized principles of good manufacturing practice and from ingredients that meet USP or NF standards, where standards for such ingredients exist (for dietary supplements, see section 3.10.20).
Official substances are prepared according to recognized principles of good manufacturing practice and from ingredients complying with specifications designed to ensure that the resultant substances meet the requirements of the compendial monographs.
3.10.10. Applicability of Standards to Drug Products, Drug Substances, and Excipients
The applicable USP or NF standard applies to any article marketed in the United States that (1) is recognized in the compendium and (2) is intended or labeled for use as a drug or as an ingredient in a drug. The applicable standard applies to such articles whether or not the added designation USP or NF is used. The standards apply equally to articles bearing the official titles or names derived by transposition of the definitive words of official titles or transposition in the order of the names of two or more active ingredients in official titles, or where there is use of synonyms with the intent or effect of suggesting a significant degree of identity with the official title or name.
3.10.20. Applicability of Standards to Medical Devices, Dietary Supplements, and Their Components and Ingredients
An article recognized in USP or NF shall comply with the compendial standards if the article is a medical device, component intended for a medical device, dietary supplement, dietary ingredient, or other ingredient that is intended for incorporation into a dietary supplement, and is labeled as conforming to the USP or NF.
Generally, dietary supplements are prepared from ingredients that meet USP, NF, or Food Chemicals Codex standards. Where such standards do not exist, substances may be used in dietary supplements if they have been shown to be of acceptable food grade quality using other suitable procedures.
3.20. Indicating Conformance
A drug product, drug substance, or excipient may use the designation USP or NF in conjunction with its official title or elsewhere on the label only when (1) a monograph is provided in the specified compendium and (2) the article complies with the identity prescribed in the specified compendium.
When a drug product, drug substance, or excipient differs from the relevant USP or NF standard of strength, quality, or purity, as determined by the application of the tests, procedures, and acceptance criteria set forth in the relevant compendium, its difference shall be plainly stated on its label.
When a drug product, drug substance, or excipient fails to comply with the identity prescribed in USP or NF or contains an added substance that interferes with the prescribed tests and procedures, the article shall be designated by a name that is clearly distinguishing and differentiating from any name recognized in USP or NF.
A medical device, dietary supplement, or ingredient or component of a medical device or dietary supplement may use the designation USP or NF in conjunction with its official title or elsewhere on the label only when (1) a monograph is provided in the specified compendium and (2) the article complies with the monograph standards and other applicable standards in the compendium.
The designation USP or NF on the label may not and does not constitute an endorsement by USP and does not represent assurance by USP that the article is known to comply with the relevant standards. USP may seek legal redress if an article purports to be or is represented as an official article in one of USP's compendia and such claim is determined by USP not to be made in good faith.
The designation USPNF may be used on the label of an article provided that the label also bears a statement such as Meets NF standards as published by USP, indicating the particular compendium to which the article purports to apply.
When the letters USP, NF, or USPNF are used on the label of an article to indicate compliance with compendial standards, the letters shall appear in conjunction with the official title of the article. The letters are not to be enclosed in any symbol such as a circle, square, etc., and shall appear in capital letters.
If a dietary supplement does not comply with all applicable compendial requirements but contains one or more dietary ingredients or other ingredients that are recognized in USP or NF, the individual ingredient(s) may be designated as complying with USP or NF standards or being of USP or NF quality provided that the designation is limited to the individual ingredient(s) and does not suggest that the dietary supplement complies with USP standards.