Monographs provide additional important information, including official names, recognized synonyms, applicable registration numbers (e.g., Chemical Abstracts Service numbers), and a description of the substance. They also provide information on properties, tests, and procedures that enable scientists to qualitatively verify the ingredient’s identity, along with tests, procedures, and acceptance criteria intended to ensure safety and purity. Monographs also give packaging and storage requirements and, in some cases, labeling requirements.
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Explore This IssueDecember/January 2008
USP terminology is closely linked to terms in the U.S. Federal Food, Drug, and Cosmetic Act (FFDCA). For this reason, USP frequently uses the word official. After its development, publication for public review, a comment period, and a final decision by USP’s Council of Experts, a USP documentary standard or monograph is finalized and becomes effective with an official date. If an RM is needed in order for analysts to conduct official monograph tests, the RM is stated to be an official USP Reference Standard. In its initial sections, FFDCA refers to official compendia and cites the existence of a USP monograph as one definition of a drug. If a USP Expert Committee publishes a monograph for a drug substance or product, then that substance or product is a drug and must comply with the standards in USP, or the label must clearly state how the substance or product differs from the monograph standards.
FFDCA’s reference to official compendia has ramifications for FCC: A food ingredient with an FCC monograph is termed an official article and may be labeled with the FCC mark in conjunction with the official title. Official food articles recognized in FCC must comply with standards set by USP if the articles are dietary supplements or dietary ingredients, or substances intended directly or indirectly for use in foods or food processing and are labeled as conforming to FCC.
When a food ingredient supplier (first party) puts the letters FCC on the certificate of analysis of the container of an ingredient, it signals to a food manufacturer (second party) that the ingredient is official, bears an official title (name), and complies with standards of purity and identity that should be maintained throughout the time the article is in commerce. These quality standards can be tested by third parties (government officials, independent testing laboratories, and others) according to the monograph published in FCC. The terms first, second, and third party are drawn from a nomenclature provided in guidance from the National Institute of Standards and Technology (NIST), as is other terminology useful to standards-setting bodies.
Careful use of terminology and related activities help food ingredient suppliers and USP leverage an FCC monograph as part of an important component of the communication process, not only to food manufacturers and government but also to the public at large. The communication establishes that a quality standard in FCC is publicly known and is being met. This ensures that all parties are able to know, understand, and utilize independently the documentary and physical standards of an article of commerce to preserve the safety and quality of foods and dietary supplements. Because of the linkages among USP, NF, and FCC, this communication can highlight the efforts of first-, second-, and third-party actors to ensure the safety not only of foods and dietary supplements but also of medicines.
Any standard has little meaning unless it includes a conformity assessment, which for FCC involves testing by the food ingredient manufacturer to ensure that the monograph specifications have been met. The manufacturer should note the results of the testing on a certificate of analysis (CoA) and should provide the CoA to the purchaser. FCC achieves its purpose when second parties (e.g., food manufacturers) require CoAs and test food ingredients to them. Under good manufacturing practices for foods, a food manufacturer may, upon receipt of a food ingredient, qualify it by means of an audit and testing program, including testing to FCC standards.