1091 LABELING OF INACTIVE INGREDIENTS
This informational chapter provides guidelines for labeling of inactive ingredients present in dosage forms.
Within the past few years a number of trade associations representing pharmaceutical manufacturers have adopted voluntary guidelines for the disclosure and labeling of inactive ingredients. This is helpful to individuals who are sensitive to particular substances and who wish to identify the presence or confirm the absence of such substances in drug products. Because of the actions of these associations, the labeling of therapeutically inactive ingredients currently is deemed to constitute good pharmaceutical practice.
Although the manufacturers represented by these associations produce most of the products sold in this country, not all manufacturers, repackagers, or labelers here or abroad are members of these associations. Further, there are some differences in association guidelines. The guidelines presented here are designed to help promote consistency in labeling.
In accordance with good pharmaceutical practice, all dosage forms [notefor requirements on parenteral and topical preparations, see the General Notices] should be labeled to state the identity of all added substances (therapeutically inactive ingredients) present therein, including colors, except that flavors and fragrances may be listed by the general term flavor or fragrance. Such listing should be in alphabetical order by name and be distinguished from the identification statement of the active ingredient(s).
The name of an inactive ingredient should be taken from the current edition of one of the following reference works (in the following order of precedence): (1) the United States Pharmacopeia or the National Formulary; (2) USAN and the USP Dictionary of Drug Names; (3) CTFA Cosmetic Ingredient Dictionary; (4) Food Chemicals Codex. An ingredient not listed in any of the aforementioned reference works should be identified by its common or usual name (the name generally recognized by consumers or health-care professionals) or, if no common or usual name is available, by its chemical or other technical name.
An ingredient that may be, but not always is, present in a product should be qualified by words such as or or may also contain.
The name of an ingredient whose identity is a trade secret may be omitted from the list if the list states and other ingredients. For the purposes of this guideline, an ingredient is considered to be a trade secret only if its presence confers a significant competitive advantage upon its manufacturer and if its identity cannot be ascertained by the use of modern analytical technology.
An incidental trace ingredient having no functional or technical effect on the product need not be listed unless it has been demonstrated to cause sensitivity reactions or allergic responses.
Inactive ingredients should be listed on the label of a container of a product intended for sale without prescription, except that in the case of a container that is too small, such information may be contained in other labeling on or within the package.