Inactive ingredient definition

Inactive ingredient means any com- ponent other than an active ingredient.

Inactive ingredient means any component other than an “active ingredient” present in a drug.

Inactive ingredient means any com- ponent of a product other than an ac- tive ingredient as defined in § 210.3(b)(7) of this chapter.Subpart B—Ingredients§ 328.10 Alcohol.(a) Any over-the-counter (OTC) drug product intended for oral ingestion shall not contain alcohol as an inactive ingredient in concentrations that ex- ceed those established in this part, un- less a specific exemption, as provided in paragraph (e) or (f) of this section, has been approved.(b) For any OTC drug product in- tended for oral ingestion and labeled for use by adults and children 12 years of age and over, the amount of alcohol in the product shall not exceed 10 per- cent.

Examples of Inactive ingredient in a sentence

• However, an applicant may seek approval of a drug product that differs from the reference listed drug in preservative, buffer, or antioxidant provided that the applicant identifies and characterizes the differences and provides information demonstrating that the differences do not affect the safety or efficacy of the proposed drug product.(iv) Inactive ingredient changes per- mitted in drug products intended for oph- thalmic or otic use.

• Unless other- wise stated in paragraphs (a)(9)(iii) through (a)(9)(v) of this section, an ap- plicant must identify and characterize the inactive ingredients in the pro- posed drug product and provide infor- mation demonstrating that such inac- tive ingredients do not affect the safe- ty or efficacy of the proposed drug product.(iii) Inactive ingredient changes per- mitted in drug products intended for par- enteral use.

• Unless other- wise stated in paragraphs (a)(9)(iii) through (a)(9)(v) of this section, an ap- plicant shall identify and characterize the inactive ingredients in the pro- posed drug product and provide infor- mation demonstrating that such inac- tive ingredients do not affect the safe- ty or efficacy of the proposed drug product.(iii) Inactive ingredient changes per- mitted in drug products intended for par- enteral use.

• However, this distinction has no material effect on the focus of this dissertation, only on who must prove consent or a lack thereof.

• However, an applicant may seek approval of a drug product that differs from the reference listed drug in preservative, buffer, or antioxidant provided that the applicant identifies and characterizes the differences and provides information demonstrating that the differences do not affect the safety or efficacy of the proposed drug product.(iv) Inactive ingredient changes per-mitted in drug products intended for oph- thalmic or otic use.

More Definitions of Inactive ingredient

Inactive ingredient means any component of a drug product other than an active ingredient;

Inactive ingredient means any component other than an active ingredient;

Inactive ingredient means any component other than an “active in- gredient. ”

Inactive ingredient means an ingredient which is not

Inactive ingredient means)) - A drug component that remains chemically unchanged during compounding but serves as the:

Inactive ingredient means any component other than an activeingredient.

Inactive ingredient means any com- ponent other than an active ingredient. 21 CFR Ch. I (4–1–02 Edition)