Cal. Code Regs. tit. 17 § 10360

Current through Register 2024 Notice Reg. No. 45, November 8, 2024

Section 10360 - New Drugs -Definition

Newness of a drug may arise by reason (among other reasons) of:

(a) The newness for drug use of any substance which composes such drug, in whole or in part, whether it be an active substance or a menstruum, excipient, carrier, coating, or other component;

(b) The newness for drug use of a combination of two or more substances, none of which is a new drug;

(c) The newness for drug use of the proportion of a substance in a combination, even though such combination containing such substance in other proportion is not a new drug;

(d) The newness of use of such drug in diagnosing, curing, mitigating, treating, or preventing a disease, or to affect a structure or function of the body, even though such drug is not a new drug when used in another disease or to affect another structure or function of the body; or

(e) The newness of a dosage, or method or duration of administration or application, or other condition of use prescribed, recommended, or suggested in the labeling of such drug, even though such drug when used in other dosage, or other method or duration of administration or application, or different condition, is not a new drug.

Cal. Code Regs. Tit. 17, § 10360

1. Amendment filed 6-27-60; effective thirtieth day thereafter (Register 60, No. 15).
2. Amendment of section heading and repealer of subsection (f) filed 12-17-85; effective thirtieth day thereafter (Register 85, No. 51).
3. Governor Newsom issued Executive Order N-68-20 (2019 CA EO 68-20), dated June 5, 2020, relating to the temporary registrations allowing entities to manufacture over-the-counter drugs or medical devices, due to the COVID-19 pandemic.

Note: Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Section 26021, Health and Safety Code.