Section 10425 - Applications(a) Each new drug application submitted for filing with the Department shall be in duplicate. If any part of the application is in a foreign language, an accurate and complete English translation shall be appended to that part.(b) An application shall not be accepted for filing if only one copy is submitted or if it is incomplete on its face in that:(1) It does not contain all the matter required by clauses (1), (2), (3), (4) and (6), of Section 26670 of the code.(2) It does not state the conditions under which the drug or device is to be used; or(3) The specimen of labeling proposed for use upon or within the retail package does not expressly or by reference to a brochure or other printed matter prescribe, recommend, or suggest the use of the drug or device under such conditions.(c) The date on which an application is received by the Department shall be considered to be the date on which the application is filed, and the Department shall notify the applicant of such date. If the applicant withdraws the application, it shall be considered as not having been filed.(d) The applicant may file an amendment to an application which has been filed and is pending before the Department, but in that case the unamended application shall be considered as having been withdrawn and the amended application shall be considered as having been filed on the date on which the amendment is received by the Department. The Department shall notify the applicant of such date.(e) After an application has become effective with respect to a drug or device the applicant may file a supplemental application with respect thereto setting forth any proposed change in the conditions under which the drug or device is to be used in the labeling thereof, in any circumstance relating to its production, or in any other information contained in the effective application. Such supplemental application may omit statements in the effective application concerning which no change is proposed.Cal. Code Regs. Tit. 17, § 10425
1. Amendment filed 8-17-56; effective thirtieth day thereafter (Register 56, No. 16).
2. Amendment filed 6-27-60; effective 30th day thereafter (Register 60, No. 15).
3. Amendment filed 12-17-85; effective thirtieth day thereafter (Register 85, No. 51). Note: Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Section 26670, Health and Safety Code.
1. Amendment filed 8-17-56; effective thirtieth day thereafter (Register 56, No. 16).
2. Amendment filed 6-27-60; effective 30th day thereafter (Register 60, No. 15).
3. Amendment filed 12-17-85; effective thirtieth day thereafter (Register 85, No. 51).