Section 10381 - Label Non-Prescription Drugs. Pregnancy/Nursing(a) Any drug not subject to Section 26660 of the Health and Safety Code which is intended for systemic absorption into the human body shall include on the label the following statement: "Caution: If pregnant or nursing a baby, consult your physician or pharmacist before using this product."
(b) Section 10381(a) shall not apply if such drug: (1) Is intended for poison control purposes.(2) Is labeled with information regarding use in pregnancy and nursing which is substantially similar to the statement required by Section 10381(a).(3) Meets both of the following: (A) It is intended to benefit the embryo, fetus or nursing infant during the period of pregnancy or lactation.(B) It is labeled with specific directions for use during the period of pregnancy or lactation pursuant to federal or state requirements.(4) Is not intended to be systemically absorbed.(5) Is oxygen intended for emergency use.(c) Any drug manufactured and labeled after 11-18-82 shall be misbranded if the information required by this section is not disclosed on the label.Cal. Code Regs. Tit. 17, § 10381
1. New section filed 10-19-81; effective thirtieth day thereafter (Register 81, No. 43).
2. Editorial correction of subsection (c) (Register 82, No. 3). Note: Authority cited: Sections 208 and 26202, Health and Safety Code. Reference: Sections 26400, 26630 and 26638, Health and Safety Code.
1. New section filed 10-19-81; effective thirtieth day thereafter (Register 81, No. 43).
2. Editorial correction of subsection (c) (Register 82, No. 3).