Section 10410 - Exemption for Prescription DevicesA device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which "adequate directions for use" cannot be prepared, shall be exempt from Section 26638 of the code if all the following conditions are met:
(a) The device is in the possession of a person (or agents or employees of the person) regularly and lawfully engaged in the manufacture, transportation, storage, or wholesale or retail distribution of such device and is to be sold only to or on the prescription or other order of such practitioner for use in the course of the practitioner's professional practice.(b) The label of the device (other than surgical instruments) bears: (1) The statement "Caution: Federal law restricts this device to sale by or on the order of a__________," or "Caution sale of this device is restricted to sale by or on the order of a__________." The blanks to be filled with the word "physician," "dentist," "veterinarian," or with the descriptive designation of any other practitioner licensed by the law of the State of California; and(2) The method of its application or use.Cal. Code Regs. Tit. 17, § 10410
1. 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: Sections 26638 and 26643, Health and Safety Code.
1. Amendment filed 12-17-85; effective thirtieth day thereafter (Register 85, No. 51).