Section 10415 - Exemption for Prescription Drugs and Veterinary Drugs(a) Exemption for Prescription Drugs. A drug subject to the requirements of Section 26660 of the code, shall be exempt from Section 26638 if all the following conditions are met: (1) The drug is: (A) In the possession of a person (or agents or employees of the person) regularly and lawfully engaged in the manufacture, transportation, storage, or wholesale distribution of prescription drugs; or(B) In the possession of a pharmacy or a public health agency, regularly and lawfully engaged in dispensing prescription drugs; and is to be dispensed in accordance with Section 26662.(2) The label of the drug bears: (A) The statement "Caution: Federal law prohibits dispensing without prescription," or "Caution: Not to be dispensed without a prescription"; and(B) The recommended or usual dosage; and(C) The route of administration, if it is not for oral use; and(D) If it is fabricated from two or more ingredients and is not designated conspicuously by a name recognized in an official compendium the quantity or proportion of each active ingredient and if it is not for oral use the names of all other ingredients. Provided, however, that the information referred to in subdivisions (B), (C), and (D) of this subparagraph may be contained in the labeling on or within the package from which it is to be dispensed, and, in the case of ampuls, too small or otherwise unable to accommodate a label but which are packaged in a container from which they are withdrawn for dispensing or use, the information referred to in subdivision (A) of this subparagraph may be placed on the outside container only.(3) The labeling of the drug (which may include brochures readily available to licensed practitioners) bears information as to the use of the drug by practitioners licensed by law to administer it: provided, however, that such information may be omitted from the labeling if it is contained in scientific literature widely disseminated among practitioners licensed by law to administer the drug.(b) Exemption for Veterinary Drugs. A drug intended solely for veterinary use which, because of toxicity or other potentiality for harmful effect, or the method of its use, is not safe for animal use except under the supervision of a licensed veterinarian, 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:(1) The drug 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 veterinary drugs and is to be sold only to or on the prescription or other order of a licensed veterinarian for use in the course of the veterinarian's professional practice.(2) The label of a drug bears: (A) The statement "Caution: Federal law restricts this drug to sale by or on the order of a licensed veterinarian," or "Caution: To be sold only by or on the order of a licensed veterinarian"; and(B) The recommended or usual dosage; and(C) The route of administration if it is not for oral use; and(D) The quantity or proportion of each active ingredient if it is fabricated from two or more ingredients and is not designated conspicuously by a name recognized in an official compendium. Provided, however, that the information referred to in subdivisions (B), (C), and (D) of this subparagraph may be contained in the labeling on or within the package from which it is to be dispensed.(3) The labeling of the drug (which may include brochures readily available to licensed veterinarians) bears information as to use of the drug by licensed veterinarians; provided, however, that such information may be omitted from the labeling if it is contained in scientific literature widely disseminated among veterinarians licensed by law to administer such drug.Cal. Code Regs. Tit. 17, § 10415
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 26660 and 26662, Health and Safety Code.
1. Amendment filed 12-17-85; effective thirtieth day thereafter (Register 85, No. 51).