4053. (a) Notwithstanding Section 4051, the board may issue a license as a designated representative to provide sufficient and qualified supervision in a wholesaler or veterinary food-animal drug retailer. The designated representative shall protect the public health and safety in the handling, storage, and shipment of dangerous drugs and dangerous devices in the wholesaler or veterinary food-animal drug retailer.
(b) An individual who is at least 18 years of age may apply for a designated representative license. In order to obtain and maintain that license, the individual shall meet all of the following requirements:
(1) The individual shall be a high school graduate, possess a general education development certificate equivalent, or have earned a degree from an accredited postsecondary institution.
(2) The individual shall have a minimum of one year of paid work experience in a licensed pharmacy, or with a drug wholesaler, drug distributor, or drug manufacturer, in the past three years, related to the distribution or dispensing of dangerous drugs or dangerous devices or meet all of the prerequisites to take the examination required for licensure as a pharmacist by the board.
(3) The individual shall complete a training program approved by the board that, at a minimum, addresses each of the following subjects:
(A) Knowledge and understanding of California law and federal law relating to the distribution of dangerous drugs and dangerous devices.
(B) Knowledge and understanding of California law and federal law relating to the distribution of controlled substances.
(C) Knowledge and understanding of quality control systems.
(D) Knowledge and understanding of the United States Pharmacopoeia standards relating to the safe storage and handling of drugs.
(E) Knowledge and understanding of prescription terminology, abbreviations, dosages, and format.
(4) The board may, by regulation, require training programs to include additional material.
(5) The board shall not issue a license as a designated representative until the applicant provides proof of completion of the required training to the board.
(c) The veterinary food-animal drug retailer or wholesaler shall not operate without a pharmacist or a designated representative on its premises.
(d) Only a pharmacist or a designated representative shall prepare and affix the label to veterinary food-animal drugs.
(e) Section 4051 shall not apply to any laboratory licensed under Section 351 of Title III of the Public Health Service Act (Public Law 78-410).
(Amended by Stats. 2021, Ch. 629, Sec. 13. (AB 1533) Effective January 1, 2022.)
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