2021 California Code
Business and Professions Code - BPC
DIVISION 2 - HEALING ARTS
CHAPTER 9 - Pharmacy
ARTICLE 3 - Scope of Practice and Exemptions
Section 4053.1.
(a) Notwithstanding Section 4051, the board may issue a license to a qualified individual as a designated representative-3PL to provide sufficient and qualified supervision of a third-party logistics provider’s place of business. The designated representative-3PL shall protect the public health and safety in the handling, storage, warehousing, distribution, and shipment of dangerous drugs and dangerous devices in the third-party logistics provider’s place of business.
(b) An individual who is at least 18 years of age may apply for a designated representative-3PL 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 meet one of the following requirements:
(A) Have a minimum of one year of paid work experience in the past three years with a third-party logistics provider.
(B) Have a minimum of one year of paid work experience in the past three years in a licensed pharmacy, or with a drug wholesaler, drug distributor, or drug manufacturer, performing duties related to the distribution or dispensing of dangerous drugs or dangerous devices.
(C) Meet all of the prerequisites to take the examination required for licensure as a pharmacist by the board.
(3) (A) The individual shall complete a training program approved by the board that, at a minimum, addresses each of the following subjects:
(i) Knowledge and understanding of California law and federal law relating to the distribution of dangerous drugs and dangerous devices.
(ii) Knowledge and understanding of California law and federal law relating to the distribution of controlled substances.
(iii) Knowledge and understanding of quality control systems.
(iv) Knowledge and understanding of the United States Pharmacopoeia or federal Food and Drug Administration standards relating to the safe storage, handling, and transport of dangerous drugs and dangerous devices.
(B) The board may, by regulation, require the training program required under this paragraph to include additional material.
(C) The board shall not issue a license as a designated representative-3PL until the applicant provides proof of completion of the training required by this paragraph to the board.
(c) A third-party logistics provider shall not operate without at least one designated representative-3PL present at each of its licensed places of business as required under Section 4160.
(Amended by Stats. 2021, Ch. 629, Sec. 14. (AB 1533) Effective January 1, 2022.)
