California § 4160 - A person shall not act as a wholesaler or third-party logistics provider of any d

§ 4160. A person shall not act as a wholesaler or third-party logistics provider of any d

(a) A person shall not act as a wholesaler or third-party logistics provider of any dangerous drug or dangerous device unless he or she has obtained a license from the board. (b) Upon approval by the board and the payment of the required fee, the board shall issue a license to the applicant. (c) (1) A separate license shall be required for each place of business owned or operated by a wholesaler or third-party logistics provider. Each place of business may only be issued a single license by the board, except as provided in paragraph (2). Each license shall be renewed annually and shall not be transferable. At all times during which a place of business is open for business, at least one designated representative, in the case of a wholesaler, or designated representative-3PL in the case of a third-party logistics provider, shall be present. A wholesaler that only acts as a reverse distributor may use either a designated representative or a designated representative-reverse distributor to fulfill this requirement. (2) A wholesaler and a third-party logistics provider under common ownership may be licensed at the same place of business provided that all of the following requirements are satisfied: (A) The wholesaler and the third-party logistics provider each separately maintain the records required under Section 4081. (B) Dangerous drugs and dangerous devices owned by the wholesaler are not commingled with the dangerous drugs and dangerous devices handled by the third-party logistics provider. (C) Any individual acting as a designated representative for the wholesaler is not concurrently acting as a designated representative-3PL on behalf of the third-party logistics provider. Nothing in this subparagraph shall be construed to prohibit an individual from concurrently holding a license to act as a designated representative and to act as a designated representative-3PL. (D) The wholesaler has its own designated representative-in-charge responsible for the operations of the wholesaler and the third-party logistics provider has its own responsible manager responsible for the operations of the third-party logistics provider. The same individual shall not concurrently serve as the responsible manager and the designated representative-in-charge for a wholesaler and a third-party logistics provider licensed at the same place of business. (E) The third-party logistics provider does not handle the prescription drugs or prescription devices owned by a prescriber. (F) The third-party logistics provider is not a reverse third-party logistics provider. (G) The wholesaler is not acting as a reverse distributor. (d) Every wholesaler shall be supervised or managed by a designated representative-in-charge. The designated representative-in-charge shall be responsible for the wholesaler’s compliance with state and federal laws governing wholesalers. As part of its initial application for a license, and for each renewal, each wholesaler shall, on a form designed by the board, provide identifying information and the California license number for a designated representative or pharmacist proposed to serve as the designated representative-in-charge. The proposed designated representative-in-charge shall be subject to approval by the board. The board shall not issue or renew a wholesaler license without identification of an approved designated representative-in-charge for the wholesaler. The designated representative-in-charge shall maintain an active license as a designated representative with the board at all times during which he or she is designated as the designated representative-in-charge. A wholesaler that only acts as a reverse distributor may identify and allow a designated representative-reverse distributor to perform in this capacity. That individual shall maintain an active license as a designated representative-reverse distributor. (e) Each place of business of a third-party logistics provider shall be supervised and managed by a responsible manager. The responsible manager shall be responsible for the compliance of the place of business with state and federal laws governing third-party logistics providers and with the third-party logistics provider’s customer specifications, except where the customer’s specifications conflict with state or federal laws. As part of its initial application for a license, and for each renewal, each third-party logistics provider shall, on a form designated by the board, provide identifying information and the California license number for a designated representative-3PL proposed to serve as the responsible manager. The proposed responsible manager shall be subject to approval by the board. The board shall not issue or renew a third-party logistics provider license without identification of an approved responsible manager for the third-party logistics provider. The responsible manager shall maintain an active license as a designated representative-3PL with the board at all times during which he or she is designated as the responsible manager. (f) A wholesaler shall notify the board in writing, on a form designed by the board, within 30 days of the date when a designated representative-in-charge ceases to act as the designated representative-in-charge, and shall on the same form propose another authorized licensee to take over as the designated representative-in-charge. The proposed replacement designated representative-in-charge shall be subject to approval by the board. If disapproved, the wholesaler shall propose another replacement within 15 days of the date of disapproval, and shall continue to name proposed replacements until a designated representative-in-charge is approved by the board. (g) A third-party logistics provider shall notify the board in writing, on a form designed by the board, within 30 days of the date when a responsible manager ceases to act as the responsible manager, and shall on the same form propose another designated representative-3PL to take over as the responsible manager. The proposed replacement responsible manager shall be subject to approval by the board. If disapproved, the third-party logistics provider shall propose another replacement within 15 days of the date of disapproval, and shall continue to name proposed replacements until a responsible manager is approved by the board. (h) A drug manufacturer premises licensed by the Food and Drug Administration or licensed pursuant to Section 111615 of the Health and Safety Code that only distributes dangerous drugs and dangerous devices of its own manufacture is exempt from this section and Section 4161. (i) The board may issue a temporary license, upon conditions and for periods of time as the board determines to be in the public interest. A temporary license fee shall be required in an amount established by the board as specified in subdivision (f) of Section 4400. When needed to protect public safety, a temporary license may be issued for a period not to exceed 180 days, subject to terms and conditions that the board deems necessary. If the board determines that a temporary license was issued by mistake or denies the application for a permanent license, the temporary license shall terminate upon either personal service of the notice of termination upon the licenseholder or service by certified mail, return receipt requested, at the licenseholder’s address of record with the board, whichever occurs first. For purposes of retaining a temporary license, or for purposes of any disciplinary or license denial proceeding before the board, the temporary licenseholder shall not be deemed to have a vested property right or interest in the license.