{"id":3004,"date":"2022-05-07T20:49:48","date_gmt":"2022-05-07T20:49:48","guid":{"rendered":"https:\/\/crowdsourcelawyers.com\/california-statutes\/?page_id=3004"},"modified":"2022-05-20T23:45:03","modified_gmt":"2022-05-20T23:45:03","slug":"business-and-professions-code-bpc-4161","status":"publish","type":"page","link":"https:\/\/crowdsourcelawyers.com\/california-statutes\/california-statutes\/business-and-professions-code-bpc-4161\/","title":{"rendered":"Business and Professions Code &#8211; BPC 4161"},"content":{"rendered":"\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-l2wc86zu-1531abb688a92974ea17a33e1c2905df\">\n#top .av-special-heading.av-l2wc86zu-1531abb688a92974ea17a33e1c2905df{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-l2wc86zu-1531abb688a92974ea17a33e1c2905df .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-l2wc86zu-1531abb688a92974ea17a33e1c2905df .av-subheading{\nfont-size:22px;\n}\n<\/style>\n<div  class='av-special-heading av-l2wc86zu-1531abb688a92974ea17a33e1c2905df av-special-heading-h1 blockquote modern-quote  avia-builder-el-0  el_before_av_hr  avia-builder-el-first '><div class='av-subheading av-subheading_above'><p>California<\/p>\n<\/div><h1 class='av-special-heading-tag '  itemprop=\"headline\"  >Business and Professions Code &#8211; BPC \u00a7 4161<\/h1><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_hr-3a876428eececa9d35452247ddb053af\">\n#top .hr.hr-invisible.av-av_hr-3a876428eececa9d35452247ddb053af{\nheight:50px;\n}\n<\/style>\n<div  class='hr av-av_hr-3a876428eececa9d35452247ddb053af hr-invisible  avia-builder-el-1  el_after_av_heading  el_before_av_textblock '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div>\n<section  class='av_textblock_section av-av_textblock-e878f05c31dff72941bf1e49a00d9ff5 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p><a href=\"https:\/\/crowdsourcelawyers.com\/\">CrowdSourceLawyers.com<\/a><\/p>\n<\/div><\/section>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-avia_sc_search-4ee94ae86cde3b232e718bb4ac84e6ad\">\n#top .avia_search_element.av-avia_sc_search-4ee94ae86cde3b232e718bb4ac84e6ad .av_searchform_wrapper{\nborder-color:#edae44;\nbackground-color:#edae44;\n}\n#top .avia_search_element.av-avia_sc_search-4ee94ae86cde3b232e718bb4ac84e6ad #s.av-input-field{\ncolor:#edae44;\n}\n#top .avia_search_element.av-avia_sc_search-4ee94ae86cde3b232e718bb4ac84e6ad .av-input-field-icon.av-search-icon{\ncolor:#edae44;\n}\n#top .avia_search_element.av-avia_sc_search-4ee94ae86cde3b232e718bb4ac84e6ad .av-input-field-icon.av-search-icon.avia-svg-icon svg:first-child{\nfill:#edae44;\nstroke:#edae44;\n}\n#top .avia_search_element.av-avia_sc_search-4ee94ae86cde3b232e718bb4ac84e6ad #searchsubmit{\nbackground-color:#edae44;\n}\n#top .avia_search_element.av-avia_sc_search-4ee94ae86cde3b232e718bb4ac84e6ad .av_searchsubmit_wrapper{\nbackground-color:#edae44;\n}\n<\/style>\n<div  class='avia_search_element av-avia_sc_search-4ee94ae86cde3b232e718bb4ac84e6ad  avia-builder-el-3  el_after_av_textblock  el_before_av_hr '><search><form action='https:\/\/crowdsourcelawyers.com\/california-statutes\/' id='searchform_element' method='get' class='' data-element_id='av-avia_sc_search-4ee94ae86cde3b232e718bb4ac84e6ad' ><div class='av_searchform_wrapper'><input type='search' value='' id='s' name='s' placeholder='Search CA statutes' aria-label='Search CA statutes' class='av-input-field ' required \/><div class='av_searchsubmit_wrapper '><input type='submit' value='Find' id='searchsubmit' class='button ' title='View results on search page' aria-label='View results on search page' \/><\/div><input type='hidden' name='numberposts' value='10' \/><input type='hidden' name='results_hide_fields' value='' \/><\/div><\/form><\/search><\/div>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_hr-3a876428eececa9d35452247ddb053af\">\n#top .hr.hr-invisible.av-av_hr-3a876428eececa9d35452247ddb053af{\nheight:50px;\n}\n<\/style>\n<div  class='hr av-av_hr-3a876428eececa9d35452247ddb053af hr-invisible  avia-builder-el-4  el_after_avia_sc_search  el_before_av_textblock '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div>\n<section  class='av_textblock_section av-l2wcata7-21ace6c2a700f06b3d2d1b5fa92225c3 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><div class=\"row\">\n<div class=\"subsection\"><\/div>\n<div class=\"subsection\">\n<div class=\"subsection\">\n<p>(a)\u2002A person located outside this state that (1) ships, sells, mails, warehouses, distributes, or delivers dangerous drugs or dangerous devices into this state or (2) sells, brokers, warehouses, or distributes dangerous drugs or devices within this state shall be considered a nonresident wholesaler or a nonresident third-party logistics provider.<\/p>\n<\/div>\n<div class=\"subsection\">\n<p>(b)\u2002A nonresident wholesaler or nonresident third-party logistics provider shall be licensed by the board prior to shipping, selling, mailing, warehousing, distributing, or delivering dangerous drugs or dangerous devices to a site located in this state or selling, brokering, warehousing, or distributing dangerous drugs or devices within this state.<\/p>\n<\/div>\n<div class=\"subsection\">\n<div class=\"subsection\">\n<p>(c)(1)\u2002A separate license shall be required for each place of business owned or operated by a nonresident wholesaler or nonresident third-party logistics provider from or through which dangerous drugs or dangerous devices are shipped, sold, mailed, warehoused, distributed, or delivered to a site located in this state or sold, brokered, warehoused, or distributed within this state. \u2002Each place of business may only be issued a single license by the board, except as provided in paragraph (2). \u2002A license shall be renewed annually and shall not be transferable.<\/p>\n<\/div>\n<div class=\"subsection\">\n<p style=\"padding-left: 40px\">(2)\u2002A nonresident wholesaler and a nonresident 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:<\/p>\n<div class=\"subsection\">\n<p style=\"padding-left: 40px\">(A)\u2002The wholesaler and the third-party logistics provider each separately maintain the records required under\u00a0<span class=\"cite\">Section 4081\u00a0<\/span>.<\/p>\n<\/div>\n<div class=\"subsection\">\n<p style=\"padding-left: 40px\">(B)\u2002Dangerous 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.<\/p>\n<\/div>\n<div class=\"subsection\">\n<p style=\"padding-left: 40px\">(C)\u2002Any 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. \u2002Nothing 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.<\/p>\n<\/div>\n<div class=\"subsection\">\n<p style=\"padding-left: 40px\">(D)\u2002The 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. \u2002The 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.<\/p>\n<\/div>\n<div class=\"subsection\">\n<p style=\"padding-left: 40px\">(E)\u2002The third-party logistics provider does not handle the prescription drugs or prescription devices owned by a prescriber.<\/p>\n<\/div>\n<div class=\"subsection\">\n<p style=\"padding-left: 40px\">(F)\u2002The third-party logistics provider is not a reverse third-party logistics provider.<\/p>\n<\/div>\n<div class=\"subsection\">\n<p style=\"padding-left: 40px\">(G)\u2002The wholesaler is not acting as a reverse distributor.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"subsection\">\n<p>(d)\u2002The following information shall be reported, in writing, to the board at the time of initial application for licensure by a nonresident wholesaler or a nonresident third-party logistics provider, on renewal of a nonresident wholesaler or nonresident third-party logistics provider license, or within 30 days of a change in that information:<\/p>\n<div class=\"subsection\">\n<p style=\"padding-left: 40px\">(1)\u2002Its agent for service of process in this state.<\/p>\n<\/div>\n<div class=\"subsection\">\n<p style=\"padding-left: 40px\">(2)\u2002Its principal corporate officers, as specified by the board, if any.<\/p>\n<\/div>\n<div class=\"subsection\">\n<p style=\"padding-left: 40px\">(3)\u2002Its general partners, as specified by the board, if any.<\/p>\n<\/div>\n<div class=\"subsection\">\n<p style=\"padding-left: 40px\">(4)\u2002Its owners if the applicant is not a corporation or partnership.<\/p>\n<\/div>\n<\/div>\n<div class=\"subsection\">\n<p>(e)\u2002A report containing the information in subdivision (d) shall be made within 30 days of any change of ownership, office, corporate officer, or partner.<\/p>\n<\/div>\n<div class=\"subsection\">\n<p>(f)\u2002A nonresident wholesaler or nonresident third-party logistics provider shall comply with all directions and requests for information from the regulatory or licensing agency of the state in which it is licensed, as well as with all requests for information made by the board.<\/p>\n<\/div>\n<div class=\"subsection\">\n<p>(g)\u2002A nonresident wholesaler or nonresident third-party logistics provider shall maintain records of dangerous drugs and dangerous devices sold, traded, transferred, warehoused, or distributed to persons in this state or within this state, so that the records are in a readily retrievable form.<\/p>\n<\/div>\n<div class=\"subsection\">\n<p>(h)\u2002A nonresident wholesaler or nonresident third-party logistics provider shall at all times maintain a valid, unexpired license, permit, or registration to conduct the business of the wholesaler or nonresident third-party logistics provider in compliance with the laws of the state in which it is a resident. \u2002An application for a nonresident wholesaler or nonresident third-party logistics provider license in this state shall include a license verification from the licensing authority in the applicant&#8217;s state of residence.<\/p>\n<\/div>\n<div class=\"subsection\">\n<div class=\"subsection\">\n<p style=\"padding-left: 40px\">(i)(1)\u2002The board shall not issue or renew a nonresident wholesaler license until the nonresident wholesaler identifies a designated representative-in-charge and notifies the board in writing of the identity and license number of the designated representative-in-charge.<\/p>\n<\/div>\n<div class=\"subsection\">\n<p style=\"padding-left: 40px\">(2)\u2002The board shall not issue or renew a nonresident third-party logistics provider license until the nonresident third-party logistics provider identifies a responsible manager and notifies the board in writing of the identity and license number of the designated representative-3PL who will be the responsible manager.<\/p>\n<\/div>\n<\/div>\n<div class=\"subsection\">\n<p>(j)\u2002The designated representative-in-charge shall be responsible for the compliance of the nonresident wholesaler with state and federal laws governing wholesalers. \u2002The responsible manager shall be responsible for the compliance of the nonresident third-party logistics provider&#8217;s place of business with state and federal laws governing third-party logistics providers. \u2002A nonresident wholesaler or nonresident third-party logistics provider shall identify and notify the board of a new designated representative-in-charge or responsible manager within 30 days of the date that the prior designated representative-in-charge or responsible manager ceases to be the designated representative-in-charge or responsible manager.<\/p>\n<\/div>\n<div class=\"subsection\">\n<p>(k)\u2002The board may issue a temporary license, upon conditions and for periods of time as the board determines to be in the public interest. \u2002A temporary license fee shall be five hundred fifty dollars ($550) or another amount established by the board not to exceed the annual fee for renewal of a license to compound\u00a0sterile drug products. \u2002When 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. \u2002If 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&#8217;s address of record with the board, whichever occurs first. \u2002Neither for purposes of retaining a temporary license, nor for purposes of any disciplinary or license denial proceeding before the board, shall the temporary licenseholder be deemed to have a vested property right or interest in the license.<\/p>\n<\/div>\n<div class=\"subsection\">\n<p>(<i>l<\/i>)\u2002The registration fee shall be the fee specified in\u00a0<span class=\"cite\">subdivision (f) of Section 4400\u00a0<\/span>.<\/p>\n<\/div>\n<p><br class=\"avia-permanent-lb\" \/><br class=\"avia-permanent-lb\" \/><\/p>\n<\/div>\n<\/div>\n<hr \/>\n<p><a href=\"https:\/\/crowdsourcelawyers.com\/\">CrowdSourceLawyers.com<\/a><\/p>\n<\/div><\/section>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":9,"featured_media":0,"parent":2019,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-3004","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Business and Professions Code - BPC 4161 - California Statutes<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, 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