54-1753. Wholesale drug distributor licensing requirement -- Minimum requirements for licensure. (1) Every wholesale distributor who engages in the wholesale distribution of prescription drugs must be licensed by the board, and every nonresident wholesale distributor must be licensed by the board if it ships prescription drugs into this state in accordance with this act before engaging in wholesale distributions of wholesale prescription drugs. The board shall exempt manufacturers distributing their own federal food and drug administration approved drugs and devices from any licensing and other requirements to the extent not required by federal law or regulation, unless particular requirements are deemed necessary and appropriate following rulemaking.
(2) The board shall require the following minimum information from each wholesale distributor applying for a license under subsection (1) of this section:
(a) The name, full business address and telephone number of the licensee;
(b) All trade or business names used by the licensee;
(c) Addresses, telephone numbers, and the names of contact persons for all facilities used by the licensee for the storage, handling, and distribution of prescription drugs;
(d) The type of ownership or operation, i.e., partnership, corporation, or sole proprietorship;
(e) The name of each person who is an owner or an operator of the licensee;
(f) A list of all licenses and permits issued to the applicant by any other state that authorizes the applicant to purchase or possess prescription drugs;
(g) The name of the applicant’s designated representative for the facility, together with the personal information statement and fingerprints, required pursuant to paragraph (h) of this subsection (2) for such individual;
(h) Each individual required by paragraph (g) of this subsection (2) to provide a personal information statement and fingerprints shall provide the following information to the board:
(i) The individual’s places of residence for the past seven (7) years;
(ii) The individual’s date and place of birth;
(iii) The individual’s occupations, positions of employment and offices held during the past seven (7) years;
(iv) The principal business and address of any business, corporation or other organization in which each such office of the individual was held or in which each such occupation or position of employment was carried on;
(v) Whether the individual has been, during the past seven (7) years, the subject of any proceeding for the revocation of any license or any criminal violation and, if so, the nature of the proceeding and the disposition of the proceeding;
(vi) Whether, during the past seven (7) years, the individual has been enjoined, either temporarily or permanently, by a court of competent jurisdiction from violating any federal or state law regulating the possession, control or distribution of prescription drugs or criminal violations, together with details concerning any such event;
(vii) A description of any involvement by the individual with any business, including any investments, other than the ownership of stock in a publicly traded company or mutual fund, during the past seven (7) years, which manufactured, administered, prescribed, distributed or stored pharmaceutical products, and any lawsuits in which such businesses were named as a party and in which the individual was also a named party in the same lawsuit or, regardless of whether the individual was a named party, in which the individual testified as a witness at trial or in a deposition;
(viii) A description of any felony criminal offense of which the individual, as an adult, was found guilty, regardless of whether adjudication of guilt was withheld or whether the individual pled guilty or nolo contendere. If the individual indicates that a criminal conviction is under appeal and submits a copy of the notice of appeal of that criminal offense, the applicant must, within fifteen (15) days after the disposition of the appeal, submit to the board a copy of the final written order of disposition; and
(ix) A photograph of the individual taken in the previous year.
(3) The information required pursuant to subsection (2) of this section shall be provided under oath.
(4) The board shall not issue a wholesale distributor license to an applicant, unless the board:
(a) Conducts a physical inspection of the facility at the address provided by the applicant as required in subsection (2)(a) of this section; and
(b) Determines that the designated representative meets the following qualifications:
(i) Is at least twenty-one (21) years of age;
(ii) Has been employed full time for at least three (3) years in a pharmacy or with a wholesale distributor in a capacity related to the dispensing and distribution of, and recordkeeping relating to, prescription drugs;
(iii) Is employed by the applicant full time in a managerial level position;
(iv) Is actively involved in and aware of the actual daily operation of the wholesale distributor;
(v) Is physically present at the facility of the applicant during regular business hours, except when the absence of the designated representative is authorized including, but not limited to, sick leave and vacation leave;
(vi) Is serving in the capacity of a designated representative for only one (1) applicant at a time, except where more than one (1) licensed wholesale distributor is colocated in the same facility and such wholesale distributors are members of an affiliated group, as defined in section 1504 of the Internal Revenue Code;
(vii) Does not have any convictions under any federal, state or local law relating to wholesale or retail prescription drug distribution or distribution of controlled substances; and
(viii) Does not have any felony convictions under federal, state or local law.
(5) The board shall submit the fingerprints provided by a person with a license application for a statewide criminal records check and for forwarding to the federal bureau of investigation for a national criminal records check of the individual.
(6) If a wholesale distributor distributes prescription drugs from more than one (1) facility, the wholesale distributor shall obtain a license for each facility.
(7) In accordance with each licensure renewal, the board shall send to each wholesale distributor licensed under this section a form setting forth the information that the wholesale distributor provided pursuant to subsection (2) of this section. Within thirty (30) days of receiving such form, the wholesale distributor must identify and state under oath to the board all changes or corrections to the information that was provided pursuant to subsection (2) of this section. Changes in, or corrections to, any information in subsection (2) of this section shall be submitted to the board as required by the board. The board may suspend or revoke the license of a wholesale distributor if such authority determines that the wholesale distributor no longer qualifies for the license issued under this section.
(8) The designated representative identified pursuant to subsection (2)(g) of this section must receive and complete continuing training in applicable federal law and the law of this state governing wholesale distribution of prescription drugs.
(9) The board may adopt rules to approve an accreditation body to evaluate a wholesaler’s operations to determine compliance with professional standards and any other applicable laws, and to perform inspections of each facility and location where wholesale distribution operations are conducted by the wholesaler.
(10) Information provided under this section shall not be disclosed to any person other than a state licensing authority, government board or government agency, provided such licensing authority, government board or agency needs such information for licensing or monitoring purposes.
54-1753. Wholesale drug distributor licensing requirement -- Minimum requirements for licensure. (1) Every wholesale distributor who engages in the wholesale distribution of prescription drugs must be licensed by the board, and every nonresident wholesale distributor must be licensed by the board if it ships prescription drugs into this state in accordance with this act before engaging in wholesale distributions of wholesale prescription drugs. The board shall exempt manufacturers distributing their own federal food and drug administration approved drugs and devices from any licensing and other requirements to the extent not required by federal law or regulation, unless particular requirements are deemed necessary and appropriate following rulemaking.
(2) The board shall require the following minimum information from each wholesale distributor applying for a license under subsection (1) of this section:
(a) The name, full business address and telephone number of the licensee;
(b) All trade or business names used by the licensee;
(c) Addresses, telephone numbers, and the names of contact persons for all facilities used by the licensee for the storage, handling, and distribution of prescription drugs;
(d) The type of ownership or operation, i.e., partnership, corporation, or sole proprietorship;
(e) The name of each person who is an owner or an operator of the licensee;
(f) A list of all licenses and permits issued to the applicant by any other state that authorizes the applicant to purchase or possess prescription drugs;
(g) The name of the applicant’s designated representative for the facility, together with the personal information statement and fingerprints, required pursuant to paragraph (h) of this subsection (2) for such individual;
(h) Each individual required by paragraph (g) of this subsection (2) to provide a personal information statement and fingerprints shall provide the following information to the board:
(i) The individual’s places of residence for the past seven (7) years;
(ii) The individual’s date and place of birth;
(iii) The individual’s occupations, positions of employment and offices held during the past seven (7) years;
(iv) The principal business and address of any business, corporation or other organization in which each such office of the individual was held or in which each such occupation or position of employment was carried on;
(v) Whether the individual has been, during the past seven (7) years, the subject of any proceeding for the revocation of any license or any criminal violation and, if so, the nature of the proceeding and the disposition of the proceeding;
(vi) Whether, during the past seven (7) years, the individual has been enjoined, either temporarily or permanently, by a court of competent jurisdiction from violating any federal or state law regulating the possession, control or distribution of prescription drugs or criminal violations, together with details concerning any such event;
(vii) A description of any involvement by the individual with any business, including any investments, other than the ownership of stock in a publicly traded company or mutual fund, during the past seven (7) years, which manufactured, administered, prescribed, distributed or stored pharmaceutical products, and any lawsuits in which such businesses were named as a party and in which the individual was also a named party in the same lawsuit or, regardless of whether the individual was a named party, in which the individual testified as a witness at trial or in a deposition;
(viii) A description of any felony criminal offense of which the individual, as an adult, was found guilty, regardless of whether adjudication of guilt was withheld or whether the individual pled guilty or nolo contendere. If the individual indicates that a criminal conviction is under appeal and submits a copy of the notice of appeal of that criminal offense, the applicant must, within fifteen (15) days after the disposition of the appeal, submit to the board a copy of the final written order of disposition; and
(ix) A photograph of the individual taken in the previous year.
(3) The information required pursuant to subsection (2) of this section shall be provided under oath.
(4) The board shall not issue a wholesale distributor license to an applicant, unless the board:
(a) Conducts a physical inspection of the facility at the address provided by the applicant as required in subsection (2)(a) of this section; and
(b) Determines that the designated representative meets the following qualifications:
(i) Is at least twenty-one (21) years of age;
(ii) Has been employed full time for at least three (3) years in a pharmacy or with a wholesale distributor in a capacity related to the dispensing and distribution of, and recordkeeping relating to, prescription drugs;
(iii) Is employed by the applicant full time in a managerial level position;
(iv) Is actively involved in and aware of the actual daily operation of the wholesale distributor;
(v) Is physically present at the facility of the applicant during regular business hours, except when the absence of the designated representative is authorized including, but not limited to, sick leave and vacation leave;
(vi) Is serving in the capacity of a designated representative for only one (1) applicant at a time, except where more than one (1) licensed wholesale distributor is colocated in the same facility and such wholesale distributors are members of an affiliated group, as defined in section 1504 of the Internal Revenue Code;
(vii) Does not have any convictions under any federal, state or local law relating to wholesale or retail prescription drug distribution or distribution of controlled substances; and
(viii) Does not have any felony convictions under federal, state or local law.
(5) The board shall submit the fingerprints provided by a person with a license application for a statewide criminal records check and for forwarding to the federal bureau of investigation for a national criminal records check of the individual.
(6) If a wholesale distributor distributes prescription drugs from more than one (1) facility, the wholesale distributor shall obtain a license for each facility.
(7) In accordance with each licensure renewal, the board shall send to each wholesale distributor licensed under this section a form setting forth the information that the wholesale distributor provided pursuant to subsection (2) of this section. Within thirty (30) days of receiving such form, the wholesale distributor must identify and state under oath to the board all changes or corrections to the information that was provided pursuant to subsection (2) of this section. Changes in, or corrections to, any information in subsection (2) of this section shall be submitted to the board as required by the board. The board may suspend or revoke the license of a wholesale distributor if such authority determines that the wholesale distributor no longer qualifies for the license issued under this section.
(8) The designated representative identified pursuant to subsection (2)(g) of this section must receive and complete continuing training in applicable federal law and the law of this state governing wholesale distribution of prescription drugs.
(9) The board may adopt rules to approve an accreditation body to evaluate a wholesaler’s operations to determine compliance with professional standards and any other applicable laws, and to perform inspections of each facility and location where wholesale distribution operations are conducted by the wholesaler.
(10) Information provided under this section shall not be disclosed to any person other than a state licensing authority, government board or government agency, provided such licensing authority, government board or agency needs such information for licensing or monitoring purposes.
54-1753. Wholesale drug distributor licensing requirement -- Minimum requirements for licensure. (1) Every wholesale distributor who engages in the wholesale distribution of prescription drugs must be licensed by the board, and every nonresident wholesale distributor must be licensed by the board if it ships prescription drugs into this state in accordance with this act before engaging in wholesale distributions of wholesale prescription drugs. The board shall exempt manufacturers distributing their own federal food and drug administration approved drugs and devices from any licensing and other requirements to the extent not required by federal law or regulation, unless particular requirements are deemed necessary and appropriate following rulemaking.
(2) The board shall require the following minimum information from each wholesale distributor applying for a license under subsection (1) of this section:
(a) The name, full business address and telephone number of the licensee;
(b) All trade or business names used by the licensee;
(c) Addresses, telephone numbers, and the names of contact persons for all facilities used by the licensee for the storage, handling, and distribution of prescription drugs;
(d) The type of ownership or operation, i.e., partnership, corporation, or sole proprietorship;
(e) The name of each person who is an owner or an operator of the licensee;
(f) A list of all licenses and permits issued to the applicant by any other state that authorizes the applicant to purchase or possess prescription drugs;
(g) The name of the applicant’s designated representative for the facility, together with the personal information statement and fingerprints, required pursuant to paragraph (h) of this subsection (2) for such individual;
(h) Each individual required by paragraph (g) of this subsection (2) to provide a personal information statement and fingerprints shall provide the following information to the board:
(i) The individual’s places of residence for the past seven (7) years;
(ii) The individual’s date and place of birth;
(iii) The individual’s occupations, positions of employment and offices held during the past seven (7) years;
(iv) The principal business and address of any business, corporation or other organization in which each such office of the individual was held or in which each such occupation or position of employment was carried on;
(v) Whether the individual has been, during the past seven (7) years, the subject of any proceeding for the revocation of any license or any criminal violation and, if so, the nature of the proceeding and the disposition of the proceeding;
(vi) Whether, during the past seven (7) years, the individual has been enjoined, either temporarily or permanently, by a court of competent jurisdiction from violating any federal or state law regulating the possession, control or distribution of prescription drugs or criminal violations, together with details concerning any such event;
(vii) A description of any involvement by the individual with any business, including any investments, other than the ownership of stock in a publicly traded company or mutual fund, during the past seven (7) years, which manufactured, administered, prescribed, distributed or stored pharmaceutical products, and any lawsuits in which such businesses were named as a party and in which the individual was also a named party in the same lawsuit or, regardless of whether the individual was a named party, in which the individual testified as a witness at trial or in a deposition;
(viii) A description of any felony criminal offense of which the individual, as an adult, was found guilty, regardless of whether adjudication of guilt was withheld or whether the individual pled guilty or nolo contendere. If the individual indicates that a criminal conviction is under appeal and submits a copy of the notice of appeal of that criminal offense, the applicant must, within fifteen (15) days after the disposition of the appeal, submit to the board a copy of the final written order of disposition; and
(ix) A photograph of the individual taken in the previous year.
(3) The information required pursuant to subsection (2) of this section shall be provided under oath.
(4) The board shall not issue a wholesale distributor license to an applicant, unless the board:
(a) Conducts a physical inspection of the facility at the address provided by the applicant as required in subsection (2)(a) of this section; and
(b) Determines that the designated representative meets the following qualifications:
(i) Is at least twenty-one (21) years of age;
(ii) Has been employed full time for at least three (3) years in a pharmacy or with a wholesale distributor in a capacity related to the dispensing and distribution of, and recordkeeping relating to, prescription drugs;
(iii) Is employed by the applicant full time in a managerial level position;
(iv) Is actively involved in and aware of the actual daily operation of the wholesale distributor;
(v) Is physically present at the facility of the applicant during regular business hours, except when the absence of the designated representative is authorized including, but not limited to, sick leave and vacation leave;
(vi) Is serving in the capacity of a designated representative for only one (1) applicant at a time, except where more than one (1) licensed wholesale distributor is colocated in the same facility and such wholesale distributors are members of an affiliated group, as defined in section 1504 of the Internal Revenue Code;
(vii) Does not have any convictions under any federal, state or local law relating to wholesale or retail prescription drug distribution or distribution of controlled substances; and
(viii) Does not have any felony convictions under federal, state or local law.
(5) The board shall submit the fingerprints provided by a person with a license application for a statewide criminal records check and for forwarding to the federal bureau of investigation for a national criminal records check of the individual.
(6) If a wholesale distributor distributes prescription drugs from more than one (1) facility, the wholesale distributor shall obtain a license for each facility.
(7) In accordance with each licensure renewal, the board shall send to each wholesale distributor licensed under this section a form setting forth the information that the wholesale distributor provided pursuant to subsection (2) of this section. Within thirty (30) days of receiving such form, the wholesale distributor must identify and state under oath to the board all changes or corrections to the information that was provided pursuant to subsection (2) of this section. Changes in, or corrections to, any information in subsection (2) of this section shall be submitted to the board as required by the board. The board may suspend or revoke the license of a wholesale distributor if such authority determines that the wholesale distributor no longer qualifies for the license issued under this section.
(8) The designated representative identified pursuant to subsection (2)(g) of this section must receive and complete continuing training in applicable federal law and the law of this state governing wholesale distribution of prescription drugs.
(9) The board may adopt rules to approve an accreditation body to evaluate a wholesaler’s operations to determine compliance with professional standards and any other applicable laws, and to perform inspections of each facility and location where wholesale distribution operations are conducted by the wholesaler.
(10) Information provided under this section shall not be disclosed to any person other than a state licensing authority, government board or government agency, provided such licensing authority, government board or agency needs such information for licensing or monitoring purposes.
