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S1377.................................................by HEALTH AND WELFARE
WHOLESALE DRUG DISTRIBUTION - Amends existing law relating to wholesale
drug distribution to provide for additional information required for
licensure; to remove a bond requirement; and to remove a requirement to
establish a fund.
02/05 Senate intro - 1st rdg - to printing
02/06 Rpt prt - to Health/Wel
02/08 Rpt out - rec d/p - to 2nd rdg
02/11 2nd rdg - to 3rd rdg
02/13 3rd rdg - PASSED - 34-0-1
AYES -- Andreason, Bair, Bastian, Bilyeu, Broadsword, Burkett,
Cameron, Coiner, Corder, Darrington, Davis, Fulcher, Gannon, Geddes,
Goedde, Hammond, Heinrich, Hill, Jorgenson, Kelly, Keough, Langhorst,
Little, Lodge, Malepeai(Sagness), McGee, McKague, Pearce, Richardson,
Schroeder, Siddoway, Stegner, Stennett, Werk
NAYS -- None
Absent and excused -- McKenzie
Floor Sponsor - Broadsword
Title apvd - to House
02/14 House intro - 1st rdg - to Health/Wel
03/11 Rpt out - rec d/p - to 2nd rdg
03/12 2nd rdg - to 3rd rdg
03/13 3rd rdg - PASSED - 66-0-4
AYES -- Anderson, Andrus, Barrett, Bayer, Bedke, Bell, Black, Block,
Bock, Boe, Bolz, Bowers, Brackett, Bradford, Chadderdon, Chavez,
Chew, Clark, Collins, Crane, Durst, Eskridge, Hagedorn, Hart,
Henbest, Henderson, Jaquet, Killen, King, Labrador, Lake, LeFavour,
Loertscher, Luker, Marriott, Mathews, McGeachin, Mortimer, Moyle,
Nielsen, Nonini, Pasley-Stuart, Patrick, Pence, Raybould, Ringo,
Roberts, Ruchti, Rusche, Sayler, Schaefer, Shepherd(02),
Shepherd(08), Shirley, Smith(30), Smith(24), Snodgrass, Stevenson,
Thayn, Thomas, Trail, Vander Woude, Wills, Wood(27), Wood(35), Mr.
Speaker
NAYS -- None
Absent and excused -- Bilbao, Harwood, Kren, Shively
Floor Sponsor - Chew
Title apvd - to Senate
03/14 To enrol
03/17 Rpt enrol - Pres signed - Sp signed
03/18 To Governor
03/18 Governor signed
Session Law Chapter 190
Effective: 03/18/08
]]]] LEGISLATURE OF THE STATE OF IDAHO ]]]] Fifty-ninth Legislature Second Regular Session - 2008IN THE SENATE SENATE BILL NO. 1377 BY HEALTH AND WELFARE COMMITTEE 1 AN ACT 2 RELATING TO WHOLESALE DRUG DISTRIBUTION; AMENDING SECTION 54-1753, IDAHO CODE, 3 TO PROVIDE FOR ADDITIONAL INFORMATION REQUIRED FOR LICENSURE AND TO REMOVE 4 A BOND REQUIREMENT; TO REMOVE A REQUIREMENT TO ESTABLISH A FUND; AND 5 DECLARING AN EMERGENCY. 6 Be It Enacted by the Legislature of the State of Idaho: 7 SECTION 1. That Section 54-1753, Idaho Code, be, and the same is hereby 8 amended to read as follows: 9 54-1753. WHOLESALE DRUG DISTRIBUTOR LICENSING REQUIREMENT -- MINIMUM 10 REQUIREMENTS FOR LICENSURE. (1) Every wholesale distributor who engages in the 11 wholesale distribution of prescription drugs must be licensed by the board, 12 and every nonresident wholesale distributor must be licensed by the board if 13 it ships prescription drugs into this state in accordance with this act before 14 engaging in wholesale distributions of wholesale prescription drugs. The board 15 shall exempt manufacturers distributing their own federal food and drug admin- 16 istration approved drugs and devices from any licensing and other requirements 17 to the extent not required by federal law or regulation, unless particular 18 requirements are deemed necessary and appropriate following rulemaking. 19 (2) The board shall require the following minimum information from each 20 wholesale distributor applying for a license under subsection (1) of this sec- 21 tion: 22 (a) The name, full business address and telephone number of the licensee; 23 (b) All trade or business names used by the licensee; 24 (c) Addresses, telephone numbers, and the names of contact persons for 25 all facilities used by the licensee for the storage, handling, and distri- 26 bution of prescription drugs; 27 (d) The type of ownership or operation, i.e., partnership, corporation, 28 or sole proprietorship; 29 (e) The name of each person who is an owner or an operator of the licen- 30 see; 31 (f) A list of all licenses and permits issued to the applicant by any 32 other state that authorizes the applicant to purchase or possess prescrip- 33 tion drugs; 34 (g) The name of the applicant's designated representative for the facil- 35 ity, together with the personal information statement and fingerprints, 36 required pursuant to paragraph (h) of this subsection (2) for such indi- 37 vidual; 38 (h) Each individual required by paragraph (g) of this subsection (2) to 39 provide a personal information statement and fingerprints shall provide 40 the following information to the board: 41 (i) The individual's places of residence for the past seven (7) 42 years; 43 (ii) The individual's date and place of birth; 2 1 (iii) The individual's occupations, positions of employment and 2 offices held during the past seven (7) years; 3 (iv) The principal business and address of any business, corpora- 4 tion or other organization in which each such office of the individ- 5 ual was held or in which each such occupation or position of employ- 6 ment was carried on; 7 (v) Whether the individual has been, during the past seven (7) 8 years, the subject of any proceeding for the revocation of any 9 license or any criminal violation and, if so, the nature of the pro- 10 ceeding and the disposition of the proceeding; 11 (vi) Whether, during the past seven (7) years, the individual has 12 been enjoined, either temporarily or permanently, by a court of com- 13 petent jurisdiction from violating any federal or state law regulat- 14 ing the possession, control or distribution of prescription drugs or 15 criminal violations, together with details concerning any such event; 16 (vii) A description of any involvement by the individual with any 17 business, including any investments, other than the ownership of 18 stock in a publicly traded company or mutual fund, during the past 19 seven (7) years, which manufactured, administered, prescribed, dis- 20 tributed or stored pharmaceutical products, and any lawsuits in which 21 such businesses were named as a party and in which the individual was 22 also a named party in the same lawsuit or, regardless of whether the 23 individual was a named party, in which the individual testified as a 24 witness at trial or in a deposition; 25 (viii) A description of any felony criminal offense of which the 26 individual, as an adult, was found guilty, regardless of whether 27 adjudication of guilt was withheld or whether the individual pled 28 guilty or nolo contendere. If the individual indicates that a crimi- 29 nal conviction is under appeal and submits a copy of the notice of 30 appeal of that criminal offense, the applicant must, within fifteen 31 (15) days after the disposition of the appeal, submit to the board a 32 copy of the final written order of disposition; and 33 (ix) A photograph of the individual taken in the previous year. 34 (3) The information required pursuant to subsection (2) of this section 35 shall be provided under oath. 36 (4) The board shall not issue a wholesale distributor license to an 37 applicant, unless the board: 38 (a) Conducts a physical inspection of the facility at the address pro- 39 vided by the applicant as required in subsection (2)(a) of this section; 40 and 41 (b) Determines that the designated representative meets the following 42 qualifications: 43 (i) Is at least twenty-one (21) years of age; 44 (ii) Has been employed full time for at least three (3) years in a 45 pharmacy or with a wholesale distributor in a capacity related to the 46 dispensing and distribution of, and recordkeeping relating to, pre- 47 scription drugs; 48 (iii) Is employed by the applicant full time in a managerial level 49 position; 50 (iv) Is actively involved in and aware of the actual daily opera- 51 tion of the wholesale distributor; 52 (v) Is physically present at the facility of the applicant during 53 regular business hours, except when the absence of the designated 54 representative is authorized including, but not limited to, sick 55 leave and vacation leave; 3 1 (vi) Is serving in the capacity of a designated representative for 2 only one (1) applicant at a time, except where more than one (1) 3 licensed wholesale distributor is colocated in the same facility and 4 such wholesale distributors are members of an affiliated group, as 5 defined in section 1504 of the Internal Revenue Code; 6 (vii) Does not have any convictions under any federal, state or 7 local law relating to wholesale or retail prescription drug distribu- 8 tion or distribution of controlled substances; and 9 (viii) Does not have any felony convictions under federal, state or 10 local law. 11 (5) The board shall submit the fingerprints provided by a person with a 12 license application for a statewide criminal records check and for forwarding 13 to the federal bureau of investigation for a national criminal records check 14 of the individual. 15 (6)The board shall require every wholesale distributor applying for a16license to submit a bond of at least one hundred thousand dollars ($100,000),17or other equivalent means of security acceptable to the board, such as an18irrevocable letter of credit or a deposit in a trust account or financial19institution, payable to a fund established by the board pursuant to subsection20(7) of this section. Chain pharmacy warehouses that are not engaged in whole-21sale distribution are exempt from the bond requirement. The purpose of the22bond is to secure payment of any fines or penalties imposed by the board and23any fees and costs incurred by the board regarding that license, which are24authorized under the law of this state and which the licensee fails to pay25thirty (30) days after the fines, penalties or costs become final. The board26may make a claim against such bond or security until one (1) year after the27licensee's license ceases to be valid. A single bond may suffice to cover all28facilities operated by the applicant in this state.29(7) The board shall establish a fund, separate from its other accounts,30in which to deposit the wholesale distributor bonds.31(8)If a wholesale distributor distributes prescription drugs from more 32 than one (1) facility, the wholesale distributor shall obtain a license for 33 each facility. 34 (97) In accordance with each licensure renewal, the board shall send to 35 each wholesale distributor licensed under this section a form setting forth 36 the information that the wholesale distributor provided pursuant to subsection 37 (2) of this section. Within thirty (30) days of receiving such form, the 38 wholesale distributor must identify and state under oath to the board all 39 changes or corrections to the information that was provided pursuant to sub- 40 section (2) of this section. Changes in, or corrections to, any information in 41 subsection (2) of this section shall be submitted to the board as required by 42 the board. The board may suspend or revoke the license of a wholesale distrib- 43 utor if such authority determines that the wholesale distributor no longer 44 qualifies for the license issued under this section. 45 (108) The designated representative identified pursuant to subsection 46 (2)(g) of this section must receive and complete continuing training in appli- 47 cable federal law and the law of this state governing wholesale distribution 48 of prescription drugs. 49 (119) The board may adopt rules to approve an accreditation body to eval- 50 uate a wholesaler's operations to determine compliance with professional stan- 51 dards and any other applicable laws, and to perform inspections of each facil- 52 ity and location where wholesale distribution operations are conducted by the 53 wholesaler. 54 (120) Information provided under this section shall not be disclosed to 55 any person other than a state licensing authority, government board or govern- 4 1 ment agency, provided such licensing authority, government board or agency 2 needs such information for licensing or monitoring purposes. 3 SECTION 2. An emergency existing therefor, which emergency is hereby 4 declared to exist, this act shall be in full force and effect on and after its 5 passage and approval.
STATEMENT OF PURPOSE
RS 17697C1
The legislature passed the Wholesale Drug Distribution Act in the
2007 session. During its implementation, the Board of Pharmacy
discovery two areas of concern. This bill addresses those
concerns. It would eliminate the bond requirement for wholesale
drug distribution licensure and clarify when the designated
representative would be required to submit a description of any
lawsuits in which such business, which employed the designated
representative over the past 7 years, were named as a party. Due
to the existing bond requirement, smaller wholesalers have
elected not to seek licensure in Idaho, eliminating the
availability of certain products and potentially raising
wholesale costs of other drugs. Clarification that only lawsuits
in which the designative representative was named as a party or
testified, eliminates the submission of thousands of pages of
irrelevant materials. The original intent of the Act will not be
affected and will help to keep counterfeit prescriptions out of
our supply chain while allowing small businesses to do business
in Idaho.
FISCAL IMPACT
There will be no impact to the state general fund.
Contact
Name: Senator Joyce Broadsword
Phone: 208-332-1338
Mark Johnston, Exec. Dir Board of Pharmacy
STATEMENT OF PURPOSE/FISCAL NOTE S 1377