SF 2189

2nd Engrossment - 83rd Legislature (2003 - 2004) Posted on 12/15/2009 12:00am

  1.1                          A bill for an act 
  1.2             relating to health; providing enforcement for gift ban 
  1.3             for prescription drug practitioners; including 
  1.4             practitioners in the gift ban; amending Minnesota 
  1.5             Statutes 2002, sections 151.34; 151.461. 
  1.6   BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA: 
  1.7      Section 1.  Minnesota Statutes 2002, section 151.34, is 
  1.8   amended to read: 
  1.9      151.34 [PROHIBITED ACTS.] 
  1.10     It shall be unlawful to: 
  1.11     (1) manufacture, sell or deliver, hold or offer for sale 
  1.12  any drug that is adulterated or misbranded; 
  1.13     (2) adulterate or misbrand any drug; 
  1.14     (3) receive in commerce any drug that is adulterated or 
  1.15  misbranded, and to deliver or proffer delivery thereof for pay 
  1.16  or otherwise; 
  1.17     (4) refuse to permit entry or inspection, or to permit the 
  1.18  taking of a sample, or to permit access to or copying of any 
  1.19  record as authorized by this chapter; 
  1.20     (5) remove or dispose of a detained or embargoed article in 
  1.21  violation of this chapter; 
  1.22     (6) alter, mutilate, destroy, obliterate, or remove the 
  1.23  whole or any part of the labeling of, or to do any other act 
  1.24  with respect to a drug, if such act is done while such drug is 
  1.25  held for sale and results in such drug being adulterated or 
  2.1   misbranded; 
  2.2      (7) use for a person's own advantage or to reveal other 
  2.3   than to the board or its authorized representative or to the 
  2.4   courts when required in any judicial proceeding under this 
  2.5   chapter any information acquired under authority of this chapter 
  2.6   concerning any method or process which is a trade secret and 
  2.7   entitled to protection; 
  2.8      (8) use on the labeling of any drug any representation or 
  2.9   suggestion that an application with respect to such drug is 
  2.10  effective under the federal act or that such drug complies with 
  2.11  such provisions; 
  2.12     (9) in the case of a manufacturer, packer, or distributor 
  2.13  offering legend drugs for sale within this state, fail to 
  2.14  maintain for transmittal or to transmit, to any practitioner 
  2.15  licensed by applicable law to administer such drug who makes 
  2.16  written request for information as to such drug, true and 
  2.17  correct copies of all printed matter which is required to be 
  2.18  included in any package in which that drug is distributed or 
  2.19  sold, or such other printed matter as is approved under the 
  2.20  federal act.  Nothing in this paragraph shall be construed to 
  2.21  exempt any person from any labeling requirement imposed by or 
  2.22  under provisions of this chapter; 
  2.23     (10) conduct a pharmacy without a pharmacist in charge; 
  2.24     (11) dispense a legend drug without first obtaining a valid 
  2.25  prescription for that drug; 
  2.26     (12) conduct a pharmacy without proper registration with 
  2.27  the board; 
  2.28     (13) practice pharmacy without being licensed to do so by 
  2.29  the board; or 
  2.30     (14) sell at retail federally restricted medical gases 
  2.31  without proper registration with the board except as provided in 
  2.32  this chapter; or 
  2.33     (15) accept a gift of value prohibited under section 
  2.34  151.461. 
  2.35     Sec. 2.  Minnesota Statutes 2002, section 151.461, is 
  2.36  amended to read: 
  3.1      151.461 [GIFTS TO PRACTITIONERS PROHIBITED.] 
  3.2      Subdivision 1.  [PROHIBITED ACTS.] It is unlawful for any 
  3.3   manufacturer or wholesale drug distributor, or any agent 
  3.4   thereof, to offer or give any gift of value to a practitioner.  
  3.5   A medical device manufacturer that distributes drugs as an 
  3.6   incidental part of its device business shall not be considered a 
  3.7   manufacturer, a wholesale drug distributor, or agent under this 
  3.8   section.  As used in this section, "gift" does not include: 
  3.9      (1) professional samples of a drug provided to a prescriber 
  3.10  for free distribution to patients; 
  3.11     (2) items with a total combined retail value, in any 
  3.12  calendar year, of not more than $50; 
  3.13     (3) a payment to the sponsor of a medical conference, 
  3.14  professional meeting, or other educational program, provided the 
  3.15  payment is not made directly to a practitioner and is used 
  3.16  solely for bona fide educational purposes; 
  3.17     (4) reasonable honoraria and payment of the reasonable 
  3.18  expenses of a practitioner who serves on the faculty at a 
  3.19  professional or educational conference or meeting; 
  3.20     (5) compensation for the substantial professional or 
  3.21  consulting services of a practitioner in connection with a 
  3.22  genuine research project; 
  3.23     (6) publications and educational materials; or 
  3.24     (7) salaries or other benefits paid to employees. 
  3.25     Subd. 2.  [ENFORCEMENT.] A person who violates this section 
  3.26  is subject to a civil penalty of up to $10,000 per violation.  
  3.27  Each prohibited gift or gift offer constitutes a separate 
  3.28  violation.  This section may be enforced by the board according 
  3.29  to sections 151.47 to 151.50 and by the attorney general 
  3.30  according to section 8.31 or 325F.70 and the public remedies 
  3.31  available under those sections apply to this section, except 
  3.32  that the maximum civil penalty is $10,000 per violation.  Civil 
  3.33  prosecution by the attorney general for actions taken in 
  3.34  violation of this section is not exclusive and does not prevent 
  3.35  any other applicable civil, criminal, or administrative remedies 
  3.36  and penalties for the same actions. 
  4.1      Sec. 3.  [EFFECTIVE DATE.] 
  4.2      Sections 1 and 2 are effective January 1, 2005.