A drug dispensed pursuant to prescription, including a drug dispensed without charge to the consumer, must be accompanied by program participation information in a manner approved by the commissioner and as permitted by law. [2001, c. 471, Pt. E, §5(AMD); 2001, c. 471, Pt. E, §8(AFF).]
1. Exceptions. The requirements of this section do not apply to: A. A drug dispensed to a consumer who has health coverage that pays part or all of the retail cost of the drug; [2001, c. 379, §1(NEW).]B. A generic drug; or [2001, c. 379, §1(NEW).]C. A drug of a manufacturer or labeler that has entered into an agreement with the department pursuant to section 2681, subsection 3. [2001, c. 379, §1(NEW).] [2001, c. 379, §1(NEW).]
2.Rulemaking. The commissioner shall adopt rules to implement this section. Rules adopted pursuant to this section are routine technical rules as defined by Title 5, chapter 375, subchapter II-A. [2001, c. 379, §1(NEW).]
3.Program participation information.[2001, c. 471, Pt. E, §6(RP); 2001, c. 471, Pt. E, §8(AFF).]
3-A. Program participation information. The rules must provide for the disclosure of program participation information, including, but not limited to, the following: A. Notification that the manufacturer or labeler has not entered into an agreement with the Department of Health and Human Services pursuant to section 2681, subsection 3; and [2001, c. 471, Pt. E, §7(NEW); 2001, c. 471, Pt. E, §8(AFF); 2003, c. 689, Pt. B, §6(REV).]B. Advice to consult a health care provider or pharmacist about access to drugs at lower prices. [2001, c. 471, Pt. E, §7(NEW); 2001, c. 471, Pt. E, §8(AFF).] [2001, c. 471, Pt. E, §7(NEW); 2001, c. 471, Pt. E, §8(AFF); 2003, c. 689, Pt. B, §6(REV).]
4.Separate writing. The requirements of this section may be met by the distribution of a separate writing that is approved by or produced and distributed by the department. [2001, c. 379, §1(NEW).]
5.Waivers. The rules must provide for waivers to the requirements of this section, particularly when the manufacturer or labeler is negotiating with the commissioner pursuant to section 2681, subsection 3. [2001, c. 379, §1(NEW).]
2001, c. 379, § 1 (NEW) . 2001, c. 471, §§E5-7 (AMD) . 2001, c. 471, §E8 (AFF) . 2003, c. 494, § 9 (AMD) . 2003, c. 689, §B6 (REV) .