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. [PL 2001, c. 471, Pt. E, §5 (AMD); PL 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; [PL 2001, c. 379, §1 (NEW).] B. A generic drug; or [PL 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. [PL 2001, c. 379, §1 (NEW).] [PL 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. [PL 2001, c. 379, §1 (NEW).] 3. Program participation information. [PL 2001, c. 471, Pt. E, §6 (RP); PL 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 [PL 2001, c. 471, Pt. E, §7 (NEW); PL 2001, c. 471, Pt. E, §8 (AFF); PL 2003, c. 689, Pt. B, §6 (REV).] B. Advice to consult a health care provider or pharmacist about access to drugs at lower prices. [PL 2001, c. 471, Pt. E, §7 (NEW); PL 2001, c. 471, Pt. E, §8 (AFF).] [PL 2001, c. 471, Pt. E, §7 (NEW); PL 2001, c. 471, Pt. E, §8 (AFF); PL 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. [PL 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. [PL 2001, c. 379, §1 (NEW).]
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