Mass. Gen. Laws ch. 94H, § 4: Notice of requirements or of noncompliance; penalty; appeal

Section 4. (a) The department shall send a notice to a pharmaceutical product manufacturer that sells or distributes a covered drug in the commonwealth that has not submitted an application for approval under section 2, informing the manufacturer of the requirements to comply with this chapter. Any manufacturer in receipt of a notice shall submit an application for approval under said section 2 within 180 calendar days of receipt of such initial notice.

(b) Upon becoming aware that a pharmaceutical product manufacturer has discontinued its drug stewardship program or has altered the program such that the program no longer fulfills the requirements of this chapter, the department shall send a notice of noncompliance to the manufacturer. A manufacturer in receipt of a notice of noncompliance shall take all required corrective steps to reestablish compliance with this chapter or submit a written appeal of the notice of noncompliance to the department within 90 days of receipt of the notice of noncompliance.

(c) If after consideration of an appeal or if the manufacturer does not appeal within 90 days of receipt of the notice of noncompliance the department determines that the manufacturer continues to be in noncompliance with this chapter, the department may assess the manufacturer a penalty in a manner to be determined by the department. If the department plans to assess a noncompliance penalty against a manufacturer pursuant to this section, the department shall send notice of the penalty and the right to appeal the penalty to the manufacturer.