Section 1 expands the definition of “drug” in the chapter of law addressing pharmacy matters.  Drug would include any compound, substance, or derivative which is not approved for human consumption by the United States Food and Drug Administration or specifically permitted by Minnesota law, and when introduced into the body, induces an effect substantially similar to that of a Schedule I or Schedule II controlled substance regardless of whether the substance is marketed for the purpose of human consumption.  This broader definition will give the Board of Pharmacy more power to regulate synthetic drugs.

Sections 2 and 3 empower the Board of Pharmacy to issue cease and desist orders to businesses that sell synthetic drugs.  The Board would have the authority to order a business to cease selling synthetic drugs that, in the Board’s opinion, are a banned substance or analog of Schedule I or Schedule II drugs.  An affected business would be entitled to an administrative hearing to change the Board’s order.

Section 4 clarifies that pharmacists and retailers may not sell synthetic drugs and are subject to the authority of the Board of Pharmacy if they do so.

Section 5 expressly prohibits the sale of synthetic drugs that induce the same or substantially similar effect as scheduled controlled substances.  

Section 6 provides that a drug is considered adulterated if it was manufactured at a facility not registered by the United States Food and Drug Administration or licensed pursuant to the standards established in Minnesota Statutes, chapter 151 (pharmacy).

Section 7 provides that a drug is deemed misbranded if the package does not include a statement of ingredients.

Sections 1 to 7 are effective August 1, 2014, and apply to violations occuring on or after that date. 

Section 8 strikes the statutory requirement that the Board of Pharmacy’s emergency drug scheduling decisions must be ratified by the Legislature to make the Board’s actions final.  The section also removes the sunset on the Board of Pharmacy’s emergency drug scheduling authority.  The Board’s authority is set to expire on August 1, 2014.

CT:rer