Guidance/Statutes
State laws regulating the practice of pharmacy in Minnesota fall into two categories: statutes and rules. Statutes are laws which have been enacted by the legislature and approved by the Governor. Only the legislature and Governor can change the statutes. The Minnesota Board of Pharmacy has the responsibility for administering all of
Chapter 151 and parts of
Chapter 152 of the Minnesota Statutes. In addition, the provisions of Minnesota Statutes
Chapter 214 apply to the operations of the Board. Select Statutes from the menu to obtain additional information about the statutes administered by the Board.
Rules, on the other hand, are laws that are promulgated (i.e. written and adopted) by the Board of Pharmacy. The statutes passed by the Legislature are often more general in nature, establishing a broad framework for regulation. The rules promulgated by the Board are usually much more specific. In essence, rules flesh out the general directions of the Legislature. All Minnesota pharmacy rules are found in
Minnesota Rules Chapter 6800. Select Rules from the menu to obtain additional information about the rules administered by the Board, including the Boards rules docket for recent rule changes.
Minnesota Statues
Sec. 214.108 states: A health-related licensing board may offer guidance to current licensees about the application of laws and rules the board is empowered to enforce. This guidance shall not bind any court or other adjudicatory bodies. Consequently, the Board has issued a number of guidance documents that may be accessed by selecting Guidance from the menu.
Federal Statutes and Rules
The Food, Drug, and Cosmetic Act contains many provisions that have an impact on the practice of pharmacy and the manufacturing and distribution of drugs.
The
Consumer Product Safety Commission administers the
Poison Prevention Packaging Act of 1970. In addition to Minnesota statutes and rules, a number of federal statutes and regulations also affect the practice of pharmacy and the manufacturing and distribution of drugs. Federal regulations concerning controlled substances can be found in
Title 21 - Food and Drugs, Part 1300 to END of the Code of Federal Regulations. Useful summaries of these regulations can be found in the
DEA Pharmacist's Manual and the DEA Practitioner's Manual. The Food, Drug, and Cosmetic Act (FDCA) contains many provisions that have an impact of the practice of pharmacy and the manufacturing and distribution of drugs. The following are links to some key FDA resources that provide the text of the FDCA or provide guidance from the FDA:
FDA Main Drugs Web page provides information and links to many resources concerning drugs.
FDA Food, Drug, and Cosmetic Act webpage provides links to sections of the FDCA.
FDA Current Good Manufacturing Practice (CGMP) webpage provides information about CGMPs.
FDA Pharmacy Compounding webpage provides information on federal statutes, regulations, and guidance's concerning compounding and outsourcing facilities. The Consumer Product Safety Commission administers the
Poison Prevention Packaging Act of 1970.
