Minnesota Board of Pharmacy - Minnesota State Legislature

Minnesota Statutes §151.06, subd. 5 states that the Board “may impose a civil penalty not exceeding
$10,000 for each separate violation, the amount of the civil penalty to be fixed so as to deprive a
licensee or registrant of any economic advantage gained by reason of the violation, to discourage
similar violations by the licensee or registrant or any other licensee or registrant, or to reimburse the
board for the cost of the investigation and proceeding, including, but not limited to, fees paid for
services provided by the Office of Administrative Hearings, legal and investigative services provided
by the Office of the Attorney General, court reporters, witnesses, reproduction of records, board
members' per diem compensation, board staff time, and travel costs and expenses incurred by board
staff and board members”.
Whether less restrictive or alternative methods of performing any function that the agency performs
could adequately protect or provide service to the public
As noted above, the Board’s primary functions are: licensing; standard-setting; compliance; provision
of technical assistance to elected public officials, other state agencies, federal agencies and units of
local government; serving as a resource to the profession and the public concerning issues involving
the practice of pharmacy, the distribution of drugs and the abuse of controlled substances;
administering the state’s Prescription Monitoring Program (PMP) and general administration of the
agency. Of these functions, only licensing, compliance and administration of the PMP might be
considered “restrictive”. Those three areas are addressed below. The Board has an open approach to
standard-setting which involves working cooperatively with educational institutions, professional
associations, other state agencies, federal agencies, accreditation organizations and other interested
parties. Likewise, the general administration of the agency and the provision of technical assistance to
elected public officials, other government agencies, the profession and the public are in no way
restrictive.
Licensing
The Board licenses pharmacists, pharmacies, drug manufacturers, drug wholesalers, medical gas
manufacturers, and medical gas wholesalers and distributors. In the Board’s judgment, less restrictive
alternatives would not adequately protect the public. As mentioned above, there are at least 1.5 million
preventable adverse drug events that occur in the United States each year, many of which are
attributable to the dispensing of drugs by pharmacists. In addition, it is critical for the health and safety
of the public that drugs and medical gases be properly manufactured, stored and distributed. Licensing
helps to ensure that only properly trained and qualified individuals will either practice pharmacy or be
responsible for the operation of pharmacies, manufacturers and wholesalers.
Three possible alternatives to licensure are registration, certification and the caveat emptor approach of
no regulation at all. Every developed country on the planet has rejected the third approach. Each of the
states in this country, plus the United States territories of Puerto Rico, the Virgin Islands and Guam,
have boards of pharmacies that are members of the National Association of Boards of Pharmacy. In
addition, the pharmacy regulatory agencies of eight of the Canadian provinces and of Australia and
New Zealand are associate members of NABP. All of the states in this country require pharmacists and
pharmacies to be licensed. Most of the states license or register drug manufacturers and all of them
license drug wholesalers. Most of the states conduct routine, unannounced inspections of the facilities
that are licensed.
Registration, in its purest form, provides only for a mechanism by which the registrants can be tracked.
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