1.1 	A bill for an act
1.2 	relating to health; modifying provisions for businesses regulated by the Board of 
1.3 	Pharmacy;amending Minnesota Statutes 2012, sections 151.19, subdivisions 1, 
1.4 	3; 151.37, subdivision 4; 151.47, subdivision 1, by adding a subdivision; 151.49; 
1.5 	proposing coding for new law in Minnesota Statutes, chapter 151; repealing 
1.6 	Minnesota Statutes 2012, sections 151.19, subdivision 2; 151.25; 151.45; 151.47, 
1.7 	subdivision 2; 151.48.
1.8 	BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:

1.9 	Section 1. Minnesota Statutes 2012, section 151.19, subdivision 1, is amended to read:
1.10 		Subdivision 1.Pharmacy registration licensure requirements. The board shall 
1.11 	require and provide for the annual registration of every pharmacy now or hereafter doing 
1.12 	business within this state. Upon the payment of any applicable fee specified in section 
1.13 	151.065, the board shall issue a registration certificate in such form as it may prescribe to 
1.14 	such persons as may be qualified by law to conduct a pharmacy. Such certificate shall 
1.15 	be displayed in a conspicuous place in the pharmacy for which it is issued and expire on 
1.16 	the 30th day of June following the date of issue. It shall be unlawful for any person to 
1.17 	conduct a pharmacy unless such certificate has been issued to the person by the board. (a) 
1.18 	No person shall operate a pharmacy without first obtaining a license from the board and 
1.19 	paying any applicable fee specified in section 151.065. The license shall be displayed in a 
1.20 	conspicuous place in the pharmacy for which it is issued and expires on June 30 following 
1.21 	the date of issue. It is unlawful for any person to operate a pharmacy unless the license 
1.22 	has been issued to the person by the board.
1.23 	(b) Application for a pharmacy license under this section shall be made in a manner 
1.24 	specified by the board.
2.1 	(c) No license shall be issued or renewed for a pharmacy located within the state 
2.2 	unless the applicant agrees to operate the pharmacy in a manner prescribed by federal and 
2.3 	state law and according to rules adopted by the board. No license shall be issued for a 
2.4 	pharmacy located outside of the state unless the applicant agrees to operate the pharmacy 
2.5 	in a manner prescribed by federal law and, when dispensing medications for residents of 
2.6 	this state, the laws of this state and Minnesota Rules.
2.7 	(d) No license shall be issued or renewed for a pharmacy that is required to be 
2.8 	licensed or registered by the state in which it is physically located unless the applicant 
2.9 	supplies the board with proof of such licensure or registration.
2.10 	(e) The board shall require a separate license for each pharmacy located within 
2.11 	the state and for each pharmacy located outside of the state at which any portion of the 
2.12 	dispensing process occurs for drugs dispensed to residents of this state.
2.13 	(f) The board shall not issue an initial or renewed license for a pharmacy unless the 
2.14 	pharmacy passes an inspection conducted by an authorized representative of the board. In 
2.15 	the case of a pharmacy located outside of the state, the board may require the applicant to 
2.16 	pay the cost of the inspection, in addition to the license fee in section 151.065, unless the 
2.17 	applicant furnishes the board with a report, issued by the appropriate regulatory agency of 
2.18 	the state in which the facility is located, of an inspection that has occurred within the 24 
2.19 	months immediately preceding receipt of the license application by the board. The board 
2.20 	may deny licensure unless the applicant submits documentation satisfactory to the board 
2.21 	that any deficiencies noted in an inspection report have been corrected.
2.22 	(g) The board shall not issue an initial or renewed license for a pharmacy located 
2.23 	outside of the state unless the applicant discloses and certifies:
2.24 	(1) the location, names, and titles of all principal corporate officers and all 
2.25 	pharmacists who are involved in dispensing drugs to residents of this state;
2.26 	(2) that it maintains its records of drugs dispensed to residents of this state so that the 
2.27 	records are readily retrievable from the records of other drugs dispensed;
2.28 	(3) that it agrees to cooperate with, and provide information to, the board concerning 
2.29 	matters related to dispensing drugs to residents of this state;
2.30 	(4) that, during its regular hours of operation, but no less than six days per week, for 
2.31 	a minimum of 40 hours per week, a toll-free telephone service is provided to facilitate 
2.32 	communication between patients in this state and a pharmacist at the pharmacy who has 
2.33 	access to the patients' records. The toll-free number must be disclosed on the label affixed 
2.34 	to each container of drugs dispensed to residents of this state; and
2.35 	(5) that, upon request of a resident of a long-term care facility located in this 
2.36 	state, the resident's authorized representative, or a contract pharmacy or licensed health 
3.1 	care facility acting on behalf of the resident, the pharmacy will dispense medications 
3.2 	prescribed for the resident in unit-dose packaging or, alternatively, comply with section 
3.3 	151.415, subdivision 5.

3.4 	Sec. 2. Minnesota Statutes 2012, section 151.19, subdivision 3, is amended to read:
3.5 		Subd. 3.Sale of federally restricted medical gases. The board shall require and 
3.6 	provide for the annual registration of every person or establishment not licensed as a 
3.7 	pharmacy or a practitioner engaged in the retail sale or distribution of federally restricted 
3.8 	medical gases. Upon the payment of any applicable fee specified in section 151.065, the 
3.9 	board shall issue a registration certificate in such form as it may prescribe to those persons 
3.10 	or places that may be qualified to sell or distribute federally restricted medical gases. The 
3.11 	certificate shall be displayed in a conspicuous place in the business for which it is issued 
3.12 	and expire on the date set by the board. It is unlawful for a person to sell or distribute 
3.13 	federally restricted medical gases unless a certificate has been issued to that person by the 
3.14 	board. (a) A person or establishment not licensed as a pharmacy or a practitioner shall not 
3.15 	engage in the retail sale or distribution of federally restricted medical gases without first 
3.16 	obtaining a registration from the board and paying the applicable fee specified in section 
3.17 	151.065. The registration shall be displayed in a conspicuous place in the business for 
3.18 	which it is issued and expires on the date set by the board. It is unlawful for a person to 
3.19 	sell or distribute federally restricted medical gases unless a certificate has been issued to 
3.20 	that person by the board.
3.21 	(b) Application for a medical gas distributor registration under this section shall be 
3.22 	made in a manner specified by the board.
3.23 	(c) No registration shall be issued or renewed for a medical gas distributor located 
3.24 	within the state unless the applicant agrees to operate in a manner prescribed by federal 
3.25 	and state law and according to the rules adopted by the board. No license shall be issued 
3.26 	for a medical gas distributor located outside of the state unless the applicant agrees to 
3.27 	operate in a manner prescribed by federal law and, when distributing medical gases for 
3.28 	residents of this state, the laws of this state and Minnesota Rules.
3.29 	(d) No registration shall be issued or renewed for a medical gas distributor that is 
3.30 	required to be licensed or registered by the state in which it is physically located unless the 
3.31 	applicant supplies the board with proof of the licensure or registration. The board may, by 
3.32 	rule, establish standards for the registration of a medical gas distributor that is not required 
3.33 	to be licensed or registered by the state in which it is physically located.
4.1 	(e) The board shall require a separate registration for each medical gas distributor 
4.2 	located within the state and for each facility located outside of the state from which 
4.3 	medical gases are distributed to residents of this state.
4.4 	(f) The board shall not issue an initial or renewed registration for a medical gas 
4.5 	distributor unless the medical gas distributor passes an inspection conducted by an 
4.6 	authorized representative of the board. In the case of a medical gas distributor located 
4.7 	outside of the state, the board may require the applicant to pay the cost of the inspection, 
4.8 	in addition to the license fee in section 151.065, unless the applicant furnishes the board 
4.9 	with a report, issued by the appropriate regulatory agency of the state in which the facility 
4.10 	is located, of an inspection that has occurred within the 24 months immediately preceding 
4.11 	receipt of the license application by the board. The board may deny licensure unless the 
4.12 	applicant submits documentation satisfactory to the board that any deficiencies noted in 
4.13 	an inspection report have been corrected.

4.14 	Sec. 3. [151.252] LICENSING OF DRUG MANUFACTURERS; FEES; 
4.15 	PROHIBITIONS.
4.16 		Subdivision 1.Requirements. (a) No person shall act as a manufacturer without 
4.17 	first obtaining a license from the board and paying any applicable fee specified in section 
4.18 	151.065.
4.19 	(b) Application for a manufacturer license under this section shall be made in a 
4.20 	manner specified by the board.
4.21 	(c) No license shall be issued or renewed for a manufacturer unless the applicant 
4.22 	agrees to operate in a manner prescribed by federal and state law and according to 
4.23 	Minnesota Rules.
4.24 	(d) No license shall be issued or renewed for a manufacturer that is required to 
4.25 	be registered pursuant to United State Code, title 21, section 360, unless the applicant 
4.26 	supplies the board with proof of registration. The board may establish by rule the 
4.27 	standards for licensure of manufacturers that are not required to be registered under United 
4.28 	States Code, title 21, section 360.
4.29 	(e) No license shall be issued or renewed for a manufacturer that is required to be 
4.30 	licensed or registered by the state in which it is physically located unless the applicant 
4.31 	supplies the board with proof of licensure or registration. The board may establish, by 
4.32 	rule, standards for the licensure of a manufacturer that is not required to be licensed or 
4.33 	registered by the state in which it is physically located.
5.1 	(f) The board shall require a separate license for each facility located within the state 
5.2 	at which manufacturing occurs and for each facility located outside of the state at which 
5.3 	drugs that are shipped into the state are manufactured.
5.4 	(g) The board shall not issue an initial or renewed license for a manufacturing 
5.5 	facility unless the facility passes an inspection conducted by an authorized representative 
5.6 	of the board. In the case of a manufacturing facility located outside of the state, the board 
5.7 	may require the applicant to pay the cost of the inspection, in addition to the license fee 
5.8 	in section 151.065, unless the applicant furnishes the board with a report, issued by the 
5.9 	appropriate regulatory agency of the state in which the facility is located or by the United 
5.10 	States Food and Drug Administration, of an inspection that has occurred within the 24 
5.11 	months immediately preceding receipt of the license application by the board. The board 
5.12 	may deny licensure unless the applicant submits documentation satisfactory to the board 
5.13 	that any deficiencies noted in an inspection report have been corrected.
5.14 		Subd. 2.Prohibition. It is unlawful for any person engaged in manufacturing to sell 
5.15 	legend drugs to anyone located in this state except as provided in this chapter.

5.16 	Sec. 4. Minnesota Statutes 2012, section 151.37, subdivision 4, is amended to read:
5.17 		Subd. 4.Research. (a) Any qualified person may use legend drugs in the course 
5.18 	of a bona fide research project, but cannot administer or dispense such drugs to human 
5.19 	beings unless such drugs are prescribed, dispensed, and administered by a person lawfully 
5.20 	authorized to do so.
5.21 	(b) Drugs may be dispensed by a pharmacy licensed by the board for use by, or 
5.22 	administration to, patients enrolled in a bona fide research study that is being conducted 
5.23 	pursuant to either an investigational new drug application approved by the United States 
5.24 	Food and Drug Administration or that has been approved by an institutional review board. 
5.25 	The protocol for the study shall be considered a prescription drug order and the drug 
5.26 	labeled as required in the protocol. Dispensing of research drugs shall not be considered 
5.27 	compounding or manufacturing or the sale of a drug at wholesale under this chapter.

5.28 	Sec. 5. Minnesota Statutes 2012, section 151.47, subdivision 1, is amended to read:
5.29 		Subdivision 1.Requirements. (a) All wholesale drug distributors are subject to the 
5.30 	requirements in paragraphs (a) to (f) of this subdivision.
5.31 	(a) (b) No person or distribution outlet shall act as a wholesale drug distributor 
5.32 	without first obtaining a license from the board and paying any applicable fee specified 
5.33 	in section 151.065.
6.1 	(c) Application for a wholesale drug distributor license under this section shall be 
6.2 	made in a manner specified by the board.
6.3 	(b) (d) No license shall be issued or renewed for a wholesale drug distributor to 
6.4 	operate unless the applicant agrees to operate in a manner prescribed by federal and state 
6.5 	law and according to the rules adopted by the board.
6.6 	(c) The board may require a separate license for each facility directly or indirectly 
6.7 	owned or operated by the same business entity within the state, or for a parent entity 
6.8 	with divisions, subsidiaries, or affiliate companies within the state, when operations 
6.9 	are conducted at more than one location and joint ownership and control exists among 
6.10 	all the entities.
6.11 	(e) No license may be issued or renewed for a drug wholesale distributor that is 
6.12 	required to be licensed or registered by the state in which it is physically located unless 
6.13 	the applicant supplies the board with proof of licensure or registration. The board may 
6.14 	establish, by rule, standards for the licensure of a drug wholesale distributor that is not 
6.15 	required to be licensed or registered by the state in which it is physically located.
6.16 	(f) The board shall require a separate license for each drug wholesale distributor 
6.17 	facility located within the state and for each drug wholesale distributor facility located 
6.18 	outside of the state from which drugs are shipped into the state or to which drugs are 
6.19 	reverse distributed.
6.20 	(g) The board shall not issue an initial or renewed license for a drug wholesale 
6.21 	distributor facility unless the facility passes an inspection conducted by an authorized 
6.22 	representative of the board. In the case of a drug wholesale distributor facility located 
6.23 	outside of the state, the board may require the applicant to pay the cost of the inspection, 
6.24 	in addition to the license fee in section 151.065, unless the applicant furnishes the board 
6.25 	with a report, issued by the appropriate regulatory agency of the state in which the facility 
6.26 	is located, of an inspection that has occurred within the 24 months immediately preceding 
6.27 	receipt of the license application by the board.  The board may deny licensure unless the 
6.28 	applicant submits documentation satisfactory to the board that any deficiencies noted in 
6.29 	an inspection report have been corrected.
6.30 	(d) (h) As a condition for receiving and retaining a wholesale drug distributor license 
6.31 	issued under sections 151.42 to 151.51, an applicant shall satisfy the board that it has 
6.32 	and will continuously maintain:
6.33 	(1) adequate storage conditions and facilities;
6.34 	(2) minimum liability and other insurance as may be required under any applicable 
6.35 	federal or state law;
7.1 	(3) a viable security system that includes an after hours central alarm, or comparable 
7.2 	entry detection capability; restricted access to the premises; comprehensive employment 
7.3 	applicant screening; and safeguards against all forms of employee theft;
7.4 	(4) a system of records describing all wholesale drug distributor activities set forth 
7.5 	in section 151.44 for at least the most recent two-year period, which shall be reasonably 
7.6 	accessible as defined by board regulations in any inspection authorized by the board;
7.7 	(5) principals and persons, including officers, directors, primary shareholders, 
7.8 	and key management executives, who must at all times demonstrate and maintain their 
7.9 	capability of conducting business in conformity with sound financial practices as well 
7.10 	as state and federal law;
7.11 	(6) complete, updated information, to be provided to the board as a condition for 
7.12 	obtaining and retaining a license, about each wholesale drug distributor to be licensed, 
7.13 	including all pertinent corporate licensee information, if applicable, or other ownership, 
7.14 	principal, key personnel, and facilities information found to be necessary by the board;
7.15 	(7) written policies and procedures that assure reasonable wholesale drug distributor 
7.16 	preparation for, protection against, and handling of any facility security or operation 
7.17 	problems, including, but not limited to, those caused by natural disaster or government 
7.18 	emergency, inventory inaccuracies or product shipping and receiving, outdated product 
7.19 	or other unauthorized product control, appropriate disposition of returned goods, and 
7.20 	product recalls;
7.21 	(8) sufficient inspection procedures for all incoming and outgoing product 
7.22 	shipments; and
7.23 	(9) operations in compliance with all federal requirements applicable to wholesale 
7.24 	drug distribution.
7.25 	(e) (i)  An agent or employee of any licensed wholesale drug distributor need not 
7.26 	seek licensure under this section.
7.27 	(f) A wholesale drug distributor shall file with the board an annual report, in a 
7.28 	form and on the date prescribed by the board, identifying all payments, honoraria, 
7.29 	reimbursement or other compensation authorized under section 151.461, clauses (3) to 
7.30 	(5), paid to practitioners in Minnesota during the preceding calendar year. The report 
7.31 	shall identify the nature and value of any payments totaling $100 or more, to a particular 
7.32 	practitioner during the year, and shall identify the practitioner. Reports filed under this 
7.33 	provision are public data.

7.34 	Sec. 6. Minnesota Statutes 2012, section 151.47, is amended by adding a subdivision 
7.35 	to read:
8.1 		Subd. 3.Prohibition. It is unlawful for any person engaged in wholesale drug 
8.2 	distribution to sell drugs to anyone located within the state or to receive drugs in reverse 
8.3 	distribution from anyone located within the state except as provided in this chapter.

8.4 	Sec. 7. Minnesota Statutes 2012, section 151.49, is amended to read:
8.5 	151.49 LICENSE RENEWAL APPLICATION PROCEDURES.
8.6 	Application blanks or notices for renewal of a license required by sections 151.42
8.7 	to 151.51 shall be mailed or otherwise provided to each licensee on or before the first 
8.8 	day of the month prior to the month in which the license expires and, if application for 
8.9 	renewal of the license with the required fee and supporting documents is not made before 
8.10 	the expiration date, the existing license or renewal shall lapse and become null and void 
8.11 	upon the date of expiration.

8.12 	Sec. 8.  REPEALER.
 8.13 	Minnesota Statutes 2012, sections 151.19, subdivision 2; 151.25; 151.45; 151.47, 
8.14 	subdivision 2; and 151.48, are repealed.