SF 2135 makes a number of changes to the Board of Pharmacy chapter and to the controlled substances chapter.

Section 1 (151.01) modifies the definitions of pharmacy, drug, director, commercial purposes, manufacturing, manufacturer, pharmacist intern, prescription drug order, legend drug, label, pharmacist in charge, legend drug, label, practitioner, practice of pharmacy, veterinary legend drug, legend medical gas, and. dispense or dispensing.  This section also adds the following new definitions:  prescription, chart order, protocol, collaborative practice, collaborative practice agreement, compounding, anticipatory compounding, extemporaneous compounding, and compounding positron emission tomography drug.

Section 2 (151.06) modifies the duties of the Board of Pharmacy.  Creates the ability to issue a cease and desist order and to enforce any cease and desist orders.

Section 3 (151.071) creates a new section that specifies disciplinary action, grounds for disciplinary action, automatic suspension, conditions on a reissued license, temporary suspension of license, evidence, mental examination and access to medical data, tax clearance certificate, and limitations on board proceedings.

Section 4 (151.072) establishes reporting requirements for persons who have knowledge of conduct that may be grounds for disciplinary action, pharmacies employing pharmacists, pharmacist interns, or pharmacy technicians, licensees and registrants who have personal knowledge of any conduct by another licensee or registrant that may be grounds for disciplinary action, and the courts if a licensee or registrant is determined to be mentally ill, mentally incompetent, guilty of a felony, guilty of a violation of federal or state narcotics laws, guilty of Medicare or Medicaid fraud, or if the court appoints a guardian or civilly commits a licensee or registrant.

Section 5 (151.073) provides immunity from civil liability for any person, facility, business or organization that makes a good faith report to the board alleging violations of this chapter.  This section also classifies the reports as investigative data.  This section also provides immunity from civil and criminal liability for any board member, board employee, or person who, within the scope of their duties, is participating or testifying regarding violations of this chapter.  Individuals who maintain records or make reports regarding adverse care events are immune from criminal and civil liability.

Section 6 (151.074) requires licensees and registrants to cooperate with the board if they are the subject of a board investigation.  Requires the board to maintain any records obtained pursuant to this section as investigative data.

Section 7 (151.075) requires the court reviewing any board disciplinary action taken under this chapter to seal the administrative record with the exception of the board’s final decision.

Section 8 (151.211) requires prescription drug orders to be retained at the location that dispensed the drug for at least two years.  This section also requires prescription drugs orders that are electronically prescribed to be kept on file in the format that they were received.  Requires electronic systems used to process and store prescription drug orders to be compliant with this chapter.  Prescription orders that are stored electronically may be stored in an electronic format and kept on file at a remote location provided the location is readily and securely accessible.  This section also adds electronic prescriptions to the refill requirements of this chapter.

Section 9 (151.251) establishes compounding requirements.

Subdivision 1 specifies that the manufacturing licensure requirements do not apply to a practitioner or a pharmacy when a pharmacist is engaged in extemporaneous compounding, anticipatory compounding, or compounding not done pursuant to a prescription drug order when permitted by this chapter.

Subdivision 2 specifies the circumstances under which a drug product may be compounded by a practitioner or pharmacist.

Subdivision 3 specifies that this section does not apply to compounded positiron emission tomography drugs or radiopharmaceuticals.

Section 10 (151.252, subd.1a) requires any person seeking to act as an outsourcing facility to apply and obtain a license from the board and pay the applicable manufacturer licensing fee.  This section also requires the facility to provide the board with proof that the outsourcing facility is registered with the FDA and in compliance with all laws and rules; requires a facility that is physically located in other states to be licensed or registered in that state; requires a separate license for each outsourcing facility; and requires the facility to pass an inspection conducted by a representative of the board.

Section 11 (151.34) Clarifies that this chapter does not apply to or interfere with the dispensing of a legend drug, including a controlled substance, that is packaged by the manufacturer and provided to the dispenser for dispensing as a professional sample, so long as the federal regulations are followed.  This section also states that the exceptions provided in this section do not apply to any compound or substance that is not approved for human consumption by the FDA or under Minnesota law, and that when introduced into the body induces a similar effect as a Schedule I or II controlled substance, regardless of whether the substance is marketed for human consumption.

Section 12 (151.34) makes it unlawful to sell any compound, substance, or derivative that is not approved for human consumption by the FDA or specifically permitted for human consumption under Minnesota law if when introduced into the body induces an effect similar to that of a Schedule I or II controlled substance.

Section 13 (151.35) states that a drug shall be considered adulterated if it is produced in a facility that was not registered by the FDA or licensed by the board.

Section 14 (151.361, subd. 2) strikes obsolete language.

Section 15 (151.37) makes a number of changes to this section regarding who may prescribe and possess prescription drugs.

Subdivision 2 makes a conforming change to prescription drug orders. 

Subdivision 4 specifies that a pharmacy may compound drugs for research studies if applicable standards regarding nonsterile and sterile compounding are followed. 

Subdivision 10a specifies that this chapter does not prohibit the purchase, possession, or use of a legend drug by an entity acting in accordance with an emergency use authorization issued by the FDA if the entity is specifically assigned in a public health response plan to perform critical functions necessary to perform critical functions necessary to support the response to a public health incident or event.

Subdivision 11 specifies that this section does not prohibit an accredited public or private postsecondary school from possessing a legend drug that is not a controlled substance listed in section 152.02, provided that certain factors are met.

Section 16 (151.44) modifies “repackers” to “repackagers” and the definition of “manufacturers” to refer to the meaning in section 151.01.

Section 17 (151.58, subd. 2) modifies the definition of “health care facility” by striking “community behavioral health hospital” within the automated drug distribution system section.

Section 18 (151.58, subd. 3) specifies that a pharmacy may use an automated drug distribution system to fill prescription drugs for patients of a health care facility provided that the policies and procedures required by this section are approved by the board.

Section 19 (151.58, subd. 5) specifies that a pharmacist employed by or working at a pharmacy that is acting as a central services pharmacy for the managing pharmacy may review, interpret, and approve all prescription drug orders before a drug is distributed from an automated drug distribution system.

Section 20 (152.02, subd. 2) adds several synthetic drugs to the Schedule I controlled substances list.

Section 21 (152.02, subd. 8b) under current law, the board may use expedited rulemaking to add a substance to the Schedule I list if that substance has a high potential of being abused, has no accepted medical use, lacks an accepted safety use under medical supervision, has unknown adverse health effects, and is currently available for use within the state.  This section strikes the language that states that the scheduling of such a substance expires the day after the adjournment of the legislative session, immediately following the substance’s scheduling, unless the legislature ratifies the addition by law.  This section also strikes the language that requires the board to notify the appropriate chairs and ranking minority members of the action and the reason for it.  This section also strikes the expiration date for the subdivision thereby permitting the board through expedited rulemaking to add certain substances to the Schedule I list.

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