1.1.................... moves to amend H.F. No. 2626 as follows:
1.2Delete everything after the enacting clause and insert:

1.3    "Section 1. [151.58] AUTOMATED DRUG DISTRIBUTION SYSTEMS.
1.4    Subdivision 1. Scope. This section applies only to the use of automated drug
1.5distribution systems located within the facilities specified in subdivision 2. Except as
1.6provided in this section, all applicable provisions of this chapter, chapter 152, and
1.7Minnesota Rules, chapter 6800, must be followed.
1.8    Subd. 2. Definitions. For purposes of this section only, the terms defined in this
1.9subdivision have the meanings given.
1.10(a) "Automated drug distribution system" or "system" means a mechanical system
1.11approved by the board that performs operations or activities, other than compounding or
1.12administration, related to the storage, packaging, or dispensing of drugs, and collects,
1.13controls, and maintains all required transaction information and records.
1.14(b) "Health care facility" means a nursing home licensed under section 144A.02;
1.15a housing with services establishment registered under section 144D.01, subdivision 4,
1.16in which a home provider licensed under chapter 144A is providing centralized storage
1.17of medications; or a community behavioral health hospital or Minnesota sex offender
1.18program facility operated by the Department of Human Services.
1.19(c) "Managing pharmacy" means a pharmacy licensed by the board that controls and
1.20is responsible for the operation of an automated drug distribution system.
1.21    Subd. 3. Authorization. A pharmacy may use an automated drug distribution
1.22system to fill prescription drug orders for patients of a health care facility. The automated
1.23drug distribution system may be located in a health care facility that is not at the same
1.24location as the managing pharmacy. When located within a health care facility, the system
1.25is considered to be an extension of the managing pharmacy.
1.26    Subd. 4. Notification. (a) At least 60 days prior to the initial use of an automated
1.27drug distribution system, the managing pharmacy must provide the board with written
2.1notification of the address at which the automated drug distribution system will be
2.2located, the manufacturer and model of the automated drug distribution system, and
2.3written policies and procedures that govern the operation of the system. The policies
2.4and procedures must address the requirements of subdivision 5 and the rules of the
2.5board. If the managing pharmacy will be using a system identical to the one for which
2.6it has previously provided notification to the board, and will be using identical policies
2.7and procedures, it must notify the board of the address at which the automated drug
2.8distribution system will be located and the manufacturer and model of the automated drug
2.9distribution system at least seven days in advance of using the system.
2.10(b) The managing pharmacy must notify the board whenever an automated drug
2.11distribution system is taken permanently out of service.
2.12(c) The managing pharmacy must notify the board whenever an automated drug
2.13distribution system is replaced. It must also provide the board with new written policies
2.14and procedures, unless an identical system is used as the replacement, 60 days prior to
2.15the replacement of the system.
2.16    Subd. 5. Operation of automated drug distribution systems. (a) The managing
2.17pharmacy and the pharmacist in charge are responsible for the operation of an automated
2.18drug distribution system.
2.19(b) Access to an automated drug distribution system must be limited to pharmacy
2.20and nonpharmacy personnel authorized to procure drugs from the system, except that field
2.21service technicians may access a system located in a health care facility for the purposes of
2.22servicing and maintaining it while being monitored either by the managing pharmacy, or a
2.23licensed nurse within the health care facility. In the case of an automated drug distribution
2.24system that is not physically located within a licensed pharmacy, access for the purpose
2.25of procuring drugs shall be limited to licensed nurses. Each person authorized to access
2.26the system must be assigned an individual specific access code. Alternatively, access to
2.27the system may be controlled through the use of biometric identification procedures. A
2.28policy specifying time access parameters, including time-outs, log-offs, and lock-outs,
2.29must be in place.
2.30(c) For the purposes of this section only, the requirements of section 151.215 are met
2.31if the following clauses are met:
2.32(1) a pharmacist employed by and working at the managing pharmacy must review,
2.33interpret, and approve all prescription drug orders before any drug is distributed from the
2.34system to be administered to a patient. A pharmacy technician may perform data entry of
2.35prescription drug orders provided that a pharmacist certifies the accuracy of the data entry
2.36before the drug can be released from the automated drug distribution system. A pharmacist
3.1must certify the accuracy of the filling of any cassettes, canisters, or other containers that
3.2contain drugs that will be loaded into the automated drug distribution system; and
3.3(2) when the automated drug dispensing system is located and used within the
3.4managing pharmacy, a pharmacist must personally supervise and take responsibility for all
3.5packaging and labeling associated with the use of an automated drug distribution system.
3.6(d) Access to drugs when a pharmacist has not reviewed and approved the
3.7prescription drug order is permitted only when a formal and written decision to allow such
3.8access is issued by the pharmacy and the therapeutics committee or its equivalent. The
3.9committee must specify the patient care circumstances in which such access is allowed,
3.10the drugs that can be accessed, and the staff that are allowed to access the drugs.
3.11(e) The loading of a automated drug dispensing system located in a health care
3.12facility may be performed by a pharmacy technician, so long as the activity is continuously
3.13supervised, through a two-way audiovisual system by a pharmacist on duty within the
3.14managing pharmacy.
3.15(f) The automated drug distribution system must be under the supervision of a
3.16pharmacist. The pharmacist is not required to be physically present at the site of the
3.17automated drug distribution system if the system is continuously monitored electronically
3.18by the managing pharmacy. A pharmacist on duty within the managing pharmacy must be
3.19continuously available to address any problems detected by the monitoring or to answer
3.20questions from the staff of the health care facility."
3.21Amend the title accordingly