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Minnesota Administrative Rules

6800.0100 DEFINITIONS.

Subpart 1.

Scope.

The terms in this chapter have the meanings given in this part and in Minnesota Statutes, section 151.01.

Subp. 1a.

Board.

"Board" means the Board of Pharmacy.

Subp. 1b.

Beyond-use date.

"Beyond-use date" means the date after which a drug should not be used.

Subp. 1c.

Central service pharmacy.

"Central service pharmacy" means a pharmacy that may provide dispensing functions, drug utilization review (DUR), packaging, labeling, or delivery of a filled prescription for another pharmacy.

Subp. 2.

Community/outpatient pharmacy.

"Community/outpatient pharmacy" means an established place in which prescriptions, drugs, medicines, chemicals, and poisons are prepared, compounded, dispensed, vended, distributed, or sold to or for the use of nonhospitalized patients and from which related pharmaceutical care services are provided. Practitioners, as defined in Minnesota Statutes, section 151.01, subdivision 23, dispensing prescription drugs to their own patients in accordance with parts 6800.9950 to 6800.9954 are not included within this definition.

Subp. 2a.

Community satellite.

"Community satellite" means a site affiliated with a licensed community pharmacy, which is dependent on the licensed community pharmacy for administrative control, staffing, and drug procurement. A community satellite must be under the direction of a licensed pharmacist and comply with the requirements of part 6800.0800, subpart 3.

Subp. 2b.

Expiration date.

"Expiration date" means the date placed on the container or label of a drug product designating the time during which the product is expected to remain within the approved shelf life specifications if stored under defined conditions, and after which it may not be used.

Subp. 3.

Hospital pharmacy.

"Hospital pharmacy" means an established place located in a licensed hospital in which prescriptions, drugs, medicines, chemicals, and poisons are prepared, compounded, dispensed, vended, distributed, or sold to hospitalized patients and from which related pharmaceutical care services are delivered.

Subp. 3a.

Hospital satellite.

"Hospital satellite" means a site in a licensed hospital, which is not physically connected with the centrally licensed pharmacy, but is within the same facility or building and is dependent on the centrally licensed pharmacy for administrative control, staffing, and drug procurement. A hospital satellite must be under the direction of a licensed pharmacist, comply with the requirements of part 6800.0800, subpart 3, and provide pharmacy services to hospital patients only.

Subp. 4.

Long-term care pharmacy.

"Long-term care pharmacy" means an established place, whether or not in conjunction with a hospital pharmacy or a community/outpatient pharmacy, in which prescriptions, drugs, medicines, chemicals, or poisons are prepared, compounded, dispensed, vended, distributed, or sold on a regular and recurring basis to or for the use of residents of a licensed nursing home, boarding care home, assisted living facility, or supervised living facility and from which related pharmaceutical care services are delivered.

Subp. 4a.

Assisted living facility.

For the purposes of this chapter, the term "assisted living facility" means a registered housing with services establishment, as defined in Minnesota Statutes, section 144D.01, subdivision 4, that provides central storage of medications for residents.

Subp. 5.

Nuclear pharmacy.

"Nuclear pharmacy" is an area, place, or premises described in a license issued by the board with reference to plans approved by the board where radioactive drugs are stored, prepared, manufactured, derived, manipulated, compounded, or dispensed and from which related clinical services are provided.

Subp. 6.

Home health care pharmacy.

"Home health care pharmacy" means an established place, whether or not in conjunction with a hospital pharmacy, long-term care pharmacy, or a community/outpatient pharmacy, in which parenteral or enteral drugs or medicines are prepared, compounded, and dispensed for the use of nonhospitalized patients and from which related pharmaceutical care services are provided.

Subp. 7.

Pharmaceutical care.

"Pharmaceutical care" means the responsible provision of drug therapy and other pharmaceutical patient care services by a pharmacist intended to achieve definite outcomes related to the cure or prevention of a disease, the elimination or reduction of a patient's symptoms, or the arresting or slowing of a disease process.

Subp. 8.

Pharmacist-in-charge.

"Pharmacist-in-charge" means a pharmacist licensed in Minnesota who has been so designated.

Subp. 9.

Pharmacist-intern; intern.

"Pharmacist-intern" and "intern" has the meaning given in part 6800.5100, subpart 5.

Subp. 10.

[Repealed, 23 SR 1597]

Subp. 11.

Prescription drug order.

"Prescription drug order" means a lawful written, oral, or electronic order of a practitioner for a drug for a specific patient. A prescription drug order must contain the information specified in this chapter and in Minnesota Statutes, section 151.01, subdivision 16.

Subp. 11a.

Prescription.

"Prescription" means a prescription drug order that is written or printed on paper, an oral order reduced to writing by a pharmacist, or an electronic order. To be valid a prescription must be issued for an individual patient by a practitioner within the scope and usual course of the practitioner's practice, and must contain the date of issue, name and address of the patient, name and quantity of the drug prescribed, directions for use, the name and address of the practitioner, and a telephone number at which the practitioner can be reached. A prescription written or printed on paper that is given to the patient or an agent of the patient, or transmitted facsimile-to-facsimile must contain the practitioner's manual signature. An electronic prescription must contain the practitioner's electronic signature.

Subp. 11b.

Chart order.

"Chart order" means a prescription drug order for a drug that is to be dispensed by a pharmacist, or by a pharmacist-intern under the direct supervision of a pharmacist, and administered by an authorized person only during the patient's stay in a hospital or long-term care facility. The chart order shall contain the name of the patient, another patient identifier such as a birth date or medical record number, the drug ordered, and any directions as the practitioner may prescribe concerning strength, dosage, frequency, and route of administration. The manual or electronic signature of the practitioner must be affixed to the chart order at the time it is written or at a later date in the case of verbal chart orders.

Subp. 12.

Prospective drug review.

"Prospective drug review" means a review of a patient's drug therapy record and prescription drug order prior to the time of dispensing for purposes of promoting therapeutic appropriateness.

Subp. 13.

[Repealed, 31 SR 1673]

Subp. 14.

Nonsterile preparation compounding.

"Nonsterile preparation compounding" means the preparation, mixing, assembling, altering, packaging, and labeling of a nonsterile drug preparation, according to United States Pharmacopeia Chapter 795.

Subp. 15.

Sterile preparation compounding.

"Sterile preparation compounding" means the preparation, mixing, assembling, altering, packaging, and labeling of a drug preparation that achieves sterility, according to United States Pharmacopeia Chapter 797.

Subp. 16.

Limited service pharmacy.

"Limited service pharmacy" means a pharmacy to which the board may assign a restricted license to perform a narrow range of the activities that constitute the practice of pharmacy.

Subp. 17.

Unique identifier.

"Unique identifier" means a manual signature or initials, a biometric identifier, or a board-approved electronic means of identifying only one individual.

Subp. 18.

High-alert drug.

"High-alert drug" means a drug that bears a heightened risk of causing significant patient harm when it is used in error.

Statutory Authority:

MS s 151.06; 151.102; 152.02

History:

17 SR 1279; 18 SR 1145; 23 SR 1597; 31 SR 1673; 36 SR 237

Published Electronically:

September 21, 2011

700 State Office Building, 100 Rev. Dr. Martin Luther King Jr. Blvd., St. Paul, MN 55155 ♦ Phone: (651) 296-2868 ♦ TTY: 1-800-627-3529 ♦ Fax: (651) 296-0569