La. Admin. Code tit. 46 § LIII-1503

Current through Register Vol. 50, No. 9, September 20, 2024

Section LIII-1503 - Definitions

A. As used in this Chapter, the following terms shall have the meaning ascribed to them in this Section:

CFR-Code of Federal Regulations

Dispensing of a Drug Pursuant to a Hospital Prescription-the professional review by a pharmacist required to place a specific drug in final association with the name of a particular hospital patient pursuant to the lawful order of a prescriber In the case of an automated medication system meeting the requirements of Chapter 12 of these rules, the final association with the name of a particular hospital patient will be deemed to have occurred when the pharmacist has given the final approval to the patient specific order in the system.

Electronic Drug Record Keeping System-a system of storing drug records electronically and capturing the positive identification of the person responsible for a specific drug transaction including, but not limited to, the prescribing, administering, or dispensing of a drug.

Hospital Off-Site Satellite Pharmacy-a pharmacy located within a hospital licensed by the Louisiana Department of Health, or its successor, the location of which is physically separate from the location of the provider pharmacy.

Hospital Patient-a person receiving health care services within a hospital facility, or an animal receiving veterinary care within a veterinary teaching hospital owned or operated by a public university in this state.

Hospital Pharmacy-a pharmacy department permitted by the board and located in a hospital licensed pursuant to R.S. 40:2100 et seq. or in a veterinary teaching hospital owned or operated by a public university in this state. For the purposes of this chapter, a hospital pharmacy is one example of a primary care treatment modality pharmacy.

Hospital Prescription-a written, electronic or oral order for a drug for use in treating a hospital patient.

Positive Identification-

Password-a private identification that is created by a user to obtain access to an electronic drug record keeping system.

Personal Identifier-a unique user name or number for identifying and tracking a specific users access to an electronic drug record keeping system such as Social Security number, user identification number, or employee number.

1. has the same meaning as defined in Section 1119 of this Part, except that a specific hospital having a closed electronic drug record keeping system may be permitted to use identifiers utilizing both a password combined with a personal identifier to document the positive identification of each user for the prescribing and administration of a drug, provided the pharmacist-in-charge has determined:

a. adequate audit controls are in place to detect and deter drug diversion;

b. adequate access controls are in place to assure the identity of the user and to assign accountability of the user for any drug transaction;

c. adequate safeguards are in place to prevent and detect the unauthorized use of an individuals password and personal identifier;

d. an ongoing quality assurance program is in place to ensure that all three provisions cited above in this definition are being fulfilled and reviewed; and

e. appropriate policies and procedures are in place to address all four provisions cited above in this definition;

2. All of the above notwithstanding, however, positive identification as defined in Section 1119 of this Part shall always be used to document the:

a. dispensing, compounding, or prepackaging of a drug;

b. removal and possession of a controlled substance to administer to a patient; and

c. waste of a controlled substance.

Provider Pharmacy-a hospital pharmacy which provides administrative control, staffing as well as products and services to a hospital off-site satellite pharmacy.

Registered Patients-a person receiving health care services within a hospital facility, or an animal receiving veterinary care within a veterinary teaching hospital owned or operated by a public university in this state.

Remote Processing Services-Repealed.

Remote Processor-Repealed.

Unit Dose-the packaging of individual prescription doses in a suitable container that have been properly labeled as to the identity of the generic, chemical, or trade name of the drug; strength; lot number; and expiration date. All unit doses qualify as "prepackaging" as used in this Chapter. However, all prepackaging is not necessarily in unit dose packaging.

La. Admin. Code tit. 46, § LIII-1503

Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988), effective January 1, 1989, amended LR 29:2093 (October 2003), effective January 1, 2004, LR 33:1132 (June 2007), LR 39:1282 (May 2013), Amended LR 29:2093 (October 2003), effective January 1, 2004, LR 33:1132 (June 2007), LR 39:1282 (May 2013), LR 40:2256 (November 2014), effective January 1, 2015, Amended LR 422147 (10/1/2015), Amended by Department of Health, Board of Pharmacy, LR 46582 (4/1/2020), Amended by the Department of Health, Board of Pharmacy, LR 46793 (6/1/2020).

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182.