13:39-9.2 Definitions
The following words and terms, as used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise.
"Drug administration" means a procedure in which a prescribed drug is given to a patient by an authorized person in accordance with all laws and rules governing such procedures.
"Formulary" means a continually revised compilation of pharmaceuticals available in the pharmacy for use in the facility developed by the Pharmacy and Therapeutics Committee.
"Health care facility" means a facility or institution licensed by the Department of Health and Senior Services pursuant to N.J.S.A. 26:2H-1 et seq.
"Health care system" means one or more health care facilities which are owned or controlled by the same legal entity.
"Institutional pharmacy" means the area in a health care facility or a health care system licensed by the Board as a pharmacy that maintains an institutional permit. "Institutional pharmacy" includes any areas of the health care facility or the health care system where pharmaceuticals are stored, compounded or dispensed.
"Medication order" means a written request for medication originated by a practitioner and intended for patient use in the health care facility, and not for use of the institution's employees or their dependents or outpatients of the facility's clinics. A valid medication order contains the date ordered, the patient's name and location within the facility, the name, dose, route, and frequency of administration of the medication, and any additional instructions. Computer-generated medication orders within an institutional setting, utilizing the practitioner's electronic signature or password will meet legal requirements for a practitioner's original handwritten signature on medication orders. Computerized signatures or passwords will be accepted provided that the facility has adequate safeguards which assure the confidentiality of each electronic signature or password and which prohibit their improper or unauthorized use.
"Pharmacy and Therapeutics Committee" means the active standing committee of the institution or health care facility which is the organizational line of communication and liaison between the medical service and pharmacists and which acts to review and promote rational drug therapy and utilization in the facility.
"Unit dose packaging" means a single unit use non-parenteral medication provided in packaging which contains the following information for each unit in the package:
1. Product name;
2. Strength and/or quantity and/or volume, where appropriate;
3. Lot number;
4. The phrase "use by" followed by the product's use by date.
i. For purposes of this paragraph, "use by date" means the earlier of one year from the date of packaging or the expiration date on the manufacturer's container;
5. Manufacturer or repackager; and
6. If there is more than one product in the single unit, a physical description of each medication in the single unit.
Amended by R. 1994 d. 351, effective July 18, 1994. See: 26 N.J.R. 1596(a), 26 N.J.R. 2905(b). Amended by R. 1998 d. 167, effective April 6, 1998. See: 29 N.J.R. 4740(b), 30 N.J.R. 1298(a). Amended N.J.A.C. reference in "Pharmacy and Therapeutics Committee" definition. Amended by R. 1999 d. 214, effective July 19, 1999. See: 31 N.J.R. 1151(a), 31 N.J.R. 1932(a). Deleted "Authorized prescriber" and "Direct supervision"; in "Health care facility", substituted a reference to patients and residents for a reference to the sick and injured; in "Unit dose drug distribution system", deleted a reference to biologicals; and added "Unit use packaging". Amended by R. 2000 d. 457, effective November 20, 2000. See: 31 N.J.R. 3044(a), 32 N.J.R. 4123(a). Inserted "Health care system"; in "Institutional pharmacy", inserted references to health care systems throughout, substituted "any" for "other" following "includes", and deleted "manufactured," following "stored,". Recodified from N.J.A.C. 13:39-9.1 and amended by R. 2005 d. 25, effective January 18, 2005. See: 36 N.J.R. 3345(a), 37 N.J.R. 295(a). Rewrote "Health care facility": in "Pharmacy and Therapeutics Committee", substituted "medical service and pharmacists" for "medical and pharmacy staff" and deleted the last sentence; rewrote "Unit use packaging". Former N.J.A.C. 13:39-9.2. Licensure of institutional pharmacies, recodified to N.J.A.C. 13:39-9.3. Amended by R. 2010 d. 090, effective June 21, 2010. See: 42 N.J.R. 132(a), 42 N.J.R. 1221(a). In definition "Medication order", substituted "a practitioner" for "an authorized prescriber" and "practitioner's" for "prescriber's" twice; deleted definition "Unit dose drug distribution system"; substituted definition "Unit dose packaging" for definition "Unit use packaging"; and rewrote definition "Unit dose packaging".