Current through Register Vol. XLI, No. 19, May 10, 2024
Section 15-1-20 - Specialized Dispensing Systems20.1. Definition. 20.1.1. Specialized dispensing systems are those systems other than traditional bottle systems used to provide controlled administration of drugs, for oral administration, to ambulatory patients, and to patients and residents of health institutions.20.2. Types. 20.2.1. A unit dose dispensing system is a system in which each individual unit of medication dosage form is in a separate container, which is intended to be placed in a larger prescription container which is complete with prescription labeling and contains several unit doses. Each individual unit-dose container shall be labeled with the following: 20.2.1.a. The name and strength of the drug;20.2.1.b. The name of the manufacturer or the packager;20.2.1.c. The lot number; and20.2.1.d. The expiration date.20.2.2. A unit of use system is a system in which all doses containing different medications to be administered at a given time are placed together in a single package, or packet, which is intended to be placed in a larger prescription container which is complete with prescription labeling and contains several unit of use packets. Each unit of use packet shall be labeled with the following: 20.2.2.a. The name and strength of each drug contained in the unit of use packet;20.2.2.b. The name of the manufacturer or the packager of each drug in the unit of use packet;20.2.2.c. The lot number of each drug in the unit use packet; and20.2.2.d. The expiration date of each drug in the unit of use packet;20.2.3. Punch card packaging is a system, which does not constitute unit does packaging, in which several doses of the same drug are packaged in a card, which is a prescription container, in which each dose has its own space and may be removed without disturbing the packaging for the remaining doses. A punch card shall be labeled with the following: 20.2.3.a. The name and strength of the drug contained in the punch card;20.2.3.b. The name of the manufacturer or packager of the drug contained in the punch card;20.2.3.c. The lot number of the drug contained in the punch card;20.2.3.d. The expiration date of the drug contained in the punch card; and20.2.3.e. All other information required to be on the label of a completed prescription order.20.3.1. All extemporaneous unit dose, unit of use, punch card or any other specialized packaging shall be done by pharmacists, pharmacy interns, or pharmacy technicians or pharmacy technician trainees under the direct supervision of a pharmacist.20.3.2. Expiration dates may be no more than twenty five percent (25%) of the time between the day of packaging and the expiration date on the stock bottle, not to exceed twelve (12) months in any case.20.3.3. These specialized packaging systems may not be used without the required prescription labeling being on the package that is intended to hold several doses for an individual patient.20.4. Methods of supplying drugs and devices.20.4.1. Institutions may not have drugs supplied in floor stock quantities unless a controlled substance permit is held by the institution.20.4.2. Drugs may be supplied by prescription for individual patients.20.4.3. Drugs, other than by prescription, may be stocked in emergency kits when the following conditions are met:20.4.3.a. Drugs in emergency kits are to be administered only by those persons licensed to administered drugs;20.4.3.b. The drugs in the emergency kit are of such nature that their absence would threaten the survival of the patients or intended recipients;20.4.3.c. The contents of the emergency kit are determined by the pharmacist consultant and the medical director and the nursing director;20.4.3.d. The emergency kit is sealed so that it is obvious if it has been opened and it is stored under secure conditions;20.4.3.e. Administration of drugs from the kit is ordered by a practitioner and a record kept of administration;20.4.3.f. Drugs stocked in the emergency kit are unit dose packaged;20.4.3.g. Any drug used from the kit is replaced only upon a prescription or physician institution order form for the patient to which the dose was administered; and20.4.3.h. Any emergency kit containing controlled substances is kept only at a facility holding a controlled substance permit from the Board.