Current through Register Vol. XLI, No. 24, June 14, 2024
Section 15-1-18 - Labeling18.1. All drugs dispensed by a licensed pharmacy shall be labeled according to the requirements of this section, and shall include all information required by federal law or regulation or state law or rule.18.1.1. All drugs dispensed for use by inpatients of a hospital or other health care facility, where the drug is not in the possession of the ultimate user prior to administration, shall meet the following requirements: 18.1.1.a. the label of a single-unit package of an individual-dose or unit-dose system of packaging of drugs shall include: 18.1.1.a.1. the name of the drug;18.1.1.a.2. the route of administration, if other than oral;18.1.1.a.3. the strength and volume, where appropriate, expressed in the metric system whenever possible;18.1.1.a.4. the control number and expiration date;18.1.1.a.5. special storage conditions, if required; and18.1.1.b. Identification of the repackager by name or by license number shall be clearly distinguishable from the rest of the label.18.1.1.c. When a multiple-dose drug distribution system is utilized, including dispensing of single unit packages, the drugs shall be dispensed in a container to which is affixed a label containing the following information: 18.1.1.c.1. identification of the dispensing pharmacy;18.1.1.c.2. the patient's name;18.1.1.c.3. the date of dispensing;18.1.1.c.4. then name of the drug dispensed; and18.1.1.c.5. the strength, expressed in the metric system whenever possible.18.1.2. All drugs dispensed to inpatients for self-administering shall be labeled in accordance with subdivision 22.18.1.4 of this section.18.1.3. Whenever any drugs are added to parental solutions, the admixtures shall bear a distinctive label indicating:18.1.3.a. the name of the solution, the lot number, and the volume of the solution;18.1.3.b. the patient's name;18.1.3.c. the infusion rate;18.1.3.d. the bottle sequence number or other system control number;18.1.3.e. the name and quantity of each additive;18.1.3.f. the date of the preparation;18.1.3.g. the beyond-use date and time of parental admixture; and18.1.3.h. ancillary precaution labels.18.1.4. All drugs dispensed to ambulatory or outpatients shall have a label affixed to the container in which the drug is dispensed, including: 18.1.4.a. the name (including store number, if any), address, and telephone number of the pharmacy dispensing the drug;18.1.4.b. the name of the patient for whom the drug is prescribed; or, if the patient is an animal, the last name of the owner, name and species of the animal; Provided that, if the prescription is for expedited partner therapy as permitted by West Virginia Code Chapter 16, Article 4F, then the words "Expedited Partner Therapy" or the designation "EPT" may be written for the name of the patient;18.1.4.c. the name of the prescribing practitioner;18.1.4.d. directions stated on the prescription order, and medication purpose/indication if included on the prescription order;18.1.4.e. the date filled;18.1.4.f. any cautions which may be required by federal or state law;18.1.4.g. the prescription number of the prescription drug order;18.1.4.h. the name or initials of the dispensing pharmacist;18.1.4.i. the proprietary or generic name of the drug dispensed, and its strength; 18.1.4.i.1. when dispensing an equivalent drug product, the word 'substitution" or the letters 'sub" shall appear on the label affixed to the container in which the drug is dispensed, followed by the generic name and manufacturer, or reasonable abbreviation, and/or distributor of the chosen product. This requirement only applies to single-entity, multiple-source drugs;18.1.4.i.2. when dispensing a single-entity, single-source drug, the trade name of the prescribed drug may also appear on the label, and the generic name of the prescribed drug may also appear on the label;18.1.4.i.3. when dispensing a fixed combination product, the United States Pharmacopeia's publication of Pharmacy Equivalent Names (PEN) for fixed combination products is the official list of abbreviations for labeling, and is the approved abbreviation for identifying the combination product dispensed;18.1.4.k. number of remaining refills;18.1.4.l. auxiliary information;18.1.4.m. the name of the manufacturer or distributor of the drug; and18.1.4.n. the beyond-use date.18.1.5. No radiopharmaceutical may be dispensed unless a label is affixed to the immediate container bearing the following information:18.1.5.a. the standard radiation symbol;18.1.5.b. the words "Caution- Radioactive Material; and18.1.5.c. the prescription number.18.1.6. No radiopharmaceutical may be dispensed unless a label is affixed to the outer or delivery container bearing the following information:18.1.6.a. the standard radiation symbol;18.1.6.b. the words "Caution- Radioactive Material";18.1.6.c. the radionuclide and chemical form;18.1.6.d. the activity and date and time of assay;18.1.6.e. the volume, if in liquid form;18.1.6.f. the requested activity and the calibrated activity;18.1.6.g. the prescription number;18.1.6.h. the patient's name or space for the patient's name. When the patient's name is not available at the time of dispensing, a 72 hour exemption is allowed to obtain the name of the patient. No later than 72 hours after dispensing the radiopharmaceutical, the pharmacist shall obtain the patient's name and it shall become a part of the prescription to be retained for a period of five years;18.1.6.i. the name and address of the nuclear pharmacy;18.1.6.j. the name of the practitioner; and18.1.6.k. the lot number of the prescription.