West Virginia Code of State Rules › Agency 11 - Medicine › Title 11 - LEGISLATIVE RULE WEST VIRGINIA BOARD OF MEDICINE › Series 11-05 - Dispensing of Prescription Drugs by Practitioners › Section 11-5-6 - Security, Packaging and Labeling

Current through Register Vol. XLI, No. 28, July 12, 2024
6.1. A dispensing practitioner must have
				immediate access to reference materials relating to the dispensing of
				medication, and must also have immediate access to the package insert, or its
				equivalent, for every prescription drug dispensed to patients.
6.2. A dispensing practitioner shall maintain
				at all times the minimum professional and technical equipment and sanitary
				appliances and environmental conditions that are necessary to prepare and
				dispense prescriptions properly.
6.3. A dispensing practitioner must maintain
				a dispensing area, where all stock quantities of prescription drugs maintained
				for dispensing to patients must be stored under conditions that prevent
				deterioration.
6.4. Prescription
				drugs must be stored in a locked or otherwise secure area to prevent access
				when the drug dispensing practitioner is not present in the office. A
				registered controlled substance dispensing practitioner shall provide
				effective, enhanced controls and procedures to guard against theft and
				diversion of controlled substances. Physical security controls shall be
				commensurate with the schedules and quantity of controlled substances in the
				possession of the registrant in normal business operations. At a minimum, these
				security controls shall include the storage of all controlled substances in an
				environmentally controlled, separately locked safe or cabinet with the access
				code or key limited to registered controlled substance dispensing
				practitioners.
6.5. A registered
				controlled substance dispensing practitioner shall notify the Board, in
				writing, of any theft or significant loss of any controlled substances upon
				discovery of the theft.
6.6. A
				prescription drug dispensed by a dispensing practitioner must be packaged in
				its own separate container and labeled with its own specific
				directions.
6.7. A practitioner
				shall package prescription drugs in appropriate containers, and shall generally
				utilize child-proof and tamper-resistant packaging. In determining the
				appropriate packaging container, the practitioner should evaluate whether the
				dispensed drug is susceptible to damage or deterioration if exposed to light,
				moisture or other environmental conditions. Paper or plastic bags, boxes or
				envelopes do not meet packaging requirements for prescription drugs and should
				not be used.
6.8. Labels for
				dispensed medications must be legible.
6.9. Prescription drugs that are not
				classified as controlled substances must be packaged in a container labeled
				with the following information:
6.9.a. The
				name, address and telephone number of the dispensing practitioner;
6.9.b. The name of the patient for whom the
				prescription drug was dispensed;
6.9.c. The date the prescription drug was
				dispensed;
6.9.d. The name of the
				actual drug dispensed (if a generic drug product is dispensed, the container
				shall be labeled with the generic name of the drug and the name of the
				manufacturer or distributor of the generic drug product. The container may not
				be labeled with a brand name unless the product dispensed is actually the brand
				name product);
6.9.e. The strength
				of the drug dispensed;
6.9.f. The
				quantity of the drug dispensed;
6.9.g. Full directions for use of the
				dispensed drug and any special storage requirements;
6.9.h. Any cautions which may be required by
				federal or state law; and
6.9.i.
				The expiration or beyond use date of the drug dispensed.