W. Va. Code R. § 11-5-6

Current through Register Vol. XLI, No. 49, December 6, 2024

Section 11-5-6 - Security, Packaging and Labeling

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.

6.10. The directions "Take as directed," or any formulation thereof which do not provide full and specific directions to the patient may cause patient confusion and do not constitute compliance with the labeling requirements of this rule.

6.11. Practitioner dispensed prescriptions for controlled substances must be packaged in a container labeled with all of the information required in subsection 6.9. Labels for dispensed controlled substances must also include:

6.11.1. An identification of the controlled substance classification of the dispensed drug (C-II, C-III, C-IV, etc.); and

6.11.2. The following statement: "Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed."

W. Va. Code R. § 11-5-6