W. Va. Code R. § 11-5-9

Current through Register Vol. XLI, No. 25, June 21, 2024

Section 11-5-9 - Dispensing Records; Inspection and Audit of Dispensing Locations

9.1. A drug dispensing practitioner must maintain records that are available for inspection by the Board and any other state or federal entity authorized to conduct such an inspection. All dispensing records:

9.1.a. Shall be maintained for a period of at least five years; and

9.1.b. Must be readily retrievable.

9.2. Patient records must facilitate an audit trail for each patient to whom prescription drugs are dispensed. They may be maintained either in a patient's chart or in an equivalent but separate patient medication record.

9.3. Daily records must facilitate an audit trail for each day on which scheduled controlled substances are dispensed. They may be maintained in a daily log or in a file of prescriptions.

9.3.a. Daily records of dispensed Schedule II controlled substances must be maintained in a separate daily log or file of prescriptions, apart from all other records.

9.3.b. Daily records of dispensed Schedule III, IV and V controlled substances may be maintained either in another separate daily log or in a file of prescriptions.

9.4. For each prescription drug dispensed, both patient records and daily records shall include:

9.4.a. The name of the patient to whom the drug was dispensed;

9.4.b. The name of the drug and the strength dispensed;

9.4.c. The quantity of the drug dispensed;

9.4.d. The date that the drug was dispensed; and

9.4.e. The directions for use.

9.5. An authorized representative or investigator for the Board may, without prior notice, enter at any reasonable hour a registered drug dispensing location and/or a location where the Board believes the unregistered dispensing of controlled substances is occurring by a licensee of the Board to conduct an audit:

9.5.a. To verify general compliance with this rule; or

9.5.b. To investigate an allegation or complaint with respect to a practitioner's dispensing practice.

9.6. A person may not deny or interfere with an entry under this section.

9.7. The Board's representative may require a practitioner or facility where dispensing occurs by a licensee of this Board to provide access to:

9.7.a. Any records relating to the practitioner's dispensing practice;

9.7.b. Any records a practitioner is required to maintain pursuant to this rule; and

9.7.c. All inventories of prescription drugs, including controlled substances, maintained at the location subject to audit.

9.8. It is a violation of this rule for a licensee of this Board to refuse to undergo or cooperate with a dispensing review or audit by the Board.

9.9. The Board's representative shall refer possible compliance issues to the appropriate Committee of the Board and/or to any other agency that has jurisdiction over a facility, place of practice or practitioner.

W. Va. Code R. § 11-5-9