W. Va. Code R. § 15-15-7 - [Effective 7/1/2025] Security

7.1. A board approved operating plan shall be implemented if a pharmacy is to be operated for a period less than regular business hours of the entire store or institution.

7.2. A device for the detection of breaking and/or entering shall be installed in each prescription department in each pharmacy. The installation and the device shall be based on accepted burglar alarm industry standards, and are subject to the following conditions:

7.2.1. The device shall be maintained in functioning order and shall have an auxiliary source of power;

7.2.2. Deactivation of the alarm system for the prescription department shall be restricted to the pharmacists working at the pharmacy, and the system shall be activated whenever a pharmacist is not on duty. The pharmacy registration holder may deactivate the system for security or surveillance purposes as long as the reason for the deactivation, the person deactivating the system, and time and date of deactivation are documented and readily retrievable to the Board; and

7.2.3. This subsection does not apply to pharmacies which are open and staffed by pharmacists 24 hours a day;

7.3. The door keys and alarm activation and de-activation codes to the prescription areas are subject to the following:

7.3.1. Only licensed pharmacists may possess any keys to the prescription area;

7.3.2. During times that an institutional pharmacy may be unattended by a pharmacist, arrangements shall be made in advance by the pharmacist-in-charge for provision of drugs to the medical staff and other authorized personnel and shall ensure that:

7.3.2.a. Drugs are properly labels;

7.3.2.b. Only prepackaged drugs are available, in amounts sufficient for immediate therapeutic requirements;

7.3.2.c. Whenever access to the cabinet occurs, written practitioner's orders and proof-of-use are provided;

7.3.2.d. All drugs in the cabinet are inventoried no less than once per week;

7.3.2.e. A complete audit of all activity concerning the cabinet is conducted no less than once per month; and

7.3.2.f. Written policies and procedures are established to implement the patient care provisions of this subdivision.

7.3.3. Whenever any drug is not available from floor supplies or night cabinets, and the drug is required to immediately treat a life-threatening situation of a patient, the drug may be obtained from the pharmacy by a supervisory nurse in accordance with the requirements of this subdivision. The pharmacist-in-charge shall, in conjunction with the appropriate committee of the institution, designate in writing one supervisory nurse in any given eight-hour shift who is responsible for obtaining drugs from the pharmacy during any emergency situation. Removal of any drug from the pharmacy by an authorized nurse shall be recorded on a suitable form showing the patient's name, and location within the institution, the name of the drug, its strength and amount, and date and time, and the signature of the nurse. The form shall be left with the container from which the drug was removed, and the supervisory nurse shall contact the pharmacist "on call";

7.4. In the absence of a pharmacist, a sign with a minimum of four-inch letters shall be prominently displayed stating: "Pharmacy Closed. No Pharmacist On Duty", and the pharmacist shall secure the pharmacy by implementing any barriers and security devices prior to leaving the pharmacy;

7.5. Except as provided in Title 15, Series 14, for central prescription filling, and this rule for direct-to-patient delivery systems, completed prescription orders shall be bagged and kept in the pharmacy and cannot be removed from the pharmacy unless the pharmacist is present and the removal is for the immediate delivery to the patient, the patient's authorized designee picking up the prescription for the patient, or person delivering the prescription to the patient at his or her residence or other place designated by the patient or the patient's authorized designee. If the patient or the patient's designee is unknown to the pharmacist, then his or her identity shall be established by photo identification card;

7.6. Dispensing does not occur until the drug is actually picked up by or delivered to the patient or patient's representative. Completed prescriptions must be picked up at or delivered from the same pharmacy at which they were prepared, except that this subsection does not apply to a mail order pharmacy licensed by the Board, a central fill pharmacy licensed by the Board, direct-to-patient delivery systems operated in accordance with this rule, or to transfers of prescription drugs by a retail pharmacy to alleviate a temporary shortage; and

7.7. Emergency facilities to provide pharmaceutical services during emergency conditions or natural disasters may be approved by the Board for a period not to exceed 180 days.

Notes

W. Va. Code R. § 15-15-7