W. Va. Code R. § 15-20-9

Current through Register Vol. XLI, No. 50, December 13, 2024
Section 15-20-9 - Required Records
9.1. Prior to accepting a donation into inventory, a donated drug repository program that dispenses donated drugs or supplies to an eligible patient shall maintain a written or electronic inventory of each donated drug or supply that shall include the following information:
9.1.1. The transaction date;
9.1.2. The name, strength, and quantity of each accepted drug; and
9.1.3. The name, address, and phone number of the eligible donor providing each drug or supply.
9.2. A donated drug repository program shall keep all donated drugs physically or electronically separated from other inventory. Donated inventory may be used to replenish purchased inventory with the same drug name and strength that was previously dispensed or administered to an eligible person. Replenishment shall follow applicable provisions of the federal 340B Drug Pricing Program. Replenishment may not be done using drugs donated by the public.
9.3. In addition to all records required for dispensing a prescription drug or supply under W. Va. Code 30-5 and rules, a donated drug repository program shall note, either on the face of a written prescription or in the electronic record of a prescription, that a donated drug was dispensed to the patient if the site dispenses both donated and non-donated drugs.
9.4. All records must be made available for audit by the Board within five business days.
9.5. All records must be kept for six years.
9.6. Prior to the first donation from a new donor, an eligible recipient shall collect an attestation signed electronically or physically by the person making the donation or that person's authorized representative, verifying and recording information required by W. Va. Code § 60B-1-5(c).

W. Va. Code R. § 15-20-9