West Virginia Code 60B-1-5 – Receipt, storage, and handling of donated drugs by an eligible recipient
(a) A donor may donate drugs to an eligible recipient.
Terms Used In West Virginia Code 60B-1-5
- Board: means the West Virginia Board of Pharmacy. See West Virginia Code 60B-1-1
- Contract: A legal written agreement that becomes binding when signed.
- Donor: The person who makes a gift.
- Donor: means any person, including an individual member of the public, or any entity legally authorized to possess drugs with a license or permit in good standing in the state in which it is located, including, but not limited to, a wholesaler or distributor, third party logistic provider, pharmacy, dispenser, clinic, surgical or health center, detention and rehabilitation center, laboratory, medical or pharmacy school, prescriber or other health care professional, or healthcare facility. See West Virginia Code 60B-1-1
- Drugs: means both prescription and nonprescription ("over-the-counter") drugs. See West Virginia Code 60B-1-1
- Eligible patient: means an indigent person. See West Virginia Code 60B-1-1
- Eligible recipient: means a pharmacy, wholesaler, reverse distributor, hospital, federally qualified health center, nonprofit clinic, healthcare facility, an entity participating in a drug donation or repository program pursuant to another state's law, or private office of a healthcare professional that has been authorized by the West Virginia Board of Pharmacy. See West Virginia Code 60B-1-1
- Health care professional: means a person who is licensed by the State of West Virginia to practice as a:
(1) Physician. See West Virginia Code 60B-1-1
- Program: means the donated drug repository program established by rule pursuant to §. See West Virginia Code 60B-1-1
- State: when applied to a part of the United States and not restricted by the context, includes the District of Columbia and the several territories, and the words "United States" also include the said district and territories. See West Virginia Code 2-2-10
- Transaction date: means the date on which ownership of the drugs is transferred between two participants of the program as established by contract or other arrangement. See West Virginia Code 60B-1-1
(b) An eligible recipient may receive, accept, donate, dispose, replenish, and store drugs that were either donated or repackaged as provided in subsection (f) of this section.
(c) Prior to the first donation from a new donor, a recipient shall verify and record the following:
(1) The donor meets the definition of “donor” as provided in § 60B-1-1 of this code;
(2) The donor’s name, address, phone number, and license number if applicable;
(3) The donor shall only make donations of drugs in accordance with the program;
(4) The donor shall ensure integrity of any drug requiring temperature control other than “room temperature storage” that is delivered by enclosing in the drug’s packaging a USP-recognized method by which the eligible recipient can easily detect improper storage or temperature variations; and
(5) If applicable, the donor shall remove or redact any patient names and prescription numbers on donated drugs or otherwise maintain patient confidentiality by executing a confidentiality agreement with the eligible recipient.
(d) An eligible recipient shall store and maintain donated drugs in a secure and temperature-controlled environment that meets the drug manufacturers’ recommendations and United States Pharmacopeial Convention (USP) standards.
(e) A participating eligible recipient 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 patient. Replenishment shall follow applicable provisions of the federal 340B Drug Pricing Program.
(f) Drugs may be repackaged as necessary for storage, replenishment, dispensing, administration, or further donation. Repackaged drugs shall be labeled with the drug name, strength, and expiration date, and shall be kept in a separate designated area until inspected and initialed by a health care professional authorized to dispense.
(g) All donations received but not yet accepted into inventory shall be kept in a separate designated area.
(h) Prior to or upon accepting a donation into inventory, an eligible recipient shall maintain a written or electronic inventory of the donation, including:
(1) The transaction date;
(2) The name, strength, and quantity of each accepted drug; and
(3) The name, address, and phone number of the donor.
(i) No record of a donation other than as described in subsection (h) of this section may be required.
(j) All records required by this chapter shall be retained in physical or electronic format, on or off the recipient’s premise for a period of six years.
(k) A donor or eligible recipient may contract with one another or a third-party to create and/or maintain records on each other’s behalf.
(l) An identifier, such as a serial number or barcode, may be used in place of any or all information required by a record or label pursuant to this chapter if it allows for such information to be readily retrievable. Upon audit by the board the identifier on requested records shall be replaced with the original information. An identifier may not be used on patient labels when dispensing or administering a drug.
(m) A drug wholesaler, distributor, supplier, or outsourcing facility registered pursuant to state law except reverse distributors, shall comply with the requirements of 21 U.S.C. §§ 360eee-1 – 360eee-4 relating to drug supply chain security. If a donation’s transaction history is required, the record of transaction history begins with the donor of the drugs, shall include all prior donations, and, if the drug was previously dispensed, may not include drug information that is not otherwise required to be on the drug’s label.