HOUSE BILL NO. 85 AMENDMENT IN THE NATURE OF A SUBSTITUTE (Proposed by the House Committee on Health, Welfare and Institutions on January 15, 2008) (Patron Prior to Substitute -- Delegate Landes) A BILL to amend and reenact § 54.1-3411.1 of the Code of Virginia, relating to donation of prescription medications.

Be it enacted by the General Assembly of Virginia:

1.  That § 54.1-3411.1 of the Code of Virginia is amended and reenacted as follows:

§ 54.1-3411.1. Prohibition on returns, exchanges, or re-dispensing of drugs; exceptions.

A. Drugs dispensed to persons pursuant to a prescription shall not be accepted for return or exchange for the purpose of re-dispensing by any pharmacist or pharmacy after such drugs have been removed from the pharmacy premises from which they were dispensed except:

1. In a hospital with an on-site hospital pharmacy wherein drugs may be returned to the pharmacy in accordance with practice standards;

2. In such cases where official compendium storage requirements are assured and the drugs are in manufacturers' original sealed containers or in sealed individual dose or unit dose packaging that meets official compendium class A or B container requirements, or better, and such return or exchange is consistent with federal law; or

3. When a dispensed drug has not been out of the possession of a delivery agent of the pharmacy.

B. Pursuant to a voluntary agreement between a nursing home or a hospital and a pharmacy, drugs may be transferred in accordance with subdivision A 2 between the nursing home or the hospital and the pharmacy for re-dispensing to patients of clinics organized in whole or in part for the delivery of health care services without charge, or to the indigent, free of charge, if the following procedures are satisfied:

1. The physical transfer shall be accomplished by a person authorized to do so by the pharmacy;

2. The person or his authorized representative from whom the prescription medication was obtained shall provide written consent for the donation and such consent shall be maintained on file at the licensed nursing home or hospital;

3. The person's name, prescription number, and any other patient identifying information, shall be obliterated from the packaging prior to removal from the licensed nursing home or hospital;

4. The drug name, strength, and expiration date or beyond-use date shall remain on the medication package label;

5. An inventory list of the drugs shall accompany the drugs being transferred that shall include, but not be limited to, the medication names, strengths, expiration dates, and quantities; and

6. Outdated drugs shall not be transferred and shall be destroyed in accordance with regulations adopted by the Board.

The pharmacist-in-charge at the pharmacy shall be responsible for determining the suitability of the product for re-dispensing. A re-dispensed prescription shall not be assigned an expiration date beyond the expiration date or beyond-use date on the label from the first dispensing and no product shall be re-dispensed more than one time. No product shall be accepted for re-dispensing by the pharmacist where integrity cannot be assured.

The Board of Pharmacy shall promulgate regulations to establish a Prescription Drug Donation Program for accepting unused previously dispensed prescription drugs that meet the criteria set forth in subdivision A2, for the purpose of re-dispensing such drugs to patients of clinics organized in whole or in part for the delivery of health care services to the indigent. Such program shall not authorize the donation of Schedule II-V controlled substances if so prohibited by federal law. No drugs shall be re-dispensed unless the integrity of the drug can be assured.

C. Nothing in this section shall authorize the donation of unused prescription drugs dispensed for use by persons eligible for coverage under Title XIX or Title XXI of the Social Security Act, as amended.

2.  That the Board shall promulgate regulations to implement the provisions of this act to be effective within 280 days of its enactment.

 

HOUSE BILL NO. 85 Offered January 9, 2008 Prefiled December 13, 2007 A BILL to amend the Code of Virginia by adding a section numbered 54.1-3412.1 and to repeal § 54.1-3411.1 of the Code of Virginia, relating to donation of prescription medications. ---------- Patron-- Landes ---------- Committee Referral Pending ----------

Be it enacted by the General Assembly of Virginia:

1.  That the Code of Virginia is amended by adding a section numbered 54.1-3412.1 as follows:

§ 54.1-3412.1.  Prescription Medication Donation Program.

A. There is hereby established the Prescription Medication Donation Program (Program) to accept and dispense prescription medications.  The program shall be administered by the Board of Pharmacy.

B. Prescription medications other than controlled substances may be accepted and redispensed under the Program only when medications remain in manufacturer's packaging, individual-dose packaging, or unit-dose packaging that is original, sealed, and tamper-evident.  Prescription medication that is packaged in single unit-doses may be accepted and dispensed if the outside packaging has been opened so long as the single unit-dose packaging is undisturbed.  The Program shall not accept medication (i) that expires within six months after the donation or (ii) that may be adulterated pursuant to § 54.1-3461. The pharmacist-in-charge at the pharmacy shall be responsible for determining the suitability of the product for redispensing. No product shall be accepted for redispensing by the pharmacist when integrity cannot be assured.

C. Prescription medications that have been accepted under the Program may be dispensed by a pharmacy to patients of clinics organized in whole or in part for the delivery of health care services to the indigent or without charge, if the following procedures are satisfied:

1. The dispensing pharmacy and the clinic comply with all federal and state laws and regulations regarding storage and prescription of medications;

2. The drug name, strength, and expiration date or beyond-use date shall remain on the medication package label;

3. Physical transfer of the prescription medications shall be accomplished by a person authorized to carry out the transfer by the pharmacy; and

4. An inventory list of all drugs transferred from the pharmacy to the clinic shall accompany the drugs.  Such inventory shall include, but not be limited to, the medication names, strengths, expiration dates, and quantities.

A redispensed prescription shall not be assigned an expiration date beyond the expiration date or beyond-use date on the label from the first dispensing, and no product shall be redispensed more than one time.

D. A pharmaceutical manufacturer participating in the Program is not liable for any claim or injury arising from the transfer of any prescription medication pursuant to this section, including liability for failure to transfer or communicate product or consumer information regarding the transferred prescription medication.

E. Persons and entities participating in the Program as prescribed by this section are not subject to civil liability or professional disciplinary action.

F. Nothing in this section shall authorize the donation of unused prescription drugs dispensed for use by persons eligible for coverage under Title XIX or Title XXI of the Social Security Act, as amended.

2.  That § 54.1-3411.1 of the Code of Virginia is repealed.