Section 725. Repackaging by a CSB, BHA, or PACE site

A. Definition. For purposes of this section, "repackaging" shall mean removing a drug from a container already dispensed and labeled by a pharmacy or medical practitioner authorized to dispense, for a particular client of a CSB, BHA, or PACE site, and placing it in a container designed for a person to be able to repackage his own dispensed prescription medications to assist with self-administration and compliance with dosage instructions. Such repackaging shall not include the preparation of a patient-specific label that includes drug name, strength, or directions for use or any other process restricted to a pharmacist or pharmacy technician under the direct supervision of a pharmacist.

B. Persons authorized to repackage. Repackaging shall be performed by a pharmacist, pharmacy technician, nurse, or such other person who has successfully completed a board-approved training program for repackaging of prescription drug orders as authorized in § 54.1-3420.2 of the Code of Virginia. A CSB, BHA, or PACE site using such other person shall maintain documentation of completion of an approved training program for at least one year from date of termination of employment or cessation of repackaging activities.

C. Requirements for repackaging.

1. The repackaging of a dispensed prescription drug order pursuant to § 54.1-3420.2 of the Code of Virginia shall only be done at a CSB, BHA, or PACE site.

2. The repackaging of dispensed prescription drugs shall be restricted to solid oral dosage forms and a maximum of a 14-day supply of drugs.

3. The drug container used for repackaging pursuant to this section shall bear a label containing the client's first and last name and name and 24-hour contact information for the CSB, BHA, or PACE site.

4. A clean, well-closed container that assists the client with self-administration shall be used when multiple doses of a repackaged drug are provided to the client at one time.

5. A prescription drug order shall not be repackaged beyond the assigned expiration date noted on the prescription label of the dispensed drug, if applicable, or beyond one year from the date the drug was originally dispensed by a pharmacy, whichever date is earlier.

D. Written information for client. At the time a repackaged drug is initially given to a client, and upon any subsequent change in the medication order, the client shall be provided written information about the name and strength of the drug and the directions for use. Such written information shall have been prepared by a pharmacy or by a nurse at the CSB, BHA, or PACE site.

E. Retention, storage, and destruction of repackaged drugs.

1. Any portion of a client's prescription drug order not placed into a container intended to assist with self-administration may be either given to the client or retained by the CSB, BHA, or PACE site for subsequent repackaging. If retained by the CSB, BHA, or PACE site, the remaining portion shall be stored within the board-approved drug storage location in the original labeled container and shall only be used for the client for whom the drug was originally dispensed.

2. Any portion of a prescription drug order remaining at the CSB, BHA, or PACE site that has exceeded any labeled expiration date or one year from the original pharmacy dispensing date on the label shall be separated from unexpired drugs, stored within a designated area of the board-approved drug storage location, and destroyed within 30 days of expiration with the written agreement of the client. Remaining portions of discontinued prescription drug orders retained by the CSB, BHA, or PACE site shall also be separated from active stock and either returned to the client or destroyed within 30 days of discontinuance with the written agreement of the client.

F. Recordkeeping.

1. A record of repackaging shall be made and maintained for one year from the date of repackaging and shall include the following:

a. Date of repackaging;

b. Name of client;

c. Prescription number of the originally dispensed prescription drug order;

d. Pharmacy name;

e. Drug name and strength;

f. Quantity of drug repackaged; and

g. Initials of the person performing the repackaging and verifying the accuracy of the repackaged drug container.

2. A record of destruction shall be made and maintained for one year for any prescription drug orders destroyed by the CSB, BHA, or PACE site and shall include the following:

a. Date of destruction;

b. Name of client;

c. Prescription number of the originally dispensed prescription drug order;

d. Drug name and strength;

e. Quantity of drug destroyed; and

f. Initials of the person performing the destruction.

Historical Notes

Derived from Volume 28, Issue 23, eff. August 15, 2012; amended, Virginia Register Volume 32, Issue 14, eff. April 21, 2016.

Statutory Authority

§ 54.1-2400 of the Code of Virginia.