Section 726. Criteria for approval of repackaging training programs

A. Application. Any person wishing to apply for approval of a repackaging training program shall submit the application fee prescribed in 18VAC110-20-20 and an application on a form approved by the board and shall meet the criteria established in this section. The application shall name a program director who is responsible for compliance with this section.

B. Curriculum. The curriculum for a repackaging training program shall include instruction in current laws and regulations applicable to a CSB, BHA, or PACE site for the purpose of assisting a client with self-administration pursuant to § 54.1-3420.2 of the Code of Virginia and in the following repackaging tasks:

1. Selection of an appropriate container;

2. Proper preparation of a container in accordance with instructions for administration;

3. Selection of the drug;

4. Counting of the drug;

5. Repackaging of the drug within the selected container;

6. Maintenance of records;

7. Proper storage of drugs;

8. Translation of medical abbreviations;

9. Review of administration records and prescriber's orders for the purpose of identifying any changes in dosage administration;

10. Reporting and recording the client's failure to take medication;

11. Identification, separation, and removal of expired or discontinued drugs; and

12. Prevention and reporting of repackaging errors.

C. Instructors and program director. Instructors for the program shall be either (i) a pharmacist with a current license in any jurisdiction and who is not currently suspended or revoked in any jurisdiction in the United States or (ii) a pharmacy technician with at least one year of experience performing technician tasks who holds a current registration in Virginia or current PTCB certification and who is not currently suspended or revoked in any jurisdiction in the United States. The program director shall maintain a list of instructors for the program.

D. Program requirements.

1. The length of the program shall be sufficient to prepare a program participant to competently perform repackaging consistent with § 54.1-3420.2 of the Code of Virginia and 18VAC110-20-725.

2. The program shall include a post-training assessment to demonstrate the knowledge and skills necessary for repackaging with safety and accuracy.

3. A program shall provide a certificate of completion to participants who successfully complete the program and provide verification of completion of the program for a participant upon request by a CSB, BHA, PACE site, or the board.

4. The program shall maintain records of training completion by persons authorized to repackage in accordance with § 54.1-3420.2 of the Code of Virginia. Records shall be retained for two years from date of completion of training or termination of the program.

5. The program shall report within 14 days any substantive change in the program to include a change in program name, program director, name of institution or business if applicable, address, program content, length of program, or location of records.

E. Expiration and renewal of program approval. A repackaging training program approval expires after two years, after which the program may apply for renewal. For continued approval, the program shall submit the renewal application, renewal fee, and a self-evaluation report on a form provided by the board at the time of renewal notification. Renewal of a program's approval is at the discretion of the board, and the decision to renew shall be based on documentation of continued compliance with the criteria set forth in this section.

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.