Administrative Code

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Virginia Administrative Code
Title 18. Professional And Occupational Licensing
Agency 110. Board Of Pharmacy
Chapter 60. Regulations Governing Pharmaceutical Processors
12/3/2021

18VAC110-60-320. Dispensing error review and reporting; quality assurance program.

A. A pharmaceutical processor or cannabis dispensing facility shall implement and comply with a quality assurance program that describes, in writing, policies and procedures to detect, identify, and prevent dispensing errors. A pharmaceutical processor or cannabis dispensing facility shall distribute the written policies and procedures to all pharmaceutical processor or cannabis dispensing facility employees and shall make the written policies and procedures readily available on the premises of the pharmaceutical processor or cannabis dispensing facility. The policies and procedures shall include:

1. Directions for communicating the details of a dispensing error to the practitioner who certified a qualifying patient and to the qualifying patient, the patient's parent or legal guardian, the patient's registered agent, or appropriate family member if the patient is deceased or is unable to fully comprehend the communication. The communication shall describe methods of correcting the dispensing error or reducing the negative impact of the error on the qualifying patient; and

2. A process to document and assess dispensing errors to determine the cause of the error and an appropriate response.

B. A pharmaceutical processor or cannabis dispensing facility shall use the findings of its quality assurance program to develop systems and workflow processes designed to prevent dispensing errors. A pharmaceutical processor or cannabis dispensing facility PIC shall:

1. Inform pharmaceutical processor or cannabis dispensing facility employees of changes to policy, procedure, systems, or processes made as a result of recommendations generated by the quality assurance program;

2. Notify all processor or facility employees that the discovery or reporting of a dispensing error shall be relayed immediately to a pharmacist on duty;

3. Ensure that a pharmacist performs a quality assurance review for each dispensing error. A pharmacist shall commence such review as soon as is reasonably possible, but no later than two business days from the date the dispensing error is discovered; and

4. Create a record of every quality assurance review. This record shall contain at least the following:

a. The date of the quality assurance review and the names and titles of the persons performing the review;

b. The pertinent data and other information relating to the dispensing error reviewed;

c. Documentation of contact with the registered patient, parent, legal guardian, or registered agent, where applicable, and the practitioner who certified the patient;

d. The findings and determinations generated by the quality assurance review; and

e. Recommended changes to pharmaceutical processor or cannabis dispensing facility policy, procedure, systems, or processes if any.

C. A pharmaceutical processor or cannabis dispensing facility shall maintain for three years a copy of the pharmaceutical processor's or cannabis dispensing facility's quality assurance program and records of all reported dispensing errors and quality assurance reviews in an orderly manner and filed by date.

Statutory Authority

§§ 54.1-3442.6 and 54.1-3447 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 35, Issue 23, eff. August 7, 2019; amended, Virginia Register Volume 37, Issue 25, eff. September 1, 2021.

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