Title of Regulation: 18VAC110-20. Regulations Governing the Practice of Pharmacy (amending 18VAC110-20-685, 18VAC110-20-700, 18VAC110-20-725, 18VAC110-20-726, 18VAC110-20-727).

Statutory Authority: §§ 54.1-2400 of the Code of Virginia.

Public Hearing Information: No public hearings are currently scheduled.

Public Comment Deadline: April 6, 2016.

Effective Date: April 21, 2016.

Agency Contact: Caroline Juran, RPh, Executive Director, Board of Pharmacy, 9960 Mayland Drive, Suite 300, Richmond, VA 23233-1463, telephone (804) 367-4416, FAX (804) 527-4472, or email caroline.juran@dhp.virginia.gov.

Basis: Regulations are promulgated under the general authority of Chapter 24 (§ 54.1-2400 et seq.) of Title 54.1 of the Code of Virginia. Section 54.1-2400 provides the Board of Pharmacy the authority to promulgate regulations. Section 54.1-3420.2 of the Code of Virginia provides: "E. Prescription drug orders dispensed to a patient and delivered to a program of all-inclusive care for the elderly (PACE) site licensed by the Department of Social Services pursuant to § 63.2-1701 and overseen by the Department of Medical Assistance Services in accordance with § 32.1-330.3 upon the signed written request of the patient or the patient's legally authorized representative may be stored, retained, and repackaged at the site on behalf of the patient for subsequent delivery or administration. The repackaging of a dispensed prescription drug order retained by the PACE site for the purpose of assisting a client with self-administration pursuant to this subsection shall only be performed by a pharmacist, pharmacy technician, nurse, or other person who has successfully completed a Board-approved training program for repackaging of prescription drug orders as authorized by this subsection. The Board shall promulgate regulations relating to training, packaging, labeling, and recordkeeping for such repackaging." The authority to promulgate regulations to establish criteria for repackaging by PACE sites is mandatory.

Purpose: The purpose of the planned regulatory action is to comply with a legislative mandate to promulgate regulations for PACE sites to receive, store, retain, and repackage prescription drug orders dispensed to a patient for the purpose of assisting a client with self-administration of the drug.

Chapter 505 of the 2015 Acts of Assembly addresses a problem for the PACE program in handling the unique prescription needs of its patient population. The legislation does two things. It authorizes the PACE sites to retain prescription medications for elderly patients, who may need assistance or monitoring of self-administration or who may not be capable of self-administering. And, it authorizes PACE personnel, who hold appropriate licensure or who have passed a training course approved by the Board of Pharmacy, to repackage a portion of a patient's medication to assist that patient with self-administration and compliance with dosage instructions.

Because of the urgent need for the change in law and for regulations to implement those changes, the Board of Pharmacy is promulgating amendments by a fast-track rulemaking process. Regulations addressing storage, repackaging, recordkeeping, and training of persons who handle drugs will ensure that client or patient needs are being met while protecting the security and integrity of the drugs and the health and safety of the client and general population.

Rationale for Using Fast-Track Process: This action will not be controversial as repackaging authorization is needed as soon as possible. Cindy Williams with Riverside Health Systems, which has a number of PACE facilities, gave public comment at the meeting on September 29, 2015, urging the board to adopt the draft regulations recommended by the Regulation Committee. The board adopted the recommendation without change.

Substance: Regulations promulgated pursuant to the legislative mandate set forth requirements for PACE sites to possess, repackage, and deliver or administer drugs and for a program to train nonpharmacists in repackaging. Amendments add PACE to requirements for other facilities (CSBs and BHAs) that have similar authority. The amendments add "PACE site" to existing requirements for labeling, storage, recordkeeping, destruction, and other requirements for repackaging in those facilities that do not have a pharmacy, persons authorized to repackage, and information to clients about repackaged drugs. There are also curricula and instructional criteria for approval of repackaging training programs and for expiration and renewal of program approval.

Issues: The advantage to the public is assurance that a facility has followed appropriate procedures in the storing, retaining, and repackaging of dispensed prescription drug orders for the purpose of assisting elderly clients with self-administration. Without proper training, there are concerns about drug safety and security and about improper dispensed of prescriptions that enable a person to remain in a community-based program. There are no disadvantages. The advantage to the Commonwealth is facilitation of a community program that assists elderly clients with health-related needs. Since there was no statutory authority for emergency regulations, the board is promulgating a fast-track action to authorize repackaging as soon as possible.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. Pursuant to Chapter 505 of the 2015 Acts of the Assembly, the Board of Pharmacy (Board) proposes to amend its pharmacy regulation to allow programs of all-inclusive care for the elderly (PACE sites) that are licensed by the Department of Social Services and overseen by the Department of Medical Assistance Services to be able to possess, repackage, deliver and administer prescription medications to their patients as community service boards (CSBs) and behavioral health authorities (BHAs) do now.

Result of Analysis. Benefits likely outweigh costs for implementing these proposed changes.

Estimated Economic Impact. Currently, the Board allows CSBs and BHAs that have obtained controlled substances registration to have staff trained in repackaging of prescription drug orders to repackage prescription drugs for these entities' clients. Pursuant to Chapter 505 of the 2015 Acts of the Assembly, the Board now proposes to add PACE sites to the list of entities that may repackage prescriptions for their clients. Pace sites will have to meet the same criteria as CSBs and BHAs do and will have to pay the fees set for approval (and renewal and late renewal) of repackaging training programs ($50, $30 and $10, respectively) and meet criteria for training programs as well as rules that trained individuals must follow in repackaging drugs. The rules for repackaging include information that must be on packaging labels, information that must be dispensed to clients with the drugs, rules for storage and destruction of drugs, and recordkeeping requirements.

PACE sites will incur the same explicit costs as CSBs and BHAs incur now; these costs comprise the $50 fee for approval of a repackaging training program to train their staff (as well as biennial fees of $30 for renewal of these programs). PACE sites will also incur implicit costs for staff time spent in training. PACE sites will likely only seek repackaging authority if they believe that the costs they would incur are outweighed by the benefits that they and their clients will accrue. The benefits of these proposed regulations have the potential to be quite large, especially for elderly clients who lack the capacity to independently follow a prescribed drug regimen.

Businesses and Entities Affected. The Department of Health Professions reports that there are eight PACE provider organizations that serve 12 licensed PACE sites in the Commonwealth. All of these entities and their clients will be affected by these regulations.

Localities Particularly Affected. No locality will be particularly affected by this regulatory change.

Projected Impact on Employment. This regulatory change is unlikely to impact employment in the Commonwealth.

Effects on the Use and Value of Private Property. This regulatory change is unlikely to affect the use or value of private property in Virginia.

Real Estate Development Costs. This proposed change will likely not affect real estate development costs.

Small Businesses:

Definition. Pursuant to § 2.2-4007.04 of the Code of Virginia, small business is defined as "a business entity, including its affiliates, that (i) is independently owned and operated and (ii) employs fewer than 500 full-time employees or has gross annual sales of less than $6 million."

Costs and Other Effects. No small business in the Commonwealth is likely to incur net costs on account of this proposed regulatory change.

Alternative Method that Minimizes Adverse Impact. No small business in the Commonwealth is likely to incur net costs on account of this proposed regulatory change.

Adverse Impacts:

Businesses: No business in the Commonwealth is likely to incur net costs on account of this proposed regulatory change.

Localities: Localities in the Commonwealth are unlikely to see any adverse impacts on account of this proposed regulatory change.

Other Entities: No entities in the Commonwealth are likely to suffer any adverse impacts on account of this proposed regulatory change.

Agency's Response to Economic Impact Analysis: The Board of Pharmacy concurs with the economic impact analysis of the Department of Planning and Budget.

Summary:

Chapter 505 of the 2015 Acts of the Assembly requires the Board of Pharmacy to promulgate regulations "relating to the training, packaging, labeling, and recordkeeping" for repackaging of prescription drug orders dispensed to a patient and delivered to a program of all-inclusive care for the elderly (PACE) site licensed by the Department of Social Services and overseen by the Department of Medical Assistance Services. The amendments add PACE sites to the repackaging requirements previously adopted for a similar purpose for community services board facilities and behavioral health authority facilities.

Part XVI
Controlled Substances Registration for Other Persons or Entities

18VAC110-20-685. Definitions for controlled substances registration.

For purposes of this part, the following definitions shall apply:

"BHA" means a behavioral health authority facility licensed by the Department of Behavioral Health and Developmental Services that holds a controlled substances registration issued by the board.

"CSB" means a community services board facility licensed by the Department of Behavioral Health and Developmental Services that holds a controlled substances registration issued by the board.

"PACE" means a program of all-inclusive care for the elderly overseen by the Department of Medical Assistance Services in accordance with § 32.1-330.3 of the Code of Virginia.

18VAC110-20-700. Requirements for supervision for controlled substances registrants.

A. A practitioner licensed in Virginia shall provide supervision for all aspects of practice related to the maintenance and use of controlled substances as follows:

1. In a hospital or nursing home without an in-house pharmacy, a pharmacist shall supervise.

2. In an emergency medical services agency, the operational medical director shall supervise.

3. For any other type of applicant or registrant, a pharmacist or a prescriber whose scope of practice is consistent with the practice of the applicant or registrant and who is approved by the board may provide the required supervision.

B. The supervising practitioner shall approve the list of drugs which may be ordered by the holder of the controlled substances registration; possession of controlled substances by the entity shall be limited to such approved drugs. The list of drugs approved by the supervising practitioner shall be maintained at the address listed on the controlled substances registration.

C. Access to the controlled substances shall be limited to (i) the supervising practitioner or to those persons who are authorized by the supervising practitioner and who are authorized by law to administer drugs in Virginia,; (ii) such other persons who have successfully completed a training program for repackaging of prescription drug orders in a CSB or, BHA, or PACE site as authorized in § 54.1-3420.2 of the Code of Virginia,; or (iii) other such persons as designated by the supervising practitioner or the responsible party to have access in an emergency situation. If approved by the supervising practitioner, pharmacy technicians may have access for the purpose of delivering controlled substances to the registrant, stocking controlled substances in automated dispensing devices, conducting inventories, audits and other recordkeeping requirements, overseeing delivery of dispensed prescriptions at an alternate delivery site, and repackaging of prescription drug orders retained by a CSB or, BHA, or PACE site as authorized in § 54.1-3420.2 of the Code of Virginia. Access to stock drugs in a crisis stabilization unit shall be limited to prescribers, nurses, or pharmacists.

D. The supervising practitioner shall establish procedures for and provide training as necessary to ensure compliance with all requirements of law and regulation, including, but not limited to, storage, security, and recordkeeping.

E. Within 14 days of a change in the responsible party or supervising practitioner assigned to the registration, either the responsible party or outgoing responsible party shall inform the board and a new application shall be submitted indicating the name and license number, if applicable, of the new responsible party or supervising practitioner.

18VAC110-20-725. Repackaging by a CSB or, 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 or, 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 or, 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 or, 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 or, 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 or, 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 or, BHA, or PACE site for subsequent repackaging. If retained by the CSB or, 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 or, 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 or, 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 or, 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.

18VAC110-20-726. 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 or, 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.

18VAC110-20-727. Pharmacists repackaging for clients of a CSB or, BHA or PACE.

A. As an alternative to repackaging as defined in 18VAC110-20-725, a pharmacist at a CSB or, BHA, or PACE site may repackage a client's prescription drugs that have been dispensed by another pharmacy into compliance packaging under the following conditions:

1. 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.

2. The compliance packaging shall comply with the requirements of 18VAC110-20-340 B.

3. 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.

4. Any portion of a prescription drug order remaining at the CSB or, 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 or, 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.

B. A primary provider pharmacy may also provide this service in compliance with the provisions of 18VAC110-20-535.