18VAC110-20 Regulations Governing the Practice of Pharmacy

REGULATIONS

Vol. 29 Iss. 25 - August 12, 2013

TITLE 18. PROFESSIONAL AND OCCUPATIONAL LICENSING

BOARD OF PHARMACY

Chapter 20

Fast-Track Regulation

Title of Regulation: 18VAC110-20. Regulations Governing the Practice of Pharmacy (amending 18VAC110-20-20, 18VAC110-20-40, 18VAC110-20-105, 18VAC110-20-270, 18VAC110-20-420, 18VAC110-20-425, 18VAC110-20-710).

Statutory Authority: §§ 54.1-2400 and 54.1-3307 of the Code of Virginia.

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: September 11, 2013.

Effective Date: September 26, 2013.

Agency Contact: Caroline Juran, RPh, Executive Director, Board of Pharmacy, 9960 Mayland Drive, Suite 300, Richmond, VA 23233-1463, telephone [phone], FAX [phone], or email [e-mail].

Basis: 18VAC110-20, Regulations Governing the Practice of Pharmacy, are promulgated under the general authority of § 54.1-2400 of the Code of Virginia, which establishes the general powers and duties of health regulatory boards, including the responsibility to promulgate regulations in accordance with the Administrative Process Act. The specific statutory authority for the Board of Pharmacy to regulate the practice of pharmacy, including the dispensing of controlled substances, is found in § 54.1-3307 of the Code of Virginia.

Purpose: The regulatory action is the result of a review conducted by staff of the Board of Pharmacy and the Department of Health Professions pursuant to the Governor's Regulatory Reform Initiative. The amendments eliminate requirements that are not necessary to protect the integrity and safety of prescription medication or to assure the competency of applicants and those renewing their technician registration. As new technology is developing and pharmacy systems change and become more automated, the board amends its regulations to facilitate pharmacy practice that maintains safeguards, reduces the possibility of human error in dispensing of prescription drugs, and protects the health, welfare, and safety of the public.

Rationale for Using Fast-Track Process: The board has opted to use the fast-track process for two reasons: (i) the action is consistent with the Governor's project to reform regulations that are unnecessarily burdensome; and (ii) the board does not anticipate any objection to the changes or the changes to be controversial.

Substance: Amendments (i) facilitate electronic renewal of licenses; (ii) accommodate verification of practical experience for pharmacy interns coming from some other states; (iii) eliminate the requirement for pharmacy technicians to submit documentation of continuing education to renew registration; (iv) allow for more than one pharmacist to be involved in verifying the accuracy of a prescription and clarify documentation for each involvement; (v) modify the requirement for labeling in unit dose dispensing systems to protect patient privacy; (vi) allow for current technology that uses compliance packaging instead of a unit dose dispensing system in hospitals or long-term care facilities; and (vii) eliminate the requirement for an alarm system for teaching institutions that only stock Schedule VI drugs.

Issues: The primary advantages of the regulatory action to the public is less burdensome and costly regulation for applicants, registrants, and pharmacies that utilize newer technology and dispensing systems. There are no disadvantages to the public. There are no advantages or disadvantages to the Commonwealth.

Small Business Impact Report of Findings: This regulatory action serves as the report of findings of the regulatory review pursuant to § 2.2-4007.1 of the Code of Virginia.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. As part of the regulatory reform initiative, the Board of Pharmacy (Board) proposes to amend its Regulations Governing the Practice of Pharmacy to: 1) delete fees that no longer are applicable, 2) allow licensees to attest that they have completed their required continuing education hours for license renewal, 3) allow more than one pharmacist to verify the accuracy of a prescription, 4) change the requirements for labeling an individual patients drug drawer, 5) allow a pharmacy providing services to a hospital or long term care facility to use a robotic pharmacy system that dispenses drugs in bar-coded unit doses or compliance packaging and 6) allow an exemption to alarm system requirements for teaching institutions that only stock schedule IV drugs.

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

Estimated Economic Impact. Current regulations contain one-time fees that were imposed for renewals between December 31, 2009 and April 30, 2010. As these fees are no longer applicable, the Board proposes to remove them from the regulations. No entity will incur costs on account of this change. Affected entities will likely benefit from the added clarity that removing obsolete, and potentially confusing, language brings.

Current regulations require pharmacy technician to provide proof that they completed continuing education in order to renew their licenses. Board staff reports, however, that the Board has not actually required pharmacy technicians to submit such proof since 2009. The Board now proposes to eliminate the requirement for proof in these regulations and instead require pharmacy technicians to attest that they have completed required continuing education when they renew their licenses. This change will benefit licensees by bringing regulations into conformity with current practice and by saving them possible bookkeeping and mailing expenses in the future if the Board left this requirement intact and instead decided that licensees once again needed to comply with regulations and provide proof of continuing education.

Board staff reports that currently section 270 of these regulations, which speaks of one pharmacist verifying the accuracy of a prescription, could be read to contradict section 276 of these regulations, which requires the identification of individual pharmacists who, jointly would be responsible for prescription dispensing functions. To fix this contradiction, the Board now proposes to add rules for multiple pharmacists to verify a dispensed prescription. These rules will require that a record be maintained identifying the date of dispensing, the name of each pharmacist involved in dispensing and the individual task for which he or she is responsible in the verification process. Affected entities will likely benefit from the added clarity that this change brings to these regulations.

Current regulations require that patients individual drug drawers in hospitals or long term care facilities be labeled with their names. As this may violate HIPPA privacy requirements, the Board proposes to change this and instead require that drawers be labeled in such a manner as to identify the patient and his location without violating health privacy laws. This change will likely benefit patients, as their privacy will be protected, and will also benefit licensees, as they will no longer be required in regulation to violate federal law.

Currently, pharmacies that provide services for hospitals and long term care facilities may in general use a robotic pharmacy system to dispense unit dose bar-coded drugs. There is a Board approved pilot program that allows dispensing of drugs in compliance packaging, also. The Board now proposes to allow these pharmacies to use robotic pharmacy systems to dispense both drugs in bar-coded unit doses and in compliance packaging. This change will benefit pharmacies that provide services for hospitals and long term care facilities by allowing them greater flexibility in choosing how to dispense drugs without paying the $250 fee and accruing time costs associated with applying to be part of the pilot program. No entity is likely to incur additional net costs on account of this change.

Current regulations require that any facility that is not staffed 24 hours a day store drugs in a fixed secured location with an alarm. These regulations currently exempt researchers, animal control officers, humane societies, alternate delivery sites and emergency medical services agencies that only stock intravenous fluids with no added drugs from this alarm requirement. The Board proposes to add teaching institutions possessing only schedule IV drugs (with low risk of theft or abuse) to the list of groups that are exempt from having to have an alarm system. This change will save eligible teaching institutions from bearing the expense of installing alarm systems on their drug closets.

Businesses and Entities Affected. The Department of Health Professions (DHP) reports that there are 1,772 pharmacies, 11,941 pharmacists and 12,227 pharmacy technicians licensed to do business in the Commonwealth. All of these entities will be affected by these proposed regulations.

Localities Particularly Affected. No localities will be particularly affected by these proposed regulations.

Projected Impact on Employment. This proposed regulatory action is unlikely to have any effect on employment in the Commonwealth.

Effects on the Use and Value of Private Property. These proposed regulatory changes are unlikely to affect the use or value of private property in the Commonwealth.

Small Businesses: Costs and Other Effects. No small business is likely to incur any additional expense on account of these regulatory changes.

Small Businesses: Alternative Method that Minimizes Adverse Impact. No small business is likely to incur any additional expense on account of these regulatory changes.

Real Estate Development Costs. This regulatory action will likely have no effect on real estate development costs in the Commonwealth.

Legal Mandate. The Department of Planning and Budget (DPB) has analyzed the economic impact of this proposed regulation in accordance with § 2.2-4007.04 of the Administrative Process Act and Executive Order Number 14 (10). Section 2.2-4007.04 requires that such economic impact analyses include, but need not be limited to, a determination of the public benefit, the projected number of businesses or other entities to whom the regulation would apply, the identity of any localities and types of businesses or other entities particularly affected, the projected number of persons and employment positions to be affected, the projected costs to affected businesses or entities to implement or comply with the regulation, and the impact on the use and value of private property. Further, if the proposed regulation has an adverse effect on small businesses, § 2.2-4007.04 requires that such economic impact analyses include (i) an identification and estimate of the number of small businesses subject to the regulation; (ii) the projected reporting, recordkeeping, and other administrative costs required for small businesses to comply with the regulation, including the type of professional skills necessary for preparing required reports and other documents; (iii) a statement of the probable effect of the regulation on affected small businesses; and (iv) a description of any less intrusive or less costly alternative methods of achieving the purpose of the regulation. The analysis presented above represents DPBs best estimate of these economic impacts.

Agency's Response to Economic Impact Analysis: The Board of Pharmacy concurs with the analysis of the Department of Planning and Budget for amendments to 18VAC110-20 relating to regulatory reform changes.

Summary:

This regulatory action is the result of the Governor's Regulatory Reform Initiative. Amendments (i) facilitate electronic renewal of licenses; (ii) accommodate verification of practical experience for pharmacy interns coming from other states; (iii) eliminate the requirement for pharmacy technicians to submit documentation of continuing education to renew registration; (iv) allow for more than one pharmacist to be involved in verifying the accuracy of a prescription and clarify documentation for each involvement; (v) modify the requirement for labeling in unit dose dispensing systems to protect patient privacy; (vi) allow for current technology that uses compliance packaging instead of a unit dose dispensing system in hospitals or long-term care facilities; and (vii) eliminate the requirement for an alarm system for teaching institutions that only stock Schedule VI drugs.

18VAC110-20-20. Fees.

A. Unless otherwise provided, fees listed in this section shall not be refundable.

B. Unless otherwise provided, any fees for taking required examinations shall be paid directly to the examination service as specified by the board.

C. Initial application fees.

1. Pharmacist license	$180
2. Pharmacy intern registration	$15
3. Pharmacy technician registration	$25
4. Pharmacy permit	$270
5. Permitted physician licensed to dispense drugs	$270
6. Medical equipment supplier permit	$180
7. Humane society permit	$20
8. Nonresident pharmacy	$270
9. Controlled substances registrations	$90
10. Innovative program approval. If the board determines that a technical consultant is required in order to make a decision on approval, any consultant fee, not to exceed the actual cost, shall also be paid by the applicant in addition to the application fee.	$250
11. Approval of a pharmacy technician training program	$150
12. Approval of a continuing education program	$100
13. Approval of a repackaging training program	$50

D. Annual renewal fees.

1. Pharmacist active license – due no later than December 31	$90
2. Pharmacist inactive license – due no later than December 31	$45
3. Pharmacy technician registration – due no later than December 31	$25
4. Pharmacy permit – due no later than April 30	$270
5. Physician permit to practice pharmacy – due no later than February 28	$270
6. Medical equipment supplier permit – due no later than February 28	$180
7. Humane society permit – due no later than February 28	$20
8. Nonresident pharmacy – due no later than April 30	$270
9. Controlled substances registrations – due no later than February 28	$90
10. Innovative program continued approval based on board order not to exceed $200 per approval period.
11. Approval of a pharmacy technician training program	$75 every two years
12. Approval of a repackaging training program	$30 every two years

E. Late fees. The following late fees shall be paid in addition to the current renewal fee to renew an expired license within one year of the expiration date or within two years in the case of a pharmacy technician training program. In addition, engaging in activities requiring a license, permit, or registration after the expiration date of such license, permit, or registration shall be grounds for disciplinary action by the board.

1. Pharmacist license	$30
2. Pharmacist inactive license	$15
3. Pharmacy technician registration	$10
4. Pharmacy permit	$90
5. Physician permit to practice pharmacy	$90
6. Medical equipment supplier permit	$60
7. Humane society permit	$5
8. Nonresident pharmacy	$90
9. Controlled substances registrations	$30
10. Approval of a pharmacy technician training program	$15
11. Approval of a repackaging training program	$10

F. Reinstatement fees. Any person or entity attempting to renew a license, permit, or registration more than one year after the expiration date, or more than two years after the expiration date in the case of a pharmacy technician training program, shall submit an application for reinstatement with any required fees. Reinstatement is at the discretion of the board and, except for reinstatement following license revocation or suspension, may be granted by the executive director of the board upon completion of an application and payment of any required fees.

1. Pharmacist license	$210
2. Pharmacist license after revocation or suspension	$500
3. Pharmacy technician registration	$35
4. Pharmacy technician registration after revocation or suspension	$125
5. Facilities or entities that cease operation and wish to resume shall not be eligible for reinstatement but shall apply for a new permit or registration. Facilities or entities that failed to renew and continued to operate for more than one renewal cycle shall pay the current and all back renewal fees for the years in which they were operating plus the following reinstatement fees:
a. Pharmacy permit	$240
b. Physician permit to practice pharmacy	$240
c. Medical equipment supplier permit	$210
d. Humane society permit	$30
e. Nonresident pharmacy	$115
f. Controlled substances registration	$180
g. Approval of a pharmacy technician training program	$75
h. Approval of a repackaging training program	$50

G. Application for change or inspection fees for facilities or other entities.

1. Change of pharmacist-in-charge	$50
2. Change of ownership for any facility	$50
3. Inspection for remodeling or change of location for any facility	150
4. Reinspection of any facility	$150
5. Board-required inspection for a robotic pharmacy system	$150
6. Board-required inspection of an innovative program location	$150
7. Change of pharmacist responsible for an approved innovative program	$25

H. Miscellaneous fees.

1. Duplicate wall certificate	$25
2. Returned check	$35

I. For the annual renewal due on the stated dates, the following fees shall be imposed for a license, permit or registration:

1. Pharmacist active license – December 31, 2009	$50
2. Pharmacist inactive license – December 31, 2009	$25
3. Pharmacy technician registration – December 31, 2009	$15
4. Pharmacy permit – April 30, 2010	$210
5. Physician permit to practice pharmacy – February 28, 2010	$210
6. Medical equipment supplier permit – February 28, 2010	$140
7. Humane society permit – February 28, 2010	$20
8. Nonresident pharmacy – April 30, 2010	$210
9. Controlled substances registrations – February 28, 2010	$50

18VAC110-20-40. Procedure for gaining practical experience.

A. Each person desiring to gain practical pharmacy experience in Virginia shall first register with the board as a pharmacy intern on a form provided by the board prior to becoming so engaged as a pharmacy intern. This requirement shall apply to any person gaining practical experience within the Commonwealth whether for licensure in Virginia or in another state.

B. In order to be eligible to register as a pharmacy intern, an applicant shall meet at least one of the following criteria:

1. The applicant shall be enrolled in and have started course work in a professional degree program of a board-approved school of pharmacy. Such registration is only valid while the student is enrolled in the school of pharmacy and is satisfactorily progressing toward meeting the requirements for licensure as a pharmacist. An expiration date shall be assigned to the registration to cover the estimated time period for the student to complete the school program and pass the required examinations. If the student is no longer enrolled in the school program, takes a voluntary break from the program, or is otherwise not actively participating in the school program, except for regularly scheduled school breaks, the registration is no longer valid and shall be returned to the board immediately;

2. The applicant is a graduate of a board-approved school of pharmacy or a graduate of a foreign school of pharmacy, has established educational equivalency and proficiency in English by obtaining the FPGEC certificate, and desires to gain required practical experience required for licensure as a pharmacist. Such applicant shall provide documentation on a board-approved form of current employment or an employment start date within 90 days in a pharmacy in Virginia with approval by the supervising pharmacist. An expiration date shall be assigned to cover the estimated time period needed to obtain the required practical experience hours and take the required examinations to become licensed as a pharmacist;

3. The applicant has already gained the required practical experience, but is an otherwise qualified applicant awaiting examination for licensure. A three-month expiration date shall be assigned to allow the applicant time to take required examinations; or

4. The applicant is an applicant for reactivation or reinstatement of a previously issued pharmacist license and is meeting board requirements for relicensure. An expiration date shall be assigned to reasonably cover the period of time necessary to meet the board requirements.

C. For documented, good cause shown, the executive director of the board may extend the expiration date of the intern registration upon submission of an application form approved by the board and payment of the initial application fee.

D. A pharmacy intern shall be supervised by a pharmacist who holds a current, unrestricted license and assumes full responsibility for the training, supervision and conduct of the intern.

E. The intern registration of a pharmacy student shall be valid only while the student is enrolled in a school of pharmacy. The registration card issued by the board shall be returned to the board upon failure to be enrolled.

F. Practical experience gained within any other state must be registered with and certified by the board of that state in order to be accepted or certified by this board. In the event that a state does not use internships to gain practical experience in pharmacy but relies on the pharmacy school to certify the hours of experience, an affidavit from the pharmacy school certifying the hours of experience gained in the United States may be accepted in lieu of board certification.

G. All practical experience of the pharmacy intern shall be evidenced by an affidavit approved by the board, which shall be filed prior to or with the application for examination for licensure.

H. An applicant for licensure by endorsement may provide verification acceptable to the board of practical experience hours worked as a pharmacist in another state within the United States in lieu of prelicensure intern hours in order to meet the practical experience requirement.

I. A pharmacy intern shall notify the board in writing of any change in address of record within 14 days of such change.

18VAC110-20-105. Renewal and reinstatement of registration.

A. Pharmacy technician registrations expire on December 31 and shall be renewed annually prior to that date by the submission of a renewal fee and renewal form. A pharmacy technician newly registered on or after July 1 shall not be required to renew that registration until December 31 of the following year. Failure to receive the application for renewal shall not relieve the pharmacy technician of the responsibility for renewing the registration by the expiration date.

B. A pharmacy technician who fails to renew his registration by the expiration date may renew his registration at any time within one year of its expiration by submission of the renewal fee and late fee, renewal form, and proof attestation of having obtained required continuing education.

C. A pharmacy technician who fails to renew his registration for more than one year following expiration and who wishes to reinstate such registration shall submit an application for reinstatement, pay the current renewal fee and a reinstatement fee, and submit documentation showing compliance with continuing education requirements. Reinstatement is at the discretion of the board and may be granted by the executive director of the board provided no grounds exist to deny said reinstatement. Conducting tasks associated with a pharmacy technician with a lapsed registration shall be illegal and may subject the registrant to disciplinary action by the board.

D. A person who fails to reinstate a pharmacy technician registration within five years of expiration, shall not be eligible for reinstatement and shall repeat an approved training program and repeat and pass the examination, or hold current PTCB certification, before applying to be reregistered.

Part VII
Prescription Order and Dispensing Standards

18VAC110-20-270. Dispensing of prescriptions; certification of completed prescriptions; supervision of pharmacy technicians.

A. In addition to the acts restricted to a pharmacist in § 54.1-3320 A of the Code of Virginia, a pharmacist shall provide personal supervision of compounding of extemporaneous preparations by pharmacy technicians.

B. A pharmacist shall determine the number of pharmacy interns, pharmacy technicians, and pharmacy technician trainees he can safely and competently supervise at one time; however, no pharmacist shall supervise more than four persons acting as pharmacy technicians at one time.

C. After the prescription has been prepared and prior to the delivery of the order, the a pharmacist shall inspect the prescription product to verify its accuracy in all respects, and place his initials on the record of dispensing as a certification of the accuracy of, and the responsibility for, the entire transaction. If more than one pharmacist is involved in verifying the accuracy of the prescription product, a record shall be maintained identifying the date of dispensing, each pharmacist involved in the process, and the individual task for which he is responsible for verifying the accuracy. Such record showing verification of accuracy shall be maintained on a pharmacy record and, if necessary, an alternate record consistent with 18VAC110-20-255 for the required time period of two years, unless otherwise specified in regulation. If the dispensing involves central or remote processing, records of pharmacist verification shall be maintained in a manner consistent with 18VAC110-20-276 and 18VAC110-20-515.

D. If a pharmacist declines to fill a prescription for any reason other than the unavailability of the drug prescribed, he shall record on the back of the prescription the word "declined"; the name, address, and telephone number of the pharmacy; the date filling of the prescription was declined; and the signature of the pharmacist.

E. If a pharmacist determines from a prescriber or by other means, including the use of his professional judgment, that a prescription presented for dispensing is a forgery, the pharmacist shall not return the forged prescription to the person presenting it. The forged prescription may be given to a law-enforcement official investigating the forgery; or it shall be retained for a minimum of 30 days before destroying it, in the event it is needed for an investigative or other legitimate purpose.

Part X
Unit Dose Dispensing Systems

18VAC110-20-420. Unit dose dispensing system.

A. A unit dose drug dispensing system may be utilized for the dispensing of drugs to patients in a hospital or long-term care facility. The following requirements shall apply regardless of whether licensed or unlicensed persons administer medications:

1. Any equipment outside the pharmacy used to house drugs to be administered in a unit dose system shall be fitted with a locking mechanism and locked at all times when unattended.

2. A signed order by the prescribing practitioner shall accompany the requests for a Schedule II drug, except that a verbal order for a hospital patient for a Schedule II controlled substance may be transmitted to a licensed nurse or pharmacist at the hospital who shall promptly reduce the order to writing in the patient's chart. Such an order shall be signed by the prescriber within 72 hours.

3. Properly trained personnel may transcribe the prescriber's drug orders to a patient profile card, fill the medication carts, and perform other such duties related to a unit dose distribution system provided these are done under the personal supervision of a pharmacist.

4. All dosages and drugs shall be labeled with the drug name, strength, lot number and expiration date when indicated.

5. The patient's individual drug drawer or tray shall be labeled with in a manner to identify the patient's name patient and his location without violating health privacy laws.

6. All unit dose drugs intended for internal use shall be maintained in the patient's individual drawer or tray unless special storage conditions are necessary.

7. A back-up dose of a drug of not more than one dose unit may be maintained in the patient's drawer, tray, or special storage area provided that the dose is maintained in the patient's drawer, tray, or special storage area with the other drugs for that patient.

8. A record shall be made and maintained within the pharmacy for a period of one year showing:

a. The date of filling of the drug cart;

b. The location of the drug cart;

c. The initials of the person who filled the drug cart; and

d. The initials of the pharmacist checking and certifying the contents of the drug cart in accordance with the provisions in 18VAC110-20-270 B C.

9. A patient profile record or medication card will be accepted as the dispensing record of the pharmacy for unit dose dispensing systems only, subject to the following conditions:

a. The record of dispensing must be entered on the patient profile record or medication card at the time the drug drawer or tray is filled.

b. In the case of Schedule II through V drugs, after the patient profile record or medication card has been completed, the card must be maintained for two years.

c. In the case of the computer-based distribution system, a uniformly maintained "fill list" or other document containing substantially the same information may be accepted as the dispensing record for Schedule II through VI drugs. Records of disposition/administration for floor stock drugs as provided in 18VAC110-20-460 B will be accepted for drugs distributed as floor stock.

B. In providing unit dose systems to hospitals or long-term care facilities where only those persons licensed to administer are administering drugs, the pharmacy shall dispense not more than a seven-day supply of a drug in a solid, oral dosage form at any one given time.

C. In addition to the requirements listed in subsection A of this section, the following requirements apply to those long-term care facilities in which unlicensed persons administer drugs:

1. The pharmacy providing medications to such facility shall dispense no more than a 72-hour supply of drugs in a solid, oral dosage form at any one given time.

2. The pharmacy shall provide to persons administering medications training specific to the particular unit dose system being used.

3. The pharmacy shall provide a medication administration record to the facility listing each drug to be administered with full dosage directions to include no abbreviations.

4. The drugs in a unit dose system shall be placed in slots within a drawer labeled or coded to indicate time of administration.

18VAC110-20-425. Robotic pharmacy systems.

A Consistent with 18VAC110-20-420, a pharmacy providing services to a hospital or a long-term care facility using a unit dose dispensing system may operate and operating a robotic pharmacy system dispensing that dispenses drugs in bar-coded unit dose, bar-coded drugs and, or compliance packaging is exempted from 18VAC110-20-270 C, provided the accuracy of the final dispensed prescription product complies with a written quality assurance plan and requirements of this chapter. The following requirements for operation of a robotic pharmacy system shall apply:

1. Pharmacists shall review for accuracy and appropriateness of therapy all data entry of prescription orders into the computer operating the system.

2. The packaging, repackaging, stocking and restocking of the robotic pharmacy system shall be performed by pharmacy technicians or pharmacists.

3. Pharmacists shall verify and check for the accuracy of all drugs packaged or repackaged for use by the robot by a visual check of both labeling and contents prior to stocking the drugs in the robotic pharmacy system. A repackaging record shall be maintained in accordance with 18VAC110-20-355 A, and the verifying pharmacist shall initial the record. Packaging and labeling, including the appropriate beyond-use date, shall conform to requirements of this chapter and current USP-NF standards.

4. A written policy and procedure must be maintained and shall include at a minimum, procedures for ensuring:

a. Accurate packaging and repackaging of all drugs for use in the robotic pharmacy system, to include properly labeled barcodes, and method for ensuring pharmacist verification of all packaged and repacked drugs compliant with this chapter;

b. Accurate stocking and restocking of the robotic pharmacy system;

c. Removing expired drugs;

d. Proper handling of drugs that may be dropped by the robotic pharmacy system;

e. Performing routine maintenance of robotic pharmacy system as indicated by manufacturer's schedules and recommendations;

f. Accurate dispensing of drugs via robotic pharmacy system for cart fills, first doses, and cart fill updates during normal operation and during any scheduled or unscheduled downtime;

g. Appropriately investigating, identifying and correcting sources of discrepancies or errors associated with the robotic pharmacy system; and

h. Maintaining quality assurance reports.

5. Pharmacists shall perform a daily random check of medications or compliance packaging picked by the robot for 5.0% of all patients' bins and 5.0% of all first doses or cart updates. Documentation of this check shall include the pharmacist's initials for each medication checked and a description of all discrepancies found.

6. All manual picks shall be checked by pharmacists.

7. If the robot picks an incorrect medication, the pharmacy shall immediately institute a 100% check of all patients' bins or doses or compliance packages and shall immediately report the error to the board. The 100% check procedure shall continue until such time as the pharmacy provides documentation to the board showing that the cause of the error has been determined and addressed and that the robot is no longer making errors, and the board allows the pharmacy to return to a reduction in checking.

8. Quarterly quality assurance reports demonstrating the accuracy of the robot shall be maintained. At a minimum, these reports shall include:

a. A summary indicating the date and description of all discrepancies that include but are not limited to discrepancies involving the packaging, repackaging and dispensing of drugs via the robotic pharmacy system found during that quarter plus a cumulative summary since initiation of the robotic pharmacy system.

b. The total number of doses packaged or compliance packages prepared for the robotic pharmacy system and total number of doses or compliance packages picked by the robot during the quarter.

c. The total number of doses or compliance packages picked by the robot that were checked in conducting the 5.0% patient bin check, 5.0% cart updates check, and 5.0% first dose check checks.

d. Dates and time associated with any scheduled or unanticipated downtime with an explanation of the problem to include the time span of the downtime and the resolution.

9. All unanticipated downtime shall be immediately reported to the board.

10. All records required by this section shall be maintained at the address of the pharmacy for a minimum of two years. Records may be maintained in offsite storage or as an electronic image that provides an exact image of the document that is clearly legible provided such offsite or electronic storage is retrievable and made available for inspection or audit within 48 hours of a request by the board or an authorized agent.

18VAC110-20-710. Requirements for storage and security for controlled substances registrants.

A. Drugs shall be stored under conditions which meet USP-NF specifications or manufacturers' suggested storage for each drug.

B. Any drug which has exceeded the expiration date shall not be administered; it shall be separated from the stock used for administration and maintained in a separate, locked area until properly disposed.

C. If a controlled substances registrant wishes to dispose of unwanted or expired Schedule II through VI drugs, he shall transfer the drugs to another person or entity authorized to possess and to provide for proper disposal of such drugs.

D. Drugs shall be maintained in a lockable cabinet, cart, device or other area which shall be locked at all times when not in use. The keys or access code shall be restricted to the supervising practitioner and persons designated access in accordance with 18VAC110-20-700 C.

E. In a facility not staffed 24 hours a day, the drugs shall be stored in a fixed and secured room, cabinet or area which has a security device for the detection of breaking which meets the following conditions:

1. The device shall be a sound, microwave, photoelectric, ultrasonic, or any other generally accepted and suitable device.

2. The installation and device shall be based on accepted alarm industry standards.

3. The device shall be maintained in operating order, have an auxiliary source of power, be monitored in accordance with accepted industry standards, be maintained in operating order; and shall be capable of sending an alarm signal to the monitoring entity if breached and the communication line is not operational.

4. The device shall fully protect all areas where prescription drugs are stored and shall be capable of detecting breaking by any means when activated.

5. Access to the alarm system shall be restricted to only designated and necessary persons, and the system shall be activated whenever the drug storage areas are closed for business.

6. An alarm system is not required for researchers, animal control officers, humane societies, alternate delivery sites as provided in 18VAC110-20-275, or emergency medical services agencies stocking only intravenous fluids with no added drug, and teaching institutions possessing only Schedule VI drugs.

VA.R. Doc. No. R13-3624; Filed July 22, 2013, 9:59 a.m.