Part II. Pharmacies
18VAC110-20-110. Pharmacy permits generally.
A. A pharmacy permit shall not be issued to a pharmacist to be simultaneously in charge of more than two pharmacies.
B. Except in an emergency, a permit holder shall not require a pharmacist to work longer than 12 continuous hours in any work day and shall allow at least six hours of off-time between consecutive shifts. A pharmacist working longer than six continuous hours shall be allowed to take a 30-minute break.
C. The PIC or the pharmacist on duty shall control all aspects of the practice of pharmacy. Any decision overriding such control of the PIC or other pharmacist on duty shall be deemed the practice of pharmacy and may be grounds for disciplinary action against the pharmacy permit.
D. A pharmacist shall not be eligible to serve as PIC until after having obtained a minimum of two years of experience practicing as a pharmacist in Virginia or another jurisdiction in the United States. The board may grant an exception to the minimum number of years of experience for good cause shown.
E. When the PIC ceases practice at a pharmacy or no longer wishes to be designated as PIC, he shall immediately return the pharmacy permit to the board indicating the effective date on which he ceased to be the PIC.
F. Although not required by law or regulation, an outgoing PIC shall have the opportunity to take a complete and accurate inventory of all Schedules II through V controlled substances on hand on the date he ceases to be the PIC, unless the owner submits written notice to the board showing good cause as to why this opportunity should not be allowed.
G. A PIC who is absent from practice for more than 30 consecutive days shall be deemed to no longer be the PIC. Pharmacists-in-charge having knowledge of upcoming absences for longer than 30 days shall be responsible for notifying the board and returning the permit. For unanticipated absences by the PIC, which exceed 15 days with no known return date within the next 15 days, the owner shall immediately notify the board and shall obtain a new PIC.
H. An application for a permit designating the new PIC shall be filed with the required fee within 14 days of the original date of resignation or termination of the PIC on a form provided by the board. It shall be unlawful for a pharmacy to operate without a new permit past the 14-day deadline unless the board receives a request for an extension prior to the deadline. The executive director for the board may grant an extension for up to an additional 14 days for good cause shown.
I. Only one pharmacy permit shall be issued to conduct a pharmacy occupying the same designated prescription department space. A pharmacy shall not engage in any other activity requiring a license or permit from the board, such as manufacturing or wholesale-distributing, out of the same designated prescription department space.
J. Before any permit is issued, the applicant shall attest to compliance with all federal, state, and local laws and ordinances. A pharmacy permit shall not be issued to any person to operate from a private dwelling or residence after September 2, 2009.
Statutory Authority
§§ 54.1-2400 and 54.1-3307 of the Code of Virginia.
Historical Notes
Derived from VR530-01-1 § 3.1, eff. October 25, 1989; amended, Virginia Register Volume 9, Issue 4, eff. December 16, 1992; Volume 10, Issue 1, eff. November 4, 1993; Volume 11, Issue 21, eff. August 9, 1995; Volume 12, Issue 21, eff. August 7, 1996; Volume 15, Issue 8, eff. February 3, 1999; Volume 20, Issue 23, eff. August 25, 2004; Volume 25, Issue 24, eff. September 2, 2009; Volume 33, Issue 10, eff. February 8, 2017; Volume 36, Issue 6, eff. December 11, 2019.
18VAC110-20-111. Pharmacy technicians.
A. Every pharmacy that employs or uses pharmacy technicians shall maintain a site-specific training program and manual for training pharmacy technicians to work at that pharmacy. The program shall include training consistent with that specific pharmacy practice to include training in proper use of site-specific computer programs and equipment, proper use of other equipment used at the pharmacy in performing technician duties, and pharmacy calculations consistent with the duties at that pharmacy.
B. Every pharmacy shall maintain documentation of successful completion of the site specific training program for each pharmacy technician for the duration of the employment and for a period of two years from date of termination of employment. Documentation for currently employed pharmacy technicians shall be maintained on site or at another location where the records are readily retrievable upon request for inspection. After employment is terminated, such documentation may be maintained at an off-site location where it is retrievable upon request.
C. Every pharmacy that employs or uses a person enrolled in a pharmacy technician training program pursuant to § 54.1-3321 of the Code of Virginia shall allow such person to conduct tasks restricted to pharmacy technicians only if the person is currently registered as a pharmacy technician trainee.
Statutory Authority
§§ 54.1-2400 and 54.1-3307 of the Code of Virginia.
Historical Notes
Derived from Volume 19, Issue 10, eff. February 26, 2003; amended, Virginia Register Volume 25, Issue 24, eff. September 2, 2009; Volume 39, Issue 7, eff. December 21, 2022.
18VAC110-20-112. Supervision of pharmacy technicians.
A. 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 performing the duties of a pharmacy technician at one time.
B. 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.
Statutory Authority
§§ 54.1-2400 and 54.1-3307 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 36, Issue 6, eff. December 11, 2019.
18VAC110-20-120. Special or limited-use pharmacy permits.
A. For good cause shown, the board may issue a special or limited-use pharmacy permit, when the scope, degree or type of pharmacy practice or service to be provided is of a special, limited or unusual nature as compared to a regular pharmacy service. The permit to be issued shall be based on special conditions of use requested by the applicant and imposed by the board in cases where certain requirements of regulations may be waived. The following conditions shall apply:
1. The application shall list the regulatory requirements for which a waiver is requested and a brief explanation as to why each requirement should not apply to that practice.
2. A policy and procedure manual detailing the type and method of operation, hours of operation, schedules of drugs to be maintained by the pharmacy, and method of documentation of continuing pharmacist control must accompany the application.
3. The issuance and continuation of such permits shall be subject to continuing compliance with the conditions set forth by the board.
B. For a special-use pharmacy located in or providing services to a free clinic that uses volunteer pharmacists on a part-time basis with pharmacy business hours less than 20 hours a week, the board may grant a waiver to the restricted access provisions of 18VAC110-20-190 under the following conditions:
1. The access is only for the purpose of repairing or upgrading essential equipment or for the purpose of securing a delivered drug order in the pharmacy.
2. The PIC shall be notified prior to each entry and give permission for the designated, specific individuals to enter.
3. If entry is by a nonpharmacist, two persons must enter together, one of whom must be an employee or volunteer of the free clinic who holds a license as a nurse, physician, or a physician assistant. Both persons must remain in the pharmacy the entire time that access is required.
4. The key or other means of unlocking the pharmacy and the alarm access code shall be maintained in a secure location within the facility in a sealed envelope or other container with the name of the "sealing" pharmacist written across the seal. If a nonpharmacist accesses the pharmacy, this means of access may be used, and the licensed health professional, as set forth in subdivision 3 of this subsection, is responsible for resealing the means of access and writing his name across the seal. The PIC shall ensure that the alarm access code is changed within 48 hours. In lieu of the pharmacist's signature across a seal, the executive director for the board may approve other methods of securing the emergency access to the prescription department.
5. A log must be maintained of each nonpharmacist entry showing date and time of entry, names of the two persons entering, purpose for entry, and notation that permission was granted by the pharmacist-in-charge and the date it was granted. Such log shall be maintained on premises for one year.
Statutory Authority
§ 54.1-2400 and Chapters 33 (§ 54.1-3300 et seq.) and 34 (§ 54.1-3400 et seq.) of Title 54.1 of the Code of Virginia.
Historical Notes
Derived from VR530-01-1 § 3.2, eff. October 25, 1989; amended, Virginia Register Volume 9, Issue 4, eff. December 16, 1992; Volume 10, Issue 1, eff. November 4, 1993; Volume 11, Issue 21, eff. August 9, 1995; Volume 20, Issue 23, eff. August 25, 2004; Volume 25, Issue 24, eff. September 2, 2009.
18VAC110-20-121. Innovative program approval.
A. An informal conference committee of the board may approve an innovative or pilot program in accordance with § 54.1-3307.2 of the Code of Virginia upon receipt of an application and fee specified in 18VAC110-20-20.
B. If the informal conference committee determines that an inspection is necessary to adequately consider an application, it may require that the applicant pay a fee specified in 18VAC110-20-20 to cover the cost of the inspection.
C. If the informal conference committee determines that a technical consultant is necessary in order for the board to make an informed decision on approval of a program, the applicant shall pay a consultant fee, not to exceed the actual cost of the consultation.
D. In the initial order granting approval of a program, the informal conference committee shall set the approval period with a schedule for submission of required reports and outcome data. The frequency of required reports shall not exceed four times a year.
E. The informal conference committee shall determine the appropriate fee for continued approval of the program based on the requirements for review and monitoring. Such renewal fee shall not exceed $260 per approval period.
Statutory Authority
§§ 54.1-2400 and 54.1-3307 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 20, Issue 23, eff. August 25, 2004; amended, Virginia Register Volume 37, Issue 2, eff. October 14, 2020.
18VAC110-20-130. Pharmacy closings; going out of business; change of ownership.
A. At least 14 days prior to the date a pharmacy closes in accordance with § 54.1-3434.01 of the Code of Virginia or goes out of business, the owner shall notify the board. The proposed disposition of all Schedule II through VI drugs, prescription dispensing records, patient information records, and other required records shall be reported to the board. If the pharmacy drug stock and records are to be transferred to another licensee, the owner shall inform the board of the name and address of the licensee to whom the drugs and records are being transferred and the date of transfer. Prescription records for prescriptions with active refills shall be transferred to another pharmacy where a patient may obtain access for the purpose of obtaining refills either at that location or in accordance with the transfer provisions of 18VAC110-20-360.
B. Exceptions to the public notice as required in § 54.1-3434.01 of the Code of Virginia and the notice required in subsection A of this section shall be approved by the board and may include sudden closing due to fire, destruction, natural disaster, death, property seizure, eviction, bankruptcy, or other emergency circumstances. If the pharmacy is not able to meet the notification requirements of § 54.1-3434.01, the owner shall ensure that the board and public are properly notified as soon as he knows of the closure and shall disclose the emergency circumstances preventing the notification within the required deadlines.
C. In the event of an exception to the notice as required in § 54.1-3434.01 of the Code of Virginia and in subsection A of this section, the PIC or owner shall provide notice as far in advance of closing as allowed by the circumstances.
D. At least 14 days prior to any change in ownership of an existing pharmacy, the owner shall notify the board of the pending change.
1. Upon any change in ownership of an existing pharmacy, the prescription dispensing records for the two years immediately preceding the date of change of ownership and other required patient information shall be provided to the new owners on the date of change of ownership in substantially the same format as previously used immediately prior to the transfer to provide continuity of pharmacy services.
2. The previous owner shall be held responsible for assuring the proper and lawful transfer of records on the date of the transfer.
3. The format of the prescription dispensing records which are transferred to a new owner shall comply with the requirements of Chapter 34 (§ 54.1-3400 et seq.) of Title 54.1 of the Code of Virginia, and this chapter. Failure to comply with this chapter during a change in ownership shall be deemed to be a closing of the existing pharmacy for which the existing pharmacy owner shall be required to provide notice to the board and public in accordance with § 54.1-3434.01 of the Code of Virginia and subsection A of this section.
Statutory Authority
§ 54.1-2400 and Chapters 33 (§ 54.1-3300 et seq.) and 34 (§ 54.1-3400 et seq.) of Title 54.1 of the Code of Virginia.
Historical Notes
Derived from VR530-01-1 § 3.3, eff. October 25, 1989; amended, Virginia Register Volume 9, Issue 4, eff. December 16, 1992; Volume 10, Issue 1, eff. November 4, 1993; Volume 11, Issue 21, eff. August 9, 1995; Volume 12, Issue 21, eff. August 7, 1996; Volume 15, Issue 8, eff. February 3, 1999; Errata, 15:12 VA.R. 1865 March 1, 1999; Volume 20, Issue 23, eff. August 25, 2004; Volume 25, Issue 24, eff. September 2, 2009.
18VAC110-20-135. Change of hours in an existing pharmacy.
The owner of the pharmacy shall be responsible for providing notice for a change in the hours of operation to the public and to the board in accordance with § 54.1-3434 of the Code of Virginia unless the change is necessitated by emergency circumstances beyond the control of the owner, or unless the change will result in an expansion of the current hours of operation. If the pharmacy is not able to post the changes 14 days in advance, as required by § 54.1-3434, the owner shall ensure that the board is notified as soon as he knows of the change and disclose the emergency circumstances preventing the required notification.
Statutory Authority
§§ 54.1-103 and 54.1-2400 and Chapters 33 (§ 54.1-3300 et seq.) and 34 (§ 54.1-3400 et seq.) of Title 54.1 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 15, Issue 26, eff. October 13, 1999; amended, Virginia Register Volume 20, Issue 23, eff. August 25, 2004.
18VAC110-20-140. New pharmacies, acquisitions, and changes to existing pharmacies.
A. Any person wishing to open a new pharmacy, engage in the acquisition of an existing pharmacy, change the location of an existing pharmacy, move the location or make structural changes to an existing prescription department, or make changes to a previously approved security system shall file an application with the board.
B. In the acquisition of an existing pharmacy, if prescription records are to be accessible to anyone for purposes other than for continuity of pharmacy services at substantially the same level offered by the previous owner or for the necessary transfer of prescription records, the owner of the pharmacy acquiring the records shall disclose such information in writing to each patient 14 days prior to the acquisition. Such release of prescription records shall be allowed only to the extent authorized by § 32.1-127.1:03 of the Code of Virginia.
C. Although a closing inventory is not required, a complete and accurate inventory shall be taken of all Schedules II through V controlled substances on hand in accordance with § 54.1-3404 of the Code of Virginia on the date the pharmacist first engages in business under the new ownership. Inventories associated with any change in PIC shall also be performed in accordance with 18VAC110-20-110.
D. The proposed location or structural changes shall be inspected by an authorized agent of the board prior to issuance of a permit.
1. Pharmacy permit applications that indicate a requested inspection date or requests that are received after the application is filed shall be honored provided a 14-day notice is allowed prior to the requested inspection date.
2. Requested inspection dates that do not allow a 14-day notice to the board may be adjusted by the board to provide 14 days for the scheduling of the inspection.
3. At the time of the inspection, the dispensing area shall comply with 18VAC110-20-150, 18VAC110-20-160, 18VAC110-20-170, 18VAC110-20-180, and 18VAC110-20-190.
4. If an applicant substantially fails to meet the requirements for issuance of a permit and a reinspection is required or if the applicant is not ready for the inspection on the established date and fails to notify the inspector or the board at least 24 hours prior to the inspection, the applicant shall pay a reinspection fee as specified in 18VAC110-20-20 prior to a reinspection being conducted.
E. Drugs shall not be stocked within the proposed pharmacy or moved to a new location until approval is granted by the inspector or board staff.
F. Once the permit is issued, prescription drugs may not be stocked earlier than two weeks prior to the designated opening date. Once prescription drugs have been placed in the pharmacy, a pharmacist shall be present on a daily basis to ensure the safety and integrity of the drugs. If there is a change in the designated opening date, the pharmacy shall notify the board office, and a pharmacist shall continue to be on site on a daily basis.
G. If the pharmacy is not operational within 90 days from the date the permit is issued, the board shall rescind the pharmacy permit unless an extension is granted for good cause shown.
Statutory Authority
§§ 54.1-2400 and 54.1-3307 of the Code of Virginia.
Historical Notes
Derived from VR530-01-1 § 3.4, eff. October 25, 1989; amended, Virginia Register Volume 9, Issue 4, eff. December 16, 1992; Volume 10, Issue 1, eff. November 4, 1993; Volume 11, Issue 21, eff. August 9, 1995; Volume 15, Issue 26, eff. October 13, 1999; Volume 20, Issue 23, eff. August 25, 2004; Volume 25, Issue 24, eff. September 2, 2009; Volume 35, Issue 23, eff. August 22, 2019; Volume 36, Issue 6, eff. December 11, 2019.
18VAC110-20-150. Physical standards for all pharmacies.
A. The prescription department shall not be less than 240 square feet. The patient waiting area or the area used for counseling, devices, cosmetics, and proprietary medicines shall not be considered a part of the minimum 240 square feet. The total area shall be consistent with the size and scope of the services provided.
B. Access to stock rooms, rest rooms, and other areas other than an office that is exclusively used by the pharmacist shall not be through the prescription department. A rest room in the prescription department, used exclusively by pharmacists and personnel assisting with dispensing functions, may be allowed provided there is another rest room outside the prescription department available to other employees and the public. This subsection shall not apply to prescription departments in existence prior to November 4, 1993.
C. The pharmacy shall be constructed of permanent and secure materials. Trailers or other moveable facilities or temporary construction shall not be permitted.
D. The entire area of the location of the pharmacy practice, including all areas where drugs are stored, shall be well lighted and well ventilated; the proper storage temperature shall be maintained to meet USP-NF specifications for drug storage.
E. The prescription department counter work space shall be used only for the compounding and dispensing of drugs and necessary recordkeeping.
F. A sink with hot and cold running water shall be within the prescription department. A pharmacy issued a limited-use permit that does not stock prescription drugs as part of its operation is exempt from this requirement.
G. Adequate refrigeration facilities equipped with a monitoring thermometer for the storage of drugs requiring cold storage temperature shall be maintained within the prescription department if the pharmacy stocks such drugs.
H. A pharmacy stocking drugs requiring cold storage temperature shall record the temperature daily and adjust the thermostat as necessary to ensure an appropriate temperature range. The record shall be maintained manually or electronically for a period of two years.
I. The physical settings of a pharmacy in which a pharmacist initiates treatment with, dispenses, or administers drugs, devices, controlled paraphernalia, or other supplies or equipment pursuant to § 54.1-3303.1 of the Code of Virginia and 18VAC110-21-46 shall protect patient confidentiality and comply with the Health Insurance Portability and Accountability Act, 42 USC § 1320d et seq.
Statutory Authority
§§ 54.1-2400 and 54.1-3303.1 of the Code of Virginia.
Historical Notes
Derived from VR530-01-1 § 3.5, eff. October 25, 1989; amended, Virginia Register Volume 9, Issue 4, eff. December 16, 1992; Volume 10, Issue 1, eff. November 4, 1993; Volume 11, Issue 21, eff. August 9, 1995; Volume 20, Issue 23, eff. August 25, 2004; Volume 36, Issue 6, eff. December 11, 2019; Volume 39, Issue 7, eff. December 21, 2022.
18VAC110-20-160. Sanitary conditions.
A. The entire area of any place bearing the name of a pharmacy shall be maintained in a clean and sanitary manner and in good repair and order.
B. Adequate trash disposal facilities and receptacles shall be available.
Statutory Authority
§§ 54.1-103 and 54.1-2400 and Chapters 33 (§ 54.1-3300 et seq.) and 34 (§ 54.1-3400 et seq.) of Title 54.1 of the Code of Virginia.
Historical Notes
Derived from VR530-01-1 § 3.6, eff. October 25, 1989; amended, Virginia Register Volume 9, Issue 4, eff. December 16, 1992; Volume 10, Issue 1, eff. November 4, 1993; Volume 11, Issue 21, eff. August 9, 1995; Volume 20, Issue 23, eff. August 25, 2004.
18VAC110-20-170. Required minimum equipment or resources.
The PIC shall be responsible for maintaining the following:
1. A current dispensing information reference source consistent with the scope of pharmacy practice at the location of the permitted pharmacy.
2. A set of Prescription Balances, sensitive to 15 milligrams, and weights or an electronic scale if the pharmacy engages in dispensing activities that require the weighing of components.
3. Other equipment, supplies, and references consistent with the pharmacy's scope of practice and with the public safety.
Statutory Authority
§§ 54.1-103 and 54.1-2400 and Chapters 33 (§ 54.1-3300 et seq.) and 34 (§ 54.1-3400 et seq.) of Title 54.1 of the Code of Virginia.
Historical Notes
Derived from VR530-01-1 § 3.7, eff. October 25, 1989; amended, Virginia Register Volume 9, Issue 4, eff. December 16, 1992; Volume 10, Issue 1, eff. November 4, 1993; Volume 11, Issue 21, eff. August 9, 1995; Volume 15, Issue 8, eff. February 3, 1999; Volume 19, Issue 19, eff. July 2, 2003; Volume 20, Issue 23, eff. August 25, 2004.
18VAC110-20-180. Security system.
A. A device for the detection of breaking shall be installed in each prescription department of each pharmacy. The installation and the device shall be based on accepted alarm industry standards and shall be subject to the following conditions:
1. The device shall be a sound, microwave, photoelectric, ultrasonic, or any other generally accepted and suitable device.
2. The device shall have at least one hard-wired communication method, be monitored in accordance with accepted industry standards, maintained in operating order, have an auxiliary source of power, and be capable of sending an alarm signal to the monitoring entity when breached if the communication line is not operational.
3. The device shall fully protect the prescription department and shall be capable of detecting breaking by any means when activated.
4. Access to the alarm system for the prescription department area of the pharmacy shall be restricted to the pharmacists working at the pharmacy, except for access by other persons in accordance with 18VAC110-20-190 B 2, and the system shall be activated whenever the prescription department is closed for business.
5. The alarm system shall include a feature by which any breach in the alarm shall be communicated by the monitoring entity to the PIC or a pharmacist working at the pharmacy.
B. Exceptions to provisions in this section:
1. Alarm systems approved prior to November 4, 1993, will be deemed to meet the requirements of subdivisions A 1, A 2, and A 3 of this section, provided that no structural changes are made in the prescription department, that no changes are made in the security system, that the prescription department is not closed while the rest of the business remains open, and that a breaking and loss of drugs does not occur. If a breaking with a loss of drugs occurs, the pharmacy shall upgrade the alarm to meet the current standards and shall file an application with the board in accordance with 18VAC110-20-140 A within 14 days of the breaking.
2. If the prescription department was located in a business with extended hours prior to November 4, 1993, and had met the special security requirements by having a floor to ceiling enclosure, a separately activated alarm system shall not be required.
3. This section shall not apply to pharmacies that are open and staffed by pharmacists 24 hours a day. If the pharmacy changes its hours or if it must be closed for any reason, the PIC or owner must immediately notify the board, file an application in accordance with 18VAC110-20-140 A, and have installed prior to closing a security system that meets the requirements of subdivisions A 1 through A 4 of this section.
Statutory Authority
§§ 54.1-2400 and 54.1-3307 of the Code of Virginia.
Historical Notes
Derived from VR530-01-1 § 3.8, eff. October 25, 1989; amended, Virginia Register Volume 9, Issue 4, eff. December 16, 1992; Volume 10, Issue 1, eff. November 4, 1993; Volume 11, Issue 21, eff. August 9, 1995; Volume 20, Issue 23, eff. August 25, 2004; Volume 25, Issue 24, eff. September 2, 2009; Volume 36, Issue 6, eff. December 11, 2019.
18VAC110-20-190. Prescription department enclosures; access to prescription department.
A. The prescription department of each pharmacy shall be provided with enclosures subject to the following conditions:
1. The enclosure shall be constructed in such a manner that it protects the prescription drugs from unauthorized entry and from pilferage at all times whether or not a pharmacist is on duty.
2. The enclosure shall be locked and alarmed at all times when a pharmacist is not on duty.
3. The enclosure shall be capable of being locked in a secure manner at any time the pharmacist on duty is not present in the prescription department.
B. The keys or other means of entry into a locked prescription department and the alarm access code shall be restricted to pharmacists practicing at the pharmacy and authorized by the PIC with the following exceptions:
1. The PIC or a pharmacist on duty, for emergency access, may place a key or other means of unlocking the prescription department and the alarm access code in a sealed envelope or other container with the pharmacist's signature across the seal in a safe or vault or other secured place within the pharmacy. This means of emergency access shall only be used to allow entrance to the prescription department by other pharmacists, or by a pharmacy technician in accordance with subsection E of this section. In lieu of the pharmacist's signature across a seal, the executive director for the board may approve other methods of securing the emergency access to the prescription department.
2. Pharmacy interns, pharmacy technicians, and other persons authorized by the PIC or pharmacist on duty may possess a key or other means of entry into a locked prescription department only when a pharmacist is on duty. Such key or other means of entry shall not allow entry when a pharmacist is not on duty.
C. The prescription department is restricted to pharmacists who are practicing at the pharmacy. Pharmacy interns, pharmacy technicians, and other persons designated by the pharmacist on duty may be allowed access by the pharmacist but only when the pharmacist is on duty. Each pharmacist while on duty shall be responsible for the security of the pharmacy, including provisions for effective control against theft or diversion of prescription drugs and devices.
D. A PIC or pharmacist on duty shall not permit access to the prescription department or controlled substances by a pharmacist, pharmacy intern, or pharmacy technician whose license or registration is currently suspended or revoked.
E. Upon a request by a patient to obtain an already-dispensed prescription, a pharmacy technician may enter the pharmacy for the sole purpose of retrieving filled prescriptions that have already been reviewed and certified for accuracy by a pharmacist and deemed ready for delivery to the patient if:
1. There is an unforeseen, unplanned absence of a pharmacist scheduled to work during regular prescription department hours;
2. Alternate pharmacist coverage cannot immediately be obtained;
3. The technician is accompanied by a member of the pharmacy's management or administration; and
4. All requirements of subsection F of this section are met.
F. Requirements for entry into the prescription department in the absence of a pharmacist.
1. The requirements for prescriptions awaiting delivery in subsection A of 18VAC110-20-200 are followed.
2. Prior to entry into the prescription department, the pharmacy technician shall obtain verbal permission from the PIC or another pharmacist regularly employed by that pharmacy to obtain and use the emergency key or other access and alarm access code and enter the pharmacy.
3. A record shall be made by the pharmacy technician of the entry to include the date and time of entry; the name and signature of the pharmacy technician; the name, title, and signature of the person accompanying the pharmacy technician; the pharmacist's name granting permission to enter and telephone number where the pharmacist was reached; the name of the patient initially requesting needed medication and the nature of the emergency; a listing of all prescriptions retrieved during that entry; and the time of exit and re-securing of the prescription department.
4. The pharmacy technician shall reseal the key and alarm access code after the pharmacy is re-secured, and the PIC shall have the alarm access code changed within 48 hours of such an entry and shall document that this has been accomplished on the record of entry.
5. All records related to entry by a pharmacy technician shall be maintained for a period of one year on premises.
Statutory Authority
§§ 54.1-2400 and 54.1-3307 of the Code of Virginia.
Historical Notes
Derived from VR530-01-1 § 3.9, eff. October 25, 1989; amended, Virginia Register Volume 9, Issue 4, eff. December 16, 1992; Volume 10, Issue 1, eff. November 4, 1993; Volume 11, Issue 21, eff. August 9, 1995; Volume 15, Issue 8, eff. February 3, 1999; Volume 20, Issue 23, eff. August 25, 2004; Volume 25, Issue 24, eff. September 2, 2009; Volume 31, Issue 20, eff. July 16, 2015.
18VAC110-20-200. Storage of drugs, devices, and controlled paraphernalia; expired drugs.
A. Prescriptions awaiting delivery. Prescriptions prepared for delivery to the patient may be placed in a secured area outside of the prescription department, not accessible to the public, where access to the prescriptions is restricted to individuals designated by the pharmacist. With the permission of the pharmacist, the prepared prescriptions may be transferred to the patient at a time when the pharmacist is not on duty. If a prescription is delivered at a time when the pharmacist is not on duty, written procedures shall be established and followed by the pharmacy that detail security of the dispensed prescriptions and a method of compliance with counseling requirements of § 54.1-3319 of the Code of Virginia. Additionally, a log shall be made and maintained of all prescriptions delivered to a patient when a pharmacist is not present to include the patient's name, prescription number, date of delivery, and signature of the person receiving the prescription. Such log shall be maintained for a period of one year.
B. Dispersion of Schedule II drugs. Schedule II drugs shall either be dispersed with other schedules of drugs or shall be maintained within a securely locked cabinet, drawer, or safe or maintained in a manner that combines the two methods for storage. The cabinet, drawer, or safe may remain unlocked during hours that the prescription department is open and a pharmacist is on duty.
C. Safeguards for controlled paraphernalia and Schedule VI medical devices. Controlled paraphernalia and Schedule VI medical devices shall not be placed in an area completely removed from the prescription department whereby patrons will have free access to such items or where the pharmacist cannot exercise reasonable supervision and control.
D. Expired, or otherwise adulterated or misbranded drugs; security. Any drug that has exceeded the expiration date or is otherwise adulterated or misbranded shall not be dispensed or sold; it shall be separated from the stock used for dispensing. Expired prescription drugs shall be maintained in a designated area within the prescription department until proper disposal.
Statutory Authority
§§ 54.1-2400 and 54.1-3307 of the Code of Virginia.
Historical Notes
Derived from VR530-01-1 § 3.10, eff. October 25, 1989; amended, Virginia Register Volume 9, Issue 4, eff. December 16, 1992; Volume 10, Issue 1, eff. November 4, 1993; Volume 11, Issue 21, eff. August 9, 1995; Volume 15, Issue 8, eff. February 3, 1999; Volume 20, Issue 23, eff. August 25, 2004; Volume 25, Issue 24, eff. September 2, 2009; Volume 36, Issue 6, eff. December 11, 2019.
18VAC110-20-210. Disposal of drugs by pharmacies.
If a PIC wishes to dispose of unwanted drugs, he shall use one of the following procedures:
1. Transfer the drugs to another person or entity authorized to possess or provide for proper disposal of such drugs; or
2. Destroy the drugs by burning in an incinerator, or other board-approved method, in compliance with all applicable local, state, and federal laws and regulations. If Schedule II through V drugs are to be destroyed, the following procedures shall apply:
a. At least 14 days prior to the destruction date, the PIC shall provide a written notice to the board office; the notice shall state the following:
(1) Date, time, manner, and place of destruction.
(2) The names of the pharmacists who will witness the destruction process.
b. If the destruction date is to be changed or the destruction does not occur, a new notice shall be provided to the board office as set forth above in subdivision 2 of this section.
c. The actual destruction shall be witnessed by the PIC and another pharmacist not employed by the pharmacy.
d. The DEA drug destruction form shall be fully completed and used as the record of all drugs to be destroyed. A copy of the destruction form shall be retained at the pharmacy with other inventory records.
Statutory Authority
§ 54.1-2400 and Chapters 33 (§ 54.1-3300 et seq.) and 34 (§ 54.1-3400 et seq.) of Title 54.1 of the Code of Virginia.
Historical Notes
Derived from VR530-01-1 § 3.11, eff. October 25, 1989; amended, Virginia Register Volume 9, Issue 4, eff. December 16, 1992; Volume 10, Issue 1, eff. November 4, 1993; Volume 11, Issue 21, eff. August 9, 1995; Volume 12, Issue 21, eff. August 7, 1996; Volume 14, Issue 15, eff. May 13, 1998; Volume 15, Issue 8, eff. February 3, 1999; Volume 20, Issue 23, eff. August 25, 2004; Volume 25, Issue 24, eff. September 2, 2009.
18VAC110-20-211. Disposal of drugs by authorized collectors.
Any narcotic treatment program, hospital or clinic with an on-site pharmacy, or pharmacy that accepts a previously dispensed drug for the purpose of destruction shall first be authorized by the DEA as a collector. A collector so authorized may receive drugs from an ultimate user, a person lawfully entitled to dispose of an ultimate user decedent's property, or a long-term care facility on behalf of an ultimate user who resides or has resided at that facility. The process used to collect and destroy drugs, along with any required recordkeeping, shall comply with applicable federal and state law.
1. Prior to collecting drugs, an authorized collector shall submit in writing to the board:
a. The name, address, and license number, if applicable, of the facility;
b. The intended method or methods of collection (i.e., collection receptacle or mail-back program); and
c. Signature of PIC or medical director of a narcotic treatment program.
2. If an authorized collector chooses to cease acting as a collector, the PIC or medical director shall notify the board within 30 days.
3. A narcotic treatment program that does not have an in-house pharmacy shall obtain a controlled substance registration.
Statutory Authority
§§ 54.1-2400 and 54.1-3307 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 32, Issue 12, eff. March 24, 2016; amended, Virginia Register Volume 36, Issue 6, eff. December 11, 2019.
18VAC110-20-215. Outsourcing facilities.
A. Any facility in the Commonwealth engaged in the sterile compounding of drugs or devices to be dispensed without a prescription for a specific patient shall obtain a permit as an outsourcing facility from the board in accordance with § 54.1-3434.05 of the Code of Virginia. Any outsourcing facility located outside of the Commonwealth that delivers in any manner Schedules II through VI drugs or devices into the Commonwealth without a prescription for a specific patient shall be registered with the board in accordance with § 54.1-3434.5 of the Code of Virginia.
B. In order to obtain or renew a permit or registration, outsourcing facilities shall submit to the board (i) documentation that the facility is registered as an outsourcing facility under the Federal Food, Drug, and Cosmetic Act and (ii) a copy of a current inspection report consistent with § 54.1-3434.05 or 54.1-3434.5 of the Code of Virginia. Outsourcing facilities that fail to demonstrate that the facility is registered as an outsourcing facility under the Federal Food, Drug, and Cosmetic Act or submit a copy of a current inspection report consistent with § 54.1-3434.05 or 54.1-3434.5 shall not meet the requirements for an initial permit or registration or for renewal of a permit or registration.
C. An outsourcing facility shall comply with all provisions of this chapter relating to a pharmacy in Parts II (18VAC110-20-110 et seq.) and IV (18VAC110-20-240 et seq.), with the following exceptions:
1. Subsections E and F of 18VAC110-20-190, relating to dispensed prescriptions.
2. Subsection A of 18VAC110-20-200, relating to prescriptions awaiting delivery.
3. Subsections B and C of 18VAC110-20-240, relating to prescriptions and chart orders.
4. 18VAC110-20-250, relating to automated data processing prescription records.
5. Subsections C, D, E, and F of 18VAC110-20-270, relating to preparation and dispensing of prescriptions.
D. In addition to applicable requirements for pharmacies, outsourcing facilities shall comply with the following:
1. Pharmacist supervision. At all times, such facilities shall be under the supervision of a PIC who routinely practices at the location designated on the permit application. A pharmacist shall be present at all times when the facility is open for business.
2. Records.
a. All records, including the receipt and disposition of drugs or devices, shall be maintained by the facility for a period of five years and shall be available to the board upon request.
b. Compounding records shall include identification and strength of the drugs and shall provide the ingredients, expiration dates, and the source of such ingredients. Records shall also include the national drug code number of the source drug or bulk active ingredient, if available; the strength of the active ingredient per unit; the dosage form and route of administration; the package description; the number of individual units produced; the national drug code number of the final product, if assigned, or lot number; and an appropriately assigned expiration date or beyond-use date.
c. Outsourcing facilities shall maintain quality control records to include stability and sterility testing for determining beyond-use dating.
E. No outsourcing facility may distribute or dispense any drug to any person pursuant to a prescription unless it also maintains a current active pharmacy permit. The pharmacy shall comply with all state and federal laws, regulations, and requirements, except it shall compound in compliance with current good manufacturing practices under § 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (21 USC § 351(a)(2)(B)).
Statutory Authority
§§ 54.1-2400, 54.1-3434.05, and 54.1-3434.5 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 33, Issue 20, eff. June 28, 2017.