Administrative Code

Virginia Administrative Code
6/13/2024

Part V. Prescription Order and Dispensing Standards

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

A. In addition to the requirements in § 54.1-3408.01 of the Code of Virginia for an oral prescription or written prescription, including those transmitted via facsimile or electronically, a prescription shall include a quantity or duration of the order by which the pharmacist can calculate the authorized quantity using directions for use. Except for prescriptions transmitted electronically in compliance with 18VAC110-20-285, written prescriptions shall also include the prescriber's manual signature. In cases of failed electronic prescriptions, Schedule VI prescriptions transmitted electronically may be routed to the pharmacy's facsimile machine and may bear an electronic signature.

B. After the prescription has been prepared and prior to the delivery of the order, 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 each pharmacist 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.

C. 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.

D. 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 may refuse to 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.

E. An on-hold prescription shall be entered into the automated data processing system if such system is employed by the pharmacy, and a pharmacist shall verify the accuracy of the data entry at that time. The pharmacist subsequently dispensing the on-hold prescription on a future date shall, at a minimum, conduct a prospective drug review consistent with § 54.1-3319 A of the Code of Virginia. If an on-hold prescription is returned to a patient prior to the initial dispensing of the drug, the pharmacist shall delete the entry in the automated data processing system.

F. A pharmacy may use a drop box for the collection of written prescriptions and refill requests. The drop box shall be located in a visible area within the permitted facility and shall be locked at all times with access to the items placed in the drop box restricted to pharmacists practicing at the pharmacy or an authorized pharmacy technician practicing at the pharmacy when a pharmacist is on duty. The drop box shall be constructed in a manner to prevent the theft or loss of a written prescription or confidential information and shall be bolted to the floor or a fixed structure. Pharmacists shall in some manner inform the public that containers left in a drop box for refill should not contain unused drugs.

Statutory Authority

§§ 54.1-2400 and 54.1-3307 of the Code of Virginia.

Historical Notes

Derived from VR530-01-1 § 6.1, 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 15, Issue 8, eff. February 3, 1999; Volume 18, Issue 12, eff. March 27, 2002; Errata, 19:11 VA.R. 1790 February 10, 2003; amended, Virginia Register Volume 25, Issue 24, eff. September 2, 2009; Volume 26, Issue 2, eff. October 28, 2009; Volume 29, Issue 25, eff. September 26, 2013; Volume 30, Issue 10, eff. February 12, 2014; Volume 36, Issue 6, eff. December 11, 2019.

18VAC110-20-275. Delivery of dispensed prescriptions.

A. Pursuant to § 54.1-3420.2 B of the Code of Virginia, in addition to direct hand delivery to a patient or patient's agent or delivery to a patient's residence, a pharmacy may deliver a dispensed prescription drug order for Schedule VI controlled substances to another pharmacy, to a practitioner of the healing arts licensed to practice pharmacy or to sell controlled substances, or to an authorized person or entity holding a controlled substances registration issued for this purpose in compliance with this section and any other applicable state or federal law. Prescription drug orders for Schedule II through Schedule V controlled substances may not be delivered to an alternate delivery location unless such delivery is authorized by federal law and regulations of the board.

B. Delivery to another pharmacy.

1. One pharmacy may fill prescriptions and deliver the prescriptions to a second pharmacy for patient pickup or direct delivery to the patient provided the two pharmacies have the same owner, or have a written contract or agreement specifying the services to be provided by each pharmacy, the responsibilities of each pharmacy, and the manner in which each pharmacy will comply with all applicable federal and state law.

2. Each pharmacy using such a drug delivery system shall maintain and comply with all procedures in a current policy and procedure manual that includes the following information:

a. A description of how each pharmacy will comply with all applicable federal and state law;

b. The procedure for maintaining required, retrievable dispensing records to include which pharmacy maintains the hard-copy prescription, which pharmacy maintains the active prescription record for refilling purposes, how each pharmacy will access prescription information necessary to carry out its assigned responsibilities, method of recordkeeping for identifying the pharmacist responsible for dispensing the prescription and counseling the patient, and how and where this information can be accessed upon request by the board;

c. The procedure for tracking the prescription during each stage of the filling, dispensing, and delivery process;

d. The procedure for identifying on the prescription label all pharmacies involved in filling and dispensing the prescription;

e. The policy and procedure for providing adequate security to protect the confidentiality and integrity of patient information;

f. The policy and procedure for ensuring accuracy and accountability in the delivery process;

g. The procedure and recordkeeping for returning to the initiating pharmacy any prescriptions that are not delivered to the patient; and

h. The procedure for informing the patient and obtaining consent for using such a dispensing and delivery process.

3. Drugs waiting to be picked up at or delivered from the second pharmacy shall be stored in accordance with subsection A of 18VAC110-20-200.

C. Delivery to a practitioner of the healing arts licensed by the board to practice pharmacy or to sell controlled substances or other authorized person or entity holding a controlled substances registration authorized for this purpose.

1. A prescription may be delivered by a pharmacy to the office of such a practitioner or other authorized person provided there is a written contract or agreement between the two parties describing the procedures for such a delivery system and the responsibilities of each party.

2. Each pharmacy using this delivery system shall maintain a policy and procedure manual that includes the following information:

a. Procedure for tracking and assuring security, accountability, integrity, and accuracy of delivery for the dispensed prescription from the time it leaves the pharmacy until it is handed to the patient or agent of the patient;

b. Procedure for providing counseling;

c. Procedure and recordkeeping for return of any prescription medications not delivered to the patient;

d. The procedure for assuring confidentiality of patient information; and

e. The procedure for informing the patient and obtaining consent for using such a delivery process.

3. Prescriptions waiting to be picked up by a patient at the alternate site shall be stored in a lockable room or lockable cabinet, cart, or other device that cannot be easily moved and that shall be locked at all times when not in use. Access shall be restricted to the licensed practitioner of the healing arts or the responsible party listed on the application for the controlled substances registration, or either person's designee.

D. The contracts or agreements and the policy and procedure manuals required by this section for alternate delivery shall be maintained both at the originating pharmacy as well as the alternate delivery site.

E. A controlled substances registration as an alternate delivery site shall only be issued to an entity without a prescriber or pharmacist present at all times the site is open if there is a valid patient health or safety reason not to deliver dispensed prescriptions directly to the patient and if compliance with all requirements for security, policies, and procedures can be reasonably assured.

F. The pharmacy and alternate delivery site shall be exempt from compliance with subsections B through E of this section if (i) the alternate delivery site is a pharmacy, a practitioner of healing arts licensed by the board to practice pharmacy or sell controlled substances, or other entity holding a controlled substances registration for the purpose of delivering controlled substances; (ii) the alternate delivery site does not routinely receive deliveries from the pharmacy; and (iii) compliance with subsections B through E of this section would create a delay in delivery that may result in potential patient harm. However, the pharmacy and alternate delivery site shall comply with following requirements:

1. To ensure appropriate coordination of patient care, the pharmacy shall notify the alternate delivery site of the anticipated arrival date of the shipment, the exact address to where the drug was shipped, the name of the patient for whom the drug was dispensed, and any special storage requirements.

2. The pharmacy shall provide counseling or ensure a process is in place for the patient to receive counseling.

3. Prescriptions delivered to the alternate delivery site shall be stored in a lockable room or lockable cabinet, cart, or other device that cannot be easily moved and that shall be locked at all times when not in use. Access shall be restricted to the licensed prescriber, pharmacist, or either person's designee.

4. The pharmacy shall provide a procedure for the return of any prescription drugs not delivered or subsequently administered to the patient.

G. A pharmacy shall not deliver dispensed drugs to a patient's residence that are intended to be subsequently transported by the patient or patient's agent to a hospital, medical clinic, prescriber's office, or pharmacy for administration and that require special storage, reconstitution or compounding prior to administration. An exception to this requirement may be made for patients with inherited bleeding disorders who may require therapy to prevent or treat bleeding episodes.

Statutory Authority

§§ 54.1-2400 and 54.1-3307 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 19, Issue 20, eff. July 16, 2003; amended, Virginia Register Volume 22, Issue 21, eff. September 10, 2006; Volume 25, Issue 24, eff. September 2, 2009; Volume 28, Issue 23, eff. August 15, 2012; Volume 37, Issue 19, eff. June 9, 2021.

18VAC110-20-276. Central or remote processing.

A. Centralized or remote processing of a prescription does not include the dispensing of a drug, but does include any of the following activities related to the dispensing process:

1. Receiving, interpreting, analyzing, or clarifying prescriptions;

2. Entering prescription and patient data into a data processing system;

3. Transferring prescription information;

4. Performing a prospective drug review as set forth in § 54.1-3319 of the Code of Virginia;

5. Obtaining refill or substitution authorizations, or otherwise communicating with the prescriber concerning a patient's prescription;

6. Interpreting clinical data for prior authorization for dispensing;

7. Performing therapeutic interventions; or

8. Providing drug information or counseling concerning a patient's prescription to the patient or patient's agent.

B. A pharmacy may outsource certain prescription processing functions as described in subsection A of this section to another pharmacy in Virginia or a registered nonresident pharmacy under the following conditions:

1. The pharmacies shall either have the same owner or have a written contract describing the scope of services to be provided and the responsibilities and accountabilities of each pharmacy in compliance with all federal and state laws and regulations related to the practice of pharmacy;

2. Any central or remote pharmacy shall comply with Virginia law and regulation with respect to requirements for supervision of pharmacy technicians and the duties that are restricted to pharmacists and pharmacy technicians. Pharmacy technicians at the remote pharmacy shall either be registered in Virginia or possess credentials substantially equivalent to those required for a technician registered in Virginia;

3. A pharmacist licensed in Virginia, whether at the remote pharmacy or the dispensing pharmacy, shall perform a check for accuracy on all processing done by the remote processor; and

4. The pharmacies shall share a common electronic file or have technology that allows sufficient information necessary to process a nondispensing function.

C. Any pharmacy that outsources prescription processing to another pharmacy shall provide notification of such to patients. A one-time written notification or a sign posted in the pharmacy in a location that is readily visible to the public will satisfy this notification requirement. The notice shall state the name of any contract pharmacy providing central or remote prescription processing. If the pharmacy uses a network of pharmacies under common ownership, this fact shall be disclosed in the notice.

D. A policy and procedure manual that relates to central or remote processing shall be maintained at each pharmacy involved in the processing of a prescription and available for inspection. The manual shall at a minimum include the following:

1. The responsibilities of each pharmacy;

2. A list of the name, address, telephone numbers, and permit/registration numbers of all pharmacies involved in central or remote processing;

3. Procedures for protecting the confidentiality and integrity of patient information;

4. Procedures for ensuring that pharmacists performing prospective drug reviews have access to appropriate drug information resources;

5. Procedures for maintaining required records;

6. Procedures for complying with all applicable laws and regulations to include counseling;

7. Procedures for objectively and systematically monitoring and evaluating the quality of the program to resolve problems and improve services; and

8. Procedures for annually reviewing the written policies and procedures for needed modifications and documenting such review.

E. In addition to any other required records, pharmacies engaged in central or remote processing shall maintain retrievable records that show, for each prescription processed, each individual processing function and identity of the pharmacist or pharmacy technician who performs a processing function and the pharmacist who checked the processing function, if applicable.

1. The records may be maintained separately by each pharmacy, or in a common electronic file shared by both pharmacies provided the system can produce a record showing each processing task, the identity of the person performing each task, and the location where each task was performed.

2. The record shall be readily retrievable for at least the past two years through the primary dispensing pharmacy, and shall be available for inspection by the board.

F. Nothing in this section shall prohibit an individual employee licensed as a pharmacist in Virginia from accessing the employer pharmacy's database from a remote location for the purpose of performing certain prescription processing functions as described in subsection A of this section, provided the pharmacy establishes controls to protect the privacy and security of confidential records.

Statutory Authority

§§ 54.1-2400 and 54.1-3307 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 21, Issue 24, eff. September 7, 2005.

18VAC110-20-280. Transmission of a prescription order by facsimile device.

A. Unless otherwise prohibited by federal law, prescription orders for Schedules III through VI drugs may be transmitted to pharmacies by facsimile (fax) device upon the following conditions:

1. The prescription shall be faxed only to the pharmacy of the patient's choice.

2. A valid faxed prescription shall contain all required information for a prescription. A written prescription shall include the prescriber's signature.

3. An authorized agent, as defined in § 54.1-3408.01 C of the Code of Virginia, may transmit an oral prescription by facsimile and shall record on the faxed prescription the agent's full name and wording that clearly indicates that the prescription being transmitted is an oral prescription.

4. A faxed prescription shall be valid only if faxed from the prescriber's practice location, except in the following situations:

a. Forwarding a faxed chart order from a long-term care facility or from a hospice, including a home hospice;

b. Faxing an oral prescription by authorized agent under the conditions set forth in subdivision 3 of this subsection; or

c. Forwarding a written prescription by an authorized agent from a long-term care facility, provided the provider pharmacy maintains written procedures for such transactions and provided the original prescription is obtained by the provider pharmacy within seven days of dispensing. The original prescription shall be attached to the faxed copy.

5. The following additional information shall be recorded on the faxed prescription:

a. The date that the prescription was faxed;

b. The printed name, address, phone number, and fax number of the authorized prescriber; and

c. The institution, if applicable, from which the prescription was faxed, including address, phone number, and fax number.

B. Prescription orders for Schedule II drugs may only be faxed for information purposes and may not serve as the original written prescription authorizing dispensing, except for orders to be administered to long-term care facility and home infusion patients in accordance with § 54.1-3408.01 B of the Code of Virginia and except for prescriptions written for a Schedule II narcotic substance for patients residing in a hospice certified by Medicare under Title XVIII or licensed by the state, which may include home hospice. The prescriber shall note on the prescription if the patient is a hospice patient, and the prescription shall meet all requirements for a written prescription, including the prescriber's manual signature.

C. If the faxed prescription is of such quality that the print will fade and not remain legible for the required retention period, the receiving pharmacist shall copy or transcribe the faxed prescription on paper of permanent quality.

D. Authorizations for refills may be faxed by the prescriber to the pharmacy provided the authorization includes patient name, address, drug name and strength, quantity, directions for use, prescriber's name, prescriber's manual signature or agent's name, and date of authorization.

Statutory Authority

§§ 54.1-2400 and 54.1-3307 of the Code of Virginia.

Historical Notes

Derived from VR530-01-1 § 6.2, 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 12, Issue 21, eff. August 7, 1996; Volume 15, Issue 8, eff. February 3, 1999; Volume 18, Issue 12, eff. March 27, 2002; Volume 20, Issue 23, eff. August 25, 2004; Volume 25, Issue 24, eff. September 2, 2009; Volume 36, Issue 6, eff. December 11, 2019.

18VAC110-20-285. Electronic transmission of prescriptions from prescriber to pharmacy.

A. Unless otherwise prohibited by law, an electronic prescription may be transmitted from the prescriber or an authorized agent as defined in § 54.1-3408.01 C of the Code of Virginia directly to the dispensing pharmacy. Electronic prescriptions of Schedule II-V controlled substances shall comply with any security or other requirements of federal law. All electronic prescriptions shall also comply with all security requirements of state law related to privacy of protected health information.

B. A pharmacy receiving an electronic prescription shall maintain such prescription record in accordance with 18VAC110-20-250 A.

C. An electronic prescription shall be transmitted only to the pharmacy of the patient's choice.

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 Virginia Register Volume 12, Issue 21, eff. August 7, 1996; amended, Virginia Register Volume 18, Issue 12, eff. March 27, 2002; Volume 20, Issue 23, eff. August 25, 2004; Volume 23, Issue 17, eff. May 30, 2007; Volume 26, Issue 22, eff. August 4, 2010.

18VAC110-20-286. Chart orders for outpatients.

A chart order may be filled by an outpatient (community/retail) pharmacy for outpatient use provided the following conditions are met:

1. The chart order was written for a patient while in a hospital or long-term care facility.

2. The pharmacist has all information necessary to constitute a valid outpatient prescription.

3. The pharmacist in an outpatient setting has direction, either written or obtained verbally, that the chart order is actually intended to be outpatient or discharge prescription orders, and not merely a listing drugs the patient was taking while an inpatient.

4. The orders include some direction related to quantity to be dispensed or authorized duration of the order by which the pharmacist can calculate the authorized quantity using directions for use and duration.

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 Virginia Register Volume 25, Issue 24, eff. September 2, 2009.

18VAC110-20-290. Dispensing of Schedule II drugs.

A. A prescription for a Schedule II drug shall be dispensed in good faith but in no case shall it be dispensed more than six months after the date on which the prescription was issued.

B. A prescription for a Schedule II drug shall not be refilled except as authorized under the conditions for partial dispensing as set forth in 18VAC110-20-310.

C. In case of an emergency situation, a pharmacist may dispense a drug listed in Schedule II upon receiving oral authorization of a prescribing practitioner provided that:

1. The quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period;

2. The prescription shall be immediately reduced to writing by the pharmacist and shall contain all information required in § 54.1-3410 of the Drug Control Act, except for the signature of the prescribing practitioner;

3. If the pharmacist does not know the practitioner, the pharmacist shall make a reasonable effort to determine that the oral authorization came from a practitioner using the practitioner's phone number as listed in the telephone directory or other good-faith efforts to ensure the practitioner's identity; and

4. Within seven days after authorizing an emergency oral prescription, the prescribing practitioner shall cause a written prescription for the emergency quantity prescribed to be delivered to the dispensing pharmacist. In addition to conforming to the requirements of § 54.1-3410 of the Drug Control Act, the prescription shall have written on its face "Authorization for Emergency Dispensing" and the date of the oral order. The written prescription may be delivered to the pharmacist in person or by mail postmarked within the seven-day period or transmitted as an electronic prescription in accordance with federal law and regulation to include annotation of the electronic prescription with the original authorization and date of the oral order. Upon receipt, the dispensing pharmacist shall attach the paper prescription to the oral emergency prescription, which had earlier been reduced to writing. The pharmacist shall notify the nearest office of the Drug Enforcement Administration and the board if the prescribing practitioner fails to deliver a written prescription to the pharmacist. Failure of the pharmacist to do so shall void the authority conferred by this subdivision to dispense without a written prescription of a prescribing practitioner.

D. When presented a prescription written for a Schedule II controlled substance, a pharmacist may add or correct the patient's address upon verification, correct the patient's name upon verification, or add the prescriber's DEA registration number to the prescription. The pharmacist may add or change the dosage form, drug strength, directions for use, drug quantity, or issue date only after oral consultation directly with and agreement of the prescriber. Such consultations and corresponding changes shall be noted by the pharmacist on the prescription. The pharmacist shall not add or change the prescriber's signature or make changes to the controlled substance prescribed, except for dispensing therapeutically equivalent drugs as permitted by law.

Statutory Authority

§§ 54.1-2400 54.1-3307 of the Code of Virginia.

Historical Notes

Derived from VR530-01-1 § 6.3, 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; Volume 26, Issue 22, eff. August 4, 2010; Volume 36, Issue 6, eff. December 11, 2019.

18VAC110-20-300. (Repealed.)

Historical Notes

Derived from VR530-01-1 § 6.3, eff. October 25, 1989; repealed, Virginia Register Volume 12, Issue 21, eff. August 7, 1996.

18VAC110-20-310. Partial dispensing of Schedule II prescriptions.

A. The partial filling of a prescription for a drug listed in Schedule II is permissible if the pharmacist is unable to supply the full quantity called for in a written or emergency oral prescription, and he makes a notation of the quantity supplied on the face of the written prescription. The remaining portion of the prescription may be dispensed within 72 hours of the first partial dispensing; however, if the remaining portion is not or cannot be dispensed within the 72-hour period, the pharmacist shall so notify the prescribing practitioner. No further quantity may be supplied beyond 72 hours without a new prescription.

B. Prescriptions for Schedule II drugs written for patients in long-term care facilities may be dispensed in partial quantities, to include individual dosage units. For each partial dispensing, the dispensing pharmacist shall record on the back of the prescription (or on another appropriate record, uniformly maintained and readily retrievable) the date of the partial dispensing, quantity dispensed, remaining quantity authorized to be dispensed, and the identification of the dispensing pharmacist. The total quantity of Schedule II drugs in all partial dispensing shall not exceed the total quantity prescribed. Schedule II prescriptions shall be valid for a period not to exceed 60 days from the issue date unless sooner terminated by the discontinuance of the drug.

C. Information pertaining to current Schedule II prescriptions for patients in a long-term care facility may be maintained in a computerized system if this system has the capability to permit:

1. Output (display or printout) of the original prescription number, date of issue, identification of prescribing practitioner, identification of patient, identification of the long-term care facility, identification of drug authorized (to include dosage form, strength, and quantity), listing of partial dispensing under each prescription, and the information required in subsection B of this section.

2. Immediate (real time) updating of the prescription record each time a partial dispensing of the prescription is conducted.

D. A prescription for a Schedule II drug may be filled in partial quantities to include individual dosage units for a patient with a medical diagnosis documenting a terminal illness under the following conditions:

1. The practitioner shall classify the patient as terminally ill, and the pharmacist shall verify and record such notation on the prescription.

2. On each partial filling, the pharmacist shall record the date, quantity dispensed, remaining quantity authorized to be dispensed, and the identity of the dispensing pharmacist.

3. Prior to the subsequent partial filling, the pharmacist shall determine that it is necessary. The total quantity of Schedule II drugs dispensed in all partial fillings shall not exceed the total quantity prescribed.

4. Schedule II prescriptions for terminally ill patients may be partially filled for a period not to exceed 60 days from the issue date unless terminated sooner.

5. Information pertaining to partial filling may be maintained in a computerized system under the conditions set forth in subsection C of this section.

E. A prescription for a Schedule II drug may be filled in partial quantities if the partial fill is requested by the patient or by the practitioner who wrote the prescription provided:

1. The total quantity dispensed in all partial fillings does not exceed the total quantity prescribed;

2. The prescription is written and filled in accordance with state and federal law; and

3. The remaining portions are filled not later than 30 days after the date on which the prescription is written.

Statutory Authority

§§ 54.1-2400 and 54.1-3307 of the Code of Virginia.

Historical Notes

Derived from VR530-01-1 § 6.5, 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 12, Issue 21, eff. August 7, 1996; Volume 33, Issue 24, eff. September 7, 2017.

18VAC110-20-320. Dispensing or refilling of Schedules III through VI prescriptions.

A. A prescription for a drug listed in Schedule III, IV, or V shall not be dispensed or refilled more than six months after the date on which such prescription was issued, and no such prescription authorized to be filled may be refilled more than five times.

1. Each refilling of a prescription shall be entered on the back of the prescription or on another record in accordance with § 54.1-3412 of the Code of Virginia and 18VAC110-20-255, initialed, and dated by the pharmacist as of the date of dispensing. If the pharmacist merely initials and dates the prescription, it shall be presumed that the entire quantity ordered was dispensed.

2. The partial dispensing of a prescription for a drug listed in Schedule III, IV, or V is permissible, provided that:

a. Each partial dispensing is recorded in the same manner as a refilling;

b. The total quantity of drug dispensed in all partial dispensing does not exceed the total quantity prescribed; and

c. No dispensing occurs after six months after the date on which the prescription order was issued.

B. A prescription for a drug listed in Schedule VI may be refilled as authorized by the practitioner. If no such authorization is given, the prescription shall not be refilled, except as provided in § 54.1-3410 C or subdivision 4 of § 54.1-3411 of the Code of Virginia. Except for drugs classified by the American Hospital Formulary Service as psychotherapeutic agents, anxiolytics, sedatives, or hypnotics or for drugs of concern as defined in § 54.1-2519 of the Code of Virginia, a pharmacist, using professional judgment and upon request by the patient, may dispense or refill a drug listed in Schedule VI with any quantity, up to the total amount authorized, taking all refills into consideration.

A prescription for a Schedule VI drug or device shall not be dispensed or refilled more than one year after the date on which it was issued unless the prescriber specifically authorizes dispensing or refilling for a longer period of time not to exceed two years.

C. As an alternative to all manual recordkeeping requirements provided for in subsections A and B of this section, an automated data processing system as provided in 18VAC110-20-250 may be used for the storage and retrieval of all or part of dispensing information for prescription drugs dispensed.

D. The timing of dispensing an authorized refill of a prescription shall be within reasonable conformity with the directions for use as indicated by the practitioner; if directions have not been provided, then any authorized refills may only be dispensed in reasonable conformity with the recommended dosage and with the exercise of sound professional judgment. An authorized refill may be dispensed early provided the pharmacist documents a valid reason for the necessity of the early refill.

Statutory Authority

§§ 54.1-2400 and 54.1-3307 of the Code of Virginia.

Historical Notes

Derived from VR530-01-1 § 6.6, 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 12, Issue 21, eff. August 7, 1996; Volume 19, Issue 20, eff. July 16, 2003; Volume 22, Issue 7, eff. January 11, 2006; Volume 25, Issue 24, eff. September 2, 2009; Volume 35, Issue 3, eff. October 31, 2018.

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