Administrative Code

Virginia Administrative Code
6/20/2024

Part XVI. Controlled Substances Registration for Other Persons or Entities

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

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

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

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

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

Statutory Authority

§ 54.1-2400 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 28, Issue 23, eff. August 15, 2012; amended, Virginia Register Volume 32, Issue 14, eff. April 21, 2016.

18VAC110-20-690. Persons or entities authorized or required to obtain a controlled substances registration.

A. A person or entity that maintains or intends to maintain a supply of Schedules II through Schedule VI controlled substances, other than manufacturers' samples, in accordance with provisions of the Drug Control Act (§ 54.1-3400 et seq. of the Code of Virginia) may apply for a controlled substances registration on forms approved by the board.

B. Persons or entities that may be registered by the board shall include hospitals without in-house pharmacies, nursing homes without in-house pharmacies that use automated drug dispensing systems, ambulatory surgery centers, outpatient clinics, alternate delivery sites, crisis stabilization units, persons authorized by the Department of Behavioral Health and Developmental Services to train individuals on the administration of naloxone and to dispense naloxone for opioid overdose reversal, and emergency medical services agencies provided such persons or entities are otherwise authorized by law and hold required licenses or appropriate credentials to administer the drugs for which the registration is being sought.

C. In determining whether to register an applicant, the board shall consider factors listed in subsections A and D of § 54.1-3423 of the Code of Virginia and compliance with applicable requirements of this chapter.

1. The proposed location shall be inspected by an authorized agent of the board prior to issuance of a controlled substances registration.

2. Controlled substances registration 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.

3. 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.

4. Any person wishing to change an approved location of the drug stock, make structural changes to an existing approved drug storage location, or make changes to a previously approved security system shall file an application with the board and be inspected.

5. Drugs shall not be stocked within the proposed drug storage location or moved to a new location until approval is granted by the board.

D. The application shall be signed by a person who will act as a responsible party for the controlled substances. The responsible party may be a prescriber, nurse, pharmacist, pharmacy technician for alternate delivery sites, a person authorized by the Department of Behavioral Health and Developmental Services to train individuals on the administration of naloxone and to dispense naloxone for opioid overdose reversal, or other person approved by the board who is authorized to administer the controlled substances.

E. The board may require a person or entity to obtain a controlled substances registration upon a determination that Schedules II through VI controlled substances have been obtained and are being used as common stock by multiple practitioners and that one or more of the following factors exist:

1. A federal, state, or local government agency has reported that the person or entity has made large purchases of controlled substances in comparison with other persons or entities in the same classification or category.

2. The person or entity has experienced a diversion, theft, or other unusual loss of controlled substances which requires reporting pursuant to § 54.1-3404 of the Drug Control Act.

3. The person or entity has failed to comply with recordkeeping requirements for controlled substances.

4. The person or entity or any other person with access to the common stock has violated any provision of federal, state, or local law or regulation relating to controlled substances.

F. The board may issue a controlled substance registration to an entity at which a patient is being treated by the use of instrumentation and diagnostic equipment through which images and medical records may be transmitted electronically for the purpose of establishing a bona fide practitioner-patient relationship and is being prescribed Schedules II through VI controlled substances when such prescribing is in compliance with federal requirements for the practice of telemedicine and the patient is not in the physical presence of a practitioner registered with the U.S. Drug Enforcement Administration provided:

1. There is a documented need for such registration, and issuance of the registration of the entity is consistent with the public interest;

2. The entity is under the general supervision of a licensed pharmacist or a practitioner of medicine, osteopathy, podiatry, dentistry, or veterinary medicine; and

3. The application is signed by a person who will act as the responsible party for the entity for the purpose of compliance with provisions of this subsection. The responsible party shall be a prescriber, nurse, pharmacist, or other person who is authorized by provisions of § 54.1-3408 of the Code of Virginia to administer controlled substances.

Statutory Authority

§ 54.1-2400 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; Volume 25, Issue 24, eff. September 2, 2009; Volume 26, Issue 22, eff. August 4, 2010; Volume 28, Issue 23, eff. August 15, 2012; Volume 35, Issue 9, eff. January 23, 2019.

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

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

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

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

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

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

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

D. The supervising practitioner shall establish procedures for and provide training as necessary to ensure compliance with all requirements of law and regulation, including storage, security, and recordkeeping.

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

Statutory Authority

§ 54.1-2400 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; Volume 25, Issue 24, eff. September 2, 2009; Volume 28, Issue 23, eff. August 15, 2012; Volume 32, Issue 14, eff. April 21, 2016; Volume 35, Issue 9, eff. January 23, 2019.

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

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

B. Any drug that 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 Schedules 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 that 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 that has a security device for the detection of breaking that 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, emergency medical services agencies stocking only intravenous fluids with no added drug, persons authorized by the Department of Behavioral Health and Developmental Services to train individuals on the administration of naloxone and to dispense naloxone for opioid overdose reversal, and teaching institutions possessing only Schedule VI drugs.

Statutory Authority

§ 54.1-2400 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; Volume 22, Issue 21, eff. September 10, 2006; Volume 25, Issue 24, eff. September 2, 2009; Volume 28, Issue 5, eff. December 22, 2011; Volume 29, Issue 25, eff. September 26, 2013; Volume 35, Issue 9, eff. January 23, 2019.

18VAC110-20-720. Requirements for recordkeeping.

The person named as the responsible party on the controlled substances registration shall be responsible for recordkeeping for Schedule II through VI drugs in accordance with provisions of § 54.1-3404 of the Code of Virginia and the following:

1. Inventories and administration records of Schedule II drugs shall be maintained separately from all other records and shall be kept in chronological order by date of administration.

2. All records shall be maintained at the same location as listed on the controlled substances registration or, if maintained in an off-site database, retrieved and made available for inspection or audit within 48 hours of a request by the board or an authorized agent.

3. In the event that an inventory is taken as the result of a theft of drugs, the inventory shall be used as the opening inventory within the current biennial period. Such an inventory does not preclude the taking of the required inventory on the required biennial inventory date. All inventories required by § 54.1-3404 of the Code of Virginia shall be signed and dated by the person taking the inventory and shall indicate whether the inventory was taken prior to the opening or after the close of business on that date. An entity which is open 24 hours a day shall clearly document whether the receipt or distribution of drugs on the inventory date occurred before or after the inventory was taken.

4. Any computerized system used to maintain records shall also provide retrieval via computer monitor display or printout of the history for drugs administered during the past two years. It shall also have the capacity of producing a printout of any data which the registrant is responsible for maintaining under the Drug Control Act (§ 54.1-3400 et seq. of the Code of Virginia).

5. The Department of Forensic Science may exclude from any inventory quantities of controlled substances used to conduct chemical analyses and controlled substances received for analyses as evidentiary material as provided in § 54.1-3404 G of the Code of Virginia.

Statutory Authority

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 18, eff. July 1, 2004; Volume 23, Issue 4, eff. November 29, 2006.

18VAC110-20-725. Repackaging by a CSB, BHA, or PACE site.

A. Definition. For purposes of this section, "repackaging" shall mean removing a drug from a container already dispensed and labeled by a pharmacy or medical practitioner authorized to dispense, for a particular client of a CSB, BHA, or PACE site, and placing it in a container designed for a person to be able to repackage his own dispensed prescription medications to assist with self-administration and compliance with dosage instructions. Such repackaging shall not include the preparation of a patient-specific label that includes drug name, strength, or directions for use or any other process restricted to a pharmacist or pharmacy technician under the direct supervision of a pharmacist.

B. Persons authorized to repackage. Repackaging shall be performed by a pharmacist, pharmacy technician, nurse, or such other person who has successfully completed a board-approved training program for repackaging of prescription drug orders as authorized in § 54.1-3420.2 of the Code of Virginia. A CSB, BHA, or PACE site using such other person shall maintain documentation of completion of an approved training program for at least one year from date of termination of employment or cessation of repackaging activities.

C. Requirements for repackaging.

1. The repackaging of a dispensed prescription drug order pursuant to § 54.1-3420.2 of the Code of Virginia shall only be done at a CSB, BHA, or PACE site.

2. The repackaging of dispensed prescription drugs shall be restricted to solid oral dosage forms and a maximum of a 14-day supply of drugs.

3. The drug container used for repackaging pursuant to this section shall bear a label containing the client's first and last name and name and 24-hour contact information for the CSB, BHA, or PACE site.

4. A clean, well-closed container that assists the client with self-administration shall be used when multiple doses of a repackaged drug are provided to the client at one time.

5. A prescription drug order shall not be repackaged beyond the assigned expiration date noted on the prescription label of the dispensed drug, if applicable, or beyond one year from the date the drug was originally dispensed by a pharmacy, whichever date is earlier.

D. Written information for client. At the time a repackaged drug is initially given to a client, and upon any subsequent change in the medication order, the client shall be provided written information about the name and strength of the drug and the directions for use. Such written information shall have been prepared by a pharmacy or by a nurse at the CSB, BHA, or PACE site.

E. Retention, storage, and destruction of repackaged drugs.

1. Any portion of a client's prescription drug order not placed into a container intended to assist with self-administration may be either given to the client or retained by the CSB, BHA, or PACE site for subsequent repackaging. If retained by the CSB, BHA, or PACE site, the remaining portion shall be stored within the board-approved drug storage location in the original labeled container and shall only be used for the client for whom the drug was originally dispensed.

2. Any portion of a prescription drug order remaining at the CSB, BHA, or PACE site that has exceeded any labeled expiration date or one year from the original pharmacy dispensing date on the label shall be separated from unexpired drugs, stored within a designated area of the board-approved drug storage location, and destroyed within 30 days of expiration with the written agreement of the client. Remaining portions of discontinued prescription drug orders retained by the CSB, BHA, or PACE site shall also be separated from active stock and either returned to the client or destroyed within 30 days of discontinuance with the written agreement of the client.

F. Recordkeeping.

1. A record of repackaging shall be made and maintained for one year from the date of repackaging and shall include the following:

a. Date of repackaging;

b. Name of client;

c. Prescription number of the originally dispensed prescription drug order;

d. Pharmacy name;

e. Drug name and strength;

f. Quantity of drug repackaged; and

g. Initials of the person performing the repackaging and verifying the accuracy of the repackaged drug container.

2. A record of destruction shall be made and maintained for one year for any prescription drug orders destroyed by the CSB, BHA, or PACE site and shall include the following:

a. Date of destruction;

b. Name of client;

c. Prescription number of the originally dispensed prescription drug order;

d. Drug name and strength;

e. Quantity of drug destroyed; and

f. Initials of the person performing the destruction.

Statutory Authority

§ 54.1-2400 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 28, Issue 23, eff. August 15, 2012; amended, Virginia Register Volume 32, Issue 14, eff. April 21, 2016.

18VAC110-20-726. Criteria for approval of repackaging training programs.

A. Application. Any person wishing to apply for approval of a repackaging training program shall submit the application fee prescribed in 18VAC110-20-20 and an application on a form approved by the board and shall meet the criteria established in this section. The application shall name a program director who is responsible for compliance with this section.

B. Curriculum. The curriculum for a repackaging training program shall include instruction in current laws and regulations applicable to a CSB, BHA, or PACE site for the purpose of assisting a client with self-administration pursuant to § 54.1-3420.2 of the Code of Virginia and in the following repackaging tasks:

1. Selection of an appropriate container;

2. Proper preparation of a container in accordance with instructions for administration;

3. Selection of the drug;

4. Counting of the drug;

5. Repackaging of the drug within the selected container;

6. Maintenance of records;

7. Proper storage of drugs;

8. Translation of medical abbreviations;

9. Review of administration records and prescriber's orders for the purpose of identifying any changes in dosage administration;

10. Reporting and recording the client's failure to take medication;

11. Identification, separation, and removal of expired or discontinued drugs; and

12. Prevention and reporting of repackaging errors.

C. Instructors and program director. Instructors for the program shall be either (i) a pharmacist with a current license in any jurisdiction and who is not currently suspended or revoked in any jurisdiction in the United States or (ii) a pharmacy technician with at least one year of experience performing technician tasks who holds a current registration in Virginia or current PTCB certification and who is not currently suspended or revoked in any jurisdiction in the United States. The program director shall maintain a list of instructors for the program.

D. Program requirements.

1. The length of the program shall be sufficient to prepare a program participant to competently perform repackaging consistent with § 54.1-3420.2 of the Code of Virginia and 18VAC110-20-725.

2. The program shall include a post-training assessment to demonstrate the knowledge and skills necessary for repackaging with safety and accuracy.

3. A program shall provide a certificate of completion to participants who successfully complete the program and provide verification of completion of the program for a participant upon request by a CSB, BHA, PACE site, or the board.

4. The program shall maintain records of training completion by persons authorized to repackage in accordance with § 54.1-3420.2 of the Code of Virginia. Records shall be retained for two years from date of completion of training or termination of the program.

5. The program shall report within 14 days any substantive change in the program to include a change in program name, program director, name of institution or business if applicable, address, program content, length of program, or location of records.

E. Expiration and renewal of program approval. A repackaging training program approval expires after two years, after which the program may apply for renewal. For continued approval, the program shall submit the renewal application, renewal fee, and a self-evaluation report on a form provided by the board at the time of renewal notification. Renewal of a program's approval is at the discretion of the board, and the decision to renew shall be based on documentation of continued compliance with the criteria set forth in this section.

Statutory Authority

§ 54.1-2400 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 28, Issue 23, eff. August 15, 2012; amended, Virginia Register Volume 32, Issue 14, eff. April 21, 2016.

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

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

1. A prescription drug order shall not be repackaged beyond the assigned expiration date noted on the prescription label of the dispensed drug, if applicable, or beyond one year from the date the drug was originally dispensed by a pharmacy, whichever date is earlier.

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

3. A record of repackaging shall be made and maintained for one year from the date of repackaging and shall include the following:

a. Date of repackaging;

b. Name of client;

c. Prescription number of the originally dispensed prescription drug order;

d. Pharmacy name;

e. Drug name and strength;

f. Quantity of drug repackaged; and

g. Initials of the person performing the repackaging and verifying the accuracy of the repackaged drug container.

4. Any portion of a prescription drug order remaining at the CSB, BHA, or PACE site that has exceeded any labeled expiration date or one year from the original pharmacy dispensing date on the label shall be separated from unexpired drugs, stored within a designated area of the board-approved drug storage location, and destroyed within 30 days of expiration with the written agreement of the client. Remaining portions of discontinued prescription drug orders retained by the CSB, BHA, or PACE site shall also be separated from active stock and either returned to the client or destroyed within 30 days of discontinuance with the written agreement of the client.

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

Statutory Authority

§ 54.1-2400 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 28, Issue 23, eff. August 15, 2012; amended, Virginia Register Volume 31, Issue 19, eff. June 17, 2015; Volume 32, Issue 14, eff. April 21, 2016.

18VAC110-20-728. Drugs for immediate treatment in crisis stabilization units.

A. In accordance with § 54.1-3423 of the Code of Virginia, a crisis stabilization unit shall apply for and obtain a controlled substances registration in order to maintain a stock of Schedule VI controlled substances for immediate treatment of patients in crisis. Schedule II through V controlled substances shall not be stocked. The responsible party listed on the application shall be a nurse who regularly administers controlled substances at the crisis stabilization unit and the supervising practitioner shall be either the medical director for the unit or a pharmacist from a provider pharmacy.

B. In consultation with a provider pharmacist, the medical director for the unit shall determine the list of controlled substances to be stocked at the crisis stabilization unit. The list shall be limited to Schedule VI controlled substances and only those drugs routinely used for treatment of patients admitted for crisis stabilization. Only drugs on this drug list may be stocked.

C. A nurse administering a drug from this stock pursuant to an oral order of a prescriber in accordance with § 54.1-3423 of the Code of Virginia shall record such order in the patient's medical record.

D. Records.

1. A record shall be maintained of all drugs received as stock by the crisis stabilization unit.

2. A record shall be made documenting administration or other authorized disposition of stocked drugs that includes the following:

a. Name of patient;

b. Date and time of administration;

c. Drug name, strength, and quantity administered;

d. Name or initials of person administering; and

e. Prescriber name.

3. Records shall be maintained at the same location listed on the controlled substances registration or, if maintained in an off-site database, retrieved and made available for inspection or audit within 48 hours of a request by the board or an authorized agent. Any computerized system used to maintain records shall also provide retrieval via computer monitor display or printout of the history for drugs administered during the past two years. It shall also have the capacity of producing a printout of any data which the registrant is responsible for maintaining.

4. Manual records may be maintained as an electronic image that provides an exact image of the document and is clearly legible.

Statutory Authority

§ 54.1-2400 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 28, Issue 23, eff. August 15, 2012.

18VAC110-20-730. Requirements for practitioner of medicine or osteopathy in free clinics.

A. Any practitioner of medicine or osteopathy who provides controlled substances that have been donated pursuant to subdivision 11 of § 54.1-3301 of the Code of Virginia shall apply for a controlled substances registration.

B. A practitioner in a free clinic may only accept donated drugs pursuant to this registration if they are donated by an entity or practitioner who holds a current active license, permit, or registration issued by the board authorizing the dispensing or distribution of drugs.

C. A practitioner shall store such donated drugs for dispensing in compliance with the storage and security requirements set forth in 18VAC110-20-710, and a drug that has exceeded its expiration date shall not be dispensed. A practitioner shall be responsible for maintaining and complying with a written procedure for reviewing inventory for the purpose of removing expired drugs.

D. A practitioner shall package any dispensed drugs in accordance with the provisions of §§ 54.1-3426 and 54.1-3427 of the Code of Virginia and 18VAC110-20-340 and 18VAC110-20-350.

E. A practitioner shall label any dispensed drugs in accordance with the provisions of §§ 54.1-3410 and 54.1-3463 of the Code of Virginia and 18VAC110-20-330 to include the free clinic name and address; name of the prescriber; patient name; date of dispensing; drug name to include the generic name if the drug has a single active ingredient; drug strength, if applicable; quantity; and directions for use.

F. A practitioner shall comply with all recordkeeping requirements of § 54.1-3404 of the Code of Virginia and shall also maintain a chronological record of all Schedule II through VI drugs dispensed showing patient name and address; date of dispensing; drug name, strength, and quantity dispensed; and name or initials of the dispensing practitioner.

G. A practitioner under this section may enter into a contract or written agreement with a pharmacy whereby the pharmacy maintains all or part of the donated stock, dispenses the prescription pursuant to a written prescription by a prescriber at the free clinic, and delivers the dispensed prescription to the free clinic for pick up by the patient in accordance with subsection C of 18VAC110-20-275.

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.

18VAC110-20-735. Requirements for dispensing of naloxone by trained individuals.

A. Persons authorized by the Department of Behavioral Health and Developmental Services to train individuals on the administration of naloxone and dispense naloxone for opioid overdose reversal pursuant to subsection Y of § 54.1-3408 of the Code of Virginia shall maintain the following records:

1. The prescriber's standing order issued in accordance with subsection Y of § 54.1-3408 of the Code of Virginia authorizing the trained individual to dispense naloxone.

2. Invoices or other records showing receipts of naloxone shall be maintained but may be stored in an electronic database or record as an electronic image that provides an exact, clearly legible image of the document or in secured storage either on site or off site. All records in off-site storage or database shall be retrieved and made available for inspection or audit within 48 hours of a request by the board or an authorized agent.

3. A manual or electronic log indicating the name, strength, lot, expiration date, and quantity of naloxone transferred to and from the controlled substances registration location to the off-site training location, along with date of transfer and the name of the trained individual approved by the Department of Behavioral Health and Developmental Services.

4. Record of dispensing indicating the name of the person receiving naloxone, address or contact information if available, date of dispensing, drug name, strength, quantity, lot number, expiration date, and the name of the trained individual approved by the Department of Behavioral Health and Developmental Services to dispense naloxone.

B. The naloxone shall be labeled with directions for use in accordance with the prescriber's standing order, date of dispensing, name of person receiving the drug, drug name and strength, and the name and the telephone number for the entity associated with the controlled substances registration.

C. The naloxone shall be stored and transported under appropriate storage conditions in accordance with the manufacturer's directions to protect it from adulteration.

D. In the event of a manufacturer recall, the supervising practitioner or responsible party associated with the controlled substances registration certificate shall ensure compliance with recall procedures as issued by the manufacturer, U.S. Food and Drug Administration, or board to ensure an affected drug is transferred to a person or entity authorized to possess the drug for return or destruction.

E. Except for a prescriber's standing order, which shall be maintained on site for a period of not less than two years from the date of the last dispensing, records shall be filed chronologically and maintained for a period of not less than two years from the date of transaction.

Statutory Authority

§ 54.1-2400 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 35, Issue 9, eff. January 23, 2019.

18VAC110-20-740. Drug donation sites.

Any pharmacy with a current active pharmacy permit may apply on a form provided by the board for registration as a drug donation site. A registered drug donation site may receive eligible donated drugs, transfer such donated drugs to another registered drug donation site, or redispense the donated drugs in accordance with § 54.1-3411.1 of the Code of Virginia to patients of clinics organized in whole or in part for the delivery of health care services to the indigent. Drugs collected under the drug donation program may not be dispensed to any other patient, sold, or otherwise distributed except as authorized in 18VAC110-20-770 or 18VAC110-20-790.

Statutory Authority

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

Historical Notes

Derived from Virginia Register Volume 27, Issue 3, eff. November 10, 2010.

18VAC110-20-750. Eligible drugs.

A. Drugs may be accepted by a registered drug donation site only if the following criteria are met:

1. Official compendium storage requirements are assured and the drugs are in manufacturers' original sealed containers or in sealed individual dose or unit dose packaging that meets official compendium Class A or B container requirements, or better, as set forth in § 54.1-3411.1 A 2 of the Code of Virginia;

2. The drugs bear an expiration date that is not less than 90 days from the date the drug is donated; and

3. The drugs have not been adulterated or misbranded.

B. The following drugs shall not be accepted by a drug donation site:

1. Schedule II-V controlled substances or any other drug if such return is inconsistent with federal law;

2. Drugs determined to be hazardous for donation based on (i) the pharmacist's professional judgment, experience or knowledge, or (ii) available reference materials;

3. Drugs that may only be dispensed to a patient registered with the drug manufacturer under a restricted distribution system; and

4. Drugs that have been previously compounded.

Statutory Authority

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

Historical Notes

Derived from Virginia Register Volume 27, Issue 3, eff. November 10, 2010.

18VAC110-20-760. Procedures for collecting eligible donated drugs.

A. A pharmacist or a pharmacy technician under the personal supervision of a pharmacist shall receive and conduct the initial screening for eligibility of donated drugs.

B. At the time of accepting donated drugs, the drug donation site shall ensure that a donor form is completed. The drug donation site shall give a copy of the donor form to the person donating the drug at the time of the donation and shall maintain the original donor form. A donor form is not required for drugs donated by a patient residing in a long-term care facility or other facility where drugs are administered to that patient if the drugs are donated directly to the provider pharmacy for that facility and such provider pharmacy is registered as a drug donation site.

C. A donor form shall include the following information:

1. A statement that the donor is the patient or patient's agent for whom the prescription drug was dispensed;

2. A statement that the donor intends to voluntarily donate the prescription drug for redispensing;

3. A statement attesting that the drugs have been properly stored at all times while in the possession of the patient according to official compendium storage requirements;

4. Contact information for the patient or patient's agent;

5. The date of donation;

6. A listing of the donated drugs to include name, strength, and quantity;

7. A statement that private health information will be protected;

8. The signature of the patient or patient's agent; and

9. The initials of the receiving pharmacist, or the initials of the receiving pharmacy technician and supervising pharmacist.

D. Donated prescription drugs shall be stored within the prescription department, separate from other drug inventory.

E. Prior to transferring any donated drugs or redispensing donated drugs, a pharmacist shall perform a final review of any donated drug for eligibility and shall ensure that all the donor's patient specific information has been removed from previous labeling or rendered unreadable.

F. A drug donation site may not charge a fee for collecting donated drugs.

Statutory Authority

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

Historical Notes

Derived from Virginia Register Volume 27, Issue 3, eff. November 10, 2010.

18VAC110-20-770. Procedure for transferring donated prescription drugs.

A. A drug donation site may transfer eligible donated prescription drugs to another drug donation site for the purpose of redispensing.

B. The transferring drug donation site shall provide a transfer record to the receiving drug donation site that includes the following:

1. The names and addresses of the transferring site and the receiving site;

2. The name, strength, and quantity of each donated drug being transferred; and

3. The date of transfer.

C. The original transfer record shall be maintained by the transferring drug donation site.

D. A copy of the transfer record shall be provided to the receiving drug donation site, the date of receipt shall be recorded on the copy, and it shall be maintained by the receiving drug donation site.

Statutory Authority

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

Historical Notes

Derived from Virginia Register Volume 27, Issue 3, eff. November 10, 2010.

18VAC110-20-780. Procedure for dispensing donated prescription drugs.

A. A drug donation site redispensing donated prescription drugs shall comply with applicable federal and state laws and regulations for dispensing prescription drugs.

B. The pharmacy redispensing donated drugs shall not charge for cost of donated drugs, but may charge a dispensing or administrative fee for each such drug redispensed, consistent with the provisions of subdivision 10 of § 54.1-3301 of the Code of Virginia.

C. Recipients of a redispensed donated drug shall sign a form prior to receiving the drug that includes a statement that the recipient understands that the drug received has been donated for the purpose of redispensing pursuant to § 54.1-3411.1 of the Code of Virginia. The drug donation site shall maintain this form.

D. A drug donation site is under no obligation to obtain a prescription drug that is not in inventory at the time of a request for such drug.

Statutory Authority

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

Historical Notes

Derived from Virginia Register Volume 27, Issue 3, eff. November 10, 2010.

18VAC110-20-790. Procedures for disposing of donated prescription drugs.

A. A drug donation site in possession of donated prescription drugs ineligible for redispensing shall dispose of such drugs in compliance with 18VAC110-20-210.

B. A drug donation site shall maintain records of disposal or transfer for disposal of donated prescription drugs separately from other pharmacy disposal records.

Statutory Authority

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

Historical Notes

Derived from Virginia Register Volume 27, Issue 3, eff. November 10, 2010.

18VAC110-20-800. Records.

A. All records required for drug donation programs shall be maintained chronologically for two years.

B. Records and prescriptions related to donated drugs shall be maintained separately from other pharmacy records.

C. Storage of records.

1. Transfer, dispensing, and disposal records may be stored in an electronic database or record.

2. Prescriptions and signed forms, as well as any other records, may be stored as an electronic image that provides an exact, clearly legible image of the document.

3. Records may be stored in secured storage, either on or offsite.

D. All records in offsite storage or database shall be retrieved and made available for inspection or audit within 48 hours of a request by the board or an authorized agent.

Statutory Authority

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

Historical Notes

Derived from Virginia Register Volume 27, Issue 3, eff. November 10, 2010.

Website addresses provided in the Virginia Administrative Code to documents incorporated by reference are for the reader's convenience only, may not necessarily be active or current, and should not be relied upon. To ensure the information incorporated by reference is accurate, the reader is encouraged to use the source document described in the regulation.

As a service to the public, the Virginia Administrative Code is provided online by the Virginia General Assembly. We are unable to answer legal questions or respond to requests for legal advice, including application of law to specific fact. To understand and protect your legal rights, you should consult an attorney.