Administrative Code

Virginia Administrative Code
5/21/2024

Part I. General Provisions

18VAC110-50-10. Definitions.

In addition to words and terms defined in §§ 54.1-3300 and 54.1-3401 of the Code of Virginia, the following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Authorized collector" means a registered manufacturer, wholesale distributor, or reverse distributor that is authorized by the U.S. Drug Enforcement Administration to 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 for the purpose of destruction.

"Authorized distributor of record" means a wholesale distributor with whom a manufacturer has entered into a written agreement under which such wholesale distributor is either authorized to distribute all of that manufacturer's prescription drug products, or only those products listed in the agreement, for such a period of time or number of shipments as specified in the agreement.

"Control number" means the unique identifying customer number assigned by the Virginia Department of Motor Vehicles to an individual when issuing a driver's license, learner's permit, or official identification card. This number is displayed on the driver's license or ID card in lieu of the social security number.

"DEA" means the U.S. Drug Enforcement Administration.

"Drop shipment" means the sale and distribution of a prescription drug in which a manufacturer or a third-party logistics provider directly ships the prescription drug to a pharmacy, chain drug warehouse, or other person authorized to dispense or administer the prescription drug, and the pharmacy, chain drug warehouse or other authorized person is invoiced by a wholesale distributor that took title to the prescription drug during the shipping, but did not take physical possession of the prescription drug.

"Expiration date" means that date placed on a drug package by the manufacturer or repacker beyond which the product may not be dispensed or used.

"FDA" means the U.S. Food and Drug Administration.

"Ultimate user" means a person who has lawfully obtained, and who possesses, a controlled substance for his own use or for the use of a member of his household or for an animal owned by him or a member of his household.

"USP-NF" means the United States Pharmacopeia-National Formulary.

Statutory Authority

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

Historical Notes

Derived from Virginia Register Volume 22, Issue 24, eff. September 6, 2006; amended, Volume 24, Issue 10, eff. February 20, 2008; Volume 32, Issue 12, eff. March 24, 2016; Volume 33, Issue 19, eff. June 29, 2017.

18VAC110-50-20. Fees.

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

B. Initial application fees.

1. Nonrestricted manufacturer permit

$350

2. Restricted manufacturer permit

$235

3. Wholesale distributor license

$350

4. Warehouser permit

$350

5. Nonresident wholesale distributor registration

$350

6. Controlled substances registration

$120

7. Third-party logistics provider permit

$350

8. Nonresident manufacturer registration

$350

9. Nonresident warehouser registration

$350

10. Nonresident third-party logistics provider registration

$350

C. Annual renewal fees shall be due on February 28 of each year.

1. Nonrestricted manufacturer permit

$350

2. Restricted manufacturer permit

$235

3. Wholesale distributor license

$350

4. Warehouser permit

$350

5. Nonresident wholesale distributor registration

$350

6. Controlled substances registration

$120

7. Third-party logistics provider permit

$350

8. Nonresident manufacturer registration

$350

9. Nonresident warehouser registration

$350

10. Nonresident third-party logistics provider registration

$350

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

1. Nonrestricted manufacturer permit

$120

2. Restricted manufacturer permit

$80

3. Wholesale distributor license

$120

4. Warehouser permit

$120

5. Nonresident wholesale distributor registration

$120

6. Controlled substances registration

$40

7. Third-party logistics provider permit

$120

8. Nonresident manufacturer registration

$120

9. Nonresident warehouser registration

$120

10. Nonresident third-party logistics provider registration

$120

E. Reinstatement fees.

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

2. Engaging in activities requiring a license, permit, or registration after the expiration date of such license, permit, or registration shall be grounds for disciplinary action by the board. Facilities or entities that cease operation and wish to resume shall not be eligible for reinstatement but shall apply for a new permit or registration.

3. Facilities or entities that failed to renew and continued to operate for more than one renewal cycle shall pay the current and all back renewal fees for the years in which they were operating plus the following reinstatement fees:

a. Nonrestricted manufacturer permit

$315

b. Restricted manufacturer permit

$275

c. Wholesale distributor license

$315

d. Warehouser permit

$315

e. Nonresident wholesale distributor registration

$315

f. Controlled substances registration

$235

g. Third-party logistics provider permit

$315

h. Nonresident manufacturer registration

$315

i. Nonresident warehouser registration

$315

j. Nonresident third-party logistics provider registration

$315

F. Application for change or inspection fees.

1. Reinspection fee

$300

2. Inspection fee for change of location, structural changes, or security system changes

$300

3. Change of ownership fee

$65

4. Change of responsible party

$65

G. The handling fee for a returned check or a dishonored credit card or debit card shall be $50.

H. The fee for verification of license, permit, or registration shall be $35.

Statutory Authority

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

Historical Notes

Derived from Virginia Register Volume 22, Issue 24, eff. September 6, 2006; amended, Virginia Register Volume 23, Issue 4, eff. November 29, 2006; Volume 26, Issue 2, eff. October 28, 2009; Volume 26, Issue 6, eff. December, 23, 2009; Volume 31, Issue 20, eff. July 16, 2015; Volume 33, Issue 19, eff. June 29, 2017; Volume 35, Issue 12, eff. March 22, 2019; Volume 37, Issue 2, eff. October 14, 2020; Volume 37, Issue 12, eff. March 18, 2021.

18VAC110-50-30. Application; location of business; inspection required.

A. Any person or entity desiring to obtain a license as a wholesale distributor; registration as a nonresident wholesale distributor, nonresident manufacturer, nonresident warehouser, or nonresident third-party logistics provider; or permit as a manufacturer, warehouser, or third-party logistics provider shall file an application with the board on a form approved by the board. An application shall be filed for a new license, registration, or permit, or for acquisition of an existing wholesale distributor, manufacturer, warehouser, nonresident wholesale distributor, nonresident manufacturer, third-party logistics provider, nonresident warehouser, or nonresident third-party logistics provider.

B. A licensee or permit holder proposing to change the location of an existing license or permit, or make structural or security system changes to an existing location, shall file an application for approval of the changes following an inspection conducted by an authorized agent of the board.

C. A license, permit, or registration shall not be issued to any wholesale distributor, manufacturer, warehouser, nonresident warehouser, nonresident wholesale distributor, nonresident manufacturer, third-party logistics provider, or nonresident third-party logistics provider to operate from a private dwelling or residence or to operate without meeting the applicable facility requirements for proper storage and distribution of drugs or devices. Before any license, permit, or registration is issued, the applicant shall demonstrate compliance with all federal, state, and local laws and ordinances.

D. If a wholesale distributor, manufacturer, warehouser, or third-party logistics provider engages in receiving, possessing, storing, using, manufacturing, distributing, or otherwise disposing of any Schedules II through V controlled substances, it shall also obtain a controlled substances registration from the board in accordance with § 54.1-3422 of the Code of Virginia and shall also be duly registered with the DEA and in compliance with all applicable laws and rules for the storage, distribution, shipping, handling, and transporting of controlled substances.

E. The proposed location, structural changes, or security system changes shall be inspected by an authorized agent of the board prior to issuance of a license or permit.

1. 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 proposed prescription drug storage area shall comply with 18VAC110-50-40 and 18VAC110-50-50, and wholesale distributors shall meet the requirements of 18VAC110-50-90.

4. If an applicant substantially fails to meet the requirements for issuance of a permit or license 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 18VAC110-50-20 prior to a reinspection being conducted.

F. Prescription drugs shall not be stocked within the proposed location or moved to a new location until approval is granted by the inspector or board staff.

Statutory Authority

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

Historical Notes

Derived from Virginia Register Volume 22, Issue 24, eff. September 6, 2006; amended, Virginia Register Volume 33, Issue 19, eff. June 29, 2017; Volume 35, Issue 12, eff. March 22, 2019.

18VAC110-50-40. Safeguards against diversion of drugs.

A. The holder of the license as a wholesale distributor or permit as a manufacturer, warehouser, or third-party logistics provider, or registration as a nonresident wholesale distributor, nonresident warehouser, nonresident third-party logistics provider, or nonresident manufacturer shall restrict access to all areas in which prescription drugs are stored or kept for sale to only those persons specifically designated as necessary for the manufacture, receipt, storage, distribution, or quality control of the controlled substance inventory and shall provide reasonable security measures to include appropriate locking devices on all access doors to these areas and adequate lighting both inside and outside the facility to deter unauthorized entry and diversion.

B. The holder of the license, permit, or registration, except for those distributors of only medical gases other than nitrous oxide, shall install a device for the detection of breaking subject to the following conditions:

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

2. One communication line installation shall be hardwired and both the installation and device shall be based on accepted burglar alarm industry standards to include wireless motion sensors.

3. The device shall be maintained in operating order, shall have an auxiliary source of power, and shall be capable of sending an alarm signal to the monitoring entity when breached if 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 the person named on the application as the responsible party or to persons specifically designated in writing in a policy and procedure manual.

6. The system shall be activated whenever the drug storage areas are closed for business.

C. Distribution or delivery of prescription drugs shall be accomplished in a manner to prevent diversion or possession of drugs by unauthorized persons.

1. The holder of the license, permit, or registration shall only deliver prescription drugs to a person authorized to possess such drugs at a location where the person is authorized to possess such drugs and only at a time when someone authorized to possess such drugs is in attendance.

2. The holder of the license, permit, or registration shall affirmatively verify that the person to whom prescription drugs are delivered is authorized by law to receive such drugs.

3. Prescription drugs may be transferred to an authorized agent of a person who may lawfully possess prescription drugs, provided the transfer occurs on the premises of the wholesale distributor, manufacturer, warehouser, third-party logistics provider, nonresident wholesale distributor, nonresident warehouser, nonresident third-party logistics provider, or nonresident manufacturer and provided the identity and authorization of the agent is verified, and such transfer is only used to meet the immediate needs of a patient.

Statutory Authority

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

Historical Notes

Derived from Virginia Register Volume 22, Issue 24, eff. September 6, 2006; amended, Virginia Register Volume 29, Issue 21, eff. August 2, 2013; Volume 33, Issue 19, eff. June 29, 2017; Volume 35, Issue 12, eff. March 22, 2019; Volume 36, Issue 6, eff. December 11, 2019.

18VAC110-50-50. Storage.

A. All prescription drugs and devices shall be stored at appropriate temperatures and under appropriate conditions in accordance with requirements, if any, in the labeling of such drugs, or with requirements of USP-NF.

B. If no specific storage requirements are established for a drug or a device, it may be held at controlled room temperature, as defined in USP-NF, to help ensure that its identity, strength, quality, and purity are not adversely affected.

C. Appropriate manual, electromechanical, or electronic temperature and humidity recording equipment, or logs shall be utilized to document proper storage of prescription drugs.

D. Packaging of the prescription drugs should be in accordance with USP-NF standards.

E. Schedule II-V controlled substances shall be separated from Schedule VI prescription drugs and stored in a secure area in accordance with DEA security requirements and standards.

F. Any facility shall be of adequate size and construction and have the proper equipment necessary for the proper storage of prescription drugs and devices as set forth in this section.

Statutory Authority

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

Historical Notes

Derived from Virginia Register Volume 22, Issue 24, eff. September 6, 2006.

18VAC110-50-51. Disposal of drugs by authorized collectors.

Any manufacturer, wholesale distributor, or reverse distributor wishing to accept for return a previously dispensed drug in Schedules II through V for the purpose of destruction from an ultimate user, or a person lawfully entitled to dispose of an ultimate user decedent's property, shall first be authorized by the DEA as a collector. The process used to collect and destroy drugs, along with any required recordkeeping, shall comply with 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 the responsible party.

2. If an authorized collector chooses to cease acting as a collector, the responsible party shall notify the board within 30 days.

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.

18VAC110-50-55. Delivery of Schedule VI devices.

A. In accordance with the provisions of subsection A of § 54.1-3415.1 of the Code of Virginia, a manufacturer, nonresident manufacturer, wholesale distributor, nonresident wholesaler distributor, third-party logistics provider, nonresident third-party logistics provider, warehouser, or nonresident warehouser licensed, permitted, or registered in Virginia may deliver Schedule VI prescription devices directly to an ultimate user or consumer on behalf of a medical equipment supplier.

1. Such delivery shall only occur in accordance with an agreement between a delivering entity named in this subsection and a medical equipment supplier in compliance with law and regulation.

2. The agreement shall be between an individual delivering entity or multiple delivering entities under shared ownership and an individual medical equipment supplier or multiple medical equipment suppliers under shared ownership. The agreement shall be applicable to all ultimate users or consumers receiving services from the medical equipment supplier who require delivery of Schedule VI prescription devices.

3. The medical equipment supplier shall represent to the delivering entity that it has complied with the provisions of § 54.1-3415.1 of the Code of Virginia regarding the existence of a valid order from a prescriber for the delivery of a Schedule VI prescription device to an ultimate user or consumer. Validation of orders of prescribers shall be the responsibility of the medical equipment supplier upon request of the board or delivering entity.

B. In accordance with the provisions of subsection B of § 54.1-3415.1 of the Code of Virginia, a manufacturer, nonresident manufacturer, wholesale distributor, nonresident wholesaler distributor, third-party logistics provider, nonresident third-party logistics provider, warehouser, or nonresident warehouser licensed, permitted, or registered in Virginia may deliver Schedule VI prescription devices directly to an ultimate user's or consumer's residence to be administered by persons authorized to administer such devices, provided that (i) such delivery is made on behalf of a medical director of a home health agency, nursing home, assisted living facility, or hospice who has requested the distribution of the Schedule VI prescription device and directs the delivery of such device to the ultimate user's or consumer's residence and (ii) the medical director on whose behalf such Schedule VI prescription device is being delivered has entered into an agreement with the manufacturer, nonresident manufacturer, wholesale distributor, nonresident wholesale distributor, warehouser, nonresident warehouser, third-party logistics provider, or nonresident third-party logistics provider for such delivery.

1. Such delivery shall only occur in accordance with an agreement between a delivering entity authorized in this subsection and a medical director of a home health agency, nursing home, assisted living facility, or hospice and in compliance with law and regulation.

2. The agreement shall be between an individual delivering entity or multiple delivering entities under shared ownership and the medical director of an individual home health agency, nursing home, assisted living facility, or hospice, or multiple such entities under shared ownership. The agreement shall be applicable to all ultimate users or consumers of the home health agency, nursing home, assisted living facility, or hospice who require delivery of Schedule VI prescription devices.

3. The home health agency, nursing home, assisted living facility, or hospice shall represent to the delivering entity that it has complied with provisions of § 54.1-3415.1 of the Code of Virginia regarding the existence of a request from a prescriber for the delivery of a Schedule VI prescription device to an ultimate user or consumer. Validation of the request from a prescriber shall be the responsibility of the home health agency, nursing home, assisted living facility, or hospice upon request of the board or delivering entity.

C. The agreement, as required by subdivisions A 1 and B 1 of this section, shall be in written or electronic format and shall be retained in a format available upon request to the board at all times the agreement is in effect and for two years after the date the agreement is terminated or concluded.

D. An agreement shall not contain any patient specific or patient health information that would be subject to the provisions of the Health Insurance Portability and Accountability Act of 1996, P.L. No. 104-191.

Statutory Authority

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

Historical Notes

Derived from Virginia Register Volume 37, Issue 12, eff. March 3, 2021.

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.