Administrative Code

Virginia Administrative Code
5/29/2024

Part XIII. Medical Equipment Suppliers

18VAC110-20-630. Issuance of a permit as a medical equipment supplier.

A. Any person or entity desiring to obtain a permit as a medical equipment supplier shall file an application with the board on a form approved by the board. An application shall be filed for a new permit or for acquisition of an existing medical equipment supplier. The application shall designate the hours of operation the location will be open to service the public and shall be signed by a person who works at the location address on the application and will act as a responsible party for that location.

B. Any change in the hours of operation expected to last for more than one week shall be reported to the board in writing and a notice posted, at least 14 days prior to the anticipated change, in a conspicuous place to the public.

1. Such notification of a change in hours of operation is not required when the change is necessitated by emergency circumstances beyond the control of the owner or responsible party or when the change will result in an expansion of the current hours of operation.

2. If the medical equipment supplier is unable to post the change in hours 14 days in advance, the responsible party or owner shall ensure the board is notified as soon as he knows of the change and disclose the emergency circumstances preventing the required notification.

C. Within 14 days of a change in the responsible party assigned to the permit, the outgoing responsible party shall inform the board, and a new application shall be submitted indicating the name of the new responsible party.

D. A permit holder proposing to change the location of an existing license or permit or make structural 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.

E. A permit shall not be issued to any medical equipment supplier 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 or permit is issued, the applicant shall demonstrate compliance with all federal, state and local laws and ordinances.

Statutory Authority

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

Historical Notes

Derived from VR530-01-1 § 14.1, 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 22, Issue 24, eff. September 6, 2006; Volume 36, Issue 6, eff. December 11, 2019; Errata, 36:9 VA.R. 1197 December 23, 2019.

18VAC110-20-640. (Repealed.)

Historical Notes

Derived from VR530-01-1 § 14.2, 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 15, Issue 8, eff. February 3, 1999; repealed, Virginia Register Volume 22, Issue 24, eff. September 6, 2006.

18VAC110-20-650. (Repealed.)

Historical Notes

Derived from VR530-01-1 § 14.3, 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; repealed, Virginia Register Volume 15, Issue 8, eff. February 3, 1999.

18VAC110-20-660. (Repealed.)

Historical Notes

Derived from VR530-01-1 §§ 14.4, 14.5, 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; repealed, Virginia Register Volume 22, Issue 24, eff. September 6, 2006.

18VAC110-20-680. Medical equipment suppliers.

A. A medical equipment supplier's location shall be inspected by the board prior to engaging in business. The location shall be clean and sanitary and shall have a system of temperature control to provide for specified storage conditions for any Schedule VI drug or device.

B. Hypodermic needles and syringes and Schedule VI drugs shall not be placed on open display or in an open area where patrons will have access to such items. No Schedule VI devices shall be placed in an area where responsible parties cannot exercise reasonable supervision and control.

C. A medical equipment supplier shall receive a valid order from a practitioner prior to dispensing and shall maintain this order on file on the premises for a period of two years from date of last dispensing. The original order may be kept at a centralized office as long as it is readily retrievable within 48 hours and a copy of the order is kept on the premises of the dispensing supplier. In lieu of a hard copy, an electronic image of an order may be maintained in an electronic database provided it preserves and provides an exact image of the order that is clearly legible and made available within 48 hours of a request by a person authorized by law to have access to prescription information.

D. Medical equipment suppliers shall make a record at the time of dispensing. This record shall be maintained on the premises for two years from date of dispensing and shall include:

1. Name and address of patient;

2. Item dispensed and quantity, if applicable; and

3. Date of dispensing.

E. A valid order authorizing the dispensing of drugs or devices may be transferred from one medical equipment supplier to another medical equipment supplier provided the order can be filled or refilled. The transfer shall be communicated either orally by direct communication between an individual at the transferring medical equipment supplier and the receiving medical equipment supplier, by facsimile machine, or by electronic transmission.

1. The transferring medical equipment supplier shall:

a. Record the word "VOID" on the face of the invali­dated order;

b. Record on the reverse side of the invalidated order the name and address of the medical equipment supplier to which it was trans­ferred, the date of the transfer, and for an oral transfer, the name of the individual receiving the prescription information and the name of the individual transferring the information.

2. The receiving medical equipment supplier shall:

a. Write the word "TRANSFER" on the face of the trans­ferred pre­scription;

b. Provide all information required to be on a valid order to include:

(1) Date of issuance of original order;

(2) Original number of refills authorized on the original order;

(3) Date of original dispensing if applicable;

(4) Number of valid refills remaining and date of last dispensing;

(5) Medical equipment supplier name and address from which the order information was transferred; and

(6) Name of transferring individual if transferred orally.

3. Both the original and transferred order shall be main­tained for a period of two years from the date of last refill. In lieu of recording the required information on the hard copy of a valid order, a medical equipment supplier may record all required information in an automated data processing system used for the storage and retrieval of dispensing information.

F. A nonresident medical equipment supplier shall register and practice in accordance with § 54.1-3435.3:1 of the Code of Virginia.

Statutory Authority

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

Historical Notes

Derived from VR530-01-1 § 14.6, 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 15, Issue 8, eff. February 3, 1999; Volume 20, Issue 23, eff. August 25, 2004; Volume 25, Issue 24, eff. September 2, 2009; Volume 33, Issue 4, eff. November 16, 2016; Volume 36, Issue 6, eff. December 11, 2019.

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.