DEVICE AND MEDICAL EQUIPMENT (DME) PERMITS

Eligibility

Any place, whether in North Carolina or outside of North Carolina, that delivers devices or medical equipment to a patient in North Carolina must hold a DME Permit prior to doing so. GS § 90-85.22(a)&(b); 21 NCAC 46.1608.

This permit requirement does not apply to a pharmaceutical manufacturer registered with the United States Food and Drug Administration (FDA), a wholly owned subsidiary of a manufacturer registered with the FDA, or the dispensing of home renal products in accordance with GS § 90-85.21C. GS § 90-85.22(c).

Devices are defined at GS § 90-85.3(e). Medical equipment is defined at GS § 90-85.3(l1). Further clarification of “ambulation assistance equipment”, “diagnostic equipment”, “mobility equipment”, “oxygen and respiratory care equipment”, and rehabilitation environmental control equipment” is found at 21 NCAC 46.1317(1), (3), (11), (13), and (17).

DME Permits are issued to the facility’s Person-In-Charge (PIC), who is responsible for the facility’s safe and legal operation. 21 NCAC 46.1608(b); 21 NCAC 46.2605(a). A PIC may only serve in that capacity for one facility. And a PIC must not have a felony criminal conviction or commit any act that causes the DME facility to be excluded from participation in a federal or state program. 21 NCAC 46.2605(b).

Instructions / Information

Step 1:
Navigate to the Board's Licensure Gateway. Click on the FACILITY MANAGEMENT tab and then click on the NEW DME tile.

Step 2:
The Licensure Gateway will present you with a series of questions. Please answer them to ensure that the correct application is presented and completed. 

Step 3:
The PIC must complete the application and attest to the accuracy of all information provided in the application. There is a $500 NON-REFUNDABLE/NON-TRANSFERRABLE application fee.

The DME application must be completed in one sitting. Incomplete applications will not be saved. The following is a list of items/information that you must have handy to complete the application:

  • NABP Business e-profile number. If you do not have an NABP Business e-profile number, navigate to the National Association of Boards of Pharmacy’s website and obtain one.

  • EIN number (Federal Tax ID number)

  • Passport quality photograph of the Person-In-Charge

  • Photographs of the DME

    • Exterior:

      • The building in which the DME facility will be or is located

      • Signage for the DME facility

      • Adjacent buildings (if applicable)

      • Arist sketches or architectural plans/drawings-in addition to, not in lieu of, above

    • Interior:

      • Office area

      • Storage space for equipment

      • Proof that the facility is equipped with a functioning lavatory where hot and cold running water or hand washing appliances or waterless hand cleaner are available

      • All adequate equipment to meet the services that that the facility is providing For example, if the facility is providing oxygen, then equipment related to oxygen should be photographed

      • Separate areas on the premise and in delivery vehicles for clean, dirty, and contaminated equipment

  • Corporate organization chart that includes all entities holding and ownership or beneficial interest in the DME facility, as well as the DME facility’s staff.

  • Certificate A: This is an ownership document and will be uploaded after you have submitted the application. Once the application is submitted, you will receive a confirmation number (see Step 4 below). Use that number to log in to the application through the Board's Licensure Gateway. Click on the pending application, and then on the Important Files header.

  • Proof of Occupancy for the facility. Please submit one of the following items to determine proof of occupancy:

    • Lease/Rental agreement - address and signature page included

    • Deed or Deed of Trust

    • Property tax statement

    • Building permit

    • Certificate of Occupancy

    • Business license

  • Disciplinary action: Be sure to upload any disciplinary action taken by another state.


Step 4:

Upon submission of a complete application, the PIC will receive an email with the confirmation number. Please log in to the Board's Licensure Gateway with your confirmation number information to upload additional documents to the application, including “Certificate A” as noted above in Step 3.

Please allow 6-8 weeks for application review. If Board staff needs additional or clarifying information about your application, you will be notified via the PIC’s email address. Prompt, complete responses from the PIC to any requests for additional information will ensure that the application review continues in a timely manner.


Step 5:

Board staff will confirm that all registration requirements have been met. If so, Board staff issue the permit. You will be notified of the issuance and the permit number via the PIC’s email address. Make sure you follow all instructions provided to you in that email.

Once the permit number has been issued, it must be used to log in through the Board's Licensure Gateway.

NOTE: The permit must be operational within six (6) months of the permit issuance date. If, due to unforeseen circumstances, the permit will not be operational within that time frame, the PIC must contact Board staff to discuss.

DME FAQs

Application

No. Board Rule .2601(c) prohibits the operation of a DME facility on residential property.

No. Once Board staff have approved a pending application, an approval email will be sent to the PIC who filed the application and the permit number issued. 

Yes. Please see the instructions below concerning change in ownership. As noted there, if a change of ownership occurs before a new permit has been obtained, the existing permit is void as a matter of law. To submit a Transfer of Ownership application, click on the Facility Management tab on the Board's Licensure Gateway and log in under the permit. Once logged in, click on the Transfer Ownership tile. A Transfer of Ownership application should be submitted at least 6-8 weeks prior to the effective date of the change. All applicants should upload an explanation of the change, which could include an organizational chart and/or pre- and post-closing chart. Out of state permits must upload a copy of the license from the home state.

Board Rule 21 NCAC 46.1603 provides:
A new pharmacy, device, or medical equipment permit is required for a new location, if there is a change to a different or successor business entity, or a change resulting in a different person or entity owning more than 50 percent interest in the permit holder, or any entity in the chain of ownership above the permit holder, except as provided in 21 NCAC 46 .1604 of this Section. A new permit is required if there is a change in the authority to control or designate a majority of the members or board of directors of a nonprofit corporation holding a pharmacy permit or any nonprofit corporation in the chain of ownership above the permit holder.

This means, if a change of ownership requiring a new permit occurs – and the pharmacy has not obtained the new permit by the effective date of the transfer of ownership – the previous permit becomes void (i.e. no longer active) as of the effective date of the transfer of ownership.

Any permit subsequently acquired would not operate retroactively. It will operate from the date of issue forward. That means that an untimely transfer of ownership would result in a pharmacy operating without a permit for a period of time, which could result in Board action for unlicensed practice of pharmacy and other collateral consequences.

Transfer of ownership permit applicants must note that a new owner of a pharmacy may not operate using an old permit under a "power of attorney" or similar.

To facilitate an orderly transfer, permit applications must be filed well in advance (6-8 weeks) of the planned transaction And, of course, permit applications proceed most quickly when they are complete, correct, and the applicant pharmacist-manager responds quickly to requests for information from Board staff. The applicant pharmacist-manager needs to monitor the permit application status and keep Board staff apprised of any changes to the transaction date. Failure to do these things can lead to significant delays in permit review and, as noted above, transferring ownership prior to a new permit’s issuance voids the existing permit.

Yes. For a change in location, Board staff can, upon receiving a timely, complete application, issue a re-registration permit (which allows the facility to retain the originally-issued permit number). To submit a Re-Registration application, click on the Facility Management tab on the Board's Licensure Gateway page and log in under the permit. Once logged in, click on the DME Re-Registration tile. A Re-Registration application should be submitted at least 6-8 weeks prior to the effective date of the change. Note that failure to obtain a new permit in advance of a change in location renders the existing permit void as a matter of law.

This type of ownership change requires a Re-Registration Application. This type of application is specifically for majority ownership changes between existing partners only. To submit a Re-Registration application, click on the Facility Management tab on the Board's Licensure Gateway page and log in under the permit. Once logged in, click on the DME Re-Registration tile. A Re-Registration application should be submitted at least 6-8 weeks prior to the effective date of the change. The applicant should upload an explanation of the change, which could include an organizational chart and/or pre and post closing chart, if applicable. An out-of-state permit must upload a copy of the license from the home state.

Please submit the application at least 6-8 weeks prior to the effective date of the transfer/re-registration. This ensures that the application may be reviewed and processed on the effective date. The Board does not “post-date” or “pre-date” a transfer of ownership. Note that failure to obtain a new permit in advance of a change renders the existing permit void as a matter of law. Again, see below:

Board Rule 21 NCAC 46.1603 provides:
A new pharmacy, device, or medical equipment permit is required for a new location, if there is a change to a different or successor business entity, or a change resulting in a different person or entity owning more than 50 percent interest in the permit holder, or any entity in the chain of ownership above the permit holder, except as provided in 21 NCAC 46 .1604 of this Section. A new permit is required if there is a change in the authority to control or designate a majority of the members or board of directors of a nonprofit corporation holding a pharmacy permit or any nonprofit corporation in the chain of ownership above the permit holder.

This means, if a change of ownership requiring a new permit occurs – and the pharmacy has not obtained the new permit by the effective date of the transfer of ownership – the previous permit becomes void (i.e. no longer active) as of the effective date of the transfer of ownership.

Any permit subsequently acquired would not operate retroactively. It will operate from the date of issue forward. That means that an untimely transfer of ownership would result in a pharmacy operating without a permit for a period of time, which could result in Board action for unlicensed practice of pharmacy and other collateral consequences.

Transfer of ownership permit applicants must note that a new owner of a pharmacy may not operate using an old permit under a "power of attorney" or similar.

To facilitate an orderly transfer, permit applications must be filed well in advance (6-8 weeks) of the planned transaction And, of course, permit applications proceed most quickly when they are complete, correct, and the applicant pharmacist-manager responds quickly to requests for information from Board staff. The applicant pharmacist-manager needs to monitor the permit application status and keep Board staff apprised of any changes to the transaction date. Failure to do these things can lead to significant delays in permit review and, as noted above, transferring ownership prior to a new permit’s issuance voids the existing permit.

Give the anticipated effective date on the application and make sure to communicate with the Board, in advance, if the date changes.

Please email Board staff concerning the effective date change. Please include the name of the DME and permit number in the email and alert Board staff of the change several business days in advance. 

Permits are non-transferable. A new owner is required to submit a Transfer of Ownership application at least six weeks in advance of the transfer. Note that failure to obtain a new permit in advance of an ownership change renders the existing permit void as a matter of law. Again, see below:

Board Rule 21 NCAC 46.1603 provides:
A new pharmacy, device, or medical equipment permit is required for a new location, if there is a change to a different or successor business entity, or a change resulting in a different person or entity owning more than 50 percent interest in the permit holder, or any entity in the chain of ownership above the permit holder, except as provided in 21 NCAC 46 .1604 of this Section. A new permit is required if there is a change in the authority to control or designate a majority of the members or board of directors of a nonprofit corporation holding a pharmacy permit or any nonprofit corporation in the chain of ownership above the permit holder.

This means, if a change of ownership requiring a new permit occurs – and the pharmacy has not obtained the new permit by the effective date of the transfer of ownership – the previous permit becomes void (i.e. no longer active) as of the effective date of the transfer of ownership.

Any permit subsequently acquired would not operate retroactively. It will operate from the date of issue forward. That means that an untimely transfer of ownership would result in a pharmacy operating without a permit for a period of time, which could result in Board action for unlicensed practice of pharmacy and other collateral consequences.

Transfer of ownership permit applicants must note that a new owner of a pharmacy may not operate using an old permit under a "power of attorney" or similar.

To facilitate an orderly transfer, permit applications must be filed well in advance (6-8 weeks) of the planned transaction And, of course, permit applications proceed most quickly when they are complete, correct, and the applicant pharmacist-manager responds quickly to requests for information from Board staff. The applicant pharmacist-manager needs to monitor the permit application status and keep Board staff apprised of any changes to the transaction date. Failure to do these things can lead to significant delays in permit review and, as noted above, transferring ownership prior to a new permit’s issuance voids the existing permit.

Yes. A Transfer of Ownership application is required if the majority of interest changes (greater than 50%) at the permit holder or in any entity in chain of ownership above the permit holder. 21 NCAC 46.1603. See also these instructions concerning change in ownership:

Board Rule 21 NCAC 46.1603 provides:
A new pharmacy, device, or medical equipment permit is required for a new location, if there is a change to a different or successor business entity, or a change resulting in a different person or entity owning more than 50 percent interest in the permit holder, or any entity in the chain of ownership above the permit holder, except as provided in 21 NCAC 46 .1604 of this Section. A new permit is required if there is a change in the authority to control or designate a majority of the members or board of directors of a nonprofit corporation holding a pharmacy permit or any nonprofit corporation in the chain of ownership above the permit holder.

This means, if a change of ownership requiring a new permit occurs – and the pharmacy has not obtained the new permit by the effective date of the transfer of ownership – the previous permit becomes void (i.e. no longer active) as of the effective date of the transfer of ownership.

Any permit subsequently acquired would not operate retroactively. It will operate from the date of issue forward. That means that an untimely transfer of ownership would result in a pharmacy operating without a permit for a period of time, which could result in Board action for unlicensed practice of pharmacy and other collateral consequences.

Transfer of ownership permit applicants must note that a new owner of a pharmacy may not operate using an old permit under a "power of attorney" or similar.

To facilitate an orderly transfer, permit applications must be filed well in advance (6-8 weeks) of the planned transaction And, of course, permit applications proceed most quickly when they are complete, correct, and the applicant pharmacist-manager responds quickly to requests for information from Board staff. The applicant pharmacist-manager needs to monitor the permit application status and keep Board staff apprised of any changes to the transaction date. Failure to do these things can lead to significant delays in permit review and, as noted above, transferring ownership prior to a new permit’s issuance voids the existing permit.

This would be considered a non-controlling owner change. To submit this type of change, please log under the permit through the Board's Licensure Gateway and click on the tile entitled Update Non-Controlling Owners. Please allow 5-7 business days for staff to review and process these updates.

Yes. If the change is less than 50%, and the change occurred in an entity in the chain of ownership above the direct pharmacy owner, the Update Non-Controlling Owners request may be submitted. Along with the update, please upload an explanation as to what changed and at what level.

No. See these instructions concerning change in ownership:

Board Rule 21 NCAC 46.1603 provides:
A new pharmacy, device, or medical equipment permit is required for a new location, if there is a change to a different or successor business entity, or a change resulting in a different person or entity owning more than 50 percent interest in the permit holder, or any entity in the chain of ownership above the permit holder, except as provided in 21 NCAC 46 .1604 of this Section. A new permit is required if there is a change in the authority to control or designate a majority of the members or board of directors of a nonprofit corporation holding a pharmacy permit or any nonprofit corporation in the chain of ownership above the permit holder.

This means, if a change of ownership requiring a new permit occurs – and the pharmacy has not obtained the new permit by the effective date of the transfer of ownership – the previous permit becomes void (i.e. no longer active) as of the effective date of the transfer of ownership.

Any permit subsequently acquired would not operate retroactively. It will operate from the date of issue forward. That means that an untimely transfer of ownership would result in a pharmacy operating without a permit for a period of time, which could result in Board action for unlicensed practice of pharmacy and other collateral consequences.

Transfer of ownership permit applicants must note that a new owner of a pharmacy may not operate using an old permit under a "power of attorney" or similar.

To facilitate an orderly transfer, permit applications must be filed well in advance (6-8 weeks) of the planned transaction And, of course, permit applications proceed most quickly when they are complete, correct, and the applicant pharmacist-manager responds quickly to requests for information from Board staff. The applicant pharmacist-manager needs to monitor the permit application status and keep Board staff apprised of any changes to the transaction date. Failure to do these things can lead to significant delays in permit review and, as noted above, transferring ownership prior to a new permit’s issuance voids the existing permit.

Once Board staff approves the application and the PIC has confirmed the date of the transfer, the application will be processed and effective on that date.

If a transfer of ownership requiring a new permit occurs, and the DME has not obtained the new permit by the effective date of the transfer of ownership, the previous permit becomes void as of the effective date of transfer of ownership. This could result in Board action. It’s extremely important to submit the application well before the transfer of ownership occurs. See also these instructions concerning change in ownership:

Board Rule 21 NCAC 46.1603 provides:
A new pharmacy, device, or medical equipment permit is required for a new location, if there is a change to a different or successor business entity, or a change resulting in a different person or entity owning more than 50 percent interest in the permit holder, or any entity in the chain of ownership above the permit holder, except as provided in 21 NCAC 46 .1604 of this Section. A new permit is required if there is a change in the authority to control or designate a majority of the members or board of directors of a nonprofit corporation holding a pharmacy permit or any nonprofit corporation in the chain of ownership above the permit holder.

This means, if a change of ownership requiring a new permit occurs – and the pharmacy has not obtained the new permit by the effective date of the transfer of ownership – the previous permit becomes void (i.e. no longer active) as of the effective date of the transfer of ownership.

Any permit subsequently acquired would not operate retroactively. It will operate from the date of issue forward. That means that an untimely transfer of ownership would result in a pharmacy operating without a permit for a period of time, which could result in Board action for unlicensed practice of pharmacy and other collateral consequences.

Transfer of ownership permit applicants must note that a new owner of a pharmacy may not operate using an old permit under a "power of attorney" or similar.

To facilitate an orderly transfer, permit applications must be filed well in advance (6-8 weeks) of the planned transaction And, of course, permit applications proceed most quickly when they are complete, correct, and the applicant pharmacist-manager responds quickly to requests for information from Board staff. The applicant pharmacist-manager needs to monitor the permit application status and keep Board staff apprised of any changes to the transaction date. Failure to do these things can lead to significant delays in permit review and, as noted above, transferring ownership prior to a new permit’s issuance voids the existing permit.

The incoming PIC must log in to the Board's Licensure Gateway under the permit and click on the Update PIC tile. Follow the prompts. The incoming PIC should allow 5-7 business days for review and processing. There is no fee for a PIC update.

Once logged in under the permit, there are several blue gears at top of the page. These icons allow the PIC to update email addresses of the PIC and the facility, hours of operation, and phone numbers.

Once logged in to the Board's Licensure Gateway under the permit, click on the View/Update Services tile. This will bring up the services page for the DME, which the PIC may – and should – update as needed.

Yes. Once logged in to the Board's Licensure Gateway under the permit, click on the Update Officers tile and make changes as needed.

Yes. Once logged in to the Board's Licensure Gateway under the permit, click on the Name Change tile and submit the request. The update should only be for a minor change to add/update the D/B/A name due to rebranding. If the DME is undergoing a change of ownership, a Change of Ownership permit application is required.

Occasionally, a county, municipality, or post office will change the address of the DME facility. In these cases, the DME is required to submit an address update. To submit an address update, please log in to the Board's Licensure Gateway under the permit, click on the Address Update tile, and follow the prompts. Please allow 5-7 days for review and processing. Note: If the DME is moving to a new address, a Re-Registration Application must be filed and the application approved prior to the move. Changing locations without an approved re-registration voids the existing permit as a matter of law.

Renewal / Closing

Instructions and FAQs regarding DME permit renewal are found here.

21 NCAC 46.2502(h) details the PIC’s responsibilities upon permanent closure of a DME facility. These responsibilities are in place to ensure that the DME’s patients are not caught by surprise by a closure and that continuity of care is maintained. Adherence to them is crucial. Please log in under the permit and click on the tile entitled Close Facility and follow the prompts to submit the closure notice. Please allow 5-7 business days for the update to be reviewed and processed.

The NC permit will need to be closed. Please log in under the permit, click on the Close Facility tile, and follow the prompts to submit the closure notice. Please allow 5-7 business days for the update to be reviewed and processed. 

General

Yes. A facility that receives and processes DME orders is engaged in the dispensing and delivery process. And, under North Carolina law, “each place” that dispenses or delivers devices or medical equipment must hold a North Carolina DME permit. In this scenario, both the organization receiving and processing DME orders and the organization to which the orders are transferred to complete the dispensing/delivery process must hold a DME permit. GS § 90-85.22

The Board of Pharmacy does not issue DMEPOS accreditations. Information about the National Association of Boards of Pharmacy DMEPOs Program is found here.

The inspection form used by Board inspectors in DME facilities is found here.

For questions about DME permits, please contact Wendy Watson at 919.246.1050 or by email at wwatson@ncbop.org.