North Carolina's Medical Equipment and Device Permits

North Carolina regulates DME suppliers through its Board of Pharmacy, and it does so by place, not by state of residence. "Each place, whether located in this State or out-of-state, that delivers medical equipment to the user of the equipment in this State shall register annually with the Board ... and obtain a medical equipment permit" (N.C. Gen. Stat. 90-85.22(b)). A parallel rule requires a device permit for each place "where devices are dispensed or delivered to the user in this State" (90-85.22(a)). The statutory fees are $500 for original registration and $200 to renew (90-85.24(a)(17)-(18)), and permits expire every December 31 (21 NCAC 46 .1609).

Device permit or medical equipment permit?

The statute stacks the three Board credentials:

• A pharmacy permit covers both: "A business that has a current pharmacy permit does not have to register and obtain a device permit," and the same goes for the medical equipment permit.
• A device permit covers dispensing devices and also medical equipment: a business with "a current device permit does not have to register and obtain a medical equipment permit."
• A medical equipment permit covers delivering medical equipment only.

A supplier that dispenses prescription devices as well as equipment should therefore apply for the device permit. The fee lines in 90-85.24 treat them together as registration "to dispense devices, deliver medical equipment, or both." The statute excludes FDA-registered pharmaceutical manufacturers, their wholly owned subsidiaries and home renal products dispensed under 90-85.21C (90-85.22(c)).

Does an out-of-state supplier need a North Carolina permit?

Yes. The statute names "out-of-state" places in both subsections, and no North Carolina location is required. An out-of-state pharmacy has its own rule and may not ship "even a single dispensed legend drug, device, or piece of medical equipment into this State until it receives a permit from the Board" (21 NCAC 46 .1607(b)). For mail-order suppliers, North Carolina is one of the clearest examples of a state that licenses by where the patient is. See mail-order DME and the states you ship to.

Who is the person in charge?

The permit is issued to a person, not just a company. "Device and medical equipment permits, whether original or renewal, shall be issued to the person in charge of the facility pursuant to a joint application of the owner and person in charge." The permit "shall not be valid until it has been countersigned by the person in charge," and stays valid "only so long as the person in charge to whom it was issued assumes his duties and responsibilities." A successor can take over by amending the application (21 NCAC 46 .1608(b)).

Three more rules attach to that person:

1. "A person shall be in charge of only one location" (21 NCAC 46 .2605(a)). A supplier with five permitted locations needs five people in charge.
2. The person in charge "or the designee of the person in charge shall be present at the facility during the hours of operation," and hours must be posted (.1608(b)).
3. Before an original permit issues, the person in charge must complete the Board's North Carolina education module on the Pharmacy Practice Act and the Board's rules, and "must personally complete the educational module and may not delegate this responsibility to any other person" (.1606).

That last rule is a good example of where a preparer's role stops. We can prepare the joint application, but the education module, the countersignature and the role itself belong to the supplier's own person. A person in charge who commits a felony, or acts as a principal in a business excluded from a federal or state program, can no longer serve (.2605(b)). See designated representatives and exemptees.

What does the Board check before issuing a permit?

Rule .1608(a) lists the standards, among them:

• adequate qualified personnel, maintained throughout the permit period;
• for medical oxygen, "Sufficient backup of oxygen in that patient's home and supplies for equipment serviced to maintain continuation of therapy for 24 hours," and an oxygen analyzer at the facility if concentrators are dispensed;
• suitable space for inventory, fabrication work and prescription records;
• a copy of North Carolina's pharmacy laws and Board rules in the facility;
• a clean, sanitary facility with hand washing available;
• compliance with USP and FDA storage, packaging and shipping requirements;
• services "available 24 hours, seven days per week when essential to the maintenance of life";
• a written complaint procedure and complaint file at each location;
• compliance with fire, building and OSHA rules.

The person in charge also keeps warranty and repair information on file at each location for three years, except for disposables (.2605(a)).

When is a new permit required?

"A new pharmacy, device, or medical equipment permit is required for a new location, 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" (21 NCAC 46 .1603). Publicly traded permit holders and some wholly owned subsidiaries are excepted (.1604). If you are buying a supplier with North Carolina permits, the new owner applies for new ones. See buying a DME company.

What happens at renewal?

"Permits issued by the Board expire on December 31 and become invalid 60 days following expiration" (.1609). A location reinstated after March 1 and before April 1 pays the maximum reinstatement and renewal fees, and "After March 31, permits and registrations issued to locations shall submit new applications and are subject to the maximum original registration fees" (.1612(a)). In short: renew in December, and treat March 31 as the date a lapsed permit becomes a new application at $500. See a renewal calendar for state DME licenses.

How do we help with North Carolina?

North Carolina is a standard state at $699 (pricing). We confirm which permit fits, prepare the joint application, organize the facility standards and policies, and track the December 31 renewal ($299 per license, per year for tracking). The owner and the person in charge sign, the person in charge completes the education module personally, and you pay the Board's fees. Board online accounts stay in your name. See the North Carolina state page.