Q: What are the record keeping requirements for a DME facility?
A: Board Rule .2604 requires that a Durable Medical Equipment (DME) facility’s orders and records for devices and medical equipment shall conform in all pertinent respects with Board Rules .2301 through .2305 of this Chapter and shall be maintained at the dispensing site.
In addition to the requirements of those rules, the serial numbers for all devices dispensed and all medical equipment delivered to outpatients shall be preserved as part of the records; provided, that this requirement shall not apply to disposable devices and medical equipment.
The same rule requires that all prescriptions and refills orders for devices and medical equipment be maintained at the dispensing site for three years.
Board Rule .2602 requires a DME facility to maintain a file copy of every item sold or rented with a serial number or tracking number or code in compliance with FDA Medical Device Tracking requirements.
Board Rule .2508 broadly allows required records to be maintained electronically, unless another rule or law specifically requires a record be created or maintained in a different format. The system that creates and maintains the electronic record must:
(1) be capable of printing the documentation so that the pharmacist-manager can provide it to the Board within 48 hours of a request;
(2) contains security features to prevent unauthorized access to the records; and
(3) contains daily back-up functionality to protect against record loss.
Q: Are expiration dates required on medical gas cylinders?
A: Board Rule .2610 requires that medical gas cylinders be affixed with “lot numbers and expiration dates.” This rule is not intended to create an expiration date requirement that would differ from that required under the federal or North Carolina Food Drug and Cosmetic Acts.
The Board is aware that the issue of medical gas cylinder expiry dating has been a matter of substantial controversy and discussion at the federal level for a number of years. The Board is aware that the federal Food and Drug Administration has, as a matter of enforcement policy, advised its inspectors to not cite medical gas suppliers for the absence of an expiration date on a medical gas cylinder. The North Carolina Department of Agriculture Food and Drug Safety Division has advised its field staff similarly.
Given Rule .2610(b)’s intent to mirror federal requirements, Board of Pharmacy staff will likewise not cite a medical gas dispenser for the absence of an expiration date on a medical gas cylinder.
Q: Does North Carolina require that a DME facility supply back-up oxygen to patients?
A: Yes. Board Rule .1608 states: "If the applicant dispenses medical oxygen to a patient, then the applicant must reasonably ensure that the following medical equipment is maintained: (A) Sufficient backup of oxygen in that patient's home and supplies for equipment serviced to maintain continuation of therapy for 24 hours;”
Q: If an entity ships glucose meters to North Carolina residents, must it obtain a DME permit?
A: Glucose meters. GS § 90-85.22(b) provides that any place delivering "medical equipment" must obtain a DME permit to ship to North Carolina residents. GS § 90-85.3(l) defines "medical equipment" to include "diagnostic equipment." Board Rule .1317(7) excludes "glucose meters" from the definition of "diagnostic equipment. Accordingly, the mere fact of shipping glucose meters to North Carolina residents would not require a business to obtain a DME permit. Of course, if the business were also shipping other items that satisfy the definition of "device" or "medical equipment" to North Carolina residents, it must obtain a DME permit.
Q: If an entity ships power wheelchairs or scooters to North Carolina residents, must it obtain a DME permit?
A: Scooters. Again, GS § 90-85.22(b) provides that any place delivering "medical equipment" must obtain a DME permit to ship to North Carolina residents. GS § 90-85.3(l) defines "medical equipment" to include "mobility equipment." Board Rule .1317(22) defines mobility equipment to "includ[e] manual or power wheelchairs and scooters." Accordingly, any business shipping motorized wheelchairs or scooters to North Carolina residents must obtain a DME permit before doing so.