21 NCAC 46 .1822             ALTERNATE DELIVERY SITES

(a)  This Rule sets out the requirements under which pharmacies may utilize alternate delivery sites for delivery of drugs, devices, or medical equipment or for receipt of prescriptions in the State of North Carolina.

(b)  Before any drugs, devices, or medical equipment may be delivered at an alternate delivery site, the pharmacy shall have been issued a pharmacy permit by the Board pursuant to G.S. 90-85.21 or G.S. 90-85.21A, and the alternate delivery site shall have been issued a limited service permit under Rule .1616 of this Chapter. The limited service permit shall be granted only if, and so long as, compliance with all requirements of this Rule can be assured.

(c)  Location.

(1)           An alternate delivery site shall be within the State of North Carolina and 60 miles or fewer from the pharmacy (via the shortest surface street route).

(2)           An alternate delivery site may not be located in the same building or on the same property as the pharmacy or any pharmacy under common ownership.

(3)           An alternate delivery site may be placed in the office of a prescriber only if the alternate delivery site is under the control of the pharmacy, which is responsible for compliance with all laws, rules, and regulations regarding the alternate delivery site, and only if the alternate delivery site is staffed with pharmacy personnel, as set forth herein. The pharmacy shall maintain the alternate delivery site in the prescriber's office only if the prescriber offers patients a choice of pharmacy. The pharmacy shall not give compensation to or receive compensation from the prescriber for the placement of the alternate delivery site or for any prescriptions delivered at the alternate delivery site.

(4)           An alternate delivery site may not be located on residential property.

(5)           The pharmacy shall notify the Board within 10 days after discontinuing patient use of any alternate delivery site.

(d)  Staffing and Management.

(1)           When the alternate delivery site is open, it must be continuously staffed by a pharmacist or certified pharmacy technician who is an employee of the pharmacy.

(2)           The alternate delivery site shall be used exclusively by the one pharmacy whose pharmacist-manager is responsible for the alternate delivery site's operation.

(3)           The dispensing pharmacist for any drugs, devices, or medical equipment delivered to an alternate delivery site shall be employed by the pharmacy and licensed with this Board.

(4)           At all times that the alternate delivery site is open, a pharmacist employed by the pharmacy must be available for counseling, as set forth in this Rule, and for consultation with the staff of the alternate delivery site.

(5)           All staff at the alternate delivery site shall wear identification badges as set forth in G.S. 90-640.

(e)  Services Limited to Prescription Pickup and Drop Off for the Pharmacy.

(1)           At the alternate delivery site, a pharmacist or a certified technician employed by the pharmacy may personally deliver any drug, device, or medical equipment to the patient or the patient's agent, after that drug, device, or medical equipment has been previously dispensed by the pharmacy. All physical steps in the dispensing process (other than delivery to the patient) must occur at the pharmacy, including, but not limited to, filling and patient-specific labeling. No drugs, devices, or medical equipment may be maintained at the alternate delivery site, other than completed patient-specific labeled and previously dispensed drugs, devices, or medical equipment that have been transported from the pharmacy to the alternate delivery site to be delivered.

(2)           At the alternate delivery site, a pharmacist or certified pharmacy technician who is an employee of the pharmacy may personally accept a written prescription from the patient or the patient's agent, so long as the prescription is then transmitted to the pharmacy so that all physical steps in the dispensing process may take place in the pharmacy. Patients or their agents may not leave prescriptions at the alternate delivery site, other than by personally delivering them to the pharmacist or certified pharmacy technician.

(f)  Requirements for Use of Alternate Delivery Site.

(1)           Before a pharmacy delivers drugs, devices, or medical equipment to a patient at an alternate delivery site, the pharmacy shall secure the affirmative consent of the patient to use the alternate delivery site. The pharmacy shall not require patients to pick up their prescriptions from an alternate delivery site, rather than at the pharmacy or through delivery mechanisms otherwise available at the pharmacy.

(2)           To ensure appropriate coordination of patient care, the pharmacy shall notify the alternate delivery site of the anticipated arrival time of the transportation of the drug, device, or medical equipment to the alternate delivery site, the name of the patient for whom the drug, device or medical equipment was dispensed, and any special storage requirements.

(3)           The hours of the alternate delivery site shall be reported to the Board, and the alternate delivery site shall be open during the hours that have been reported to the Board. Emergency closure of the alternate delivery site shall require the pharmacist-manager of the pharmacy to follow the procedures in Rule .2516 of this Chapter.

(4)           The pharmacist or certified pharmacy technician at the alternate delivery site shall convey the pharmacy's offer to counsel a patient as required by Rule .2504 of this Chapter and shall provide the ability for the patient to have an immediate real-time consultation with a pharmacist licensed by this Board and employed by the pharmacy who has access to all of the pharmacy's information related to the patient. The communication link shall protect the confidentiality of the patient's information. A pharmacist who is responsible for counseling may not provide that service for more than three limited service permits simultaneously. A certified pharmacy technician staffing an alternate delivery site may not perform counseling of any sort.

(5)           The alternate delivery site shall have real-time access to the pharmacy's information system and shall comply with all recordkeeping requirements for drugs, devices, and medical equipment delivered at the site.

(6)           The pharmacist or certified pharmacy technician delivering drugs, devices, or medical equipment has the authority conferred by Rule .1817 of this Section with respect to proof of identification.

(7)           Controlled substances may be delivered to an alternate delivery site only if permitted by state and federal controlled substances laws. If permitted, both the pharmacy and alternate delivery site shall comply with any federal and state controlled substance laws and rules, including but not limited to receiving any registrations that may be required for any alternate delivery site, before any controlled substances are delivered to any alternate delivery site. The pharmacist or certified pharmacy technician delivering drugs at the alternate delivery site must comply with G.S. 90-106.1 in delivering any drugs covered by that statute from an alternate delivery site and shall visually confirm that the person seeking the delivery is the same as the person on the photographic identification provided.

(8)           The pharmacy shall retrieve any drugs, devices, or medical equipment not delivered to the patient within twenty-one days of being delivered to the alternate delivery site.

(9)           Drugs, devices, or medical equipment that are not picked up by a patient may be returned to stock under the same conditions as if the item had been maintained in the pharmacy, as long as the requirements of this Rule for operating the alternate delivery site have been followed and the drugs, devices, or medical equipment can be returned to stock consistent with the public health, safety, and welfare.

(g)  Safety and Security.

(1)           The pharmacist-manager shall not deliver drugs, devices, or medical equipment to or at the alternate delivery site unless the pharmacist-manager is satisfied that drugs, devices, or medical equipment may be as safely and effectively stored and delivered at the alternate delivery site as in the pharmacy itself.

(2)           Drugs, devices, or medical equipment delivered to the alternate delivery site shall be stored in a lockable room or lockable cabinet or other irremovable device. The lockable storage must remain locked at all times except when a drug, device, or medical equipment is being actively removed from storage. If prescriptions require special storage, such as refrigeration, those storage devices must be similarly secured. Access shall be restricted to the pharmacist or certified pharmacy technician who is personally delivering the prescriptions.

(3)           The pharmacy shall ensure the transportation and storage of any drugs, devices, and medical equipment at temperatures, humidities, and other environmental conditions to ensure that they do not become adulterated under G.S. 106-133 and to ensure that they are transported and stored in accordance with manufacturer's specifications, if any, for those items.

(4)           The pharmacy shall ensure that there is continuous, recorded video surveillance of the storage and delivery of drugs, devices, and medical equipment at the alternate delivery site. It shall maintain any recordings for a minimum of 90 days.

(h)  Policies and Procedures: The pharmacy must develop and implement written policies and procedures to ensure that the requirements of the Pharmacy Practice Act, Article 4A of Chapter 90 of the General Statutes, and its rules and regulations are complied with at the alternate delivery site. These shall include:

(1)           Tracking and maintaining the security of delivery of drugs, devices, and medical equipment between the pharmacy and the alternate delivery site.

(2)           Maintaining the security of the alternate delivery site and the drugs, devices, and medical equipment at the alternate delivery site.

(3)           Transporting and maintaining any drugs, devices, and medical equipment in the appropriate environmental conditions.

(4)           Describing the assignment of responsibilities to, and training of, pharmacy personnel regarding the transportation, storage, and delivery procedures for the alternate delivery site.

(5)           Offering to counsel and providing counseling at the alternate delivery site, including keeping records of offers to counsel.

(6)           Orienting participating patients on use of the alternate delivery site; notifying patients when their dispensed prescription will be available at the alternate delivery site; and ensuring that use of the alternate delivery site does not interfere with the delivery of drugs, devices, and medical equipment to patients.

(7)           Keeping records of the delivery of drugs, devices, and medical equipment to patients at the alternative delivery site.

(8)           Returning to the pharmacy any drugs, devices, or medical equipment that are not delivered to the patient.

(9)           Assuring confidentiality of patient information.

(10)         Inspecting the alternate delivery site during each required inspection.

This written manual of policies and procedures shall be maintained both in the pharmacy and at the alternate delivery site. The manual shall be reviewed and updated annually.

(i)  The pharmacy shall record and review any incident involving a complaint, delivery error, or omission regarding an alternate delivery site as part of the pharmacy's quality assurance program.

(j)  This Rule does not prohibit the use of other delivery methods set forth in Rule .1821(b)(1) of this Section, which are exclusive.

History Note:        Authority G.S. 90-85.6; 90-85.15A; 90-85.21; 90-85.21A; 90-85.26;

Eff. September 1, 2026.