North Carolina § 90-85 - 3. Definitions.

§ 90-85. 3. Definitions.

"Administer" means the direct application of a drug to the body of a patient by injection, inhalation, ingestion or other means. "Board" means the North Carolina Board of Pharmacy. "Certified pharmacy technician" means a pharmacy technician who (i) has passed a nationally recognized pharmacy technician certification board examination, or its equivalent, that has been approved by the Board and (ii) obtains and maintains certification from a nationally recognized pharmacy technician certification board that has been approved by the Board. "Clinical pharmacist practitioner" means a licensed pharmacist who meets the guidelines and criteria for such title established by the joint subcommittee of the North Carolina Medical Board and the North Carolina Board of Pharmacy and is authorized to enter into drug therapy management agreements with physicians in accordance with the provisions of G.S. 90-18.4. "Compounding" means taking two or more ingredients and combining them into a dosage form of a drug, exclusive of compounding by a drug manufacturer, distributor, or packer. "Deliver" means the actual, constructive or attempted transfer of a drug, a device, or medical equipment from one person to another. "Device" means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar or related article including any component part or accessory, whose label or labeling bears the statement "Caution: federal law requires dispensing by or on the order of a physician." The term does not include: Devices used in the normal course of treating patients by health care facilities and agencies licensed under Chapter 131E or Article 2 of Chapter 122C of the General Statutes; Devices used or provided in the treatment of patients by medical doctors, dentists, physical therapists, occupational therapists, speech pathologists, optometrists, chiropractors, podiatrists, and nurses licensed under Chapter 90 of the General Statutes, provided they do not dispense devices used to administer or dispense drugs. "Dispense" means preparing and packaging a prescription drug or device in a container and labeling the container with information required by State and federal law. Filling or refilling drug containers with prescription drugs for subsequent use by a patient is "dispensing". Providing quantities of unit dose prescription drugs for subsequent administration is "dispensing". "Drug" means: Any article recognized as a drug in the United States Pharmacopeia, or in any other drug compendium or any supplement thereto, or an article recognized as a drug by the United States Food and Drug Administration; Any article, other than food or devices, intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals; Any article, other than food or devices, intended to affect the structure or any function of the body of man or other animals; and Any article intended for use as a component of any articles specified in clause (1), (2) or (3) of this subsection. "Emancipated minor" means any person under the age of 18 who is or has been married or who is or has been a parent; or whose parents or guardians have surrendered their rights to the minor's services and earnings as well as their right to custody and control of the minor's person; or who has been emancipated by an appropriate court order. "Health care provider" means any licensed health care professional; any agent or employee of any health care institution, health care insurer, health care professional school; or a member of any allied health profession. "Immunizing pharmacist" means a licensed pharmacist who meets all of the following qualifications: Holds a current provider level cardiopulmonary resuscitation certification issued by the American Heart Association or the American Red Cross, or an equivalent certification. Has successfully completed a certificate program in vaccine administration accredited by the Centers for Disease Control and Prevention, the Accreditation Council for Pharmacy Education, or a similar health authority or professional body approved by the Board. Maintains documentation of three hours of continuing education every two years, designed to maintain competency in the disease states, drugs, and vaccine administration. Has successfully completed training approved by the Division of Public Health's Immunization Branch for participation in the North Carolina Immunization Registry. Has notified the North Carolina Board of Pharmacy and the North Carolina Medical Board of immunizing pharmacist status. (Effective until October 1, 2021) Administers vaccines or immunizations in accordance with G.S. 90-18.15B. "Label" means a display of written, printed or graphic matter upon the immediate or outside container of any drug. "Labeling" means preparing and affixing a label to any drug container, exclusive of labeling by a manufacturer, packer or distributor of a nonprescription drug or a commercially packaged prescription drug or device. "License" means a license to practice pharmacy including a renewal license issued by the Board. "Medical equipment" means any of the following items that are intended for use by the consumer in the consumer's place of residence: A device. Ambulation assistance equipment. Mobility equipment. Rehabilitation seating. Oxygen and respiratory care equipment. Rehabilitation environmental control equipment. Diagnostic equipment. A bed prescribed by a physician to treat or alleviate a medical condition. "Mobile pharmacy" means a pharmacy that meets all of the following conditions: Is either self-propelled or moveable by another vehicle that is self-propelled. Is operated by a nonprofit corporation. Dispenses prescription drugs at no charge or at a reduced charge to persons whose family income is less than two hundred percent (200%) of the federal poverty level and who do not receive reimbursement for the cost of the dispensed prescription drugs from Medicare, Medicaid, a private insurance company, or a governmental unit. "Permit" means a permit to operate a pharmacy, deliver medical equipment, or dispense devices, including a renewal license issued by the Board. "Person" means an individual, corporation, partnership, association, unit of government, or other legal entity. "Person in loco parentis" means the person who has assumed parental responsibilities for a child. "Pharmacist" means a person licensed under this Article to practice pharmacy. "Pharmacy" means any place where prescription drugs are dispensed or compounded. "Pharmacy personnel" means pharmacists and pharmacy technicians. "Pharmacy technician" means a person who may, under the supervision of a pharmacist, perform technical functions to assist the pharmacist in preparing and dispensing prescription medications. "Practice of pharmacy" is as specified in G.S. 90-85.3A. "Prescription drug" means a drug that under federal law is required, prior to being dispensed or delivered, to be labeled with the following statement: "Prescription order" means a written or verbal order for a prescription drug, prescription device, or pharmaceutical service from a person authorized by law to prescribe such drug, device, or service. A prescription order includes an order entered in a chart or other medical record of a patient. "Unit dose medication system" means a system in which each dose of medication is individually packaged in a properly sealed and properly labeled container. (6) (Effective October 1, 2021) Administers vaccines, long-acting injectable medications, or immunizations in accordance with G.S. 90-18.15B. The term "medical equipment" does not include (i) medical equipment used or dispensed in the normal course of treating patients by or on behalf of home care agencies, hospitals, and nursing facilities licensed under Chapter 131E of the General Statutes or hospitals or agencies licensed under Article 2 of Chapter 122C of the General Statutes; (ii) medical equipment used or dispensed by professionals licensed under Chapters 90 or 93D of the General Statutes, provided the professional is practicing within the scope of that professional's practice act; (iii) upper and lower extremity prosthetics and related orthotics; or (iv) canes, crutches, walkers, and bathtub grab bars. "Caution: Federal law prohibits dispensing without prescription." History (1981 (Reg. Sess., 1982), c. 1188, s. 1; 1983, c. 196, ss. 1-3; 1991, c. 578, s. 1; 1993 (Reg. Sess., 1994), c. 692, s. 2; 1995, c. 94, s. 24; 1999-246, s. 1; 1999-290, ss. 4, 5; 2001-375, s. 1; 2002-159, s. 37; 2013-246, ss. 1, 2; 2013-379, s. 1; 2021-3, s. 2.9(b).) Subdivision (i1)(6) Set Out Twice. - The first version of subdivision (il)(6) set out above is effective until October 1, 2021. The second version of subdivision (il)(6) set out above is effective October 1, 2021. Editor's Note. - Subsection (q3) as added by Session Laws 2013-379, s. 1, was redesignated as subsection (b1) and former subsection (b1) was redesignated as subsection (b2) at the direction of the Revisor of Statutes to maintain alphabetical order. Session Laws 2011-315, s. 3, provides: "A pharmacist licensed under Article 4A of Chapter 90 who may administer vaccines under 21 NCAC 46.2507 and 21 NCAC 32U.0101 shall be granted the authority to administer influenza vaccine to patients aged 14 years and older pursuant to 21 NCAC 46.2507 and 21 NCAC 32U.0101." Session Laws 2013-246, s. 7, provides: "Notwithstanding the provisions of Sections 1 through 5 of this act, pharmacists who were qualified to administer influenza, pneumococcal, and zoster vaccines prior to the effective date of this act may continue to administer these vaccines in accordance with the provisions of 21 NCAC 46.2507 until June 30, 2014. Notwithstanding the provisions of Sections 1 through 5 of this act, 21 NCAC 46.2507(c)(5), 21 NCAC 32U.0101(c)(5), or any other provision of law, pharmacists who were qualified to administer influenza, pneumococcal, and zoster vaccines prior to the effective date of this act may administer the influenza vaccine to persons at least 14 years old in accordance with the provisions of 21 NCAC 46.2507 until June 30, 2014." Session Laws 2013-246, s. 7 is effective October 1, 2013. Session Laws 2020-3, s. 3A.1(a), provides: "Unless the context clearly indicates otherwise, the following definitions apply in this Part: "(1) CDC. - The federal Centers for Disease Control and Prevention. "(2) COVID-19. - Coronavirus disease 2019. "(3) COVID-19 diagnostic test. - A test the federal Food and Drug Administration has authorized for emergency use or approved to detect the presence of the severe acute respiratory syndrome coronavirus 2. "(4) COVID-19 emergency. - The period beginning March 10, 2020, and ending on the date the Governor signs an executive order rescinding Executive Order No. 116, Declaration of a State of Emergency to Coordinate Response and Protective Actions to Prevent the Spread of COVID-19. "(5) COVID-19 antibody test. - A serological blood test the federal Food and Drug Administration has authorized for emergency use or approved to measure the amount of antibodies or proteins present in the blood when the body is responding to an infection caused by the severe acute respiratory syndrome coronavirus 2." Session Laws 2020-3, s. 3D.3(a)-(d), as amended by Session Laws 2021-3, s. 2.8(a), provides: "(a) In the event the Centers for Disease Control and Prevention recommends an immunization or vaccination for COVID-19 at a time when the General Assembly is not in regular session, any person may petition the State Health Director, in writing, to authorize immunizing pharmacists, as defined in G.S. 90-85.3 , to administer the recommended immunization or vaccination for COVID-19 by means of a statewide standing order. The State Health Director shall, within 30 days after receiving such petition, consult with the following entities in evaluating the petition and respond by either approving or denying the petition: Representatives of the North Carolina Academy of Family Physicians, the North Carolina Medical Society, the North Carolina Pediatric Society, the North Carolina Association of Community Pharmacists, the North Carolina Association of Pharmacists, and the North Carolina Retail Merchants Association. "(b) Following the consultation provided in subsection (a) of this section, if the State Health Director approves the petition, the State Health Director may issue a statewide standing order authorizing the administration of an immunization or vaccination of COVID-19 by immunizing pharmacists. If the State Health Director issues a statewide standing order, it shall expire upon the adjournment of the next regular session of the General Assembly. "(c) If the State Health Director approves the petition as provided in subsection (a) of this section, the State Health Director shall, within 10 days after approval, consult with the entities listed in subsection (a) of this section to develop and submit to the North Carolina Board of Medicine, the North Carolina Board of Nursing, the North Carolina Board of Pharmacy, and the Joint Legislative Oversight Committee on Health and Human Services a minimum standard screening questionnaire and safety procedures for written protocols for the administration of the recommended immunization or vaccination for COVID-19 by immunizing pharmacists. In the event that the questionnaire and recommended standards are not developed and submitted within the 10-day period as provided in this subsection, then the Immunization Branch of the Department of Health and Human Services, Division of Public Health, shall develop the questionnaire and recommended standards within the next 10 days and submit them to the North Carolina Board of Medicine, the North Carolina Board of Nursing, the North Carolina Board of Pharmacy, and the Joint Legislative Oversight Committee on Health and Human Services. At a minimum, immunizing pharmacists who administer the recommended immunization or vaccination for COVID-19 shall be required to comply with all the requirements of G.S. 90-85.15 B. "(c1) The State Health Director shall amend, reissue, or replace any existing statewide standing order issued pursuant to this section, to ensure that the statewide standing order is consistent with federal law and guidance pertaining to qualified individuals who may administer a COVID-19 vaccine, including P.L. 109-148, "The Public Readiness and Emergence Preparedness Act," as amended, and associated declarations of public health emergencies and advisory opinions issued by the Secretary of the United States Department of Health and Human Services. "(d) All of the following individuals shall be immune from any civil or criminal liability for actions authorized by this section as follows: "(1) The State Health Director acting pursuant to this section. "(2) Any pharmacist or qualified individual under State or federal law who administers a COVID-19 immunization or vaccine pursuant to a statewide standing order issued under this section." Session Laws 2020-3, s. 5, is a severability clause. Session Laws 2021-3, s. 2.9(c), provides: "The North Carolina Board of Pharmacy may adopt temporary rules to implement this section." Effect of Amendments. - Session Laws 2013-246, ss. 1 and 2, effective October 1, 2013, added subsection (i1); and rewrote subsection (r). Session Laws 2013-379, s. 1, effective October 1, 2013, added subsection (q3). Session Laws 2021-3, s. 2.9(b), effective October 1, 2021, substituted "vaccines, long-acting injectable medications,” for "vaccines” in subsection (i1). Legal Periodicals. - For note, "Don't Try This at Home: The FDA's Restrictive Regulation of Home-Testing Devices," see 67 Duke L.J. 383 (2017).