Pharmacy Practice FAQs
PHARMACY
Q: May a pharmacy legally sell "supplements" that contain CBD (cannabidiol)? A: No. On December 20, 2018, FDA Commissioner Scott Gottlieb issued a statement explaining that while the Farm Bill of 2018 removed hemp from the federal Controlled Substances Act, "Congress explicitly preserved the [FDA's] authority to regulate products containing cannabis or cannabis-derived compounds under the FD&C Act." Hence, the FDA "treat[s] products containing cannabis or cannabis-derived compounds as [it does] any other FDA-regulated products." Importantly, FDA reminded the regulated community that it is "unlawful under the FD&C Act . . . to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp derived. This is because both CBD and THC are active ingredients in FDA-approved drugs and were the subject of substantial clinical investigations before they were marketed as . . . dietary supplements." The full statement is found here: FDA CBD Statement In late February 2019, the North Carolina Department of Agriculture -- which directly regulates industrial hemp products in North Carolina -- began sending letters to businesses that manufacture or sell CBD-containing products emphasizing that "North Carolina has routinely adopted by reference the federal Food, Drug & Cosmetic Act and implementing regulations. The violation of these federal laws and regulations would equally be a violation of state laws and regulations." The Department of Agriculture's letter -- like Commissioner Gottlieb's statement -- emphasizes that "CBD is the active ingredient in the approved drug product Epidiolex" and that "[s]ince CBD is the active ingredient in the approved drug product Epidiolex, it is currently excluded from being a dietary supplement under section 210(ff)(3)(B)(i) and (ii) of the FD&C Act." The North Carolina Department of Agriculture further emphasized that "CBD products marketed with claims to prevent, mitigate, diagnose, treat or cure diseases" make those products "drugs under the FD&C Act." Accordingly, "CBD in products other than the approved drug Epidiolex and which make health claims would be a new drug that cannot legally be introduced into interstate commerce." The full text of the Department of Agriculture letter is found here: NC Department of Agriculture CBD Statement.
Q: May pharmacies perform “rapid diagnostic” and other “CLIA-waived” tests? A: Board staff have received numerous questions about pharmacies' ability to perform "rapid diagnostic" and other "CLIA-waived" tests. Some point-of-care tests for things like streptococcus infection, blood glucose levels, and cholesterol levels are approved by the FDA as so-called “CLIA-waived” tests. CLIA refers to the Clinical Laboratory Improvement Amendments Act, a federal statute that, as the name suggests, governs clinical laboratories. When FDA approves an in vitro diagnostic device, it may designate the device as approved “for home use or that, as determined by the Secretary, are simple laboratory examinations and procedures that have an insignificant risk of an erroneous result, including those that . . . employ methodologies that are so simple and accurate as to render the likelihood of erroneous results by the user negligible, or . . . the Secretary has determined pose no unreasonable risk of harm to the patient if performed incorrectly.” 42 USC § 263a(d)(3). If so deemed by the FDA, these tests may be performed in a laboratory that has applied for a waiver of CLIA requirements. 42 USC § 263a(d)(2). CLIA-waived tests don’t require, as a condition of FDA approval, any sort of “prescription” or medical order. Unlike some states, North Carolina law does not impose a separate layer of regulations on top of CLIA: If a facility – including a pharmacy – meets the criteria to perform CLIA-waived tests and obtains from the federal Centers for Medicare and Medicaid Services a CLIA waiver, then that facility may perform any CLIA-waived tests. A pharmacy performing a CLIA-waived test cannot allow its pharmacists to use the results of a CLIA-waived test to prescribe drug therapy independently, or to do anything with the test results besides provide them to the patient and/or communicate them to the patient’s provider of choice. (The exception would be a CPP whose agreement with the supervising physician authorizes the CPP to act on test results.)
Direct-to-Patient Dispensing System Q: What are the rules governing direct-to-patient dispensing systems? A: Board Rule .1821 authorizes the use of direct-to-patient dispensing systems and sets the standards that govern their operation. This guidance document details the rules and standards governing DTP systems. It also provides step-by-step instructions to add an on-site DTP system to an existing pharmacy’s services, or to apply for an off-site DTP system limited-service permit.
Q: May employers or other groups set up “drop-off/pick-up” locations that are not in a pharmacy? (For example, one inquiry the Board received was from an employer who wanted to set up a station at the work site to which a pharmacy would deliver all prescriptions for employees who would then pick up the prescriptions there.) A: Such “drop-off/pick-up” sites do not comply with the North Carolina Pharmacy Practice Act. Under that statute, a pharmacy is “any place where prescription drugs are dispensed or compounded” and any such place must be permitted by the Board of Pharmacy. Final dispensing to patients at a non-permitted site as contemplated in these inquiries would not comply with North Carolina law.
Q: Does the Board of Pharmacy regulate insurers, prescription benefit managers, or other payment matters involving pharmacy? A: No. The North Carolina Department of Insurance regulates those matters: NC Department of Insurance Pharmacy Complaint Resources
Q: Does North Carolina have a “pharmacy of choice” statute? A: Yes. GS § 58-51-37 – a part of the North Carolina Insurance Code – is a pharmacy of choice statute. Questions concerning its application, or complaints about potential violations, should be reported to the NC Department of Insurance: NC Department of Insurance Pharmacy Complaint Resources
Q: What are the rules governing limited-service permits? A: Board Rule .1616 defines when a pharmacy is eligible to obtain a limited-service permit, as well as a pharmacist-manager’s responsibilities to a limited-service permit. This guidance document provides further details.
Q: Must a physician register with the Board of Pharmacy to dispense prescription drugs? A: Yes. Physicians who dispense drugs for a fee or other charge must annually register with the Board. GS § 90-85.21(b). The registration fee is $75.00. Dispensing physicians must perform dispensing activities themselves. As discussed above, dispensing physicians must follow all relevant laws and regulations that apply to pharmacists governing dispensing, including packaging, labeling, recordkeeping, patient counseling, and prospective DUR.
Q: May a dispensing physician delegate dispensing functions to other staff? A: No. Dispensing physicians must perform all dispensing themselves.
Q: May PAs and NPs dispense prescription drugs? A: Yes. PAs and NPs may dispense prescription drugs from a place holding a pharmacy permit and under the supervision of a pharmacist-manager. Board Rules .1703 and .1706 detail the requirements. Dispensing PAs and NPs must register with the Board prior to dispensing prescription drugs. Instructions are available in the licensing FAQs on this website.
Q: Are Physician Assistants and Nurse Practitioners who only dispense sample medications required to register with the Board? A: No. The Board does not interpret Rule .1703’s requirements to apply to a PA or NP who is engaged in traditional sampling – i.e., handing out, free of any charge (whether direct or indirect), starter doses or packets of prescription drug samples received from a prescription drug manufacturer in compliance with the Prescription Drug Marketing Act.
Q: May registered nurses (RNs) dispense prescription drugs from a health department? A: Yes. GS § 90-85.34A states the conditions under which a registered nurse at a local health department may dispense prescription drugs other than controlled substances. The registered nurse must have received training in the labeling and packaging of prescription drugs; dispensing must occur only at a local health department clinic; only prescription drugs contained in a formulary recommended by NC DHHS and approved by the Board of Pharmacy may be dispensed; the local health department must hold a pharmacy permit (see this guidance, which includes information on how a local health department may hold a limited service pharmacy permit); written procedures for storage, packaging, labeling, and delivery of prescription drugs are in place; the pharmacist-manager, or designated pharmacist, must review dispensing records at least weekly, provide consultation where appropriate, and be responsible for all dispensing activity at the health department.
Q: What drugs may registered nurses (RNs) dispense from a health department? A: Effective October 1, 2022, the following formulary (recommended by NCDHHS and approved by the Board of Pharmacy) governs RN dispensing from a health department:
OTC Sales of Syringes and Needles Q: May a pharmacist sell syringes and needles to a patient without a prescription? A: Yes. This guidance document covers the legal and public health aspects of over-the-counter syringe and needle sales: http://www.ncbop.org/faqs/FAQsNonPrescriptionSyringeSalesNC.pdf.
Q: What requirements does North Carolina law place on drug manufacturers to accept returns of outdated drug products? A: GS § 90-85.28(a)(5) permits a pharmacist to substitute an “equivalent drug product” when authorized by the prescriber. An “equivalent drug product” is, among other things, one whose manufacturer has “adequate provisions for return of outdated drugs, through the distributor or otherwise.” Board Rule .2901 specifies that “adequate provisions for return” means that drugs can be returned up to six months after the label expiration date for prompt full credit or replacement. A finding by the Board that a manufacturer does not meet this standard will cause that manufacturer's products to be ineligible for use in drug product substitution.
Q: Does the Board enforce patient counseling requirements? A: Yes. If an investigation or inspection finds that offers to counsel are not made and counseling does not occur on a regular basis, then the matter may be brought to a pre-hearing conference for disciplinary action.
Q: Does the phrase "Do you have any questions?" when directed at the patient satisfy the Board's requirement for offering to counsel patients under the patient counseling rule? A: No. Board Rule .2504 requires that an offer to counsel “shall be communicated in a positive manner to encourage acceptance.” The phrase "Do you have any questions?" is a question, not an offer of anything. Most patients do not know what questions to ask.
Q: Does the law limit the hours a pharmacist may be required to work each day and require rest and meal breaks? A: Yes. Board Rule .2512 provides:
Q: What dispensing tasks may a pharmacy technician perform when a supervising pharmacist is taking a break? A: The Board has issued a policy statement concerning pharmacy technician activities during pharmacist breaks.
Q: How do I obtain Board approval to increase the pharmacist-to-technician ratio at my pharmacy? A: A pharmacist may not supervise more than two pharmacy technicians unless: (1) the pharmacist-manager receives written approval from the Board in advance; and (2) each additional technician is certified. (See G.S. § 90-85.15A.) To request an increase above the 1:2 pharmacist-to-technician ratio, log in to the Board's Gateway to access that application. Follow this link for more detail on the ratio approval process, including specific instructions for pharmacist-managers applying for a pharmacist:technician ratio of 6:1 or greater.
Q: What are Board requirements for submitting Drug Disaster & Loss Reports, Incident Reports, and Drug Disposal Forms? A: Drug Disaster & Loss Reports, Incident Reports, and Drug Disposal Forms must be submitted by pharmacist manager or designated permit personnel through the Licensure Gateway. *NOTE* Board staff does not accept these forms by fax, email, or USPS. The pharmacist-manager is responsible for providing these reports via the Licensure Gateway. A reminder to all pharmacist -managers on statutes and rules pertaining to these reports:
Q: What forms do Board staff use to conduct pharmacy inspections? A: North Carolina pharmacists may find it beneficial to review Board inspection forms as a means of self-monitoring compliance with pharmacy law. Click on the appropriate form below to view or download:
Professional Limited Liability Companies and Pharmacies Q: May I, or am I required to, operate my pharmacy under a professional limited liability company (PLLC)? A: GS § 57D-2-02 and GS § 55B-2 establish the types of “professional service” businesses that are eligible to incorporate as a PLLC. The practice of pharmacy is not included among eligible “professional service” businesses. Board staff cannot provide advice on corporate form or formation. Pharmacists should consult their own attorney or the North Carolina Secretary of State’s office.
Q: Are pharmacies required to create and maintain a quality assurance program? A: Yes. GS § 90-85.47 requires that all pharmacies “establish or participate in” a quality assurance (QA) program to enhance the quality of health care and reduce medication errors in this State by facilitating a process for the continuous review of the practice of pharmacy. The statute details the content, recordkeeping, and other aspects of a quality assurance program.
Q: Does North Carolina law prohibit health care providers from paying each other referral fees? A: Yes. GS § 90-401 provides: “A health care provider shall not financially compensate in any manner a person, firm, or corporation for recommending or securing the health care provider’s employment by a patient, or as a reward for having made a recommendation resulting in the health care provider’s employment by a patient. No health care provider who refers a patient of that health care provider to another health care provider shall receive financial or other compensation from the health care provider receiving the referral as a payment solely or primarily for the referral.” NCGS Section 90-401 (emphasis added). Violation of this statute “shall be grounds for the offending health care provider’s licensing board to suspend or revoke the health care provider’s license, to refuse to renew the health care provider’s license, or to take any other disciplinary action authorized by law. The North Carolina Medical Board emphasizes to its licensees that they “may not accept payment of any kind, in any form, from any source, such as a pharmaceutical company or pharmacist, an optical company, or the manufacturer of medical appliances and devices, for prescribing or referring a patient to said source.” Medical Board Position Statement 10.1.1: Referral Fees and Fee Splitting
Remote Medication Order Processing Q: May North Carolina-permitted pharmacies engage in remote medication order processing arrangements with other permitted pharmacies? A: Yes. Board Rule .1816 authorizes two pharmacies to enter into a remote medication order processing arrangement. This guidance document provides a detailed review of standards governing such arrangements.
Q: May a North Carolina-permitted pharmacy deploy its own pharmacy personnel to perform remote medication order processing services outside the permitted pharmacy? A: Yes. Board Rule .2515 authorizes pharmacies to deploy their pharmacy personnel to perform remote medication order processing services from outside the pharmacy. This document provides a guide to Rule .2515’s operation.
Q: Are IV therapy clinics required to obtain and hold a pharmacy permit? A: This guidance document details North Carolina and federal law governing when an IV therapy clinic must obtain a pharmacy permit, and what standards apply to products compounded at an IV therapy clinic.
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