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Pharmacy Practice FAQs

AUTOMATED DISPENSING DEVICES/AUXILIARY MEDICATION INVENTORIES

add, automated dispensing device, automated medication system, robotic, mechanical, health care facility, ads, auxiliary medication inventory, emergency kit, ancillary drug cabinet, patient care unit

Auxiliary Medication Inventory. An “auxiliary medication inventory” is a supply of medications “which may include patient care unit medication inventories, ancillary drug cabinet inventories, and emergency kits” that “may be required to meet the immediate therapeutic needs of patients, but that are not reasonably available from the health care facility pharmacy in sufficient time to prevent prolonged discomfort or risk of harm to the health care facility’s patients.” 21 NCAC 46.1414(d)(1) The standards that apply to an auxiliary medication inventory’s creation and operation are found at Board Rule .1414(d)

Automated Dispensing Device. (*NOTE* Board rules use the terms “automated medication system” and “automated dispensing and drug supply device” interchangeably.) An automated dispensing device is a “robotic, mechanical, or computerized device that is not used for drug compounding” but “is designed to . . . [d]istribute drugs in a licensed health care facility that holds a pharmacy permit” or “[p]ackage drugs for final distribution by a pharmacist.” 21 NCAC 46.3401(1) Distribution means “the process of providing a drug to an individual authorized to administer drugs and licensed as a health care provider in the state of North Carolina pursuant to an order issued by an authorized prescriber.” 21 NCAC 46.3401(2) The general requirements for operating an automated dispensing device are found at Board Rule .3402. Standards governing the stocking or restocking of an automated medication system are found at Board Rule .3404. When used in a health care facility pharmacy, Board Rule. 1419 sets forth specific policies and procedures that the facility must create to govern the device’s operation.

add, ads, automated dispensing device, automated dispensing system, auxiliary medication inventory, emergency kit, ancillary drug cabinet, patient care unit, nursing home, long-term care, limited service permit

Yes. As noted above, Board Rule .1419 sets forth the policies and procedures that a health care facility must create to govern the device’s operation. Paragraph(e) specifically provides that that an automated dispensing device “that is used solely as an Auxiliary Medication Inventory as defined in 21 NCAC 46.1414(d) shall be governed by the requirements of that Rule.” In other words, an automated dispensing device may be used as an auxiliary medication inventory. When it is, that use is governed by the auxiliary medication inventory standards.

add, ads, automated dispensing device, automated dispensing system, auxiliary medication inventory, emergency kit, ancillary drug cabinet, patient care unit, nursing home, long-term care, limited service permit, controlled substance

If controlled substances are placed an auxiliary medication inventory, that storage must comply with 10A NCAC 26E.0408, which allows skilled nursing facilities, intermediate care facilities, and combination facilities licensed by the Department of Health and Human Services to have a controlled substance emergency kit. 21 NCAC 46.1414(d)(7) This requirement applies equally when an automated medication system is being used as an auxiliary medication inventory.

A controlled substance emergency kit (whether contained in an automated medication system or other inventory) can contain no more than seven (7) controlled (II-V) drug entities, as determined by the medical staff and as approved by the pharmaceutical service committee. Controlled substances for emergency use shall be obtained through purchase orders from the licensed pharmacist who regularly provides medications to the facility. If CIIs are purchased, DEA order forms must be used. The controlled substances must be provided in unit-dose form. “A facility shall not be permitted to possess more than 5 doses of each controlled substance entity for each 50 licensed beds or fraction thereof.”

Any emergency kit containing controlled substances must be locked and stored with access limited to authorized personnel. Only those designated by the director of the facility shall have access to these controlled-substance-containing emergency kits. The facility must be registered with the DEA, or have received an exemption, to use controlled substances in this manner, as would be required for any other use.

The primary responsibility for the proper control and accountability of such drugs in the facility belongs to the “pharmacist-supplier” of the controlled drugs used in the emergency kit.

add, ads, automated dispensing device, automated dispensing system, auxiliary medication inventory, emergency kit, ancillary drug cabinet, patient care unit, nursing home, long-term care, limited service permit, controlled substance

Yes. Federal Drug Enforcement Administration rules – 21 CFR § 1301.17(c) and § 1301.27 – allow, where state law permits (and North Carolina law does permit), a retail pharmacy to obtain a DEA registration for, and to install, an automated dispensing system at a long term care facility. These systems allow dispensing of single dosage controlled-substance units and can mitigate the problem of excess controlled-substance stocks and disposal.

Under Board rules, an automated dispensing device may only be installed at a facility holding a pharmacy permit. A limited-service permit may be obtained for the installation of automated dispensing systems in a long-term care facility.

As noted above, the automated dispensing device may be used as an auxiliary medication inventory to meet immediate therapeutic needs of patients when obtaining a drug from the health care facility pharmacy in time to prevent prolonged discomfort or risk of harm to the patient is not reasonably available.

add, ads, automated dispensing device, automated dispensing system, auxiliary medication inventory, emergency kit, ancillary drug cabinet, patient care unit, nursing home, long-term care, limited service permit, controlled substance

Yes. Board Rule .1414(d)(5) requires that the accessing personnel “provide a copy of both the record of withdrawal and patient medication order to the health care facility pharmacy’s pharmacist manager.” Electronic transmission of the order and inventory report, as long as accessible by pharmacy, is a “copy” to the pharmacy.

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Board Rule .1414(c)(1) requires that “all drugs dispensed from within a health care facility pharmacy are labeled and identified up to the point of administration.” Rule .1419(c) authorizes the removal of “drugs from the dispensing devices . . . in the quantity of doses needed to satisfy immediate patient needs.” In this scenario, the label must identify the medication name, strength, lot number, manufacturer, and expiration date. In many cases this is accomplished by the manufacturer’s labeling. If, however, the medication is not in manufacturer packaging containing this information, the pharmacy must affix a label with the required information. This allows the medication to be identified up to the point of administration.

add, ads, automated dispensing device, automated dispensing system, auxiliary medication inventory, emergency kit, ancillary drug cabinet, patient care unit, nursing home, long-term care, limited service permit, labeling, override medication, emergency use

Yes. Board Rule .3401(3) defines an “override medication” as a medication that a Multidisciplinary Committee determines may “be removed from an automated medication system prior to pharmacist review because . . . the clinical status of the patient would compromised by delay” or a medication that has “a low risk of drug allergy, drug interaction, dosing error, or adverse patient outcome, which may be removed from an automated medication system independent of a pharmacist’s review of the medication order or clinical status of the patient.”

Board Rule .3402(e) states that the Multidisciplinary Committee must determine “override medications” and set policies and procedures about the operation of the automated dispensing device. Those would include policies and procedures about timely transmittal of orders after an override medication has been removed from the device.

Board Rule .1419(d)'s general requirement of pharmacist order review prior to release of a medication from an automated dispensing device does not supersede the specific provisions in Rules .3401 and .3402 allowing immediate access to “override medications” prior to pharmacist review of an order.

BIOSIMILARS

biosimilars, substitute, brand, brand product, interchangeable biological product, interchangeable biosimilar

Yes. GS § 90-85.28(a) allows a pharmacist to select an “interchangeable biological product” when the prescriber authorizes substitution for a brand name product.

A pharmacist who dispenses an interchangeable biosimilar to a patient must, within five business days, “communicate to the prescriber the product name and manufacturer of the specific biological product dispensed to the patient.” The statute lists five means of making this communication electronically. An entry into any of the following “that is electronically accessible to the prescriber” by “the pharmacist or a designee is presumed to provide the required communication and notice to the prescriber”: “(1) An interoperable electronic medical records system. (2) Electronic prescribing technology. (3) A pharmacy benefit management system. (4) The North Carolina Health Information Exchange Network. (5) A pharmacy record.”

Absent one of these methods, the statute says that “the pharmacist or a designee shall provide the required communication to the prescriber by facsimile, telephone, electronic transmission, or other prevailing means.” The statute specifies that there is no required communication to the prescriber if there is no FDA-approved interchangeable biosimilar for the product prescribed or if a refill prescription is not changed from the product dispensed on the prior filling of the prescription.” GS § 90-85.28(b2)

biosimilars, substitute, brand, interchangeable biosimilar, purple book, biosimilarity

The FDA maintains the Purple Book, which lists biological products, including any biosimilar or interchangeable biosimilar licensed by FDA under the Public Health Service Act (the PHS Act). The lists include the date a biological product was licensed under 351(a) of the PHS Act and whether FDA evaluated the biological product for reference product exclusivity under section 351(k)(7) of the PHS Act. The Purple Book will also enable a user to see whether a biological product licensed under section 351(k) of the PHS Act has been determined by FDA to be biosimilar to or interchangeable with a reference biological product (an already-licensed FDA biological product). Biosimilar and interchangeable biological products licensed under section 351(k) of the PHS Act will be listed under the reference product to which biosimilarity or interchangeability was demonstrated.

COMPLAINTS TO THE NC BOARD OF PHARMACY

complaint, file complaint

The most efficient means of filing a complaint with the Board of Pharmacy is to use the Board’s online complaint submission system, found here.

You may also call the Board office during normal business hours at (919) 246-1050 and Board staff will assist you with getting a complaint filed.

COMPOUNDING

Statutes, Rules, and Standards Governing Compounding

compounding, compounded drug products, DQSA, drug quality and security act, USP, United States Pharmacopeia

Board Rule .2801 governs the preparation of compounded drug products. Compounding is also governed by the federal Drug Quality and Security Act and by applicable United States Pharmacopeia chapter standards, which are incorporated as a matter of federal and state law.

compounding, compounded drug products, dqsa, drug quality and security act

The Drug Quality and Security Act of 2013 (“DQSA”) broadly governs the compounding of drug products by pharmacies. The Food and Drug Administration maintains comprehensive guidance on the DQSA’s provisions, associated guidance documents, and FDA policies here: FDA Human Drug Compounding Resource Page

The basic contours of the DQSA are discussed in a two-part article published by the National Association of Boards of Pharmacy titled “The Drug Quality and Security Act: What Does It Mean for Compounding Pharmacies?” Part 1 and Part 2.

dqsa, drug quality and security act, veterinary drugs, office use, animal drugs

No. The federal Drug Quality and Security Act speaks to compounding of human drug products. The FDA’s most current statement of regulatory policy governing veterinary compounding may be found here: FDA Regulation of Animal Drugs. Included in the resources at this link is FDA’s final Guidance for Industry #256, Compounding Animal Drugs from Bulk Drug Substances.

reporting, compounding, non-sterile compounding, sterile compounding

Pharmacies that hold a permit from the North Carolina Board of Pharmacy and that engage in any type of compounding are required to notify the Board. Such pharmacies must report (both on an initial permit application and as part of each annual renewal): (1) whether they compound; (2) whether the pharmacy engages in non-sterile compounding; and (3) whether the pharmacy engages in sterile compounding.

usp, united states pharmacopeia, compounding, dqsa, sterile, non-sterile, drug preparation, chapter, 795, 797, 800, 825

Yes. Both the federal DQSA and North Carolina Board of Pharmacy rule incorporate applicable USP chapter standards governing the preparation of non-sterile and sterile compounded drug products.

USP chapter <795> governs non-sterile compounded drug product preparation: USP General Chapter <795>

USP chapter <797> governs compounded sterile drug product preparation: USP General Chapter <797>

USP chapter <800> governs the handling of hazardous substances. It is incorporated into revised USP chapters <795> and <797> that became effective November 1, 2023, and therefore applies to compounding activities involving hazardous drug products after that date: USP General Chapter <800>

USP chapter <825> governs compounding activities involving radiopharmaceuticals. It is incorporated into revised USP chapters <795> and <797> that became effective November 1, 2023, and therefore applies to compounding activities involving radiopharmaceuticals after that date: USP General Chapter <825>

sterile compounding facilities, compounding, certification tests, environmental sampling, 797, usp

All certification testing and documentation must be compliant with USP Chapter <797>. See Board Rule .2801. The Pharmacy Manager and/or Designated Compounding Pharmacist should review certification and environmental sampling reports to ensure that appropriate tests are performed and are in compliance with USP Chapter <797> and that the results are compliant with the action levels set forth in USP Chapter <797>. This guidance discusses certification tests and required documentation for a sterile compounding facility and sterile compounding equipment. It also provides guidance on environmental sampling and documentation requirements.

compounding record, master formulation record, sterile products, 797, usp

USP Chapter <797> requires that a compounding record be created and maintained. Board rules have always required a compounding record and did so well before implementation and enforcement of USP standards for compounding:
 Guidance to Compounding Record and Master Formulation Record Requirements

compounding, compounded products, hazardous medications, usp, 800, non-compounding

Yes, but in North Carolina, USP chapter <800> is not enforceable under Board rule for non-compounding activities. The Board views compliance as a best practice for pharmacies who are doing non-compounding activities with hazardous medications. As pharmacists know, USP Chapter <800> standards are designed to protect pharmacists, pharmacy staff, patients, and the public from the harmful effects of exposure to hazardous medications.

As USP Chapter <800> standards for non-compounding activities become commonly followed, North Carolina law is likely to reflect that doing so is considered standard of practice. In that case, failure to comply may be evidence of negligence. Therefore, you are encouraged to evaluate (and to continue to re-evaluate) to what extent compliance reflects the appropriate standard of care. Board staff will continue to make observations during inspections to help identify potential risk for handling Hazardous Medications and will provide education on how to comply with USP Chapter <800> standards to minimize risk to pharmacy staff, patients, and the public. These observations regarding USP Chapter <800> compliance in non-compounding activities involving Hazardous Medications will not, by themselves, serve as a basis for disciplinary action by the Board:
Board Statement on USP Chapter <800> and Non-Compounding Activities

Board Staff have created helpful educational information that addresses identification of Hazardous Drugs, instructions on conducting an Assessment of Risk, and templates for non-compounding pharmacies to develop Standard Operating Procedures (SOPs) addressed in USP<800>. This informational material is for pharmacies that DO NOT compound with hazardous medications: Guidance on USP <800> Assessment of Risk and Other Educational Information.

Specific Compounded Products

compound, compounding, use, semaglutide

On April 28, 2023, FDA officials clarified semaglutide’s shortage status. This statement has been updated to reflect that FDA clarification. In response to several inquiries, Board staff have assembled a statement concerning if, when, and how semaglutide may be compounded.

compound, compounding, commercially available product, federal food drug cosmetic act, shortage, usp

In general, no. The federal Food Drug & Cosmetic Act prohibits pharmacies from compounding “drug products that are essentially copies of a commercially available drug product.” FD&C Act § 503A(b)(1)(D)

FDA has issued enforcement guidance on how the “essential copy” restriction is interpreted and applied: Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act

FDA does not consider a drug to be “commercially available” if it appears in FDA's Shortage Database. On April 27, 2023, FDA officials clarified that a drug is considered in shortage by the FDA if it is listed in the database and its “status” is described as “currently in shortage.”

When compounding any drug product, the substances used to compound must: (1) comply with the standards of an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph, if a monograph exists, and the USP chapter on pharmacy compounding; (2) if such a monograph does not exist, then the substances used must be components of drugs approved by the Secretary [of HHS]; or (3) if such a monograph does not exist and the drug substance is not a component of a drug approved by the Secretary [of HHS], appear on a list developed by the Secretary through regulation. FD&C Act § 503A(b)(1)(A)(i)

The pharmacy must ensure that the API used in compounding is a pharmaceutical grade product, accompanied by a valid certificate of analysis, and is sourced from an establishment registered with FDA under Section 510 of the FD&C Act. FD&C Act § 503A(b)(1)(A)(ii) – (iii)

compounding, usp, flavor, flavoring, bud

USP considers adding flavoring to a conventionally manufactured product to fall within the scope of compounding, because there are known instances when flavoring components have destabilized a product. If a pharmacy adds flavoring to a manufactured product it must take into account the manufacturer’s Beyond Use Date (BUD) and the effect on stability caused by adding flavoring. If a flavoring component is added to a manufactured product that does not contain a preservative (e.g., reconstitution of amoxicillin oral suspension) the BUD is 14 days refrigerated or shorter if indicated in the manufacturer’s labeling. If a flavoring component is added to a manufactured product that contains a preservative (e.g., pyridostigmine oral solution), then the BUD is 35 days in controlled room temperature or refrigerated or shorter if indicated in the manufacturer’s labeling. When adding flavoring the compounding record must include the flavor manufacturer or product, lot number, and expiration date. All of this information about the flavoring must be documented in the patient record notes for the prescription.

compounding, domperidone

Domperidone compounding is permissible only as part of an investigational new drug application (IND). Domperidone is not a drug approved for human use in the United States. Accordingly, any domperidone product dispensed in the United States outside of an IND is unapproved, adulterated, and misbranded under both federal and North Carolina law. Notwithstanding misleading Internet information to the contrary, it is not legal in the United States to acquire, compound, dispense, or administer domperidone outside of an IND. The FDA has long provided clear guidance on this point, which may be found here: How to Request Domperidone for Expanded Access Use

As FDA’s information further states, “FDA has determined that domperidone should not be compounded or used to enhance breast milk production in lactating women.” Domperidone may be useful for “some patients with severe gastrointestinal disorders . . . that are refractory to standard therapy.” A physician who would like to prescribe domperidone for this indication may contact FDA to open an Investigational New Drug Application (IND). An FDA-authorized IND would “allow the importation, interstate shipment, and administration of the drug even though it is not approved for sale in the U.S.”

unc health, mucositis mixture, sleepy butter, formulary, usp, 795, oral formulation, mucosal liquid formulation

UNC Health Care’s Mucositis Mixture is a part of the system’s formulary. The approved recipe by the Pharmacy and Therapeutics Committee is:

Diphenhydramine liquid 2.5 mg/mL
Maalox suspension (or formulary equivalent)
Lidocaine, viscous 2%

Admix equal volumes of the three ingredients. UNC usually dispenses 300 mL total volume.

Oral Formulation. USP <795> requires that water-containing oral formulations be assigned a BUD that is no longer than 14 days under refrigerated storage conditions. The directions for an oral formulation of Mucositis Mixture would be “swish and swallow” or similar.

Mucosal Liquid Formulation. USP <795> requires that water-containing topical, dermal, and mucosal liquid and semisolid formulations be assigned a beyond used date (BUD) that is no longer than 30 days under room temperature storage. The directions for a mucosal liquid formulation of Mucositis Mixture would be “swish and spit” or similar.

If a pharmacy compounds one batch of Mucositis Mixture to fulfil all Mucositis Mixture prescriptions – whether the directions are “swish and spit” mucosal formulation or “swish and swallow” oral formulations – the assigned beyond used date (BUD) must be the stricter one: no longer than 14 days under refrigerated storage.

USP <795> allows for a longer BUD for Mucositis Mixture Mouthwash if the pharmacy has independent stability data justifying the extended BUD.

dukes magic mouthwash, mouthwash, compound, usp, 795, oral formulation, mucosal liquid formulation

Pharmacists occasionally receive a prescription to compound “Duke’s Magic Mouthwash” that does not contain further information about the compound’s composition. The default formula for Duke’s Magic Mouthwash is:

1. Nystatin Suspension, 100,000 u/ml, 30 mL. or Nystatin Powder 3 Million Units
2. Hydrocortisone 60 mg
3. Diphenhydramine HCL Syrup
q.s. ad. 240 ml.

The appropriate USP <795> BUD for Magic Mouthwash depends on whether it is compounded and dispensed as an oral formulation or as a mucosal formulation.

Oral Formulation. USP <795> requires that water-containing oral formulations be assigned a beyond used date (BUD) that is no longer than 14 days under refrigerated storage conditions. The directions for an oral formulation of Magic Mouthwash would be “swish and swallow” or similar.

Mucosal Liquid Formulation. USP <795> requires that water-containing topical, dermal, and mucosal liquid and semisolid formulations be assigned a beyond used date BUD that is no longer than 30 days under room temperature storage. The directions for a mucosal liquid formulation of Magic Mouthwash would be “swish and spit” or similar.

If a pharmacy compounds one batch of Magic Mouthwash to fulfil all Magic Mouthwash prescriptions – whether the directions are “swish and spit” mucosal formulation or “swish and swallow” oral formulations – the assigned beyond used date (BUD) must be the stricter one: no longer than 14 days under refrigerated storage.

USP <795> allows for a longer BUD for Magic Mouthwash if the pharmacy has independent stability data justifying the extended BUD.

usp, 795, tap water, reconstitute, purified water, sterile water

No, USP <795> states that Purified Water shall be used for compounding nonsterile drug preparations when formulations indicate the inclusion of water. This is also required when reconstituting medications such as antibiotics. Purified Water is different than Sterile water for irrigation. Sterile water for irrigation is not considered potable water and is not intended for oral administration. 

CONTROLLED SUBSTANCES

Butalbital Products

butalbital, schedule iii, controlled substances, exempted

At present, exempted butalbital products remain exempted. The federal Drug Enforcement Administration has, however, published a proposed rule that, if adopted, would revoke the exempted prescription product status for all butalbital products previously granted exemptions. If the rule is adopted, these products will become subject to all schedule III controls under the Controlled Substances Act, and this action would impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule III controlled substances on persons who handle (manufacture, distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess) or propose to handle butalbital products. DEA’s proposed rule is found here:

Proposed DEA Rule Moving All Butalbital Products to Schedule III. The comment period on the proposed rule is closed, but DEA has not yet taken final action. Board staff will publish any action that the DEA chooses to take.

Changes to Controlled Substance Prescriptions

controlled substances, changes to prescriptions, schedule ii

After consulting with the prescribing practitioner (you must speak directly to the practitioner, not his/her agent), the pharmacist may modify or add the following:

  • date of issue - may be added but not changed;

  • patient’s address;

  • drug strength;

  • drug dosage form;

  • drug quantity - may be modified in conjunction with change in strength only, not to exceed the original total dosage prescribed; and

  • directions for use.

A pharmacist may never change the name of the drug (except to generic when appropriate), name of the patient, or the signature of the practitioner.

In late 2022, various industry reports suggested that DEA would no longer allow any changes to a Schedule II prescription made pursuant to a verbal consultation between the prescriber and dispenser. DEA clarified that, while it is considering rulemaking on this topic, pharmacists and pharmacies could continue to follow long-standing guidance on limited changes to Schedule II prescriptions pursuant to a verbal consultation with the prescriber.

controlled substances, changes to prescriptions, schedule ii, acetaminophen, vicodin, hydrocodone

Yes. If a pharmacist receives a prescription for a combination product containing a schedule II drug and acetaminophen that appears to have a missing, incorrect, or unavailable acetaminophen dosage, the pharmacist may add or change the amount of acetaminophen written on the prescription after speaking directly with the prescriber and documenting the clarification on the prescription.

Examples:

(a) A prescriber writes for “Vicodin 5/325.” As pharmacists know, Vicodin is now formulated as hydrocodone 5mg /acetaminophen 300 mg. The pharmacist may call the prescriber to clarify which product was intended – e.g., Vicodin 5/300 or another hydrocodone 5 mg/acetaminophen product containing 325 mg of acetaminophen per dosage unit (see (b) below). The pharmacist must document on the prescription the changes made after consultation with the prescriber.

(b) A prescriber writes for “Vicodin 5/325,” but the prescriber intended to write for Norco (hydrocodone 5 mg /acetaminophen 325 mg). The pharmacist may change the brand name to match the correct combination product intended. The pharmacist must document the clarification after consultation with the prescriber.

legal, add dea number, controlled substance

Yes. Board staff has received a number of inquiries from pharmacists on this topic. These inquiries derive, it appears, from third-party payor auditors who have demanded recoupment based on supposedly “illegal” controlled substance prescriptions on which the pharmacist has added the prescriber’s DEA number. Assertions that the addition of a DEA number to a controlled substance by a pharmacist is “illegal” are, in a word, false.

controlled substance prescriptions, hand-sign, hand-date

No. North Carolina law does not require pharmacists to hand-sign and hand-date controlled substance prescriptions they fill. The North Carolina Controlled Substances Act once required this, but the General Assembly repealed this provision in August 2007 as part of a broader amendment to the recordkeeping provisions of the Pharmacy Practice Act. Accordingly, the hand signature and dating requirements no longer exist under North Carolina law.

Controlled Substance Reporting System (CSRS)

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The Drug Control Unit of the Department of Health and Human Services administers the CSRS.

DHHS has produced a user’s manual for the CSRS: Dispenser Reporting Manual

Information and FAQs may be accessed here: NCDHHS North Carolina Controlled Substance Reporting System Resources

Pharmacy personnel with questions about CSRS access should contact DHHS’ Drug Control Unit: nccsrs@dhhs.nc.gov; or Kristen Weisberg, 919-715-2067.

controlled substances, csrs, nccsrs, controlled substances reporting system, gabapentin

The CSRS requires (GS § 90-113.73(b)) dispensers to report the following information for all dispensed controlled substances and (effective March 1, 2024) gabapentin:

(1) The dispenser's DEA number.
(2) The name of the patient for whom the controlled substance is being dispensed, and the patient’s:
a. Full address, including city, state, and zip code,
b. Telephone number, and
c. Date of birth.
(3) The date the prescription was written.
(4) The date the prescription was filled.
(5) The prescription number.
(6) Whether the prescription is new or a refill.
(7) Metric quantity of the dispensed drug.
(8) Estimated days of supply of dispensed drug, if provided to the dispenser.
(9) National Drug Code of dispensed drug.
(10) Prescriber’s DEA number.
(11) Prescriber's national provider identification number, for any prescriber that has a national provider identification number. A pharmacy shall not be subject to a civil penalty for failure to report the prescriber's national provider identification number when it is not received by the pharmacy.
(12) Method of payment for the prescription.

The North Carolina Drug Control Unit has specific guidance on gabapentin reporting, including instruction on how a pharmacy that does not hold a DEA registration may register with the CSRS.

controlled substances, csrs, nccsrs, controlled substances reporting system, dispenser, dispenser definition

The act defines (GS § 90-113.72(4)) a dispenser as “a person who delivers a Schedule II through V controlled substance to an ultimate user in North Carolina, but does not include any of the following:

a. A licensed hospital or long-term care pharmacy that dispenses such substances for the purpose of inpatient administration.
b. A person authorized to administer such a substance pursuant to Chapter 90 of the General Statutes.
c. A wholesale distributor of a Schedule II through V controlled substance.”

DHHS advises that, in determining whether a particular facility is a “dispenser”, facility personnel should ask themselves whether the dispensing will occur for administration to a patient population that is resident at, or confined within, the facility. If so, then the facility is not likely to be considered a “dispenser” for reporting purposes. If not, then the facility is likely a “dispenser” for reporting purposes.

Some specific examples:

Emergency Departments. Dispensing of controlled substances to emergency department patients, including the dispensing of 24-hour “send home” packs, would not trigger a reporting requirement.

Hospital patients. Dispensing of controlled substances to hospital patients while receiving care at the hospital does not trigger a reporting requirement. This includes outpatient surgery.

Dispensing controlled substances to a hospital patient for administration outside the hospital on an outpatient basis does trigger a reporting requirement.

Long-Term Care Facility, Assisted Living Facility, Group Homes, Hospice Facility. These facilities are expressly excluded from the definition of a “dispenser” unless the facility has its own pharmacy that dispenses medications for administration outside the facility.

Health Departments, Mental Health Facilities, Free Clinics. Dispensing controlled substances to outpatients of these facilities does trigger a reporting requirement.

Prisons or Jails. Dispensing to inmates confined to the facility does not trigger a reporting requirement.

controlled substances, csrs, nccsrs, controlled substances reporting system, samples, prescription drug samples

The North Carolina Controlled Substance Reporting System statute provides (GS § 90-113.73(d)) an express exemption for Schedule V non-narcotic, non-anorectic controlled substance samples: “A dispenser shall not be required to report instances in which a Schedule V non-narcotic, non-anorectic Schedule V controlled substance is provided directly to the ultimate user for the purpose of assessing a therapeutic response when prescribed according to indications approved by the United States Food and Drug Administration.”

Pharmacies are, of course, prohibited by federal law from dispensing prescription drug samples of any sort. This reporting exemption, then, only applies in practical terms to physicians or other health care providers who are permitted by federal law to provide samples to patients.

CSOS (DEA Controlled Substance Ordering System)

dea, controlled substance ordering system, csos, csos enrollment

DEA CSOS Enrollment Portal

dea, controlled substance ordering system, csos, documented receipt, schedule ii

Board staff sometimes note during an inspection that a pharmacy has not properly documented receipt of Schedule II controlled substance orders when using the CSOS.

Board staff have found the CSOS orders were properly placed in accordance with 21 Code of Federal Regulations (CFR) 1305.21 and 1305.22(a). However, upon receipt of the controlled substances, a copy of the E-222 form was printed and receipt of the order manually noted on paper. This paper receipt process violates 21 CFR 1305.22(g), although Board staff have found these violations to be unintentional and are treating them as an educational issue, not a disciplinary one. Under that federal rule, when a purchaser receives a shipment, the purchaser must create a record of the quantity of each item received and the date received, and that record must be electronically linked to the original order and archived.

Board staff strongly recommend that pharmacies ordering Schedule II controlled substances using CSOS, but unsure how to electronically link the receipt with the original order, contact the Schedule II controlled substance supplier for assistance. 

Dispensing Controlled Substances for the Treatment of Substance Use Disorder

controlled substances, treatment of substance use disorder, substance use, methadone, buprenorphine, data-waiver, mate act, dea

Methadone may be used for the treatment of pain, and any pharmacy may dispense methadone if the prescription is for a legitimate medical purpose and prescribed in the ordinary course of medical practice. This would include using methadone as part of a formal pain management program in which a patient is switched from other licit drugs to methadone to control or gradually reduce dosage of pain medication.

Methadone may only be prescribed and administered to maintain narcotic addiction or to detoxify a patient when the prescriber is registered by Drug Enforcement Administration (DEA) as a narcotic treatment facility (NTF). In such cases, the drug may only be administered by the NTF.

On December 29, 2022, with the signing of the Consolidated Appropriations Act of 2023 (the Act), Congress eliminated the “DATA-Waiver Program”, under which prescribers were required to obtain an “X” DEA number to prescribe medications like buprenorphine for the treatment of opioid use disorder ("OUD"). All practitioners who have a current DEA registration that includes Schedule III authority may prescribe buprenorphine for OUD in their practice if permitted by applicable state law. North Carolina rules and laws do not conflict with this authority to prescribe buprenorphine for opioid use disorder with a current DEA registration.

Accordingly:

A DATA-Waiver registration is no longer required to treat patients with buprenorphine for opioid use disorder. Prescriptions for buprenorphine only require a standard DEA registration number. The previously used DATA-Waiver registration numbers are no longer needed for any prescription.

There are no longer any limits or patient caps on the number of patients a prescriber may treat for opioid use disorder with buprenorphine.

Separately, the Act also introduced new training requirements for all prescribers. These requirements went into effect on June 21, 2023. The DEA has outlined the requirements for DEA-registered practitioners to meet the new, one-time Medication Access and Training Expansion Act (MATE Act) training requirement that will be tied to their initial or renewal DEA registration. This requirement applies to practitioners holding individual DEA registrations. A pharmacist who is not an individual DEA registrant – i.e., practice pharmacy under the DEA registration of the employing pharmacy – is not required to obtain this training. But pharmacists such as Clinical Pharmacist Practitioners who are individual DEA registrants that prescribe controlled substances are subject to the requirement.

There are three ways that practitioners may meet this training requirement, which are outlined in DEA's letter. The letter also defines which accredited groups may provide training to meet the requirement, key points related to the training, and a list of practitioners who have been deemed to satisfy the training.

The DEA’s letter is found here: DEA MATE Training Letter. Recommendations for curricular elements in substance use disorders training is also available from the Substance Abuse and Mental Health Services Administration. If you have any additional questions on this issue, please contact the DEA Diversion Control Division Policy Section at ODLP@dea.gov or (571) 362-3260.

Disposal of Controlled (and Non-Controlled) Substances

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When a prescription drug has left the pharmacy, the pharmacy cannot know whether the drug was kept and stored in a manner that would prevent the drug’s adulteration. Accordingly, a pharmacy may not accept a return of a prescription drug once it has left the pharmacy. The Board has created signage addressing this issue which may be downloaded here for posting in your pharmacy.

North Carolina law does allow the donation of prescription drugs in certain circumstances. More information is found here: Drug Donation FAQ

drug disposal, disposing drugs, controlled substances

The NCBOP Drug Disposal Form can be found by logging into the facility portal. The Drug Disposal Form Tab is located at the bottom of the facility page.

1. Complete the form making sure a current e-mail address is listed. The form can be saved to be completed later; a confirmation number will be provided to access the form again. Once the form is submitted, you will not be able to access the form to make changes.

Community/retail pharmacies are to use this form for controlled or non-controlled medications; however, when listing controlled substances, a separate form(s) must be used. Do not combine controlled and non-controlled medications.

Hospitals, clinics and nursing homes (see #3) may use this form for non-controlled medications only. Duplicate/multiple forms are permitted. These forms shall be retained by the pharmacy for a period of three (3) years.

2. Once the form is submitted and reviewed by staff, an e-mail will be sent to notify the permit that approval for drug disposal has been given. The e-mail should be retained in the pharmacy for (3) years.

3. Contact the NC Department of Health & Human Services, Drug Control Unit at (919) 733-1765 for disposal or destruction of controlled substance medications in:

- Hospitals

- Nursing homes that are skilled facilities with a ten (10) bed limit. Note: this does not include assisted living facilities.

- Clinics include: EMS, Veterinary clinics, Methadone clinics, outpatient surgery clinics, weight loss clinics and physician practices with more than one (1) practitioner using common stock of controlled substance medications.

The Drug Control Unit has more information available here: NCDHHS Drug Control Unit FAQs.

Electronic Prescriptions

electronic prescriptions, controlled substances, e-prescribing

The DEA maintains a guidance document here: DEA Guidance on Electronic Prescriptions for Controlled Substances

Employees With Felony Convictions Involving Controlled Substances

controlled substances, felony, felony conviction, dea, pharmacists manual

No. 21 CFR § 1301.76(a) prohibits a DEA registrant from employing “as an agent or employee who has access to controlled substances, any person who has been convicted of a felony offense relating to controlled substances or who, at any time, had an application for registration with the DEA denied, had a DEA registration revoked or has surrendered a DEA registration for cause.”

The DEA Pharmacist's Manual (revised 2022) provides further information on this restriction, as well as instruction on how a DEA registrant may request a waiver of this restriction.

Inventory

controlled substances, inventory, log

The federal Controlled Substances Act requires a DEA registrant to conduct an initial inventory, which is an actual physical count of all controlled substances in the registrant’s possession. 21 U.S.C. 827(a)(1). The registrant must complete a new inventory at least every two years. 21 CFR § 1304.11(c).

Board Rule .2502(c) requires that, when a change of pharmacist-manager or ownership of a pharmacy occurs, the successor pharmacist-manager must complete an inventory of all controlled substances within ten (10) days.

This inventory log may be helpful when conducting inventories required by federal law or Board rule.

Naloxone Dispensing

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Yes. The State Health Director’s standing order authorizing pharmacists to dispense “FDA-approved naloxone products used in accordance with approved directions,” listing those products and directions, and directing pharmacists that “product selection should be made based on patient preference, availability, insurance coverage, and other pertinent factors” is found here: Naloxone Standing Order for Pharmacists.

That order includes the list of FDA-approved naloxone products, but those are also listed here: Naloxone Products for Pharmacist Dispensing.

The North Carolina Department of Health and Human Services has put together an FAQ document that walks pharmacists through utilization of the statewide standing order.

Additional resources for safe and proper dispensing of naloxone products are found here: Naloxone Saves.

*NOTE* The statewide standing order does not expire. It will be renewed upon change in the State Health Director or updated if any relevant information regarding naloxone administration becomes available. If local standing orders specify an expiration date, they should be reviewed and updated in accordance with the order.

naloxone distribution, naloxone dispensing

Yes. North Carolina law authorizes certain organizations to distribute (as opposed to dispense) naloxone. Amanda Fuller Moore, NC DHHS Division of Public Health Pharmacist, has coordinated with DHHS officials and BOP staff to produce this guidance chart, which pharmacists will find helpful as they develop their approaches to naloxone dispensing and distribution: Naloxone Dispensing versus Naloxone Distribution.

Partial Fills / Refills of Controlled Substance Prescriptions

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Federal regulations provide that prescriptions for drugs in Schedules III and IV shall not be filled or refilled more than 6 months after the date of issue.

North Carolina law provides (GS § 90-106(b)) that “No Schedule II substance shall be dispensed pursuant to a written prescription more than six months after the date it was prescribed.”

controlled substances, schedule ii, partial fill

Yes. The federal Controlled Substances Act permits a pharmacy to provide a partial fill of a Schedule II controlled substance prescription if: (1) state law does not prohibit partial fills of Schedule II prescriptions (North Carolina law does not prohibit partial fills of this sort); (2) the prescription is written and filled in compliance with federal and state law; (3) the partial fill is requested by the patient or the prescriber; and (4) the total quantity dispensed in all partial fills does not exceed the total quantity prescribed. 21 USC § 829(f)

controlled substances, schedule ii, partial fills

In general, the total amount of a Schedule II controlled substance prescription may be filled no later than 30 days from the date the prescription was written. 21 USC § 829(f)

DEA rules have long allowed a Schedule II controlled substance prescription for a patient in a Long-Term Care Facility, or a patient with a documented terminal illness diagnosis, to be dispensed by partial fills for up to 60 days from the date of the prescription.

If a pharmacist receives a verbal Schedule II controlled substance prescription pursuant to an emergency, the pharmacist may provide a partial fill, but must provide the remainder of the prescription amount within 72 hours. After 72 hours, no further dispensing on the emergency prescription is allowed. All other requirements regarding the need to receive a hard copy (or valid electronic) prescription within seven days remain. 21 USC § 829(f)

controlled substances, schedule ii, partial fills, full quantity

Prior federal Controlled Substances Act amendments in October 2016, DEA rules did so limit partial fills of Schedule II prescriptions. The statutory changes superseded DEA’s rules on this matter.

controlled substances, schedule ii, do not fill until

Yes, within limits established by DEA, prescribers may issue multiple prescriptions for a Schedule II controlled substances on the same day to be filled sequentially. DEA Rule 21 CFR § 1306.12 details that authority.

controlled substances, schedule v, refill limit

No. Prescriptions for Schedule V drugs may be refilled as authorized.

Photo ID for Controlled Substances

controlled substances, photo id, photo identification

For some controlled substances, yes. This guidance document details the operation of S.L. 2011-349, which created the photo identification requirement: Controlled Substance Photo ID Guidance

Prescription Contents

controlled substances, pre-printed, prescription blanks

No. A North Carolina DHHS rule 10A NCAC 26E.0307 prohibits the preprinting of the name of the controlled substance on prescription blanks.

A computer-generated controlled substance prescription is not considered “pre-printed” so long as the prescription was generated for an individual patient, and not “mass printed.”

controlled substances, prescriber, prescription blank, prescriber information

Under North Carolina law, GS § 106-134.1(4)(a), a written prescription must “bear the printed or stamped name, address, telephone number, and DEA number of the prescriber in addition to his legal signature.”

The federal Controlled Substances Act specifies that all prescriptions for controlled substances must bear: (1) the full name and address of the patient; (2) the drug name, strength, dosage form; (3) quantity prescribed; (4) directions for use; (5) the name, address and DEA number of the prescriber; and (6) the prescriber's signature.

controlled substances, office use, schedule ii, schedule iii, schedule iv, schedule v, transfer of controlled substances

Federal law prohibits the issuance of a controlled substance prescription for “office use.”

A health care provider and individual DEA registrant may complete a Schedule II Order form (DEA 222) for a drug in Schedule II and send it to the supplier which can be a pharmacy. The supplier keeps one copy and sends the other copy to DEA: Note the instructions in the margin of the form.

Orders for drugs in Schedule III, IV, or V can occur on an invoice and the supplier (pharmacy) keeps these invoices with other CS records noting that these are outgoing items.

NOTE: Under North Carolina law, any such transfer of controlled substances for “office use” would likely be a wholesale transaction requiring the pharmacy to obtain and hold a North Carolina prescription drug wholesaler permit. Drug wholesale licenses are handled by the NC Department of Agriculture's Food & Drug Protection Division. Please visit NC Department of Agriculture Food and Drug Protection Division for information.

Pseudoephedrine Products

pseudoephedrine, pse, controlled substance

No.

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North Carolina law requires all sellers of pseudoephedrine containing products to participate in a real-time electronic program for the purpose of tracking illegal pseudoephedrine purchases -- the National Precursor Log Exchange (NPLEx).

This October 27, 2011 letter to Pharmacy Managers from then-NC SBI Director Gregory S. McLeod outlines those requirements.

This November 16, 2011 follow-up letter to Pharmacy Managers from then-NC SBI Director Gregory S. McLeod includes NPLEx account login, training, and support instructions and information.

To avoid double record keeping, the North Carolina Mental Health Commission has deemed reporting into the NPLEX system as a "form approved by the commission," thus eliminating the requirement for keeping two logs and obtaining two signatures. By reporting in to the NPLEX system, NPLEX is essentially keeping your log for you and electronically storing it. Law enforcement may retrieve the information from NPLEX. If the system is down, you must keep the log and obtain the signature as previously required.

A pharmacy must still post a sign visible in 10-point bold face print near the place where the electronic signature is obtained that says the following:

"North Carolina law strictly prohibits the purchase of more than 3.6 grams total of certain products containing pseudoephedrine per day, and more than 9 grams total of certain products containing pseudoephedrine within a 30-day period. This store will maintain a record of all sales of these products which may be accessible to law enforcement officers."

This should be called to the customers' attention at the time the signature is obtained.

The PSE restrictions apply only to the retail sales of ephedrine and pseudoephedrine products sold behind a pharmacy counter and do not apply to valid prescriptions dispensed to a consumer.

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Read the guidance document from the DEA Office of Diversion Control.

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Under the North Carolina statute, “[a]ny pseudoephedrine product in the form of a tablet or caplet containing pseudoephedrine as the sole active ingredient or in combination with other active ingredients shall be stored and sold behind a pharmacy counter.” Pseudoephedrine products “in the form of a liquid, liquid capsule, gel capsule or pediatric product” are not subject to regulation under the North Carolina statute. North Carolina amended its statute to make clear that “such products shall be subject to the requirements of the Combat Methamphetamine Act of 2005.”

The federal statute applies to all pseudoephedrine products - including liquids, liquid capsules, gel capsules, and pediatric formulations. The U.S. Attorney General is authorized to exempt pseudoephedrine products by regulation, but no such regulations have been promulgated.

pseudoephedrine sales, controlled substance, pseudoephedrine limits, pse

North Carolina and federal limitations are the same: no more than 3.6 grams of pseudoephedrine base, regardless of the number of transactions, in a single day; no more than 9 grams of pseudoephedrine base in a 30-day period.

pseudoephedrine sales, pse, controlled substance, sale of pseudoephedrine containing products, retail sale, retailer, hospital pharmacies

The North Carolina statute imposes limitations on the “retail sale” of pseudoephedrine products and upon “retailers.” The Act defines a retailer as “an entity that is the general owner of an establishment where pseudoephedrine products are available for sale.”

Likewise, the federal statute regulates the sale of pseudoephedrine products “at retail,” which is defined as “a sale or purchase for personal use.”

Since it is unlikely that a hospital would be considered a “retailer” because hospitals are not normally engaged in the practice of retail sales of medication, the statutes should rarely, if ever, apply to hospital pharmacies.

Red Flags / Refusal To Fill

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Under Board Rule .1801, pharmacists may refuse to fill or refill prescriptions if they believe it would be harmful to the patient, or if there's a question as to its validity or they believe it is not in the patient's best interest.

The federal Controlled Substances Act places on pharmacists a corresponding responsibility to ensure that a controlled substance prescription is issued for a legitimate medical purpose in the ordinary course of medical practice.

Some resources that may assist pharmacists in their assessment of controlled substance prescriptions:

Controlled Substances Pocket Card

Red Flags Video. The National Association of Boards of Pharmacy collaborated with the Anti-Diversion Industry Working Group (ADIWG) to prepare a video intended to educate pharmacists and increase their awareness of potential red flags when filling controlled substance prescriptions. This video introduces the world of diversion through the eyes of former diverters and abusers who reveal the tricks of their trade. The video illustrates that diverters and abusers can be found in every race, gender, and age group.

DEA Guidance on Preventing Diversion

controlled substances, nc medical board, opiates, opioids, treatment of pain

The North Carolina Medical Board's policy on the use of opiates to treat pain is found here: Medical Board Position Statement 4.1.3: Policy of the Use of Opioids for the Treatment of Pain. Pharmacists are encouraged to familiarize themselves with the guidelines.

STOP Act (The Strengthen Opioid Misuse Prevention Act of 2017)

controlled substances, targeted cs, stop act, strengthen opioid misuse prevention act

Yes. The Strengthen Opioid Misuse Prevention (“STOP”) Act imposes requirements on the prescribing, dispensing, and monitoring of “targeted controlled substances.” This guidance document details the STOP Act’s provisions and their impact on pharmacy practice: Pharmacist's Guide to the STOP Act

Take-Back Programs

controlled substance, return of controlled substances, disposal, take-back programs

Yes, but only in compliance with DEA rules. On September 9, 2014, DEA issued rules governing disposal of controlled substances. This rule allows – but does not require – retail pharmacies (and certain other DEA registrants) to become authorized collectors of controlled substances for disposal. This new rule authorizes ultimate users (i.e., patients) to transfer unwanted and unused controlled substances in their lawful possession to an authorized collector for safe, secure, and responsible disposal.

Pharmacies interested in participating in take-back programs under the rule are strongly advised to read the full rule, found here: 21 CFR § 1317, Subpart B

More expansive information and guidance is available from the DEA: DEA Drug Disposal Information 

Theft or Loss of Controlled (and Non-Controlled) Drugs

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DEA Rule 21 CFR § 1301.76 requires a registrant to notify the field division office of DEA, in writing, of the theft or significant loss of any controlled substances within ONE BUSINESS DAY of discovery of such loss or theft. Registrants are also required to complete a DEA 106 form regarding the loss or theft. When determining whether a loss is significant, a registrant should consider the factors listed in paragraph (b) of the rule.

A North Carolina Board of Pharmacy Drug Disaster & Loss Report must also be completed and filed with the Board within 10 days of the drug loss/theft. This requirement applies to theft or loss of any prescription drug, not just controlled substances. To access the report, click here to access the Board's Gateway. Select the FACILITY MANAGEMENT tab and then select PHARMACY from the pharmacy type drop-down. Log in using your pharmacy permit number, then scroll down to see REPORTS.

Transferring a Controlled Substance Prescription

controlled substances, transfers, refill, pharmacy student, technician

Under federal law, an original prescription for a C-III, C-IV, or C-V substance may be transferred for refill on a one-time basis. If pharmacies electronically share a “real-time, on-line database,” then those sharing pharmacies “may transfer up to the maximum refills permitted by law and the prescriber’s authorization.” 21 CFR § 1306.25(a)

Federal law, however, requires that any transfer of a C-III, C-IV, or C-V prescription be “communicated directly between two licensed pharmacists . . . .” 21 CFR § 1306.25(a)(1) Thus, under federal law, neither technicians, nor certified technicians, nor pharmacy students may transfer or receive transfers of prescriptions for controlled substances.

controlled substances, on file prescription, transfer of electronic prescriptions

On July 27, 2023, the DEA issued a new final rule governing the transfer of electronic controlled substance prescriptions prior to initial fill. The rule is here.

DEA commentary notes that SCRIPT Standard Version 2017071 enables the transfer of prescriptions between pharmacies, and it acknowledges that some pharmacies may need to coordinate with their pharmacy technology vendors to have the SCRIPT transaction used to transfer prescriptions between pharmacies incorporated into their pharmacy applications.

Questions regarding implementation of the rule should be directed to DEA's Greensboro office at (336) 632-4297.

DEA (DRUG ENFORCEMENT ADMINISTRATION)

Form 222 and Power of Attorney

dea, dea registration number, form 222

DEA issued a direct final rule to clarify that either the purchaser or the supplier may enter a supplier’s DEA registration number on the single-sheet DEA Form 222. That rule was effective October 18, 2021:
Federal Register : Clarification Regarding the Supplier's DEA Registration Number on the Single-Sheet DEA Form 222.

dea, dea power of attorney

A model DEA Power of Attorney form is found here: Model DEA Power of Attorney Form

dea, multiple powers of attorney, power of attorney

Yes, as long as the requirements of 21 CFR § 1305.07 are met. That rule recognizes powers of attorney and specifies the form. The power of attorney must be signed by the person who signed the most recent application for registration or re-registration and by the person receiving the authority. The rule allows multiple powers of attorney: 21 CFR 1305.05

Pharmacist’s Manual

pharmacists manual, dea

The most current version of the DEA Pharmacist’s Manual is found here: DEA Pharmacist's Manual (revised 2022)

DME FACILITIES

dme, durable medical equipment, record keeping requirements, devices

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.

dme, expiration dates, medical gas cylinder, durable

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. 

dme, oxygen, backup oxygen, durable

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;”

dme, dme permit, glucose, glucose meters, medical equipment, device, durable

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.

dme, dme permit, scooters, mobility equipment, wheelchairs, durable, power

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(7) 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.

DRUG DONATION / DISPENSING OF DONATED DRUGS

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Yes, in certain circumstances. This guidance document details which drugs are eligible for donation, who eligible donors are, and who eligible recipients are: Drug Donation FAQ.

donate, drug donation, samples, free clinic, charitable

Yes. The recipient free or charitable clinic must, however, conform to
FDA guidance on the receipt and dispensing of donated samples.

pharmacy permit, samples, dispensing samples

The federal Prescription Drug Marketing Act (“PDMA”) prohibits a pharmacy from receiving or dispensing sample medications. A free or charitable clinic, however, may provide samples of prescription drugs to patients so long as the samples are obtained in conformance with the PDMA and are provided to the patient under the direct supervision of the physician charged by the PDMA with responsibility for appropriate receipt and disbursement of prescription drug samples.

A pharmacy permit is not required if prescription drug samples are the only prescription drugs being provided to patients. The key question is whether the prescription drugs provided to patients are truly “samples.” For instance, full course of therapy or month-long prepackaged medications received from manufacturers or other organizations are almost certainly not samples, and a pharmacy permit would be required for dispensing. It is the responsibility of the pharmacist manager to ensure that any prescription drugs provided to patients – even if received prepackaged – meet all federal and state labeling requirements.

DRUG INFORMATION CENTERS IN NC

poison control center, drug information

Contact information for North Carlina Poison Control and drug information centers in North Carolina is here:
Drug Information Centers.

FDA

Adverse Drug Effect Reporting

adverse, drug effect, reporting, human drug

Yes. Effective January 1, 2008, FDA required pharmacists to distribute with all prescriptions information alerting patients that they may call a toll-free telephone number to report adverse drug effects to the FDA:
Toll-Free Number for Reporting Adverse Effects on Labeling for Human Drug Products.

adverse, drug effect, reporting, fda medwatch

Pharmacists or members of the public may report a potential adverse drug effect to the FDA by calling 1-800-332-1088, or by submitting a report online here: MedWatch Online Voluntary Reporting Form.

Clozapine REMS System

clozapine, rems

On November 2, 2022, FDA advised that is temporarily exercising additional enforcement discretion with respect to certain Clozapine REMS program requirements to ensure continuity of care for patients taking clozapine. FDA is aware health care professionals and patients continue to experience ongoing difficulties with the Clozapine REMS program, including issues with patient access to clozapine for patients recently discharged from an inpatient setting.

To address the concern that inpatient pharmacies are only allowed to dispense a 7-days’ supply of clozapine to the patient upon discharge, FDA does not intend to object if:

  • Inpatient pharmacies dispense a days’ supply of clozapine that aligns with the patient’s monitoring frequency (e.g., weekly monitoring = 7 days’ supply, twice monthly monitoring = 14 days’ supply, monthly monitoring = 30 days’ supply) upon discharge from an inpatient facility.

FDA continues to exercise the enforcement discretion announced in November 2021, including that FDA does not intend to object if:

  • Pharmacists dispense clozapine without a REMS dispense authorization (RDA).

  • Wholesalers ship clozapine to pharmacies and health care settings without confirming enrollment in the REMS.

Abrupt discontinuation of clozapine can result in significant complications for patient treatment. Health care professionals should use their clinical judgment with regard to prescribing and dispensing clozapine to patients with an absolute neutrophil count (ANC) within the acceptable range.

We understand that difficulties with the Clozapine REMS program have caused frustration and have led to problems with patient access to clozapine. FDA takes these concerns seriously. Continuity of care, patient access to clozapine, and patient safety are our highest priorities. We are working closely with the Clozapine REMS program administrators to address these challenges and to avoid interruptions in patient care.

We encourage pharmacists and prescribers to continue working with the Clozapine REMS to complete certification and prescribers should continue to enroll patients and submit the Patient Status Form.

If you have questions or concerns about the Clozapine REMS Program or its website, please contact FDA at druginfo@fda.hhs.gov, 1-855-543-3784 or 301-796-3400.

FDA’s Intergovernmental Affairs (IGA) staff is here to assist state/local/territorial/tribal officials, including the national associations representing them, on FDA policy-related matters. If you have further questions, please contact FDA’s IGA team at IGA@fda.hhs.gov.

Drug Recalls
Drug Safety And Availability Resources

drug safety, rems, recalls

The FDA maintains a Drug Safety and Availability Resource Page. It provides links to information on drug labeling; REMS programs; post-market studies of drugs’ safety, efficacy, or optimal use; clinical trials; drug-specific safety information; warning letters; recalls; and consumer articles.

Drug Shortages

shortage, fda

The federal Food and Drug Administration maintains a database listing drugs that are in shortage, the reported reason for the shortage, and the anticipated date that the shortage will resolve. The database is found here: FDA Drug Shortage Database.

Medication Guides

medication guide

Medication Guides are part of a drug’s FDA-approved labeling, and must be distributed to patients with the medication:
What Are Medication Guides. The FDA maintains a searchable Medication Guide Database.

Quinine Sulfate

quinine sulfate, leg cramps

No. FDA guidance on the dispensing of quinine products is found here: FDA Quinine Monograph.

FREE OR CHARITABLE CLINIC PHARMACIES

physician assistant, nurse practitioner, pa, np, free clinic, charitable

Yes, as long as the NP/PA is registered with the Board of Pharmacy and dispensing from a place holding a pharmacy permit and under the supervision of the pharmacist manager in compliance with Board Rule .1703 and Board Rule .1706.

nurse practitioner, physician assistant, np, pa, free clinic, charitable, drug samples, register, dispenser

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.

physician, free clinic, charitable

Yes. A physician is not required to register with the Board of Pharmacy to do so as long as the drugs are dispensed without any fee or other charge to the patient.

volunteer, technicians, free clinic, charitable, registration requirement

Yes. Board Rule .3301(c) specifies that pharmacy technicians who provide services solely at a free clinic (as defined at
GS § 90-85.44) are required to register as technicians, but are exempt from the registration fee. Accordingly, technicians practicing solely at free clinics should complete the online registration application. The registration fee will be waived upon verification of the free clinic site.

free clinic, charitable, mail

Yes. Nothing in the Pharmacy Practice Act or associated rules prohibits a licensed in-state free or charitable clinics from mailing medications to patients that reside in North Carolina and can do so as long as all regulations are met for in-state pharmacies.

If the free or charitable clinic wishes to mail prescription drugs to patients residing outside of North Carolina, it is the responsibility of the pharmacy to ensure they are operating within the laws of the state to which the prescription medications are mailed.

controlled substances, dea number, free clinic, charitable

Yes. A DEA number is required by any pharmacy that orders, stores, or dispenses any controlled substances.  

OUTSOURCING FACILITIES

pharmacy permit, 503b, outsourcing facility

In some circumstances, yes. This guidance document details the circumstances in which a 503B outsourcing facility must obtain (or maintain) a pharmacy permit.

pharmacy permit, 503b, outsourcing facility, fda

Yes. All outsourcing facilities must obtain a permit from the North Carolina Department of Agriculture’s Food and Drug Protection Division. More information here.

PATIENT PRIVACY / HIPAA

Health Insurance Portability and Accountability Act (HIPAA)

hipaa, hippa, health insurance portability accountability act, patient privacy

The federal Department of Health and Human Services maintains a comprehensive HIPAA Resource Page.

phi, protected health information, hope act, patient privacy, hipaa

Board staff recommends the following guidelines in the event law enforcement agencies seek PHI from a pharmacy.

(1) A pharmacy may disclose PHI to any law enforcement agency at any time if the pharmacy believes in good faith that such information constitutes evidence of criminal conduct that occurred on the pharmacy’s premises. For instance, if an employee of the pharmacy was stealing drugs or if an individual presented a forged prescription, the pharmacy may disclose PHI relevant to such crime.

(2) If a law enforcement officer serves a court ordered warrant or court issued subpoena upon the pharmacy, the pharmacy may disclose the PHI sought.

(3) The 2018 HOPE Act authorizes certain law enforcement officers to obtain pharmacy records directly. This guidance document explains those provisions of the Act, which went into effect on July 1, 2019.

(4) Other situations should be reviewed on a case-by-case basis. In the event that a law enforcement officer who is not qualified under the HOPE Act seeks PHI without a court order or warrant, the pharmacy should document the following and use its best judgment in determining whether to release PHI to a law enforcement officer:

a. Identity of law enforcement agency seeking disclosure of PHI;
b. Name of officer;
c. Description of PHI sought; and
d. Description of specific oversight activity in which the law enforcement officer is engaged.

phi, protected health information, patient privacy, hipaa

A Board rule provides that a pharmacist may disclose pharmacy records to investigators of other occupational licensing boards whose licensees have prescribing authority.

hipaa, patient records, patient profile, patient privacy, phi

Yes. HIPAA authorizes a patient to view their entire patient profile from the pharmacy.

Disposal of PHI / Prescription Records

disposal of phi, prescription records, protected health information, hipaa, patient privacy

Board Rule .2305 addresses the security of confidential patient information. Furthermore, the federal HIPAA statute sets strict requirements for protecting, and disposing of, protected health information (PHI).

PHARMACIST

Immunizing Pharmacist Authority

immunizing authority, vaccination

This guidance details state-law pharmacist vaccination authority, including training requirements and the authority of pharmacy technicians and pharmacy interns to administer vaccines under the supervision of an immunizing pharmacist.

immunization registry, vaccination

The NC Department of Health and Human Services has information and training for the NC Immunization Registry available here.

influenza, immunization registry, vaccination

No. GS § § 90-85.15B(d)(3) exempts influenza vaccines from the requirement to report pharmacist-administered vaccines to the Immunization Registry.

drug therapy, hormonal contraception, prenatal vitamin, smoking cessation, hiv exposure prophylaxis, glucagon, hypoglycemia, training program, immunizing authority, vaccination, vaccine

GS § 90-85.15B(c2) grants “immunizing pharmacists” authority to dispense, deliver, and administer drug therapy for these conditions.

This guidance document details this grant of authority and below are links to the statewide protocols that pharmacists must follow when exercising the authority.

*NOTE* Immunizing pharmacists who wish to exercise the authority to provide oral or transdermal hormonal contraceptive therapy are required by the protocol to complete the North Carolina Hormonal Contraceptive Training Program. Additional detail on the program and how to report completion to the Board is found in the guidance document.

immunizing authority, long-acting, injectables, lai

This guidance document and Board Rule .2514 detail immunizing pharmacists’ authority to administer long-acting injectables, including training, recordkeeping, and reporting requirements.

Pharmacist Conscience Matters

morals, ethics, conscientious objection, conscience

The Board has adopted a policy statement on the intersection of professional practice and individual conscience decisions.

pain management, end of life care, palliative, terminal illness

Through dialogue with members of the healthcare community and consumers, a number of perceived regulatory barriers to adequate pain management in end-of-life care have been expressed to the Boards of Medicine, Nursing, and Pharmacy. The following statement attempts to address these misperceptions by outlining practice expectations for physicians and other health care professionals authorized to prescribe medications, as well as nurses and pharmacists involved in this aspect of end-of-life care. The statement is based on: the legal scope of practice for each of these licensed health professionals; professional collaboration and communication among health professionals providing palliative care; and a standard of care that assures on-going pain assessment, a therapeutic plan for pain management interventions; and evidence of adequate symptom management for the dying patient.

It is the position of all three Boards that patients and their families should be assured of competent, comprehensive palliative care at the end of their lives. Physicians, nurses and pharmacists should be knowledgeable regarding effective and compassionate pain relief, and patients and their families should be assured such relief will be provided.

Because of the overwhelming concern of patients about pain relief, the physician needs to give special attention to the effective assessment of pain. It is particularly important that the physician frankly but sensitively discuss with the patient and the family their concerns and choices at the end of life. As part of this discussion, the physician should make clear that, in some end-of-life care situations, there are inherent risks associated with effective pain relief. The Medical Board will assume opioid use in such patients is appropriate if the responsible physician is familiar with and abides by acceptable medical guidelines regarding such use, is knowledgeable about effective and compassionate pain relief, and maintains an appropriate medical record that details a pain management plan. Because the Board is aware of the inherent risks associated with effective pain relief in such situations, it will not interpret their occurrence as subject to discipline by the Board.

With regard to pharmacy practice, North Carolina has no quantity restrictions on dispensing controlled substances including those in Schedule II. This is significant when utilizing the federal rule that allows the partial filling of Schedule II prescriptions. In these situations, it would minimize expenses and unnecessary waste of drugs if the prescriber would note on the prescription that the patient is terminally ill and specify the largest anticipated quantity that could be needed for the next two months. The pharmacist could then dispense smaller quantities of the prescription to meet the patient’s needs up to the total quantity authorized.

Government-approved labeling for dosage level and frequency can be useful as guidance for patient care. Health professionals may, on occasion, determine that higher levels are justified in specific cases. However, these occasions would be exceptions to general practice and would need to be properly documented to establish informed consent of the patient and family. Federal and state rules also allow the fax transmittal of an original prescription for Schedule II drugs for hospice patients. If the prescriber notes the hospice status of the patient on the faxed document, it serves as the original. Pharmacy rules also allow the emergency refilling of prescriptions in Schedules III, IV, and V. While this does not apply to Schedule II drugs, it can be useful in situations where the patient is using Xanax for anxiety.

The nurse is often the health professional most involved in on-going pain assessment, implementing the prescribed pain management plan, evaluating the patient’s response to such interventions and adjusting medication levels based on patient status. In order to achieve adequate pain management, the prescription must provide dosage ranges and frequency parameters within which the nurse may adjust (titrate) medication in order to achieve adequate pain control. Consistent with the licensee’s scope of practice, the RN or LPN is accountable for implementing the pain management plan utilizing his/her knowledge base and documented assessment of the patient’s needs. The nurse has the authority to adjust medication levels within the dosage and frequency ranges stipulated by the prescriber and according to the agency’s established protocols.

However, the nurse does not have the authority to change the medical pain management plan. When adequate pain management is not achieved under the currently prescribed treatment plan, the nurse is responsible for reporting such findings to the prescriber and documenting this communication. Only the physician or other health professional with authority to prescribe may change the medical pain management plan.

Communication and collaboration between members of the healthcare team, and the patient and family are essential in achieving adequate pain management in end-of-life care.

Within this interdisciplinary framework for end-of-life care, effective pain management should include:

  • thorough documentation of all aspects of the patient’s assessment and care;

  • a working diagnosis and therapeutic treatment plan including pharmacologic and non-pharmacologic interventions;

  • regular and documented evaluation of response to the interventions and, as appropriate, revisions to the treatment plan;

  • evidence of communication among care providers;

  • education of the patient and family; and,

  • a clear understanding by the patient, the family and healthcare team of the treatment goals.

It is important to remind health professionals that licensing boards hold each licensee accountable for providing safe, effective care. Exercising this standard of care requires the application of knowledge, skills, as well as ethical principles focused on optimum patient care while taking all appropriate measures to relieve suffering. The healthcare team should give primary importance to the expressed desires of the patient tempered by the judgment and legal responsibilities of each licensed health professional as to what is in the patient’s best interest.

Pharmacists / Pharmacy Personnel / Pharmacy Students With Substance Use Disorders

resources, students, pharmacists, substance abuse, substance use, disorder, ncphp, treatment

The North Carolina Professionals Health Program ("NCPHP") works with the Board to provide clinical resources and support to pharmacists, pharmacy technicians, and pharmacy students struggling with substance abuse and misuse. NCPHP can be reached at (919) 870-4480.

stan haywood fund, ncphp, substance use, treatment, financial assistance, disorder, substance abuse

Yes. The Board and NCPHP established the L. Stanley Haywood Recovery Fund in April 2018. The Fund provides financial support to qualifying pharmacists and pharmacy personnel in need of substance use assessment, treatment, and monitoring services. NCPHP works with pharmacy personnel to determine their eligibility for Haywood Recovery Fund assistance.

stan haywood fund, ncphp, substance use, treatment, financial assistance, disorder, substance abuse

Yes. In coordination with NCPHP, Board staff have created a way for individuals licensed or registered with the NC Board of Pharmacy to contribute to this Fund at any time and in any amount. Simply log in to the Board’s Licensure Gateway and select the blue tile labeled Donate to Stan Haywood Recovery Fund to be taken directly to NCPHP’s donation site.

Members of the public who wish to contribute may do so by visiting this link: L. Stan Haywood Recovery Fund Donation Page.

PHARMACY

CBD-Containing Products

supplements, cbd, cannabidiol, epidiolex, hemp, farm bill, fda, cannabis, thc

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.

CLIA-Waived Tests

rapid diagnostic, tests, clia, clia-waived tests, clinical laboratory improvement amendments act

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

Dtp, dtp systems, direct to patient, direct-to-patient, kiosk, locker, dispensing system, lsp, limited service permit

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.

“Drop-Off / Pick-Up” Locations

drop-off, pick-up, locations

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.

Insurance Issues

insurance, insurers, pbm, prescription benefit managers, payment, reimbursement

No. The North Carolina Department of Insurance regulates those matters: 
NC Department of Insurance Pharmacy Complaint Resources.

pharmacy of choice, insurance, pbm, prescription benefit managers, payment, reimbursement

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.

Limited-Service Permit

lsp, limited-service permit

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.

Non-Pharmacist Dispensers

physician, dispensing, non-pharmacist, dur

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 are required to comply with all laws governing the practice of pharmacy and distribution of drugs, including appropriate packaging, labeling, recordkeeping, patient counseling, and prospective drug utilization review (DUR). Likely areas for noncompliance include: failure to conduct DUR, delegating dispensing functions to office staff, incomplete labeling, failure to conduct appropriate patient counseling, poor record keeping, and failure to use child resistant containers.

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.

physician, dispensing, non-pharmacist

No. Dispensing physicians must perform all dispensing themselves.

physician assistant, nurse practitioner, pa, np, dispensing, non-pharmacist

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.

physician assistant, nurse practitioner, pa, np, dispensing, sample medications, drug samples, starter dose, non-pharmacist

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.

registered nurse, rn, health department, dispensing, non-pharmacist

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.

rn dispensing, registered nurse, non-pharmacist, health department, formulary

Effective October 1, 2022, the following formulary (recommended by NCDHHS and approved by the Board of Pharmacy) governs RN dispensing from a health department:

  1. Anti-tuberculosis drugs, as recommended by the North Carolina Department of Health and Human Services in the North Carolina Tuberculosis Policy Manual (available at www.ncdhhs.gov), when used for the treatment and control of tuberculosis;

  2. Anti-infective agents used in the control of sexually-transmitted diseases as recommended by the United States Centers for Disease Control in the Sexually Transmitted Diseases Treatment Guidelines (available at www.cdc.gov);

  3. Natural or synthetic hormones and contraceptive devices when used for the prevention of pregnancy;

  4. Topical preparations for the treatment of lice, scabies, impetigo, diaper rash, vaginitis, and related skin conditions;

  5. Vitamin and mineral supplements;

  6. Opioid antagonists prescribed pursuant to GS § 90-12.7;

  7. Epinephrine auto-injectors prescribed pursuant to GS § 115C-375.2A;

  8. Over-the-counter nicotine replacement therapies;

  9. Folic acid for prevention of neural tube defects and other related conditions;

  10. Low-dose aspirin for prevention or delayed onset of preeclampsia in pregnant individuals with increased risk of pre-eclampsia as defined by the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine (criteria available at ACOG Practice Advisory)

registered nurse, rn, health care facility, non-pharmacist, labeling requirement, parenteral admixture

Board Rule .1414(c)(2) requires that “[f]or admixtures prepared outside the health care facility pharmacy, the pharmacist-manager shall develop policies and procedures for preparation and labeling.” A nurse’s preparation of a parenteral admixture for immediate administration to a patient in the health care facility is one that occurs “outside the health care facility pharmacy.” Accordingly, the pharmacist-manager must have policies and procedures in place adequate to oversee the practice and to require labeling that ensures the right medication gets to the right patient.

OTC Sales of Syringes

otc syringe sales, needles, syringes

Yes. This guidance document covers the legal and public health aspects of over-the-counter syringe and needle sales.

Outdated Drug Returns

outdated drugs, equivalent drug product, drug returns

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.

Patient Counseling

patient counseling

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. 

patient counseling, offer to counsel

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.

A valid offer to counsel must do two things: (1) specifically state what it is that is being offered; and (2) specifically state who will provide the counseling. For example: “Would you like to discuss your medication with the pharmacist?”; “Mr. Smith, this is a new prescription. Would you like to speak with the pharmacist about the medication?”; “Ms. Jones, the pharmacist would like to speak to you about this prescription medication. Do you have a moment?”

Pharmacist Breaks

pharmacist breaks, rest, meal, working conditions

Yes. Board Rule .2512 provides:

1) A permit holder shall not require a pharmacist to work longer than 12 continuous hours per workday. And

2) A pharmacist working longer than 6 continuous hours per workday shall be allowed during that time period to take a 30-minute meal break and one additional 15-minute break.

pharmacist breaks, technician

The Board has issued a policy statement concerning pharmacy technician activities during pharmacist breaks.

Pharmacist:Technician Ratio

pharmacist ratio, technician ratio, pt ratio

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.

Pharmacy Forms

pharmacist-manager, drug disaster, drug loss, incident report, drug disposal, pm responsibilities

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:

  1. Drug Disaster and Loss Reports - GS § 90-85.25(b) states that “the pharmacist in charge of a pharmacy shall report within 10 days to the Board any disaster, accident, theft, or emergency which may affect the strength, purity, labeling of drugs and devices in the pharmacy”.

  2. Incident Reports - Board Rule .2502(l) states that “The pharmacist-manager shall report to the Board of Pharmacy information that reasonably suggests that there is a probability that a prescription drug or device dispensed from a location holding a permit has caused or contributed to the death of a patient or customer. This report shall be filed in writing on a form provided by the Board within 14 days of the owner representative or pharmacist-manager's becoming aware of the event. The pharmacist-manager shall retain all documents, labels, vials, supplies, substances and internal investigative reports relating to the event. All such items shall be made available to the Board upon request”.

  3. Drug Disposal FormsBoard Rule .3001(a) states that “All registrants under GS § 90-85.21 shall develop and implement policies and procedures to guarantee that all outdated, improperly labeled, adulterated, damaged, or unwanted drugs or drug containers with worn, illegible or missing labels are destroyed or disposed of so as to render them unusable.”

pharmacy, inspection, form, inspection policy

North Carolina pharmacists may find it beneficial to review the Board’s inspection policy and Board inspection forms as a means of self-monitoring compliance with the Pharmacy Practice Act, North Carolina Administrative Code, and USP Compounding Standards.

North Carolina Board of Pharmacy Inspection Policy and Process.

Click on the appropriate form below to view or download:

Professional Limited Liability Companies and Pharmacies

pllc, professional limited liability company

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.

Quality Assurance Programs

qa, quality assurance, recordkeeping

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.

Referral Fees

compensation, referral fee, fee splitting

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

centralized pharmacy, remote medication order processing, rmop, nabp, verify, remote work

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.

Note that pharmacists providing remote medication order processing services from an out-of-state pharmacy permitted in North Carolina must either hold an individual North Carolina license to practice pharmacy or a current NABP Verify credential. This document provides detailed instructions on how out-of-state pharmacists may obtain an NABP Verify credential and register with the Board as required by Rule .1816.

centralized pharmacy, remote medication order processing, rmop, remote work

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.

Walk-In IV Therapy Clinics

iv therapy, clinic, hydration, walk-in

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.

PRESCRIPTIONS

DEA Number on Non-Controlled Prescriptions

Dea number, non-controlled

No. Though the relevant statutory language is somewhat unclear, all agencies that regulate prescriptions for non-controlled substances agree that North Carolina law does not require a DEA number on such prescriptions.

Epinephrine Auto Injectors / Epinephrine Auto Injectors in Schools

epi, epipen, auto-injector, epinephrine, anaphylaxis, twinject, adrenaclick

Yes. GS § 90-21.15A allows a prescriber to prescribe an epinephrine auto-injector to an “authorized entity” (defined as “any entity or organization . . . at which allergens capable of causing anaphylaxis may be present, including, but not limited to, recreation camps, colleges, universities, day care facilities, youth sports leagues, amusement parks, restaurants, places of employment, and sports arenas”). Pharmacists may dispense such prescriptions “issued in the name of an authorized entity.”

epi, epipen, auto-injector, epinephrine, twinject, adrenaclick, anaphylaxis, schools

Board staff has compiled guidance on supplying epinephrine auto-injectors to schools.

epi, epipen, auto-injector, epinephrine, anaphylaxis, patient counsel, twinject, adrenaclick, proper use

As pharmacists are aware, there are several epinephrine auto injector products on the market – e.g., EpiPen, Twinject, Adrenaclick. Because epinephrine auto injectors are used in emergency situations, it is crucial that pharmacists dispensing these devices ensure that the patient or the patient’s caregiver is adequately trained on their proper use at the time of dispensing. Pharmacists must not assume that the patient or patient’s caregiver has been trained by others.

Of course, if a prescriber writes for a particular epinephrine auto injector and signs the prescription “dispense as written” (or handwrites “brand medically necessary” where Medicaid patients are concerned), the pharmacist must dispense the indicated product.

If substitution is permitted, the pharmacist may do so as allowed by North Carolina law.

The pharmacist should be certain that the patient or patient’s caregiver has been trained on proper use of the particular device dispensed. Absent such training, a patient’s life could be placed in danger.

Expedited Partner Therapy (EPT)

ept, expedited partner therapy, std, sti, chlamydia, gonorrhea, trichomoniasis

Expedited Partner Therapy (EPT) is a strategy for treating the sex partner(s) of people diagnosed with chlamydia (Chlamydia trachomatis) and gonorrhea (Neisseria gonorrhoeae). EPT allows health care providers to provide patients with medication or a prescription for their sex partner(s) without a prior medical evaluation or clinical assessment of those partners. EPT also might have a role in partner management for trichomoniasis; however, no partner management intervention has been reported to be more effective than any other in reducing trichomoniasis reinfection rates.

ept, expedited partner therapy, std, sti, chlamydia, gonorrhea, trichomoniasis

Studies have found EPT decreases rates of chlamydia and gonorrhea reinfection and increases the number of sex partners reported and therefore treated for chlamydia and/or gonorrhea: CDC Resources for Expedited Partner Therapy.

ept, expedited partner therapy, std, sti, chlamydia, gonorrhea, trichomoniasis

EPT is recommended for the sex partners of heterosexual men and women in the 60 days prior to the chlamydia or gonorrhea diagnosis, or the most recent sexual partner if the patient’s last sexual encounter was more than 60 days ago. Considering the limited available data on the efficacy of EPT use among MSM compared to heterosexuals, and the higher potential for co-infections with other bacterial STIs or HIV among MSM partners, shared clinical decision-making regarding EPT is recommended.

ept, expedited partner therapy, std, sti, chlamydia

The recommended treatment for chlamydia is doxycycline 100 mg orally twice daily for 7 days; for partners where doxycycline is contraindicated, azithromycin 1 gram orally in a single dose is an acceptable alternative EPT regimen for chlamydia.

ept, expedited partner therapy, std, sti, gonorrhea

For gonorrhea, every effort should be made to ensure that a patient’s sex partners from the past 60 days are evaluated clinically and treated with the recommended regimen of a single dose of ceftriaxone 500 mg IM. However, because that is not always possible, providers should still consider EPT for partners of patients diagnosed with gonorrhea who are unlikely to access timely evaluation and treatment. In those cases, if a chlamydia infection in the patient has been excluded, a single 800 mg oral dose of cefixime, could be used. If a chlamydia negative test result has not been documented for the patient, the partner may be treated with a single 800 mg dose of oral cefixime plus oral doxycycline 100 mg twice daily for 7 days. If adherence to a multiday dosing regimen is a considerable concern or doxycycline is contraindicated, a single oral dose of azithromycin 1 gram can be substituted for chlamydia coverage instead of doxycycline.

*Note* Azithromycin has lower treatment efficacy among persons with rectal chlamydia. Alternative regimens should be considered if the partner is known to have an allergy to one of the recommended therapies. More guidance available at CDC Resources for Expedited Partner Therapy.

ept, expedited partner therapy, std, sti, trichomoniasis, trichomonas

The recommended treatment for trichomonas is metronidazole 500 mg twice daily for 7 days for women or metronidazole 2 grams orally in a single dose for men.

ept, eligibility, expedited partner therapy, std, sti, chlamydia, gonorrhea, trichomoniasis

Providers using EPT are required to give patients educational materials to give to their sex partner(s). These materials address allergic reactions, potential side effects, and contraindications to taking EPT regimen prescribed. Other states have been using EPT for over ten years and no adverse events and/or life-threatening allergic reactions have been reported to date.

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The pharmacist should label the drug for the named partner in accordance with normal procedures as specified by the Pharmacy Practice Act. If the partner is unnamed, the pharmacy may create a unique identifier and use that instead of a name for both labeling and record keeping purposes. An example of this if John Doe was the patient and his partner’s name was not known, could be “John Doe Partner ABC.” Sites should use a log to connect partners back to patients and can use any nomenclature that suits their needs as long as it can be tracked to a single partner and single patient.

ept, eligibility, expedited partner therapy, std, sti, chlamydia, gonorrhea, trichomoniasis, unknown partner, patient counseling

The pharmacist is not required to obtain an EPT partner’s name, address, or demographics; however, the pharmacist should ask the patient about any known allergies or other drugs being taken by their partner(s). The pharmacist should also provide the patient with written information on each EPT prescription and instruct the patient to give it to each partner with the medication(s). The pharmacist should advise the patient to encourage each partner to call the pharmacist before taking the drug if they have any questions or concerns regarding the EPT prescription provided.

Labeling

prescription label, generic name, brand name

Board Rule .1818 provides that prescription labels shall contain the generic name of the drug even if the brand name is on the container. The purpose of this rule is to make it possible for hospital personnel to easily identify products from the labels on prescription containers that may arrive with the patient in the emergency department. For example, a prescription for Cordarone could be labeled as "Cordarone (Amiodarone)" if the brand name was dispensed. If the generic was dispensed the label would only need to contain the word "Amiodarone".

Compounded products should contain a list of active ingredients. Exceptions could be made for standard items such as "Duke’s Mouthwash" or "Compounded Cafergot".

Label requirements, prescription label

The following information must be on every prescription label:

  1. Name and address of the dispensing pharmacy.

  2. Serial number of the prescription.

  3. Date of the prescription.

  4. Name of the prescriber.

  5. Name of the patient.

  6. Name and strength of the drug.

  7. The generic name of the drug, even if the generic drug is unavailable to dispense or even if the substitution of a generic drug is not authorized.

  8. Directions for use.

  9. Appropriate cautionary statements.

  10. “Filled by” or “dispensed by” with the name of the dispensing pharmacist. The name must include, at a minimum, the first initial and full last name of the dispensing pharmacist.

  11. If the dispensed drug is a “tranquilizer or sedative,” it should bear the warning “The consumption of alcoholic beverages while on this medication can be harmful to your health” if the prescriber so directs on the prescription.

  12. If the prescription is dispensed in a container other than the manufacturer’s original container, a discard date, which shall be the earlier of one year from the date dispensed or the manufacturer’s expiration date, whichever is earlier.

  13. If the prescription is dispensed in the manufacturer’s original container, the label must not obscure the expiration date and storage statement when the product is dispensed in the manufacturer's original container.

21 U.S.C. § 353(b)(2); GS § 90-85.29, GS § 106-134.1(b), 21 NCAC 46.1818.

These requirements do not prohibit pharmacists from including additional information on the label. For example, no federal or North Carolina statute requires that the label indicate the number of refills remaining. But such information is, for obvious reasons, typically included on the prescription label.

Narrow Therapeutic Index (NTI) Drugs

nti drugs, nti, narrow therapeutic index drugs

GS 90-85.27(4a) defines narrow therapeutic index drugs as those “having a narrowly defined range between risk and benefit. Such drugs have less than a twofold difference in the minimum toxic concentration and minimum effective concentration in the blood or are those drug product formulations that exhibit limited or erratic absorption, formulation-dependent bioavailability, and wide intrapatient pharmacokinetic variability that requires blood-level monitoring.”

nti drugs, nti list, narrow therapeutic index drugs

The North Carolina NTI list includes:

Carbamazepine: all oral dosage forms
Cyclosporine: all oral dosage forms
Digoxin: all oral dosage forms
Ethosuximide
Levothyroxine sodium tablets
Lithium (including all salts): all oral dosage forms
Phenytoin (including all salts): all oral dosage forms
Procainamide
Tacrolimus: all oral dosage forms
Theophylline (including all salts): all oral dosage forms
Warfarin sodium tablets

nti drugs, nti, narrow therapeutic index drugs

A first-time prescription for an NTI drug must be dispensed as written (if the prescriber so designates) or may be substituted by an equivalent drug product (if the prescriber so designates). The pharmacist must refill the NTI prescription (or new prescriptions continuing NTI drug therapy) with the same manufacturer’s product initially dispensed to the patient. The pharmacist may not dispense a different manufacturer’s product on a refill (or new prescription continuing NTI drug therapy) until the pharmacist obtains the documented consent of the prescriber and the patient for the change.  

nti drugs, nti, narrow therapeutic index drugs, fda, ab rating

No. An AB Rating from the Food and Drug Administration in its Orange Book publication does not change the application of the NTI law as noted above.

Prescriptions Issued by Physician Assistants or Nurse Practitioners

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PA and NP prescribing authority is regulated by the North Carolina Medical Board:

    Physician Assistant Prescribing Authority
    Nurse Practitioner Prescribing Authority

supervising physician, prescriptive authority, prescribing authority, physician assistant, nurse practitioner, pa, np

No. A supervising physician’s information is not required on NP- or PA-issued prescriptions. On February 1, 2021, the NC Medical Board amended the prescribing authority rule for physicians’ assistants by removing the supervising physician information requirement for prescriptions written by physicians’ assistants. 21 NCAC 32S .0212 On August 1, 2021, the NC Medical Board amended the prescribing authority rule for nurse practitioners by removing the supervising physician information requirement for prescriptions written by nurse practitioners. 21 NCAC 32M .0109.

Even before the Medical Board’s 2021 rule amendments (as detailed in long-standing Board guidance, see Item 2403 in the April 2020 Board of Pharmacy Newsletter), the absence of a supervising physician’s name and telephone number did not render a PA- or NP-issued prescription "invalid," “illegal,” or otherwise ineligible for dispensing under the North Carolina Food Drug and Cosmetic Act or the North Carolina Pharmacy Practice Act.

Prescriber Retirement, Death, or Loss of License

prescriber retirement, prescriber death, deceased prescriber, prescriber loss of license

Yes. A physician’s (or other prescriber’s) death, retirement, or loss of license does not void prescriptions written prior to the date the physician ceased practicing. As long as, in your professional judgment, the prescription was written for a legitimate medical purpose and pursuant to a valid physician-patient relationship, you may fill the prescription and any authorized refills.

Prescribers Treating Family Members

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The North Carolina Medical Board has the following position statement with respect to self- or family member-prescribing: Self-Treatment and Treatment of Family Members

Public Health Registered Nurses Transmitting Standing Orders

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Yes. A registered nurse at a public health department may act as the agent of the prescriber for the purpose of transcribing a standing order for a prescription medication to a written prescription blank for dispensing by an in-house or contracted pharmacy. The public health registered nurse should include on the prescription the standing order prescriber’s name and credentials, as well as the registered nurse’s name and an indication “per standing order” (or similar). Ex. Jane Smith, MD/by Mary Jones, RN/per standing order. Each transcribed prescription does not have to include a copy of the standing order, but public health departments are encouraged to provide their contracted pharmacies with reference copies of standing orders to facilitate the prescribing and dispensing process.

Refills

refills, combine refills, combining refills

Board Rule .1802(b) allows a pharmacist to combine refills and dispense up to the total amount authorized if “deemed appropriate in the pharmacist’s professional judgment.” Pharmacists may not combine refills for dispensing for controlled substances or psychotherapeutic drugs unless the prescriber authorizes the pharmacist to do so.

Refill, emergency refills

If the prescription has no refills remaining Board Rule .1809 authorizes a pharmacist to provide a one-time emergency refill for up to a 30-day supply when the prescriber is not available to authorize refills. If the pharmacist determines, in her professional judgment, that the medication is “essential to the maintenance of life or to the continuation or therapy in a chronic condition” and that “interruption of therapy might reasonably produce undesirable health consequences,” then the pharmacist may dispense the emergency refill. The pharmacist must create an order containing all prescription information required by law, sign the order, and notify the prescriber or prescriber’s office of the emergency dispensing within 72 hours. Schedule II controlled substances may not be dispensed as an emergency refill.

refill, emergency refill, one-time

If the prescription has no refills remaining, Board Rule .1815 authorizes a pharmacist to provide a one-time emergency refill for up to a 90-day supply when the prescriber is “unable to provide medical services” (e.g., a natural disaster prevents the prescriber from providing medical services; the prescriber passes away). A Schedule II controlled substance may not be dispensed as an emergency refill.

refill, prn, professional judgment

No. GS § 90-85.32 states that “prescriptions marked PRN shall not be refilled more than one year after the date issued by the prescriber unless otherwise specified.” If a prescription indicates a specific number of refills or a specific duration of refills that extend beyond one year, it may be refilled as refills come due. Different, specific rules govern refill limits on controlled substance prescriptions. And pharmacists must exercise professional judgment in filling or refilling all prescriptions, as specified in Board Rule .1801.

Telemedicine Encounters

telemedicine, professional judgment

Yes, upon appropriate exercise of professional judgment. The pharmacist must exercise professional judgment, as noted in Board Rule .1801. A pharmacists shall not fill or refill a prescription “if, in the exercise of professional judgment, there is or reasonably may be a question regarding the order’s accuracy validity, authenticity, or safety for the patient.”

nc medical board, telemedicine, refill

At one time, Board rule .1801 provided that a pharmacist could not fill or refill a prescription if the pharmacist knew or reasonably should have known that a prescription was issued in the absence of a prior prescriber-patient relationship or a physical examination. That rule reflected the Medical Board’s then-position on telemedicine-based prescribing.

In late 2014, however, the Medical Board amended its position on telemedicine, which is found here: Medical Board Telemedicine Position Statement. That position notes that telemedicine-based encounters may be appropriate for evaluating patients “if the licensee employs technology sufficient to accurately diagnose and treat the patient in conformity with the applicable standard of care.” In response to the revised Medical Board position, the Board of Pharmacy amended Board Rule .1801 to state that a prescription order is valid if “issued by a health care provider for a legitimate medical purpose, in the context of a patient-prescriber relationship, and in the course of legitimate professional practice as recognized by the [Medical Board].”

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The Medical Board’s statement states: “It is the position of the Board that prescribing controlled substances for the treatment of pain by means of telemedicine is not consistent with the standard of care.” Medical Board Telemedicine Position Statement.

Furthermore, the federal Controlled Substances Act and regulations state that a pharmacist may only dispense a prescription for a controlled substance issued for legitimate medical purpose in the usual course of professional practice.

The Ryan Haight Online Pharmacy Consumer Protection Act governs the issuance of controlled substance prescriptions. Please consult Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications.

Transfers

transfer, transferring prescriptions, patient request

On a semi-regular basis, Board staff receive calls from pharmacists raising concerns or complaints about prescription transfer practices. Typically, the concern or complaint takes one of the following forms: (a) the pharmacist complains that another pharmacy (or, more frequently, a particular pharmacist) refuses to transfer prescriptions upon request; (b) the pharmacist complains that another pharmacy (or pharmacist) agrees to transfer prescriptions, but takes a long time to do so; (c) the pharmacist complains that another pharmacy (or pharmacist) is “tricking” or “coercing” patients into transferring prescriptions.

Board Rule .1806 authorizes the transfer of prescriptions among pharmacies, and it sets forth procedural and recordkeeping requirements for doing so. Pharmacists seldom have questions about these procedural or recordkeeping requirements. Instead, most of the focus in these situations is one word in the rule – “permissible.” The introductory language of Rule .1806 says that the “transfer of original prescription information for the purpose of refill dispensing is permissible between pharmacies . . . .” Pharmacies or pharmacists who have refused to transfer a prescription typically respond to a complaint by saying that the rule makes transfers “permissible,” and not “mandatory.” What tends to get lost in this blinkered argument is the most important factor – the patient.

Patients have the right to select their pharmacy provider. Patients have many reasons for choosing a particular pharmacy in the first instance or deciding that they wish to change to a different pharmacy. Whatever those reasons, the patient is the decision maker. A patient’s wishes must be respected not only because it’s the right thing to do, but also to avoid interruption of care that could well prove harmful to the patient.

With this background in mind, this is how Board staff approach transfer complaints:

1. Pharmacists are expected to consult with one another professionally and politely to resolve transfer issues. Staff often find that the root of a transfer dispute is a personal or business conflict among pharmacists or pharmacies. These sorts of disputes are not a reason to involve the Board, nor are they a reason to delay (or deny) a patient’s care.

2. In some cases, a pharmacist alleged to have wrongly refused a transfer will state that he/she simply wants to confirm the request with the patient. That, in and of itself, doesn’t necessarily raise an issue. But “I’m checking with the patient” must not become a pretext for denying a transfer or delaying one to such a degree that the patient’s continuity of care is jeopardized. And pharmacy policies and procedures that incentivize staff pharmacists to delay or deny transfers place those pharmacists, the pharmacist-manager, and the pharmacy permit in potential jeopardy.

3. Board staff treats a transfer complaint from a patient as a higher priority matter than a transfer complaint from a pharmacist. This is because, as noted above, transfer complaints relayed by pharmacists are often rooted in personal or business conflicts. Direct patient complaints are more typically rooted in potential harm resulting from interrupted drug therapy. A patient who alerts the Board that his/her transfer request is not being honored, or is not being honored in a timely fashion, will find a ready ear and a helping hand from Board staff.

4. If, after a patient complaint, neither professional consultation among the pharmacists nor informal intervention of Board staff (usually by way of a phone call to both pharmacists with a suggestion that the patient’s request be met without further delay), Board staff will open a case and pursue it as a disciplinary matter focusing on potential negligence in a pharmacist’s/pharmacy’s outright refusal to transfer or a dilatory transfer.

5. Pharmacies are expected to have adequate staff on hand to fulfill a patient’s transfer request in a timely fashion. As noted in Item 2389 of the July 2019 Newsletter, in recent months some pharmacies have abruptly closed without adequate (and legally required) notice to patients. Predictably, this results in the pharmacy receiving the prescription files getting bombarded with transfer requests. The pharmacist-manager of the receiving pharmacy must staff it sufficiently to accomplish timely transfers. Failure to do so will lead to a Board staff investigation and potential discipline.

6. If a pharmacy or pharmacist complains to the Board that it believes a patient was “tricked” or “coerced” into transferring prescriptions, Board staff needs, at a minimum, the patient’s name and contact information and strongly prefers to receive the complaint from the patient directly. In Board staff’s experience, most often the patient explains that he/she did authorize a transfer but was uncomfortable admitting this to his/her now-former pharmacy. But if a patient directly alleges that he/she experienced a transfer that he/she did not authorize, that is a serious matter that could involve not only the Board of Pharmacy, but also law enforcement agencies or the North Carolina Attorney General’s office.

transfer, transferring prescriptions, refills, maximum, controlled substances

Yes, provided that refills remain on the prescription.

Prescriptions for non-controlled drugs may be transferred from one pharmacy to another providing that refill authorizations remain.

Federal law limits the transfer of prescriptions for controlled substances. DEA rule 21 CFR 1306.25(a) permits a one-time transfer of a prescription for a Schedule III, IV, or V prescription. Pharmacies that electronically share a real-time, online database may transfer up to the maximum refills permitted by law and the prescriber’s authorization.

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Under federal law, an original prescription for a C-III, C-IV, or C-V substance may be transferred for refill on a one-time basis. If pharmacies electronically share a “real-time, on-line database,” then those sharing pharmacies “may transfer up to the maximum refills permitted by law and the prescriber’s authorization.” 21 CFR 1306.25(a)

Federal law, however, requires that any transfer of a C-III, C-IV, or C-V prescription be “communicated directly between two licensed pharmacists . . . .” 21 CFR 1306.25(a)(1)

Veterinary Prescriptions

npi number, national provider identifier, veterinary, veterinarian, dea number

No. A veterinarian (or, for that matter, any other health care provider) who writes a prescription for a drug that is not a controlled substance does not need a DEA number to do so. Nor does North Carolina law require a DEA number to appear on a prescription for a non-controlled substance.

Moreover, veterinarians are not eligible to obtain an NPI number. In 2013, the Centers for Medicare and Medicaid Services clarified that veterinarians do not meet the regulatory definition of “health care provider” for purposes of obtaining an NPI. More information can be found here.

The Board appreciates, as always, pharmacists’ efforts to ensure that prescriptions comply with all applicable laws and rules. But demanding a DEA number for a non-controlled substance prescription and/or an NPI number from a veterinarian who is not eligible to obtain one is not required by law. And doing so can pose a barrier to timely, effective treatment of veterinary patients.

veterinary pharmacy, veterinary medicine, animal patients, references, veterinarian

The following references are critical:

Plumb's Veterinary Drug Handbook
-complete monographs for all veterinary drugs
-pharmacology and dosing for all non-human species
-drug interactions
-administration information
-incompatibilities and laboratory interference
-regulatory information (food animal warnings, performance animal warnings)

Veterinary Drug Handbook, Client Information Edition
-patient education information for all drugs used in veterinary medicine
-animal-specific patient education information for human drugs used in animal patients
-human caregiver warnings for drugs administered to veterinary patients

Saunders Comprehensive Veterinary Dictionary
-comprehensive description of veterinary medical terms and anatomical terminology
-required text for veterinary students

The Compendium of Veterinary Drug Products
-comprehensive listing of animal health products.
-alphabetical index of manufacturers and their products,
-alphabetical cross-reference of ingredients and brand names
-product category index
-product monographs
-alphabetical index of products

Material Safety Data Sheets for veterinary drug products are required by NIOSH regulations and would be required for any pharmacy stocking these items, regardless of state rules.

WHOLESALING / PRESCRIPTION DRUG WHOLESALERS

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North Carolina law provides an exemption wholesaling registration requirements to allow limited transfers between or among pharmacies only under very specific circumstances in GS § 106-145.2(10)(e): "The sale, purchase, or trade of a prescription drug or an offer to sell, purchase or trade a prescription drug for emergency medical reasons. Emergency medical reasons include transfers of prescription drugs by a retail pharmacy to another retail pharmacy to alleviate a temporary shortage when the gross dollar value of the transfer does not exceed 5% of the total prescription drug sales revenue of either the transferor or transferee pharmacy during a 12 consecutive month period."

Prescription drug transfers between or among pharmacies that fall outside this limited, emergency exception are wholesale transactions would require a North Carolina wholesaler license. Note that the sale of excess stock to another pharmacy would be a wholesale activity.

Pharmacists should also be aware that transfers of prescription drugs between or among pharmacies must comply with the requirements of Title II of the federal Drug Quality and Security Act, also known as the Drug Supply Chain Security Act. More information is found here: FDA Guidance on Drug Supply Chain Security Act

Pharmacists should also be aware that any transfer of controlled substances between or among pharmacies requires compliance with all pertinent provisions of the federal Controlled Substances Act and associated regulations. Helpful guidance may be found in the Drug Enforcement Administration Pharmacist’s Manual, available here: DEA Pharmacist's Manual (revised 2022)

drug supply chain security act, dqsa, product tracing, fda, department of agriculture

Pharmacists with questions about Drug Supply Chain Security Act’s application to pharmacy operations should contact the North Carolina Department of Agriculture’s Food and Drug Protection Division and consult the FDA Guidance on Drug Supply Chain Security Act

department of agriculture, wholesalers, wholesaler database

The Department of Agriculture maintains a searchable, on-line database of prescription drug wholesalers licensed in North Carolina: The database is available here: NC Department of Agriculture Wholesaler Database.

department of agriculture, wholesale, wholesalers, fda, secondary wholesaling, gray market

No. Board staff and North Carolina Department Agriculture and Consumer Services, Food & Drug Protection staff (the latter are responsible for wholesale prescription drug regulation in North Carolina) have received multiple inquiries regarding contacts from businesses that represent themselves as Internet-based marketplaces for independent pharmacies. The business model described is an on-line point of product exchange, allowing independent pharmacies to buy and sell over-stocked prescription drug inventory and prescription drugs in short supply among themselves. Typically, such businesses suggest that, under FDA guidelines, a pharmacy may transfer up to 5% of its annual sales to another pharmacy without a wholesale license. Board staff and Food & Drug Protection staff view these models as inconsistent with both federal and state law governing wholesale prescription drug transactions. North Carolina General Statutes are consistent with applicable portions of the federal Food, Drug & Cosmetic Act with respect to limited transfers of prescription drugs between pharmacies for legitimate emergency medical reasons; transfers between retail pharmacies without a wholesale license simply for inventory management reasons are not allowed in North Carolina.

Board and Food & Drug Protection staff also are concerned that such business models are but another version of the “secondary” and “gray market” wholesaling. Staff has cautioned about this practice for years. See Item 2240 in the April 2012 Newsletter.

drug wholesale license, department of agriculture, wholesaler

Drug wholesale licenses are handled by the NC Department of Agriculture's Food & Drug Protection Division. Please visit Food and Drug Protection Division for information.