Pharmacy Practice FAQsCONTROLLED SUBSTANCES
Changes to Controlled Substance Prescriptions Q: What changes can be made to Schedule II Prescriptions? A: 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:
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.
Q: May a pharmacist change or add the correct amount of acetaminophen to a prescription for a combination product containing a schedule II drug and acetaminophen? A: 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.
Q: Is it "legal" for a pharmacist to add a DEA number to a controlled substance prescription when the prescriber omits that information? A: 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.
Q: May a practitioner prescribe other medications on a prescription that already includes a Schedule II medication? A: Yes.
Q: Are pharmacists required to hand-sign and hand-date controlled substance prescriptions? A: 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.
Q: Are pharmacists required to "cancel" a prescription for a controlled substance by drawing a line from one corner to the other of the prescription document? A: No, this is not a federal or state requirement.
Controlled Substance Reporting System Q: How do I access the NC Controlled Substances Reporting System (“CSRS”)? A: 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; Kristen Weisberg; or John Womble. (984) 236-5100.
Q: What information must be reported to the CSRS? A: 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.
Q: What qualifies as a “dispenser” required to report to the CSRS? A: 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. 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.
Q: Are there any exemptions to Controlled Substance Reporting System requirements regarding distribution of controlled substance samples? A: 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.”
CSOS (DEA Controlled Substance Ordering System) Q: How do I access the DEA's Controlled Substance Ordering System (CSOS)?
Q: What is the proper way to document receipt of Schedule II controlled substance orders when using DEA's CSOS? A: 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 Q: Under what circumstances may a health care provider prescribe methadone or a buprenorphine product? A: 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. 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 Substances (and Non-Controlled Substances) Q: May a patient return prescription drugs to a pharmacy? A: 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. North Carolina law does allow the donation of prescription drugs in certain circumstances. More information is found here: Drug Donation FAQ
Q: How should a pharmacy dispose of drugs, both non-controlled medications & controlled substances? A: 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: The Drug Control Unit has more information available here: NCDHHS Drug Control Unit FAQs
Q: Where can I find guidance from the DEA on electronic prescribing of controlled substances? A: The DEA maintains a guidance document here: DEA Guidance on Electronic Prescriptions for Controlled Substances
Employees With Felony Convictions Involving Controlled Substances Q: May a DEA registrant employ a person who has been convicted of a felony relating to controlled substances who would have access to controlled substances? A: 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.
Q: How often must a pharmacy conduct a complete controlled substances inventory? A: 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.
Q: May a pharmacy dispense naloxone pursuant to a statewide standing order? A: 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. 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.
Q: May a pharmacy provide naloxone to other organizations for distribution to vulnerable patient populations? A: 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 Substances Prescriptions Q: Do controlled substance prescription orders or prescription documents have an expiration date? A: 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.”
Q: May I dispense partial fills of a Schedule II controlled substance prescription? A: 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)
Q: For how long may I provide partial fills of a Schedule II controlled substance prescription? A: 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)
Q: I thought that I could only do a partial fill of a Schedule II prescription if the pharmacy is “unable to supply the full quantity” and that I had only 72 hours to provide the remainder of the prescription? A: 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.
Q: Can I fill Schedule II prescriptions bearing a "do not fill until" date? A: 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.
Q: Is there a six month/five refill limit on Schedule V controlled substances? A: No. Prescriptions for Schedule V drugs may be refilled as authorized.
Photo ID for Controlled Substances Q: Must a pharmacy obtain a photo identification prior to dispensing controlled substances? A: 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
Q: Can prescription blanks for controlled substances be pre-printed? A: 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.”
Q: What information is required to be on a prescriber’s prescription blank? A: 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.
Q: May a prescriber order Schedule II, III, IV, and V controlled substances for office use? A: 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.
Q: Is pseudoephedrine a controlled substance under North Carolina law? A: No.
Q: How does North Carolina law regulate the sale of pseudoephedrine containing products? A: 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." Here is the applicable state law, § 90-113.54. Posting of signs: https://www.ncleg.gov/EnactedLegislation/Statutes/PDF/BySection/Chapter_90/GS_90-113.54.pdf 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.
Q: What are requirements imposed on pseudoephedrine product sales by the federal Combat Methamphetamine Epidemic Act of 2005? A: Read the guidance document from the DEA Office of Diversion Control.
Q: What are the training and training log requirements for the sale of pseudoephedrine products in NC?
Q: What pseudoephedrine products are subject to the statute? A: 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.
Q: How much pseudoephedrine can I sell a customer? A: 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.
Q: Does either the state or federal pseudoephedrine statute apply to hospital pharmacies? A: 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.
Q: What do Board rules say about refusing to fill or refill a prescription? A: 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: 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
Q: What is the NC Medical Board's position on the use of opiates to treat pain? A: 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) Q: Does North Carolina have a statute that governs the prescribing, dispensing, and monitoring of “targeted controlled substances”? A: 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
Q: Are pharmacies allowed to accept returns of controlled substances for destruction? A: 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 Q: What is my responsibility as a pharmacist in case of drug loss or theft? A: 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 Q: May a technician, certified technician, or pharmacy student transfer or receive transfers of prescriptions for controlled substances? A: 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.
Q: May a pharmacy transfer an “on file” prescription for a controlled substance that the pharmacy never dispensed? A: 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.
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