Pharmacist FAQsFrequently Asked Questions for Pharmacists on Controlled Substances/Controlled Substance Reporting Act Q: Are pharmacists required to hand sign and date controlled substance prescriptions? A: North Carolina Law no longer requires pharmacists to hand sign and date controlled substance prescriptions they fill. The North Carolina Controlled Substances Act required for many years that pharmacists hand sign and date all controlled substance prescriptions that they filled. The General Assembly repealed this provision – formerly located at N.C.G.S. § 90-106(h) – in August 2007 as part of a broader amendment to the recordkeeping provisions of the Pharmacy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: Can I fill Schedule II prescriptions bearing a "do not fill until" date? A: Yes, within limits established by DEA: Effective December 19, 2007 prescribers will be authorized to write multiple prescriptions on the same day to be filled sequentially for schedule II controlled substances. The Drug Enforcement Agency (DEA) issued the final rule on Monday, November 19 (http://a257.g.akamaitech.net/7/257/2422/01jan20071800/edocket.access.gpo.gov/2007/pdf/E7-22558.pdf), which reflects APhA's recommendation to remove language that could have been interpreted to add an additional duty on health providers (including pharmacists) for schedule II prescriptions. However, the DEA chose not to defer to prescribers on the most appropriate time limitation, instead retaining the 90-day the prescription order limit in the original proposed rule. The new regulation does not affect State laws and regulations, which may be more restrictive. Specifically, the new rule amends Title 21 of the Code of Federal Regulations, Part 1306 as follows:
3. Section 1306.14 is amended by adding a new paragraph (e) to read as follows:
APhA's statement to the DEA on the proposed regulation can be accessed here. -------------------------------------------------------------------------------- Link to Dispenser Reporting Manual (from NC Department of Health and Human Services Division of Mental Health, Developmental Disabilities and Substance Abuse Services Controlled Substances Reporting System) CONTROLLED SUBSTANCE REPORTING ACT Q. When will the controlled substance reporting system in North Carolina go into effect? A. The Department of Health and Human Services, which administers the act, reports that the system will go live on July 1, 2007. Electronic reports would be made monthly for the first year, then every two weeks afterward.
Q. What information must be reported under the controlled substance reporting act? A. The requirements of the act are at NCGS 90-113.70 [http://www.ncga.state.nc.us/EnactedLegislation/Statutes/PDF/ByArticle/Chapter_90/Article_5E.pdf]. Questions about the act should be directed to Johnny Womble of the Department of Health and Human Services, johnny.womble@ncmail.net. The act requires dispensers to report:
Q. Must my facility report controlled substance dispensing under the act? A. The act defines 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:
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: How can I access the latest edition of the DEA's Practitioner's Manual? A: DEA recently released the 2006 edition of its Practitioner’s Manual: An Informational Outline of the Controlled Substances Act. Prepared by the DEA Office of Diversion Control, the manual is designed to assist practitioners (physicians, dentists, veterinarians, and other registrants authorized to prescribe, dispense, and administer controlled substances) in their understanding of the federal Controlled Substances Act and its implementing regulations as they pertain to their professions. The manual is accessible on the DEA Web site at www.deadiversion.usdoj.gov/pubs/manuals/pract/pract_manual090506.pdf. ------------------------------------------------------------------------------- Q: What is my responsibility as a pharmacist in case of drug loss or theft? A: Pursuant to a change in DEA CFR 21-1301.76, (April 1, 2006) – a DEA registrant shall 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 regarding the loss or theft. When determining whether a loss if significant, a registrant should consider the factors listed in 1301.76 (b). A Drug Disaster & Loss Report should also be completed and filed with the NC Board of Pharmacy office within 10 days of the drug loss/theft. ------------------------------------------------------------------------------- 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 C.F.R. § 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 C.F.R. § 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: Can prescription blanks for controlled substances be preprinted? A: A North Carolina rule prohibits the preprinting of the name of the controlled substance on prescription blanks. This rule can be found at NCAC45.G Drug Commission-Pertinent Rules on the Board’s Website under Drug Law. -------------------------------------------------------------------------------- Q: What refill authority exists for Physician Assistants, Nurse Practitioners and Clinical Pharmacist Practitioners? -------------------------------------------------------------------------------- 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. -------------------------------------------------------------------------------- Q: Where can I find information on the State Controlled Substances Act? A: Please contact: Department of Health & Human Services Phone: (919) 715-2771
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