Current through Register Vol. 56, No. 6, March 18, 2024
(a) No prescription for a controlled substance listed in Schedule III or IV shall be filled or refilled more than six months after the date on which such prescription was issued and no such prescription authorized to be refilled may be refilled more than five times.
(b) A prescription for a controlled substance listed in Schedule V may be refilled only as expressly authorized by the prescribing individual practitioner on the prescription. If no such authorization is given, the prescription may not be refilled.
(c) Each refilling of a prescription shall be entered on the back of the prescription or on the electronic prescription record (or on another appropriate uniformly maintained, readily retrievable record, such as medication records), which indicates by the number of the prescription the following information:
1. The name and dosage of the controlled substance;
2. The date of each refilling;
3. The quantity dispensed;
4. The identity or initials of the dispensing pharmacist in each refilling; and
5. The total number of refills for that prescription, initialed, and dated by the pharmacist as of the date of dispensing, and shall state the amount dispensed.
(d) If the pharmacist merely initials and dates the back of the prescription or annotates the electronic prescription record he or she shall be deemed to have dispensed a refill for the full face amount of the prescription.
(e) Additional quantities of controlled substances listed in Schedule III or IV may only be authorized by a prescribing practitioner through issuance of a new prescription as provided in 13:45H-7.13, which shall be a new and separate prescription.
(f) As an alternative to the procedures provided by (a) through (e) above, an automated data processing system may be used for the storage and retrieval of refill information for prescription orders for controlled substances in Schedules III, IV, and V subject to the following conditions:
1. Any such proposed computerized system must provide on-line retrieval (via computer monitor display or hard-copy printout) of original prescription order information for those prescription orders that are currently authorized for refilling. This shall include, but is not limited to, data such as the original prescription number, date of issuance of the original prescription order by the practitioner, date of first filing, full name and address of the patient, name, address, and DEA registration number of the practitioner, and the name, strength, dosage form, quantity of the controlled substance prescribed (and the quantity dispensed if different from the quantity prescribed), and the total number of refills authorized by the prescribing practitioner.
2. Any such proposed computerized system must also provide on-line retrieval (via computer monitor display or hard-copy printout) of the current refill history for Schedule III or IV controlled substance prescription orders (those authorized for refill during the past six months). This refill history shall include, but not be limited to, the name of the controlled substance, the date of refill, the quantity dispensed, the identification code, or name or initials of the dispensing pharmacist for each refill and the total number of refills dispensed to date for that prescription order.
3. Documentation of the fact that the refill information entered into the computer each time a pharmacist refills an original prescription order for a Schedule III, IV, or V controlled substance is correct must be provided by the individual pharmacist who makes use of such a system. If such a system provides a hard-copy printout of each day's controlled substance prescription order refill data, that printout shall be verified, dated, and signed by the individual pharmacist who refilled such a prescription order. The individual pharmacist must verify that the data indicated is correct and then sign this document in the same manner as he or she would sign a check or legal document (for example, J.H. Smith, or John H. Smith). This document shall be maintained at that pharmacy for a period of five years from the dispensing date. This printout of the day's controlled substance prescription order refill data must be provided to each pharmacy using such a computerized system within 72 hours of the date on which the refill was dispensed. It must be verified and signed by each pharmacist who is involved with such dispensing. In lieu of such a printout, the pharmacy shall maintain a bound log book, or separate file, in which each individual pharmacist involved in such dispensing shall sign a statement (in the manner previously described) each day, attesting to the fact that the refill information entered into the computer that day has been reviewed by him or her and is correct as shown. Such a book or file must be maintained at the pharmacy employing such a system for a period of five years after the date of dispensing the appropriately authorized refill.
4. Any such computerized system shall have the capability of producing a printout of any refill data which the user pharmacy is responsible for maintaining under the Act, and its implementing regulations. For example, this would include a refill-by-refill audit trail for any specific strength and dosage form of any controlled substance (by either brand or generic name or both). Such a printout must indicate name of the prescribing practitioner, name and address of the patient, quantity dispensed on each refill, date of dispensing for each refill, name and identification code of the dispensing pharmacist, and the number of the original prescription order. In any computerized system employed by a user pharmacy, the central recordkeeping location must be capable of sending the printout to the pharmacy within 48 hours and if a representative of the Drug Control Unit request a copy of such printout from the user pharmacy, it must, if requested to do so by the representative of the Drug Control Unit verify the printout transmittal capability of its system by documentation (for example, postmark).
5. In the event that a pharmacy that employs such a computerized system experiences system down-time, the pharmacy must have an auxiliary procedure that will be used for documentation of refills of Schedules III, IV, and V controlled substance prescription orders. This auxiliary procedure must insure that refills are authorized by the original prescription order, that the maximum number of refills has not been exceeded, and that all of the appropriate data is retained for on-line data entry as soon as the computer system is available for use again.
(g) When filing refill information for original prescription orders for Schedule III, IV, or V controlled substances, a pharmacy may use only one of the two systems described in this section.
