South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 1200 - Controlled Substances Listed in Schedules III, IV and V › Section 61-4.1200.1202 - Refilling of Prescriptions

Current through Register Vol. 48, No. 6, June 28, 2024
(a) No prescription for a controlled
				substance listed in schedule III, IV, or V shall be filled or refilled more
				than six months after the date on which such prescription was issued and no
				such prescription may be refilled more than five times. Additional quantities
				of controlled substances listed in schedule III, IV, or V may only be
				authorized by a prescribing practitioner through issuance of a new prescription
				as provided in §
									1201 which shall be a new and
				separate prescription.
(b) 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
				shall provide online retrieval (via CRT display or hard-copy printout)
				information for those prescription orders which 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, 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 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
				shall also provide on-line retrieval (via CRT display or hard-copy printout) of
				the current refill history for Schedule III, IV, or V controlled substance
				prescription orders (those authorized for refill during the past six months).
				This refill history shall include, but is not 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 shall be provided by the individual pharmacist
				who makes use of such a system. If such a system provides a hard-copy of each
				day's controlled substance prescription order refill data, that print-out shall
				be verified, dated, and signed by the individual pharmacist who refilled such a
				prescription order. The individual pharmacist shall 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 (e.g. J.H. Smith or John H. Smith).
				This document shall be maintained in a separate file at that pharmacy for a
				period of two years from the dispensing date. This printout of the day's
				controlled substance prescription order refill data shall be provided to each
				pharmacy using such a computerized system within 72 hours of the date on which
				the refill was dispensed. It shall 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 shall be maintained at the
				pharmacy employing such a system for a period of two years after the date of
				dispensing the appropriately authorized refill.
(4) Any such computerized system shall have
				the capability of producing a print-out of any refill data which the user
				pharmacy is responsible for maintaining under the Act and its implementing
				regulation. For example, this would include a refill-by-refill audit trail for
				any specified strength and dosage form of any controlled substance (by either
				brand or generic name or both.) Such a print-out shall indicate name of the
				prescribing practitioner, name and address of the patient, quantity dispensed
				on each refill, date of dispensing for each refill, name or 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
				record-keeping location shall be capable of sending the print-out to the
				pharmacy within 48 hours, and if a DEA Special Agent or compliance Investigator
				or an Inspector from DHEC requests a copy of such print-out from the user
				pharmacy it shall, if requested to do so by the Agent, Investigator, or
				Inspector verify the print-out transmittal capability of its system by
				documentation (e.g. postmark).
(5)
				In the event that a pharmacy which employs such a computerized system
				experiences system down-time, the pharmacy shall have an auxiliary procedure
				which will be used for the documentation of refills of Schedule III, IV, and V
				controlled substance prescription orders. This auxiliary procedure shall 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.