CHAPTER 44:58:07
RECORDS, REPORTS, AND INVENTORIES
Section
44:58:07:01 and 44:58:07:02 Repealed.
44:58:07:03 Inventory requirements.
44:58:07:04 Acquisition, dispensing, and distribution records.
44:58:07:05 Theft reports.
44:58:07:06 to 44:58:07:08 Repealed.
44:58:07:09 Emergency supplies of controlled substances in long term care facilities.
44:58:07:01. Record, report, and inventory requirements generally.Repealed.
Source: 1 SDR 30, effective October 7, 1974; repealed, 6 SDR 93, effective July 1, 1980.
44:58:07:02. Record, report, and inventory requirements specifically.Repealed.
Source: 1 SDR 30, effective October 7, 1974; repealed, 6 SDR 93, effective July 1, 1980.
44:58:07:03. Inventory requirements. Upon registration, a registrant shall make a written, typed, or printed inventory of all stocks of controlled substances. After the initial inventory is taken, the registrant shall take a new inventory of all stocks of controlled substances on hand at least every two years. The biennial inventory may be taken on any date which is within two years of the previous inventory date. The inventory shall contain the following:
(1) An exact count or measure of all Schedule I and II substances;
(2) An estimated count or measure of all Schedule III or IV substances; if a container holds more than 1,000 doses, the registrant shall make an accurate count; and
(3) The date, time of day (opening or closing of business), signature of the person taking the inventory, and signature of the registrant if not the same individual.
Substances which are added to the list of controlled substances shall be inventoried on the date when the control takes effect and thereafter with the biennial inventory.
Source: 6 SDR 93, effective July 1, 1980; 25 SDR 48, effective October 1, 1998.
General Authority:SDCL 34-20B-41.
Law Implemented:SDCL 34-20B-39, 34-20B-40.
44:58:07:04. Acquisition, dispensing, and distribution records. A dispenser shall maintain the records required to acquire, distribute, or dispense controlled substances in a readily retrievable manner. The following minimum standards shall be met:
(1) Acquisition of Schedule I and II substances will be verified through official order forms of the DEA;
(2) Acquisition of Schedule III and IV substances will be verified through invoices or other records;
(3) Dispensing of all controlled substances will be verified through prescriptions or other chronological records as follows:
(a) The records shall include the name and address of the patient (or species and name and address of the owner if the patient is an animal), the date, the controlled substance and dose, the quantity dispensed, and the name, address, and DEA number of the prescriber;
(b) A separate file shall be maintained for dispensed substances listed in Schedule II;
(c) Schedule III and IV records may be maintained in a separate file or marked with a red "C" at least one inch high and filed with the prescriptions for noncontrolled drugs. If the pharmacy uses an automated data processing system or electronic record keeping system for prescriptions which permits identification by prescription number and retrieval of original documents by prescriber's name, patient's name, controlled substance dispensed, and date filled, then the requirement to mark the hard copy prescription with a red "C" is waived; and
(4) Distribution of controlled substances to another registrant as provided under subdivision 44:58:02:21(1) shall be as follows:
(a) Distribution of Schedule I and II substances will be verified by the supplier's copy of the official DEA order form; and
(b) Distribution of Schedule III and IV substances will be verified by invoices.
Source: 6 SDR 93, effective July 1, 1980; 11 SDR 36, effective September 11, 1984; 25 SDR 48, effective October 1, 1998.
General Authority:SDCL 34-20B-41.
Law Implemented:SDCL 34-20B-39, 34-20B-40.
44:58:07:05. Theft reports. A registrant shall notify the division of the theft or loss of a controlled substance within 48 hours. The report shall include the names and quantities of drugs and the circumstances involved in the theft or loss.
Source: 11 SDR 36, effective September 11, 1984; 21 SDR 219, effective June 27, 1995.
General Authority:SDCL 34-20B-41.
Law Implemented:SDCL 34-20B-39, 34-20B-40, 34-20B-44, 34-20B-48.
44:58:07:06. Emergency supplies.Repealed.
Source: 25 SDR 48, effective October 1, 1998; repealed, 27 SDR 59, effective December 17, 2000.
44:58:07:07. Limits on Schedule II controlled substances.Repealed.
Source: 25 SDR 48, effective October 1, 1998; repealed, 27 SDR 59, effective December 17, 2000.
44:58:07:08. Limits on Schedule III and IV controlled substances.Repealed.
Source: 25 SDR 48, effective October 1, 1998; repealed, 27 SDR 59, effective December 17, 2000.
44:58:07:09. Emergency supplies of controlled substances in long term care facilities. Emergency supplies of controlled substances may be kept in long term care facilities under the following circumstances:
(1) The pharmacist supplying the controlled substances retains ownership and responsibility for the controlled substances, including a monthly physical inventory;
(2) The controlled substances are stored in a manner that allows only those individuals authorized to administer the controlled substance access to them;
(3) The controlled substances are stored in a sealed emergency box or in a separate locked cabinet, with a complete and accurate record kept of the controlled substances in the box or cabinet and their disposition;
(4) The facility notifies the pharmacist within 36 hours after the withdrawal of a Schedule II controlled substance and within 72 hours after the withdrawal of a Schedule III or IV controlled substance and the pharmacist replaces the controlled substance within 72 hours after notification; and
(5) No more than five different controlled substances are stored in the emergency box, which may contain no more than six doses of any Schedule II controlled substance, no more than six doses of any Schedule III or IV injectable controlled substance, and no more than 12 doses of any oral Schedule III or IV controlled substance.
Source: 25 SDR 48, effective October 1, 1998.
General Authority:SDCL 34-20B-41.
Law Implemented:SDCL 34-20B-41.
