Iowa Administrative Code › Agency 657 - Pharmacy Board › Chapter 10 - Controlled Substances › Rule 657-10.18 - Schedule Ii Perpetual Inventory

Current through Register Vol. 47, No. 3, July 24, 2024
Each registrant located in Iowa that maintains Schedule II
				controlled substances shall maintain a perpetual inventory system for all
				Schedule II controlled substances pursuant to this rule. All records relating
				to the perpetual inventory shall be maintained at the registered location and
				shall be available for inspection and copying by the board or its
				representative for a period of two years from the date of the record. The
				perpetual inventory shall accurately reflect the on-hand inventory of Schedule
				II substances, and the registrant is responsible for ensuring that the
				perpetual inventory record is accurate and matches the actual on-hand inventory
				at all times.
(1)
Record
			 format.
The perpetual inventory record may be maintained in a manual
			 or an electronic record format. Any electronic record shall provide for
			 hard-copy printout of all transactions recorded in the perpetual inventory
			 record for any specified period of time and shall state the current inventory
			 quantities of each drug at the time the record is printed.
(2)
Information included.
The perpetual inventory record shall identify all receipts for and
			 disbursements of Schedule II controlled substances by drug or by national drug
			 code (NDC) number. The record shall be updated to identify each receipt,
			 disbursement, and current balance of each individual drug or NDC number. The
			 record shall also include incident reports and reconciliation records pursuant
			 to subrules 10.18(3) and 10.18(4).
(3)
Changes to a record.
If
			 a perpetual inventory record is able to be changed, the individual making a
			 change to the record shall complete an incident report documenting the change.
			 The incident report shall identify the specific information that was changed
			 including the information before and after the change, shall identify the
			 individual making the change, and shall include the date and the reason the
			 record was changed. If the electronic record system documents within the
			 perpetual inventory record all of the information that must be included in an
			 incident report, a separate report is not required.
(4)
Reconciliation.
The
			 registrant shall be responsible for reconciling or ensuring the completion of a
			 reconciliation of the perpetual inventory balance with the physical inventory
			 of all Schedule II controlled substances at least annually. Any discrepancies
			 discovered during reconciliation shall be investigated and reported to the
			 pharmacist in charge or responsible individual immediately but no later than
			 one business day following the discovery. The registrant shall determine the
			 need for further investigation, and significant losses shall be reported to the
			 board pursuant to rule
			 657-10.21 (124) and to the DEA
			 pursuant to federal DEA regulations. Periodic reconciliation records shall be
			 maintained and available for review and copying by the board or its authorized
			 agents for a period of two years from the date of the record. The
			 reconciliation process shall be completed using the following procedures or a
			 combination thereof:
a. The individual
			 responsible for a disbursement shall verify that the physical inventory matches
			 the perpetual inventory following each transaction and documents that
			 reconciliation in the perpetual inventory record. If controlled substances are
			 maintained on the patient care unit, the nurse or other responsible licensed
			 health care provider verifies that the physical inventory matches the perpetual
			 inventory following each dispensing and documents that reconciliation in the
			 perpetual inventory record. If any Schedule II controlled substances in the
			 registrant's current inventory have been disbursed and verified in this manner
			 within the year and there are no discrepancies noted, no additional
			 reconciliation action is required. A perpetual inventory record for a drug that
			 has had no activity within the year shall be reconciled pursuant to paragraph
			 10.18(4)
"b."
b. A
			 physical count of each Schedule II controlled substance stocked by the
			 registrant that has not been reconciled pursuant to paragraph
			 10.18(4)
"a"
shall be completed at least once each year, and
			 that count shall be reconciled with the perpetual inventory record balance. The
			 physical count and reconciliation may be completed over a period of time not to
			 exceed one year in a manner that ensures that the perpetual inventory and the
			 physical inventory of Schedule II controlled substances are annually
			 reconciled. The individual performing the reconciliation shall record the date,
			 the time, the individual's initials or unique identification, and any
			 discrepancies between the physical inventory and the perpetual
			 inventory.