Authority: IC 25-26-13-4

Affected: IC 25-26-13-17; IC 35-38

Sec. 9. (a) Emergency drug kits supplied by pharmacies with a Type III or Type VI permit shall be in compliance with this section.

(b) All drugs in the emergency kit shall be provided and owned by a single supplying pharmacy.

(c) All drugs in the emergency drug kit shall be selected and approved by a committee whose membership includes, at a minimum, the following:

1. (1) The facility's consultant pharmacist.
2. (2) A licensed nurse.
3. (3) A physician (medical doctor or doctor of osteopathy).
4. (4) The facility administrator.

(d) The selection process must identify drugs and quantities thereof in the emergency drug kit.

(e) The lists of drugs and quantities included in the emergency drug kit shall be reviewed as required periodically, but no less often than yearly.

(f) Labeling as follows:

1. (1) The exterior labeling of the emergency drug kit as described in this subsection shall contain, at a minimum, the following:

   1. (A) Drug name (trade name, generic name, or active ingredients).
   2. (B) Drug strength or size, if any.
   3. (C) Quantity included therein.
   4. (D) Expiration date of the kit as defined in this section.

2. (2) All drugs contained in the emergency drug kit as described in this section shall be labeled, at a minimum, with the following:

   1. (A) Drug name (trade name, generic name, or active ingredients).
   2. (B) Drug strength or size, if applicable.
   3. (C) Name of the manufacturer, packer, or distributor.
   4. (D) Lot number.
   5. (E) Expiration date.

(g) The expiration date of the emergency drug kit, as required in subsection (f)(1)(D) shall be the earliest date of expiration of any of the drugs included in the kit at any time.

(h) All emergency kits subject to this subsection:

1. (1) shall be stored in a secure area, suitable for the prevention of unauthorized access to or diversion of the drugs therein;
2. (2) if controlled substances, as defined in IC 35-38, are stored in such a manner as to facilitate periodic reconciliation by the facility nursing staff, that reconciliation shall be recorded in an appropriate manner as determined by the committee described under this section; and
3. (3) all controlled substances contained in emergency drug kits shall remain the property of the supplying pharmacy and as such shall be included in the pharmacy's biennial inventory as required by 21 CFR 1303.04 and 21 CFR 1301.11.

(i) The nurse responsible for removing drugs from an emergency drug kit shall record or cause to be recorded, in a manner designated under subsection (h)(2), the following minimum information:

1. (1) Name of the patient.
2. (2) Name of the drug.
3. (3) Strength of the drug.
4. (4) Quantity removed.
5. (5) Date of removal.
6. (6) Time of removal.

(j) Removal of a controlled substance in Schedule II pursuant to an oral authorization from a practitioner shall be documented, and the nurse accepting such authorization is responsible for compliance with 856 IAC 2-6-7 regarding prescription requirements for controlled substances in Schedule II.

(k) Removal of a controlled substance in Schedule III, IV, or V, pursuant to an oral authorization from a practitioner, shall be documented, and the nurse accepting such authorization is responsible for compliance with 856 IAC 2-6-12.

(l) Whenever an emergency kit is opened, for any reason, the supplying pharmacy shall be notified in a timely manner, and the pharmacy shall restock, if necessary, and reseal the kit promptly so as to prevent risk of harm to patients of the facility.

(Indiana Board of Pharmacy; 856 IAC 1-28.1-9; filed Dec 26, 2001, 2:44 p.m.: 25 IR 1639; readopted filed Sep 26, 2008, 10:55 a.m.: 20081015- IR-856080346RFA; readopted filed Dec 1, 2014, 8:33 a.m.: 20141231-IR-856140392RFA; readopted filed Oct 6, 2020, 12:03 p.m.: 20201104-IR-856200443RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)