Authority: IC 25-26-13-4

Affected: IC 25-26-13-17

Sec. 12. (a) All drugs and devices in pharmacies located within institutions shall be obtained and used in accordance with written policies and procedures that have been prepared or approved by the qualifying pharmacist or pharmacist in charge and the medical staff who explain the:

1. (1) selection;
2. (2) distribution;
3. (3) storage; and

4. (4) safe and effective use of:

   1. (A) drugs;
   2. (B) new drugs;
   3. (C) investigational new drugs; and
   4. (D) devices;
5. in the facility.

(b) The pharmacist in charge of the pharmacy located within an institution shall be responsible for the following:

1. (1) The safe and efficient:

   1. (A) distribution;
   2. (B) control;
   3. (C) storage; and
   4. (D) accountability;
2. for all drugs and devices.
3. (2) The compliance with all applicable Indiana and federal laws and rules.

(c) Labeling requirements are as follows:

1. (1) All drugs, other than unit-of-use packages, dispensed by an institutional pharmacy, intended for use within the facility, shall be distributed in appropriate containers and adequately labeled so as to identify, at a minimum, the following:

   1. (A) Patient identification.
   2. (B) Brand name or generic name, or both.
   3. (C) Strength, if applicable.
   4. (D) Route of administration.
   5. (E) Quantity.
   6. (F) Pharmacist's initials.
   7. (G) Location of the patient within the institution.

2. (2) Unit-of-use packages shall contain information to adequately label them, at a minimum, as follows:

   1. (A) Drug name (brand or generic, or both).
   2. (B) Strength, if applicable.
   3. (C) Control number and/or expiration date.

3. (3) All drugs dispensed by an institutional pharmacy to patients about to be discharged, or temporarily discharged, from institutions with Type III or Type IV permits, shall be labeled with the following minimum information:

   1. (A) Name, address, and telephone number of the institutional pharmacy.
   2. (B) Date and identifying serial number.
   3. (C) Name of patient.
   4. (D) Name of drug and strength, if applicable.
   5. (E) Directions for use by the patient and route of administration.
   6. (F) Name of prescribing practitioner.
   7. (G) Precautionary information if any contained in the prescription.

(d) Requirements for the disposition of discontinued or recalled drugs are as follows:

1. (1) The qualifying pharmacist or pharmacist in charge shall be responsible for the development and implementation of policies and procedures for the return to the pharmacy of drugs and containers that are:

   1. (A) discontinued, outdated, or recalled; or
   2. (B) in containers with worn, illegible, or missing labels;
2. for proper disposition.
3. (2) The qualifying pharmacist or pharmacist in charge or his or her designee shall make proper disposition of such drugs at the storage site.

(e) The qualifying pharmacist or pharmacist in charge shall ensure that drugs are dispensed from the institutional pharmacy only upon authorized practitioner's:

1. (1) written orders;
2. (2) direct copies;
3. (3) facsimiles thereof; or
4. (4) electronically transmitted by other means and printed or displayed appropriately.

(f) Accountability requirements are as follows:

1. (1) The qualifying pharmacist or pharmacist in charge of an institutional pharmacy shall ensure that policies and procedures documenting the trail of:

   1. (A) controlled substances; and
   2. (B) such other drugs as may be specified by the appropriate committee of the institutional facility, from ordering and receiving by the pharmacy through administration or wastage of drug at the patient level.

2. (2) The qualifying pharmacist or pharmacist in charge shall be responsible for review of this process on a continual basis by review of:

   1. (A) proofs-of-use documentation; or
   2. (B) other electronic documentation methodology.

3. (3) At a minimum, the documentation process shall be able to identify the following:

   1. (A) The name of the drug.
   2. (B) The dose.
   3. (C) The patient's name.
   4. (D) The date and time of administration to the patient.
   5. (E) The identification of the individual administering.
   6. (F) The record of aliquot portion destroyed, if any, and identification of witness.

(g) All records and reports that are required for pharmacy functions shall be maintained according to policies and procedures developed within the institution with the approval of the pharmacist in charge for a period of not less than two (2) years.

(Indiana Board of Pharmacy; 856 IAC 1-28.1-12; filed Dec 26, 2001, 2:44 p.m.: 25 IR 1641; 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)