Authority: IC 16-21-1-7; IC 16-21-2-2.5

Affected: IC 16-21-1

Sec. 1. The center must provide drugs and biologicals in a safe and effective manner, in accordance with accepted professional practice, and under the direction of an individual designated responsible for pharmaceutical services. Pharmaceutical services must have the following:

1. (1) A:

   1. (A) designated professional person with prescriptive authority; or
   2. (B) pharmacist;
2. who is responsible for the control of drug stocks in the center.
3. (2) Records of stock supplies of all scheduled substances, including an accounting for all items purchased and dispensed.

4. (3) Written policies and procedures developed, implemented, maintained, and made available to personnel, including, but not limited to, the following:

   1. (A) Drug:

      1. (i) handling;
      2. (ii) storing;
      3. (iii) labeling;
      4. (iv) dispensing; and
      5. (v) administration according to established center policies and acceptable standards of practice.

   2. (B) Reporting of adverse reactions and medication errors to the:

      1. (i) licensed health professional responsible for the patient; and
      2. (ii) appropriate committee;
   3. and documented in the patient's record.

   4. (C) Drugs must be accurately and clearly labeled and stored in specially designated, well-illuminated cabinets, closets, or storerooms and the following:

      1. (i) Drug cabinets must be accessible only to authorized personnel.
      2. (ii) Drug cabinets for storage of controlled drugs listed in Schedule II of the Comprehensive Drug Abuse Prevention and Control Act of 1976 and other drugs subject to abuse must be permanently affixed compartments that are separately locked.
      3. (iii) Drug carts with controlled drugs as designated in item (ii) must be securely affixed when not in use.

   5. (D) Instructions to the patient on the use of take-home medication is the responsibility of the:

      1. (i) prescribing physician; or
      2. (ii) certified nurse midwife.
5. (4) A formulary.
6. (5) A list of available emergency drugs.

(Indiana Department of Health; 410 IAC 27-16-1; filed Feb 3, 2006, 2:00 p.m.: 29 IR 1919; readopted filed Jul 12, 2012, 12:09 p.m.: 20120808-IR-410120265RFA; readopted filed Sep 26, 2018, 2:48 p.m.: 20181024-IR-410180328RFA; readopted filed Nov 14, 2024, 1:24 p.m.: 20241211-IR-410230798RFA)