Authority: IC 25-26-13-4

Affected: IC 25-26-13-18

Sec. 13. (a) Each sterile pharmaceutical product dispensed to a patient shall be labeled with the following:

1. (1) Date of preparation by the pharmacy.
2. (2) Patient name and bed number, if an institutionalized patient.
3. (3) Name of each drug in the preparation, strength, and amount.
4. (4) Expiration date of the preparation, including time, if applicable.
5. (5) Identity of the pharmacist compounding and dispensing the sterile pharmaceutical, and identity of other authorized personnel preparing the product, if applicable.
6. (6) Other information required by the dispensing pharmacy regarding storage requirements or special warnings.

(b) In addition, if the patient residing at home or outside the facility where the sterile pharmaceutical is prepared, the following labeling requirements apply:

1. (1) Identifying prescription number.
2. (2) Prescriber's full name.
3. (3) Name, address, and telephone number of the licensed pharmacy.
4. (4) Directions for use shall be provided, either on the label or by other written instructions, including infusion rate and date and time of administration.

(Indiana Board of Pharmacy; 856 IAC 1-30-13; filed Jan 28, 1992, 5:00 p.m.: 15 IR 1020, eff Jan 1, 1992 [IC 4-22-2- 36 suspends the effectiveness of a rule document for thirty (30) days after filing with the secretary of state. LSA Document #91-6 was filed Jan 28, 1992.]; errata filed Mar 17, 1992, 10:20 a.m.: 15 IR 1394; readopted filed Dec 2, 2001, 12:35 p.m.: 25 IR 1337; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR- 856230795RFA)