Authority: IC 25-26-13-4

Affected: IC 25-26-13-18

Sec. 7. Each pharmacy preparing and dispensing, or holding itself out to prepare or dispense, sterile pharmaceuticals shall maintain a policy and procedure manual relating to the compounding, dispensing, delivery, administration, storage, and use of sterile pharmaceutical products, pursuant to prescriptions or drug orders, or both, as part of the pharmacy policy and procedure manual or as a separate policy and procedure manual. This manual shall be available at the pharmacy for inspection by the board or its designated inspector. The manual shall be reviewed annually by the pharmacist-in-charge or the qualifying pharmacist and revised if needed. The manual shall include the name of the pharmacist-in-charge of the preparation of sterile pharmaceuticals and policies and procedures for the following:

1. (1) Clinical services provided.
2. (2) The handling, storage, disposal, and cleanup of accidental spills of hazardous drugs, if they are prepared.
3. (3) Disposal of unused supplies and drugs.
4. (4) Drug destruction and returns.
5. (5) Drug dispensing.
6. (6) Drug labeling and relabeling.
7. (7) Drug storage.
8. (8) Duties and qualifications for professional and nonprofessional staff.
9. (9) Equipment.
10. (10) Handling of infectious wastes, if drug products or administration devices are returned to the pharmacy after administration in the case of home administration.
11. (11) Infusion devices and drug delivery systems, if utilized.
12. (12) Investigational drugs, if dispensed.

13. (13) Quality assurance procedures to include the following:

    1. (A) Recall procedures.
    2. (B) Storage and expiration dating.
    3. (C) Educational procedures for professional staff, nonprofessional staff, and the patient, if needed, in the case of home administration.
    4. (D) Sterile procedures to include monitoring the temperature of the refrigerator, routine maintenance, and report of hood certification.
    5. (E) Sterility testing or monitoring, if employed, in the case of routine bulk compounding from nonsterile chemicals.
14. (14) Reference manuals.
15. (15) Sterile product preparation procedures.

(Indiana Board of Pharmacy; 856 IAC 1-30-7; filed Jan 28, 1992, 5:00 p.m.: 15 IR 1018, 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.]; readopted filed Nov 13, 2001, 3:55 p.m.: 25 IR 1330; filed Apr 6, 2005, 4:00 p.m.: 28 IR 2386; 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)