856 IAC 1-21-1 - Resale of returned substances

Authority: IC 25-26-13-4

Affected: IC 25-26-13-25

Sec. 1.

(a) This section implements and interprets IC 25-26-13-25 (h) concerning the resale or redistribution of medications.

(b) For a medication to have been properly stored and securely maintained according to sound pharmacy practices, the storage and administration of medications in the institutional facility must be under the immediate control of licensed nursing personnel.

(c) If the medication was originally packaged by the dispensing pharmacy, it cannot be resold or redistributed unless:

(1) the medication has been repackaged into unit-dose packaging using packaging materials that meets Class A or Class B standards, found in the United States Pharmacopeia (U.S.P.), page 1574, published by the United States Pharmacopeia, 22nd Revision, January 1, 1990, United States Pharmacopeia Convention, Inc., 12601 Twinbrook Parkway, Rockville, Maryland 20852, which standards are incorporated herein by reference; and

(2) the repackaging process complies with the standards as found in the "Proper Treatment of Products Subjected to Additional Manipulations, Section 1191" of the United States Pharmacopeia, page 1705, 22nd Revision, 1990, which section is incorporated herein by reference.

(d) A medication repackaged under the provisions of subsection (c) shall be labeled with an expiration date of not greater than one (1) year until the manufacturer's expiration date, whichever is earlier.

Notes

856 IAC 1-21-1

Indiana Board of Pharmacy; Reg 21, Sec 1; filed Jun 18, 1962, 10:00 a.m.: Rules and Regs. 1963, p. 128; filed Mar 31, 1992, 5:00 p.m.: 15 IR 1391; readopted filed Dec 2, 2001, 12:35 p.m.: 25 IR 1334; readopted filed Sep 26, 2008, 10:55 a.m.: 20081015-IR-856080346RFA Readopted filed 12/1/2014, 8:33 a.m.: 20141231-IR-856140392RFA Readopted filed 10/6/2020, 12:03 p.m.: 20201104-IR-856200443RFA Readopted filed 2/15/2024, 1:16 p.m.: 20240313-IR-856230795RFA