S.D. Admin. R. 20:51:13:02.01

Current through Register Vol. 51, page 67, December 16, 2024

Section 20:51:13:02.01 - Return of unused unit dose and unit of issue drugs by patients in hospice programs, nursing facilities, or assisted living facilities

Only unused unit dose or unit of issue drugs from patients in a hospice program, a nursing facility, or an assisted living facility may be returned to the pharmacy that dispensed the drugs for credit and redispensing in accordance with the following requirements:

(1) The facility or hospice program consults with a licensed pharmacist for oversight of the drug distribution to ensure that a person trained and knowledgeable in the storage, use, and administration of the drug has been in control of any drug being returned to the pharmacy and that the unit dose or unit of issue drug has not come into the physical possession of the person for whom it was prescribed;

(2) The pharmacy's manager has received written approval from the board of a protocol detailing the procedure used to repackage, label, transfer, restock, redispense, and credit any unit dose or unit of issue drugs returned to the pharmacy;

(3) The drugs are provided in the manufacturer's unit dose packaging or are repackaged by the pharmacy in accordance with chapter 20:51;21;

(4) The unit dose package is labeled by the manufacturer with the drug lot number and expiration date;

(5) If the drug is repackaged by the pharmacy, each single unit dose or each unit of issue prepackaged or repackaged container must include:

(a) The name and strength of the medication;

(b) A suitable expiration date, not later than the expiration date on the manufacturer's container or one year from the date the drug is prepackaged or repackaged;

(c) The date the product was prepackaged or repackaged;

(d) The manufacturer's lot number, expiration date, and identity un;ess maintained in the internal records of the pharmacy; and

(e) The identity of the pharmacist responsible for prepackaging or repackaging unless maintained in the internal records of the pharmacy;

(6) The drug's packaging is tamper resistant and shows no evidence of contamination, such as an opened or stained container;

(7) The unit dose drugs have not reached the expiration date;

(8) The drugs have not been dispensed in packaging that intermingles different drugs in a single compartment; and

(9) The drugs are not controlled drugs.

Unused unit dose drugs that are returned under this section may be redispensed pursuant to § 20:51:13:02.03.

S.D. Admin. R. 20:51:13:02.01

10 SDR 38, effective 10/27/1983; 12 SDR 82, effective 11/19/1985; 12 SDR 151, 12 SDR 155, effective 7/1/1986; 18 SDR 95, effective 11/25/1991; 29 SDR 37, effective 9/26/2002; SL 2004, ch 249, §3, effective 7/1/2004; 50 SDR 138, effective 6/2/2024

General Authority: SDCL 36-11-11(1).

Law Implemented: SDCL 34-20H-2, 36-11-46.6.

Unit dose systems, chapter 20:51:21.