S.D. Admin. R. 20:51:21:01.01

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

Section 20:51:21:01.01 - Prepackaging and repackaging

In a pharmacy, prepackaging and repackaging may be done only by a pharmacist. An intern or a technician may perform prepackaging and repackaging under the direct supervision of a pharmacist. All packaged drugs may be dispensed or distributed only from the premises where the drugs are prepackaged or repackaged. Such drugs may only be distributed to a location that is under the same ownership as, or is affiliated with, the premises where drugs are prepackaged or repackaged. Any container used for prepackaging or repackaging must meet United States Pharmacopeia compendium requirements. A drug's packaging must meet the requirements of § 20:51:13:02.01 for the drug to be returned for credit or redispensing.

For purposes of this section:

(1) "Prepackaged," means to prepare a drug in a container for dispensing, prior to the receipt of an order. The packaging may be in a unit dose, single dose, or unit of issue package for use in a unit dose dispensing system, in a container suitable for a traditional dispensing system, or in a customized patient drug package; and

(2) "Repackaged," means to prepare a unit dose, single dose, unit of issue package, customized patient drug package, or traditional dispensing system package for dispensing pursuant to an existing order.

S.D. Admin. R. 20:51:21:01.01

29 SDR 37, effective 9/26/2002; 50 SDR 138, effective 6/2/2024

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

Law Implemented: SDCL 36-11-2.2.