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Legislation & Regulation

South Dakota Legislation

http://legis.state.sd.us/statutes/index.aspx

36-11-46.   Dispensing of substandard drugs prohibited--Violation as misdemeanor. No person may compound, dispense, sell, or offer for sale, or cause to be compounded, dispensed, sold or offered for sale any medicine or preparation under or by a name recognized in the United States Pharmacopoeia or National Formulary, for internal or external use, which differs from the standard of strength, quality or purity as determined by the test laid down in the United States Pharmacopoeia or National Formulary, official at the time of such compounding, dispensing, sale, or offering for sale. A violation of this section is a Class 2 misdemeanor.
Source: SL 1967, ch 102, § 20 (b); SL 1978, ch 271, § 1; SL 1992, ch 158, § 84

36-11-46.1.   Dispensing equivalent drug products. A pharmacist dispensing a prescription drug order for a drug product prescribed by its brand name may select any equivalent drug product, if the manufacturer or distributor of the equivalent drug product holds, if applicable, either an approved new drug application or an approved abbreviated new drug application, unless other approval by law or from the Federal Food and Drug Administration is required.
Source: SL 1978, ch 271, § 3; SL 1993, ch 277, § 2.

36-11-46.2.   Written prescription to prohibit substitution--Notation by pharmacist. A practitioner may prohibit a pharmacist from selecting an equivalent drug product by handwriting on the prescription drug order the words "brand necessary" or words of similar meaning. The prohibition may not be preprinted or stamped on the prescription drug order. This selection does not preclude a reminder of the procedure required for the practitioner to prohibit selection by a pharmacist from being preprinted on the prescription drug order. If an oral prescription is given to a pharmacist, the practitioner or practitioner's authorized agent shall instruct the pharmacist if selection of an equivalent drug product is prohibited. The pharmacist shall note the instructions on the file copy of the prescription drug order.
Source: SL 1978, ch 271, § 4; SL 1990, ch 306, § 2; SL 1993, ch 277, § 3.

36-11-46.3.   Notification to person receiving equivalent drug product--Right of refusal. The pharmacist or the pharmacist's agent shall inform the person receiving the drug pursuant to the prescription drug order of the selection of an equivalent drug product and of the person's right to refuse the product selected. A pharmacist shall, upon request of the prescribing practitioner, provide information regarding substitutions of equivalent drug products.
Source: SL 1978, ch 271, § 5; SL 1990, ch 306, § 3; SL 1993, ch 277, § 4.

36-11-46.4.   Standards for selecting prescription drug. A pharmacist may not select a product unless it has been manufactured, labeled, or distributed by a manufacturer, labeler, or distributor who:

             (1)      Marks capsules and tablets with an identification code or monogram;
             (2)      Labels products with their expiration date;
             (3)      Provides reasonable services to accept return goods that have                                     reached their expiration date;
             (4)      Maintains reasonable resources for product information;
             (5)      Maintains recall capabilities for unsafe or defective drugs; and
             (6)      Makes available therapeutic equivalency ratings.
Source: SL 1978, ch 271, § 6; SL 1990, ch 306, § 4; SL 1993, ch 277, § 5.

36-11-46.5.   Liability for dispensing substituted drug. A pharmacist who selects an equivalent drug product pursuant to this chapter assumes no greater liability for selecting the dispensed drug than would be incurred in filling a prescription for a drug product prescribed by its established or generic name.
Source: SL 1986, ch 309.

36-11-46.6.   Label to contain drug name--Form when generic equivalent selected--Contents of prescription files--Label information. The pharmacist shall, unless otherwise instructed by the prescriber, label the prescription container with the name of the dispensed drug. If the dispensed drug does not have a brand name, the prescription label shall indicate the generic name or the United States Pharmacopoeia pharmacy equivalent name of the drug dispensed. If a pharmacist selects a generically equivalent drug product for the brand name drug product prescribed, the prescription container label shall identify the generic name and may identify the brand name for which the selection is made. The dual identification allowed under this section shall take the form of the following statement on the prescription container label: "(generic name) Generic for (brand name)". The pharmacy file copy of each prescription shall include the brand name, if any, or the name of the manufacturer, labeler, or distributor of the drug product dispensed. The prescription container label shall include all information required by federal and state law or by rule promulgated by the board pursuant to chapter 1-26.
Source: SL 1990, ch 306, § 5; SL 1993, ch 278, § 6; SL 2001, ch 201, § 1.

36-11-46.7.   Equivalent drug requirements not applicable to hospital patients. The requirements of §§ 36-11-46.1 to 36-11-46.3, inclusive, and § 36-11-46.6 do not apply to an order to dispense a drug to a hospital patient.
Source: SL 1990, ch 306, § 6; SL 1993, ch 277, § 6.

36-11-46.8.   Cause of action for selection of equivalent drug product. The selection of an equivalent drug product does not, in itself, in the absence of willful misconduct or negligence, constitute a cause of action against the practitioner.
Source: SL 1993, ch 277, § 7.

Food & Drug Administration

http://www.fda.gov/

Contacts:
Sioux Falls R.P., 230 South Phillips Ave, Rm. 406, Sioux Falls, SD 57104
Howard A. Burmester, Resident in Charge (RIC), HFR-CE8594, (605) 330-4383 FAX (605) 330-4384

Main Number and Emergency (after hours) Answering Service (612) 334-4100
W. Charles Becoat, District Director, HFR-CE800, (612) 334-4100 FAX (612) 334-4134