PART XVI. LEGEND DRUGS
§1060.11. Definitions
For the purpose of this Part:
(1) "Code imprint" means a series of letters or numbers assigned by the manufacturer or distributor to a specific drug, or marks or monograms unique to the manufacturer, distributor, or both. The National Drug Code may be used as a code imprint.
(2) "Distributor" means any corporation, person, or entity not engaged in the manufacture of a legend drug product, who distributes for resale and distribution a legend drug product under the label of such corporation, person, or entity.
(3) "Legend drug" means any drug or drug product bearing on the label of the manufacturer or distributor, as required by the Federal Food and Drug Administration, the statement "Caution: Federal law prohibits dispensing without prescription."
(4) "Solid dosage forms" means capsules or tablets intended for oral administration.
Added by Acts 1982, No. 872, §1, eff. Jan. 1, 1984; Redesignated from R.S. 40:1237 by HCR 84 of 2015 R.S.
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