Oral solids labelling

Immediate release solid oral dosage forms are classified as either having rapid or slow dissolution rates. Immediate release dosage forms are those for which >85% of the labeled amount dissolves within 30 min. Dissolution testing must be performed with US Pharmacopeia (USP) Apparatus I at 100 rpm (or Apparatus II at 50 rpm) in a volume of <900 ml of each of the following (i) 0.1 N hydrochloric acid or simulated gastric fluid USP without enzymes (ii) a pH 4.5 buffer and... 

The USP requires that pharmacists apply, for articles requiring constitution before use, a suitable BUD for the constituted product as identified in the labeling by the manufacturer. For solid oral dosage forms in multiple- and single-unit containers, the BUD is one year or the manufacturer s expiration date, whichever is earlier. 

Rapidly dissolving products An immediate-release solid oral drug product is considered rapidly dissolving when not less than 80% of the label amount of the drug substance dissolves within 15 minutes in each of the following media (1) pH 1.2, (2) pH 4.0, and (3) pH 6.8. 

For all other dosage forms (e.g., solid oral dosage forms, dry powders, aqueous liquid, semisolid, and suspension dosage forms) that have been demonstrated to be stable at the ICH-recommended conditions (25° 2°C/60% RH 5%, or 30°C/60% RH 5%) or at non-ICH conditions, such as 30°, 25°-30°, or 25°C without humidity controls and intended to be stored at room temperature, the recommended labeling statement is... 

Butler, A. M., and Cushman, M., Distribution of ascorbic acid in the blood and its nutritional significance. J. Clin. Invest. 19, 459-467 (1940). Butterworth, C. E., Jr., Baugh, C. M., and Krumdieck, C., A study of folate absorption and metabolism in man utilizing carbon-14 labeled polyglutamates synthesized by the solid phase method. J. Clin. Invest. 48, 1131-1142 (1969). Carter, D. E., Goldman, J. M., Bressler, R., Huxtable, R. J., Christian, C. D., and Heine, M. W., Effect of oral contraceptives on drug metabolism. Clin. Pharmacol. Ther. 15,22-31 (1974). 

Pharmacists dispensing solid oral medication may use their discretion as to the beyond use dating for the product. It cannot exceed the expiration date stated on the manufacturer s label. There is no Federal requirement that expiration dates be included on the prescription label prior to dispensing to the consumer. The FDA does require beyond use dating for drug products dispensed to patients in long-term care facilities. 

Containers of solid oral dosage forms should be provided with a label. When the preparation has a primary and a secondary container, both containers should be labelled. The label should meet the requirements described in Sect 37.3. 

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