(packaging) The material, both physical and informational, that contains or accompanies a marketed or investigational therapeutic agent once it is fully prepared for release to patients and/or subjects in clinical trials.

(drug package) The drug product container with any accompanying materials or components. This may include the protective packaging, labeling, administration devices, etc.

Containers, packaging, and packaging materials for drugs and BIOLOGICAL PRODUCTS. These include those in ampule, capsule, tablet, solution or other forms. Packaging includes immediate-containers, secondary-containers, and cartons. In the United States, such packaging is controlled under the Federal Food, Drug, and Cosmetic Act which also stipulates requirements for tamper-resistance and child-resistance. Similar laws govern use elsewhere. (From Code of Federal Regulations, 21 CFR 1 Section 210, 1993) DRUG LABELING is also available.