§ 101.4 - Labeling terminology.

§ 101.4 Labeling terminology.

Terms pertaining to identification and packaging of biological products shall mean:

(a) Label. All written, graphic, or printed matter:

(1) Upon or attached to a final container of a biological product;

(2) Appearing upon any immediate carton or box used to package such final container; and

(3) Appearing on any accompanying enclosures (leaflets, inserts, or circulars) on which required information or directions as to the use of the biological product shall be found.

(b) Labeling. All labels and other written, printed, or graphic matter accompanying the final container.

(c) Final container. The unit, bottle, vial, ampule, tube, or other receptacle into which any biological product is filled for distribution and sale.

(d) True name. The name entered on the product license or permit at the time of issuance to differentiate the biological product from others: Provided, That, the principal part of such name shall be emphasized on such license or permit by being more prominently lettered than descriptive terms which may be necessary to complete the differentiation.

(e) Serial number. Numbers or numbers and letters used to identify and distinguish one serial from others.

(f) Expiration date. A date designating the end of the period during which a biological product, when properly stored and handled, can be expected with reasonable certainty, to be efficacious.

(g) Label number. A number assigned by Animal and Plant Health Inspection Service to each label or sketch submitted for review.

(h) Master label. The finished carton, container, or enclosure label for the smallest size final container that is authorized for a biological product, that serves as the Master template label applicable to all other size containers or cartons of the same product that is marketed by a licensee, subsidiary, division, or distributor.

[38 FR 8426, Apr. 2, 1973, as amended at 42 FR 63770, Dec. 20, 1977; 56 FR 66782, Dec. 26, 1991; 61 FR 29464, June 11, 1996]