---
kind: "section"
citation: "9 C.F.R. § 101.4"
title: "9"
number: "101.4"
heading: "Labeling terminology."
url: "https://uscodex.org/cfr/9/101.4"
---

# §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.

## Notes

### Amendments

[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]

### Authority

Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.

### Source

Source: 38 FR 8426, Apr. 2, 1973, unless otherwise noted.

### Amendments

[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]