21 C.F.R. Subpart G—Labeling Standards
Title 21 - Food and Drugs
(a) Full label. The following items shall appear on the label affixed to each container of a product capable of bearing a full label: (1) The proper name of the product; (2) The name, address, and license number of manufacturer; (3) The lot number or other lot identification; (4) The expiration date; (5) The recommended individual dose, for multiple dose containers. (6) The statement: “‘Rx only’” for prescription biologicals. (7) If a Medication Guide is required under part 208 of this chapter, the statement required under §208.24(d) of this chapter instructing the authorized dispenser to provide a Medication Guide to each patient to whom the drug is dispensed and stating how the Medication Guide is provided, except where the container label is too small, the required statement may be placed on the package label. (b) Package label information. If the container is not enclosed in a package, all the items required for a package label shall appear on the container label. (c) Partial label. If the container is capable of bearing only a partial label, the container shall show as a minimum the name (expressed either as the proper or common name), the lot number or other lot identification and the name of the manufacturer; in addition, for multiple dose containers, the recommended individual dose. Containers bearing partial labels shall be placed in a package which bears all the items required for a package label. (d) No container label. If the container is incapable of bearing any label, the items required for a container label may be omitted, provided the container is placed in a package which bears all the items required for a package label. (e) Visual inspection. When the label has been affixed to the container a sufficient area of the container shall remain uncovered for its full length or circumference to permit inspection of the contents. [38 FR 32056, Nov. 20, 1973, as amended at 47 FR 22518, May 25, 1982; 63 FR 66400, Dec. 1, 1998; 67 FR 4907, Feb. 1, 2002] The following items shall appear on the label affixed to each package containing a product: (a) The proper name of the product; (b) The name, address, and license number of manufacturer; (c) The lot number or other lot identification; (d) The expiration date; (e) The preservative used and its concentration, or if no preservative is used and the absence of a preservative is a safety factor, the words “no preservative”; (f) The number of containers, if more than one; (g) The amount of product in the container expressed as (1) the number of doses, (2) volume, (3) units of potency, (4) weight, (5) equivalent volume (for dried product to be reconstituted), or (6) such combination of the foregoing as needed for an accurate description of the contents, whichever is applicable; (h) The recommended storage temperature; (i) The words “Shake Well”, “Do not Freeze” or the equivalent, as well as other instructions, when indicated by the character of the product; (j) The recommended individual dose if the enclosed container(s) is a multiple-dose container; (k) The route of administration recommended, or reference to such directions in an enclosed circular; (l) Known sensitizing substances, or reference to an enclosed circular containing appropriate information; (m) The type and calculated amount of antibiotics added during manufacture; (n) The inactive ingredients when a safety factor, or reference to an enclosed circular containing appropriate information; (o) The adjuvant, if present; (p) The source of the product when a factor in safe administration; (q) The identity of each microorganism used in manufacture, and, where applicable, the production medium and the method of inactivation, or reference to an enclosed circular containing appropriate information; (r) Minimum potency of product expressed in terms of official standard of potency or, if potency is a factor and no U.S. standard of potency has been prescribed, the words “No U.S. standard of potency.” (s) The statement: “‘Rx only’” for prescription biologicals. [38 FR 32056, Nov. 20, 1973, as amended at 47 FR 22518, May 25, 1982; 55 FR 10423, Mar. 21, 1990; 67 FR 4907, Feb. 1, 2002] (a) Position. The proper name of the product on the package label shall be placed above any trademark or trade name identifying the product and symmetrically arranged with respect to other printing on the label. (b) Prominence. The point size and typeface of the proper name shall be at least as prominent as the point size and typeface used in designating the trademark and trade name. The contrast in color value between the proper name and the background shall be at least as great as the color value between the trademark and trade name and the background. Typography, layout, contrast, and other printing features shall not be used in a manner that will affect adversely the prominence of the proper name. (c) Legible type. All items required to be on the container label and package label shall be in legible type. “Legible type” is type of a size and character which can be read with ease when held in a good light and with normal vision. If two or more licensed manufacturers participate in the manufacture of a biological product, the name, address, and license number of each must appear on the package label, and on the label of the container if capable of bearing a full label. [64 FR 56453, Oct. 20, 1999] The name and address of the distributor of a product may appear on the label provided that the name, address, and license number of the manufacturer also appears on the label and the name of the distributor is qualified by one of the following phrases: “Manufactured for _____”, “Distributed by ______”, “Manufactured by _____ for _____”, “Manufactured for _____ by ____”, “Distributor: _____”, or “Marketed by _____”. The qualifying phrases may be abbreviated. [61 FR 57330, Nov. 6, 1996] Labels on packages or containers of products for export may be adapted to meet specific requirements of the regulations of the country to which the product is to be exported provided that in all such cases the minimum label requirements prescribed in §610.60 are observed. Biological products must comply with the bar code requirements at §201.25 of this chapter. However, the bar code requirements do not apply to devices regulated by the Center for Biologics Evaluation and Research or to blood and blood components intended for transfusion. For blood and blood components intended for transfusion, the requirements at §606.121(c)(13) of this chapter apply instead. [69 FR 9171, Feb. 26, 2004]
Title 21: Food and Drugs
PART 610—GENERAL BIOLOGICAL PRODUCTS STANDARDS
Subpart G—Labeling Standards
§ 610.60 Container label.
§ 610.61 Package label.
§ 610.62 Proper name; package label; legible type.
§ 610.63 Divided manufacturing responsibility to be shown.
§ 610.64 Name and address of distributor.
§ 610.65 Products for export.
§ 610.67 Bar code label requirements.
