Do. Do.

1 year from date of collection of source blood (-18 °C or colder).

(a) 26 days from date of collection of source blood (between 1 and 6 °C). (b) 40 days from date of collection of source blood only when CPDA-1 solution is used as the anticoagulant (between 1 and 6 °C).

5 years from date of collection of source blood (-18 °C or colder).

72 hours from time of collection of source blood, provided labeling recommends storage (20 to 24 °C or between 1 and 6 °C). 5 days if certain approved containers are used (20 to 24 °C).

In lieu of expiration date, the collection date shall appear on the label.

10 years (at the recommended storage temperature stated on the label). 10 years.

(a) 5 years.

(b) 3 years provided labeling recommends storage at room temperature, no warmer than 30 °C).

72 hours from time of collection of source blood, provided labeling recommends storage at 20 to 24 °C or between 1 and 6 °C. 5 days if certain approved containers are used (20 to 24 °C).

Not applicable.

2 years (from date of manufacture). 1 year.

1 year, provided labeling recommends

storage at a temperature which will maintain ice continuously in a solid

state.

Dating period after leaving manufacturer's storage when stored at 2 to 8 °C (unless otherwise stated)

D

30 days, provided labeling recommends storage between 2 and 8 °C and container has been unopened.

1 year, provided labeling recommends storage at a temperature which will maintain ice continuously in a solid state.

30 days, provided labeling recommends storage between 2 and 8 °C and container has been unopened.

1 year, provided labeling recommends storage at a temperature which will maintain ice continuously in a solid state.

30 days, provided labeling recommends storage between 2 and 8 °C and container has been unopened.

1 year, provided labeling recommends storage at a temperature which will maintain ice continuously in a solid state.

30 days, provided labeling recommends storage between 2 and 8 °C and container has been unopened.

18 months.

Do.

Do.

6 months.

Thirty-five days from earliest date of collection if kept in liquid form (indefinite storage of reagent red blood cell source material at 65 °C or colder). (a) 21 days from date of collection of source blood, provided labeling recommends storage between 1 and 6 °C and the hermetic seal is not broken during processing.

(b) 24 hours after plasma removal, provided labeling recommends storage between 1 and 6 °C and the hermetic seal is broken during processing. (a) 21 days from date of collection of source blood, provided labeling recommends storage between 1 and 6 °C and the hermetic seal is not broken during processing.

(b) 24 hours after plasma removal, provided labeling recommends storage between 1 and 6 °C and the hermetic seal is broken during processing. (a) 35 days from date of collection of source blood, provided labeling recommends storage between 1 and 6 °C and the hermetic seal is not broken during processing.

(b) 24 hours after plasma removal, provided labeling recommends storage between 1 and 6 °C and the hermetic seal is broken during processing.

(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: "Caution: Federal law prohibits dispensing without prescription," for prescription biologi

cals.

(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]

(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;

(1) 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;

(0) 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: "Caution: Federal law prohibits dispensing without prescription," for prescription biologicals. [38 FR 32056, Nov. 20, 1973, as amended at 47 FR 22518, May 25, 1982; 55 FR 10423, Mar. 21, 1990]

§ 610.62 Proper name; package label; legible type.

(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.

§ 610.63 Divided manufacturing responsibility to be shown.

If two or more establishments participate in the manufacture of a 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.

§ 610.64 Name of selling agent or distributor.

The name and address of the selling agent or distributor of a product may appear on the label under the designation of "selling agent" or "distributor" provided that the name and address of the manufacturer is given precedence in prominence.