21 CFR 610.60 - Container 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.
(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.
Title 21 published on 2015-04-01
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 610 after this date.
- 21 CFR 201.57 — Specific Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products Described in § 201.56(b)(1).
- 21 CFR 660.2 — General Requirements.
- 21 CFR 660.55 — Labeling.
- 21 CFR 640.84 — Labeling.
- 21 CFR 640.94 — Labeling.
- 21 CFR 660.45 — Labeling.
- 21 CFR 601.22 — Products in Short Supply; Initial Manufacturing at Other Than Licensed Location.