21 CFR 610.61 - Package label.
(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.
Title 21 published on 2015-12-03
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 660.28 — Labeling.
- 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 610.68 — Exceptions or Alternatives to Labeling Requirements for Biological Products Held by the Strategic National Stockpile.
- 21 CFR 660.55 — Labeling.
- 21 CFR 640.84 — Labeling.
- 21 CFR 640.94 — Labeling.
- 21 CFR 660.45 — Labeling.