Source: https://www.ecfr.gov/cgi-bin/text-idx?mc=true&node=se21.4.201_156&rgn=div8
Timestamp: 2019-11-15 01:06:42
Document Index: 737845367

Matched Legal Cases: ['art 201', '§201', '§201', '§201', '§314', '§201', '§201', '§201', '§201', '§201', '§201', '§201', '§201', '§201', '§201', '§201', '§201', '§201', '§201', '§201']

Title 21 → Chapter I → Subchapter C → Part 201 → Subpart B → §201.56
§201.56 Requirements on content and format of labeling for human prescription drug and biological products.
(a) General requirements. Prescription drug labeling described in §201.100(d) must meet the following general requirements:
(2) The labeling must be informative and accurate and neither promotional in tone nor false or misleading in any particular. In accordance with §§314.70 and 601.12 of this chapter, the labeling must be updated when new information becomes available that causes the labeling to become inaccurate, false, or misleading.
(b) Categories of prescription drugs subject to the labeling content and format requirements in §§201.56(d) and 201.57. (1) The following categories of prescription drug products are subject to the labeling requirements in paragraph (d) of this section and §201.57 in accordance with the implementation schedule in paragraph (c) of this section:
(2) Prescription drug products not described in paragraph (b)(1) of this section are subject to the labeling requirements in paragraph (e) of this section and §201.80.
(c) Schedule for implementing the labeling content and format requirements in §§201.56(d) and 201.57. For products described in paragraph (b)(1) of this section, labeling conforming to the requirements in paragraph (d) of this section and §201.57 must be submitted according to the following schedule:
(1) Prescription drug labeling described in §201.100(d) must contain the specific information required under §201.57(a), (b), and (c) under the following headings and subheadings and in the following order:
(2) Additional nonstandard subheadings that are used to enhance labeling organization, presentation, or ease of use (e.g., for individual warnings or precautions, or for each drug interaction) must be assigned a decimal number that corresponds to their placement in labeling. The decimal numbers must be consistent with the standardized identifying numbers listed in paragraph (d)(1) of this section (e.g., subheadings added to the “Warnings and Precautions” section must be numbered 5.1, 5.2, and so on).
(5) Any risk information that is required under §201.57(c)(9)(iv) is considered “appropriate pediatric contraindications, warnings, or precautions” within the meaning of section 505A(l)(2) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355A(l)(2)), whether such information appears in the “Contraindications,” “Warnings and Precautions,” or “Use in Specific Populations” section of labeling.
(1) Prescription drug labeling described in §201.100(d) must contain the specific information required under §201.80 under the following section headings and in the following order:
(2) The labeling may contain the following additional section headings if appropriate and if in compliance with §201.80(l) and (m):
(4) The labeling may contain a “Product Title” section preceding the “Description” section and containing only the information required by §201.80(a)(1)(i), (a)(1)(ii), (a)(1)(iii), and (a)(1)(iv) and §201.100(e). The information required by §201.80(a)(1)(i) through (a)(1)(iv) must appear in the “Description” section of the labeling, whether or not it also appears in a “Product Title.”
(6) The requirement in §201.80(f)(2) to reprint any FDA-approved patient labeling at the end of prescription drug labeling or accompany the prescription drug labeling must be implemented no later than June 30, 2007.