The information on this page is current as of Mar 22, 2024.
For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).
| [Code of Federal Regulations] |
| [Title 21, Volume 5] |
| [CITE: 21CFR312.6] |
| TITLE 21--FOOD AND DRUGS |
| CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES |
| SUBCHAPTER D - DRUGS FOR HUMAN USE |
Subpart A - General Provisions
| Sec. 312.6 Labeling of an investigational new drug. |
(a) The immediate package of an investigational new drug intended for human use shall bear a label with the statement "Caution: New Drug - Limited by Federal (or United States) law to investigational use."
(b) The label or labeling of an investigational new drug shall not bear any statement that is false or misleading in any particular and shall not represent that the investigational new drug is safe or effective for the purposes for which it is being investigated.
(c) The appropriate FDA Center Director, according to the procedures set forth in §§ 201.26 or 610.68 of this chapter, may grant an exception or alternative to the provision in paragraph (a) of this section, to the extent that this provision is not explicitly required by statute, for specified lots, batches, or other units of a human drug product that is or will be included in the Strategic National Stockpile.
This website has been translated to Spanish from English, and is updated often. It is possible that some links will connect you to content only available in English or some of the words on the page will appear in English until translation has been completed (usually within 24 hours). We appreciate your patience with the translation process. In the case of any discrepancy in meaning, the English version is considered official. Thank you for visiting esp.fda.gov/tabaco.
Page Last Updated: 03/22/2024