# 21 CFR § 310.100: New drug status opinions; statement of policy > Federal · Regulations · In force URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-310.100 ## Section - **Citation:** 21 CFR § 310.100 - **Heading:** New drug status opinions; statement of policy - **Jurisdiction:** Federal - **Kind:** Regulations - **Status:** In force - **Text as of:** September 22, 2026 - **Source:** Publisher's official text - **Location:** Title 21—Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER D—DRUGS FOR HUMAN USE > PART 310—NEW DRUGS > Subpart B—Specific Administrative Rulings and Decisions ## Text (a) Over the years since 1938 the Food and Drug Administration has given informal advice to inquirers as to the new drug status of preparations. These drugs have sometimes been identified only by general statements of composition. Generally, such informal opinions were incorporated in letters that did not explicitly relate all of the necessary conditions and qualifications such as the quantitative formula for the drug and the conditions under which it was prescribed, recommended, or suggested. This has contributed to misunderstanding and misinterpretation of such opinions. (b) These informal opinions that an article is “not a new drug” or “no longer a new drug” require reexamination under the Kefauver-Harris Act (Public Law 87-781; 76 Stat. 788-89). In particular, when approval of a new drug application is withdrawn under provisions of section 505(e) of the Federal Food, Drug, and Cosmetic Act, a drug generally recognized as safe may become a “new drug” within the meaning of section 201(p) of said act as amended by the Kefauver-Harris Act on October 10, 1962. This is of special importance by reason of proposed actions to withdraw approval of new drug applications for lack of substantial evidence of effectiveness as a result of reports of the National Academy of Sciences—National Research Council on its review of drug effectiveness; for example, see the notice published in the Federal Register of January 23, 1968 (33 FR 818), regarding rutin, quercetin, et al. (c) Any marketed drug is a “new drug” if any labeling change made after October 9, 1962, recommends or suggests new conditions of use under which the drug is not generally recognized as safe and effective by qualified experts. Undisclosed or unreported side effects as well as the emergence of new knowledge presenting questions with respect to the safety or effectiveness of a drug may result in its becoming a “new drug” even though it was previously considered “not a new drug.” Any previously given informal advice that an article is “not a new drug” does not apply to such an article if it has been changed in formulation, manufacture control, or labeling in a way that may significantly affect the safety of the drug. (d) For these reasons, all opinions previously given by the Food and Drug Administration to the effect that an article is “not a new drug” or is “no longer a new drug” are hereby revoked. This does not mean that all articles that were the subjects of such prior opinions will be regarded as new drugs. The prior opinions will be replaced by opinions of the Food and Drug Administration that are qualified and current on when an article is “not a new drug,” as set forth in this subchapter. [39 FR 11680, Mar. 29, 1974] ## Nearby sections - [21 CFR § 310.3 § 310.3 Definitions and interpretations.](https://www.frixlaw.com/law-library/statutes/ecfr-21-310.3.md) - [21 CFR § 310.4 § 310.4 Biologics; products subject to license control.](https://www.frixlaw.com/law-library/statutes/ecfr-21-310.4.md) - [21 CFR § 310.6 § 310.6 Applicability of “new drug” or safety or effectiveness findings in drug efficacy study implementation notices and notices of opportunity for hearing to identical, related, and similar drug products.](https://www.frixlaw.com/law-library/statutes/ecfr-21-310.6.md) - [21 CFR § 310.100 § 310.100 New drug status opinions; statement of policy.](https://www.frixlaw.com/law-library/statutes/ecfr-21-310.100.md) - [21 CFR § 310.103 § 310.103 New drug substances intended for hypersensitivity testing.](https://www.frixlaw.com/law-library/statutes/ecfr-21-310.103.md) - [21 CFR § 310.200 § 310.200 Prescription-exemption procedure.](https://www.frixlaw.com/law-library/statutes/ecfr-21-310.200.md) - [21 CFR § 310.201 § 310.201 Exemption for certain drugs limited by new-drug applications to prescription sale.](https://www.frixlaw.com/law-library/statutes/ecfr-21-310.201.md) - [21 CFR § 310.305 § 310.305 Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications.](https://www.frixlaw.com/law-library/statutes/ecfr-21-310.305.md) - [21 CFR § 310.306 § 310.306 Notification of a permanent discontinuance or an interruption in manufacturing of marketed prescription drugs for human use without approved new drug applications.](https://www.frixlaw.com/law-library/statutes/ecfr-21-310.306.md) - [21 CFR § 310.501 § 310.501 Patient package inserts for oral contraceptives.](https://www.frixlaw.com/law-library/statutes/ecfr-21-310.501.md) - [21 CFR § 310.502 § 310.502 Certain drugs accorded new drug status through rulemaking procedures.](https://www.frixlaw.com/law-library/statutes/ecfr-21-310.502.md) - [21 CFR § 310.503 § 310.503 Requirements regarding certain radioactive drugs.](https://www.frixlaw.com/law-library/statutes/ecfr-21-310.503.md) - [21 CFR § 310.509 § 310.509 Parenteral drug products in plastic containers.](https://www.frixlaw.com/law-library/statutes/ecfr-21-310.509.md) - [21 CFR § 310.515 § 310.515 Patient package inserts for estrogens.](https://www.frixlaw.com/law-library/statutes/ecfr-21-310.515.md) --- Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/ecfr-21-310.100. Check the current official text before relying on it. Not legal advice.