# 21 CFR § 310.3: Definitions and interpretations > Federal · Regulations · In force URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-310.3 ## Section - **Citation:** 21 CFR § 310.3 - **Heading:** Definitions and interpretations - **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 A—General Provisions ## Text As used in this part: (a) The term act means the Federal Food, Drug, and Cosmetic Act, as amended (secs. 201-902, 52 Stat. 1040 et seq., as amended; 21 U.S.C. 321-392). (b) Department means the Department of Health and Human Services. (c) Secretary means the Secretary of Health and Human Services. (d) Commissioner means the Commissioner of Food and Drugs. (e) The term person includes individuals, partnerships, corporations, and associations. (f) The definitions and interpretations of terms contained in section 201 of the act shall be applicable to such terms when used in the regulations in this part. (g) New drug substance means any substance that when used in the manufacture, processing, or packing of a drug, causes that drug to be a new drug, but does not include intermediates used in the synthesis of such substance. (h) The newness of a drug may arise by reason (among other reasons) of: (1) The newness for drug use of any substance which composes such drug, in whole or in part, whether it be an active substance or a menstruum, excipient, carrier, coating, or other component. (2) The newness for a drug use of a combination of two or more substances, none of which is a new drug. (3) The newness for drug use of the proportion of a substance in a combination, even though such combination containing such substance in other proportion is not a new drug. (4) The newness of use of such drug in diagnosing, curing, mitigating, treating, or preventing a disease, or to affect a structure or function of the body, even though such drug is not a new drug when used in another disease or to affect another structure or function of the body. (5) The newness of a dosage, or method or duration of administration or application, or other condition of use prescribed, recommended, or suggested in the labeling of such drug, even though such drug when used in other dosage, or other method or duration of administration or application, or different condition, is not a new drug. (i) [Reserved] (j) The term sponsor means the person or agency who assumes responsibility for an investigation of a new drug, including responsibility for compliance with applicable provisions of the act and regulations. The “sponsor” may be an individual, partnership, corporation, or Government agency and may be a manufacturer, scientific institution, or an investigator regularly and lawfully engaged in the investigation of new drugs. (k) The phrase related drug(s) includes other brands, potencies, dosage forms, salts, and esters of the same drug moiety, including articles prepared or manufactured by other manufacturers: and any other drug containing a component so related by chemical structure or known pharmacological properties that, in the opinion of experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, it is prudent to assume or ascertain the liability of similar side effects and contraindications. (l) Special packaging as defined in section 2(4) of the Poison Prevention Packaging Act of 1970 means packaging that is designed or constructed to be significantly difficult for children under 5 years of age to open or obtain a toxic or harmful amount of the substance contained therein within a reasonable time and not difficult for normal adults to use properly, but does not mean packaging which all such children cannot open or obtain a toxic or harmful amount within a reasonable time. (m) [Reserved] (n) The term radioactive drug means any substance defined as a drug in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act which exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons and includes any nonradioactive reagent kit or nuclide generator which is intended to be used in the preparation of any such substance but does not include drugs such as carbon-containing compounds or potassium-containing salts which contain trace quantities of naturally occurring radionuclides. The term “radioactive drug” includes a “radioactive biological product” as defined in § 600.3(ee) of this chapter. [39 FR 11680, Mar. 29, 1974, as amended at 39 FR 20484, June 11, 1974; 40 FR 31307, July 25, 1975; 46 FR 8952, Jan. 27, 1981; 50 FR 7492, Feb. 22, 1985] ## 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-21-310.3. Check the current official text before relying on it. Not legal advice.