cfr_sections
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75 rows where agency = "FDA" and part_number = 201 sorted by section_id
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| section_id ▼ | title_number | title_name | chapter | subchapter | part_number | part_name | subpart | subpart_name | section_number | section_heading | agency | authority | source_citation | amendment_citations | full_text |
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| 21:21:4.0.1.1.2.1.1.1 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | A | Subpart A—General Labeling Provisions | § 201.1 Drugs; name and place of business of manufacturer, packer, or distributor. | FDA | [45 FR 25775, Apr. 15, 1980; 45 FR 72118, Oct. 31, 1980, as amended at 48 FR 37620, Aug. 19, 1983; 81 FR 60212, Aug. 31, 2016; 89 FR 51767, June 18, 2024] | (a) A drug or drug product (as defined in § 320.1 of this chapter) in finished package form is misbranded under section 502 (a) and (b)(1) of the act if its label does not bear conspicuously the name and place of business of the manufacturer, packer, or distributor. This paragraph does not apply to any drug or drug product dispensed in accordance with section 503(b)(1) of the act. (b) As used in this section, and for purposes of section 502(a) and (b)(1) of the Federal Food, Drug, and Cosmetic Act, the manufacturer of a drug product is the person who performs all of the following operations that are required to produce the product: (1) Mixing; (2) Granulating; (3) Milling; (4) Molding; (5) Lyophilizing; (6) Tableting; (7) Encapsulating; (8) Coating; (9) Sterilizing; (10) Filling sterile or aerosol drugs into dispensing containers; and (11) With respect to a medical gas, fabricating the gas by chemical reaction, physical separation, compression of atmospheric air, purification ( e.g., re-processing an industrial gas into a medical gas), combining two or more distinct medical gases, or other process. (c) If no person performs all of the applicable operations listed in paragraph (b) of this section, no person may be represented as manufacturer except as follows: (1) If the person performs more than one half of the applicable operations listed in paragraph (b) of this section and acknowledges the contribution of other persons who have performed the remaining applicable operations by stating on the product label that “Certain manufacturing operations have been performed by other firms.”; or (2) If the person performs at least one applicable operation listed in paragraph (b) of this section and identifies by appropriate designation all other persons who have performed the remaining applicable operations, e.g., “Made by (Person A), Filled by (Person B), Sterilized by (Person C)”; or (3) If the person performs at least one applicable operation listed in paragraph (b) of this section and the person is lis… | |||
| 21:21:4.0.1.1.2.1.1.10 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | A | Subpart A—General Labeling Provisions | § 201.19 Drugs; use of term “infant”. | FDA | [40 FR 13998, Mar. 27, 1975, as amended at 42 FR 14091, Mar. 15, 1977; 44 FR 16006, Mar. 16, 1979] | The regulations affecting special dietary foods (§ 105.3(e) of this chapter) define an infant as a child not more than 12 months old. Apart from this, the Food and Drug Administration has not established any definition of the term infant. Some question has arisen whether, for the purposes of drug labeling, an infant means a child up to 1 year of age or a child up to 2 years of age. Until the term is more precisely defined by legislation or formal regulation, where the exact meaning of the term is significant, manufacturers should qualify any reference to “infant” to indicate whether it refers to a child who is not more than 1 year of age, or a child not more than 2 years of age. | |||
| 21:21:4.0.1.1.2.1.1.11 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | A | Subpart A—General Labeling Provisions | § 201.20 Declaration of presence of FD&C Yellow No. 5 and/or FD&C Yellow No. 6 in certain drugs for human use. | FDA | [45 FR 60422, Sept. 12, 1980, as amended at 51 FR 41783, Nov. 19, 1986; 52 FR 21509, June 8, 1987; 59 FR 60898, Nov. 29, 1994] | (a) The label for over-the-counter and prescription drug products intended for human use administered orally, nasally, rectally, or vaginally, or for use in the area of the eye, containing FD&C Yellow No. 5 as a color additive using the names FD&C Yellow No. 5 and tartrazine. The labeling for over-the-counter and prescription drug products shall bear a statement such as “Contains FD&C Yellow No. 5 (tartrazine) as a color additive” or “Contains color additives including FD&C Yellow No. 5 (tartrazine)”. The labels of certain drug products subject to this labeling requirement that are also cosmetics, such as antibacterial mouthwashes and fluoride toothpastes, need not comply with this requirement provided they comply with the requirements of § 701.3 of this chapter. (b) For prescription drugs for human use containing FD&C Yellow No. 5 that are administered orally, nasally, vaginally, or rectally, or for use in the area of the eye, the labeling required by § 201.100(d) shall bear the warning statement “This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.” This warning statement shall appear in the “Precautions” section of the labeling. (c) The label for over-the-counter drug products intended for human use administered orally, nasally, rectally, or vaginally containing FD&C Yellow No. 6 shall specifically declare the presence of FD&C Yellow No. 6 by listing the color additive using the name FD&C Yellow No. 6. The labeling for over-the-counter and prescription drug products containing FD&C Yellow No. 6 shall declare the presence of FD&C Yellow No. 6. The labels of certain drug products subject to this labeling requirement that are also cosmetics, such as antibacterial mouthwashes and fluoride toothpastes, need not comply with this requ… | |||
| 21:21:4.0.1.1.2.1.1.12 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | A | Subpart A—General Labeling Provisions | § 201.21 Declaration of presence of phenylalanine as a component of aspartame in over-the-counter and prescription drugs for human use. | FDA | [52 FR 2111, Jan. 20, 1987; 52 FR 12152, Apr. 15, 1987; 53 FR 4135, Feb. 12, 1988] | (a) Aspartame is the methylester of a dipeptide composed of two amino acids, phenylalanine and aspartic acid. When these two amino acids are so combined to form aspartame (1-methyl N -L-α-aspartyl-L-phenylalanine), they produce an intensely sweet-tasting substance, approximately 180 times as sweet as sucrose. The Food and Drug Administration has determined that aspartame when used at a level no higher than reasonably required to perform its intended technical function is safe for use as an inactive ingredient in human drug products, provided persons with phenylketonuria, who must restrict carefully their phenylalanine intake, are alerted to the presence of phenylalanine in the drug product and the amount of the ingredient in each dosage unit. (b) The label and labeling of all over-the-counter human drug products containing aspartame as an inactive ingredient shall bear a statement to the following effect: Phenylketonurics: Contains Phenylalanine (_)mg Per (Dosage Unit). (c) The package labeling and other labeling providing professional use information concerning prescription drugs for human use containing aspartame as an inactive ingredient shall bear a statement to the following effect under the “Precautions” section of the labeling, as required in § 201.57(f)(2): Phenylketonurics: Contains Phenylalanine (_)mg Per (Dosage Unit). (d) Holders of approved new drug applications who reformulate their drug products under the provisions of this section shall submit supplements under § 314.70 of this chapter to provide for the new composition and the labeling changes. | |||
| 21:21:4.0.1.1.2.1.1.13 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | A | Subpart A—General Labeling Provisions | § 201.22 Prescription drugs containing sulfites; required warning statements. | FDA | [51 FR 43904, Dec. 5, 1986] | (a) Sulfites are chemical substances that are added to certain drug products to inhibit the oxidation of the active drug ingredient. Oxidation of the active drug ingredient may result in instability and a loss of potency of the drug product. Examples of specific sulfites used to inhibit this oxidation process include sodium bisulfite, sodium metabisulfite, sodium sulfite, potassium bisulfite, and potassium metabisulfite. Recent studies have demonstrated that sulfites may cause allergic-type reactions in certain susceptible persons, especially asthmatics. The labeling for any prescription drug product to which sulfites have been added as an inactive ingredient, regardless of the amount added, must bear the warning specified in paragraph (b) or (c) of this section. (b) The labeling required by §§ 201.57 and 201.100(d) for prescription drugs for human use containing a sulfite, except epinephrine for injection when intended for use in allergic or other emergency situations, shall bear the warning statement “Contains ( insert the name of the sulfite, e.g., sodium metabisulfite ), a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.” This statement shall appear in the “Warnings” section of the labeling. (c) The labeling required by §§ 201.57 and 201.100(d) for sulfite-containing epinephrine for injection for use in allergic emergency situations shall bear the warning statement “Epinephrine is the preferred treatment for serious allergic or other emergency situations even though this product contains ( insert the name of the sulfite, e.g., sodium metabisulfite ), a sulfite that may in other products cause allergic-type reactions including anaphylactic symptoms or life-threatening or less severe asthmatic episodes in certai… | |||
| 21:21:4.0.1.1.2.1.1.14 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | A | Subpart A—General Labeling Provisions | § 201.23 Required pediatric studies. | FDA | [63 FR 66668, Dec. 2, 1998] | (a) A manufacturer of a marketed drug product, including a biological drug product, that is used in a substantial number of pediatric patients, or that provides a meaningful therapeutic benefit over existing treatments for pediatric patients, as defined in §§ 314.55(c)(5) and 601.27(c)(5) of this chapter, but whose label does not provide adequate information to support its safe and effective use in pediatric populations for the approved indications may be required to submit an application containing data adequate to assess whether the drug product is safe and effective in pediatric populations. The application may be required to contain adequate evidence to support dosage and administration in some or all pediatric subpopulations, including neonates, infants, children, and adolescents, depending upon the known or appropriate use of the drug product in such subpopulations. The applicant may also be required to develop a pediatric formulation for a drug product that represents a meaningful therapeutic benefit over existing therapies for pediatric populations for whom a pediatric formulation is necessary, unless the manufacturer demonstrates that reasonable attempts to produce a pediatric formulation have failed. (b) The Food and Drug Administration (FDA) may by order, in the form of a letter, after notifying the manufacturer of its intent to require an assessment of pediatric safety and effectiveness of a pediatric formulation, and after offering an opportunity for a written response and a meeting, which may include an advisory committee meeting, require a manufacturer to submit an application containing the information or request for approval of a pediatric formulation described in paragraph (a) of this section within a time specified in the order, if FDA finds that: (1) The drug product is used in a substantial number of pediatric patients for the labeled indications and the absence of adequate labeling could pose significant risks to pediatric patients; or (2) There is reason to believe that the drug product … | |||
| 21:21:4.0.1.1.2.1.1.15 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | A | Subpart A—General Labeling Provisions | § 201.24 Labeling for systemic antibacterial drug products. | FDA | [68 FR 6081, Feb. 6, 2003] | The labeling of all systemic drug products intended for human use indicated to treat a bacterial infection, except a mycobacterial infection, must bear the following statements: (a) At the beginning of the label, under the product name, the labeling must state: To reduce the development of drug-resistant bacteria and maintain the effectiveness of ( insert name of antibacterial drug product ) and other antibacterial drugs, ( insert name of antibacterial drug product ) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ( insert name of antibacterial drug product ) and other antibacterial drugs, ( insert name of antibacterial drug product ) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (b) In the “Indications and Usage” section, the labeling must state: To reduce the development of drug-resistant bacteria and maintain the effectiveness of ( insert name of antibacterial drug product ) and other antibacterial drugs, ( insert name of antibacterial drug product ) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ( insert name of antibacterial drug product ) and other antibacterial drugs, ( insert name of antibacterial drug product ) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial … | |||
| 21:21:4.0.1.1.2.1.1.16 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | A | Subpart A—General Labeling Provisions | § 201.25 Bar code label requirements. | FDA | [69 FR 9170, Feb. 26, 2004, as amended at 76 FR 12847, Mar. 9, 2011; 80 FR 18090, Apr. 3, 2015; 81 FR 60212, Aug. 31, 2016] | (a) Who is subject to these bar code requirements? Manufacturers, repackers, relabelers, and private label distributors of a human prescription drug product or an over-the-counter (OTC) drug product that is regulated under the Federal Food, Drug, and Cosmetic Act or the Public Health Service Act are subject to these bar code requirements unless they are exempt from the registration and drug listing requirements in section 510 of the Federal Food, Drug, and Cosmetic Act. (b) What drugs are subject to these bar code requirements? The following drug products are subject to the bar code label requirements: (1) Prescription drug products, however: (i) The bar code requirement does not apply to the following entities: (A) Prescription drug samples; (B) Allergenic extracts; (C) Intrauterine contraceptive devices regulated as drugs; (D) Medical gases; (E) Radiopharmaceuticals; and (F) Low-density polyethylene form fill and seal containers that are not packaged with an overwrap. (ii) The bar code requirement does not apply to prescription drugs sold by a manufacturer, repacker, relabeler, or private label distributor directly to patients, but versions of the same drug product that are sold to or used in hospitals are subject to the bar code requirements. (2) Biological products; and (3) OTC drug products that are dispensed pursuant to an order and are commonly used in hospitals. For purposes of this section, an OTC drug product is “commonly used in hospitals” if it is packaged for hospital use, labeled for hospital use (or uses similar terms), or marketed, promoted, or sold to hospitals. (c) What does the bar code look like? Where does the bar code go? (1) Each drug product described in paragraph (b) of this section must have a bar code that contains, at a minimum, the appropriate National Drug Code (NDC) number in a linear bar code that meets European Article Number/Uniform Code Council (EAN/UCC) or Health Industry Business Communications Council (HIBCC) standards or another standard or format that has… | |||
| 21:21:4.0.1.1.2.1.1.17 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | A | Subpart A—General Labeling Provisions | § 201.26 Exceptions or alternatives to labeling requirements for human drug products held by the Strategic National Stockpile. | FDA | [72 FR 73599, Dec. 28, 2007] | (a) The appropriate FDA Center Director may grant an exception or alternative to any provision listed in paragraph (f) of this section and not explicitly required by statute, for specified lots, batches, or other units of a human drug product, if the Center Director determines that compliance with such labeling requirement could adversely affect the safety, effectiveness, or availability of such product that is or will be included in the Strategic National Stockpile. (b)(1)(i) A Strategic National Stockpile official or any entity that manufactures (including labeling, packing, relabeling, or repackaging), distributes, or stores a human drug product that is or will be included in the Strategic National Stockpile may submit, with written concurrence from a Strategic National Stockpile official, a written request for an exception or alternative described in paragraph (a) of this section to the Center Director. (ii) The Center Director may grant an exception or alternative described in paragraph (a) of this section on his or her own initiative. (2) A written request for an exception or alternative described in paragraph (a) of this section must: (i) Identify the specified lots, batches, or other units of the human drug product that would be subject to the exception or alternative; (ii) Identify the labeling provision(s) listed in paragraph (f) of this section that are the subject of the exception or alternative request; (iii) Explain why compliance with such labeling provision(s) could adversely affect the safety, effectiveness, or availability of the specified lots, batches, or other units of a human drug product that are or will be held in the Strategic National Stockpile; (iv) Describe any proposed safeguards or conditions that will be implemented so that the labeling of the product includes appropriate information necessary for the safe and effective use of the product, given the anticipated circumstances of use of the product; (v) Provide a draft of the proposed labeling of the specified lots, batches, o… | |||
| 21:21:4.0.1.1.2.1.1.2 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | A | Subpart A—General Labeling Provisions | § 201.2 Drugs and devices; National Drug Code numbers. | FDA | [40 FR 52002, Nov. 7, 1975, as amended at 81 FR 60212, Aug. 31, 2016] | The National Drug Code (NDC) number is requested but not required to appear on all drug labels and in all drug labeling, including the label of any prescription drug container furnished to a consumer. | |||
| 21:21:4.0.1.1.2.1.1.3 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | A | Subpart A—General Labeling Provisions | § 201.5 Drugs; adequate directions for use. | FDA | [41 FR 6908, Feb. 13, 1976] | Adequate directions for use means directions under which the layman can use a drug safely and for the purposes for which it is intended. (Section 201.128 defines “intended use.”) Directions for use may be inadequate because, among other reasons, of omission, in whole or in part, or incorrect specification of: (a) Statements of all conditions, purposes, or uses for which such drug is intended, including conditions, purposes, or uses for which it is prescribed, recommended, or suggested in its oral, written, printed, or graphic advertising, and conditions, purposes, or uses for which the drug is commonly used; except that such statements shall not refer to conditions, uses, or purposes for which the drug can be safely used only under the supervision of a practitioner licensed by law and for which it is advertised solely to such practitioner. (b) Quantity of dose, including usual quantities for each of the uses for which it is intended and usual quantities for persons of different ages and different physical conditions. (c) Frequency of administration or application. (d) Duration of administration or application. (e) Time of administration or application (in relation to time of meals, time of onset of symptoms, or other time factors). (f) Route or method of administration or application. (g) Preparation for use, i.e., shaking, dilution, adjustment of temperature, or, other manipulation or process. | |||
| 21:21:4.0.1.1.2.1.1.4 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | A | Subpart A—General Labeling Provisions | § 201.6 Drugs; misleading statements. | FDA | [41 FR 6908, Feb. 13, 1976] | (a) Among representations in the labeling of a drug which render such drug misbranded is a false or misleading representation with respect to another drug or a device or a food or cosmetic. (b) The labeling of a drug which contains two or more ingredients may be misleading by reason, among other reasons, of the designation of such drug in such labeling by a name which includes or suggests the name of one or more but not all such ingredients, even though the names of all such ingredients are stated elsewhere in the labeling. | |||
| 21:21:4.0.1.1.2.1.1.5 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | A | Subpart A—General Labeling Provisions | § 201.10 Drugs; statement of ingredients. | FDA | [40 FR 13998, Mar. 27, 1975, as amended at 67 FR 4906, Feb. 1, 2002; 89 FR 51767, June 18, 2024] | (a) The ingredient information required by section 502(e) of the Federal Food, Drug, and Cosmetic Act shall appear together, without any intervening written, printed, or graphic matter, except the proprietary names of ingredients, which may be included with the listing of established names, and such statements that are specifically required for certain ingredients by the act or regulations in this chapter. (b) The term ingredient applies to any substance in the drug, whether added to the formulation as a single substance or in admixture with other substances. (c) The labeling of a drug may be misleading by reason (among other reasons) of: (1) The order in which the names of the ingredients present in the drug appear in the labeling, or the relative prominence otherwise given such names. (2) Failure to reveal the proportion of, or other fact with respect to, an ingredient present in such drug, when such proportion or other fact is material in the light of the representation that such ingredient is present in such drug. (3) The employment of a fanciful proprietary name for a drug or ingredient in such a manner as to imply that the drug or ingredient has some unique effectiveness or composition when, in fact, the drug or ingredient is a common substance, the limitations of which are readily recognized when the drug or ingredient is listed by its established name. (4) The featuring in the labeling of inert or inactive ingredients in a manner that creates an impression of value greater than their true functional role in the formulation. (5) Designation of a drug or ingredient by a proprietary name that, because of similarity in spelling or pronunciation, may be confused with the proprietary name or the established name of a different drug or ingredient. (d)(1) If the drug is in tablet or capsule form or other unit dosage form, any statement of the quantity of an ingredient contained therein shall express the quantity of such ingredient in each such unit. If the drug is not in unit dosage form, any statement … | |||
| 21:21:4.0.1.1.2.1.1.6 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | A | Subpart A—General Labeling Provisions | § 201.15 Drugs; prominence of required label statements. | FDA | [41 FR 6908, Feb. 13, 1976] | (a) A word, statement, or other information required by or under authority of the act to appear on the label may lack that prominence and conspicuousness required by section 502(c) of the act by reason, among other reasons, of: (1) The failure of such word, statement, or information to appear on the part or panel of the label which is presented or displayed under customary conditions of purchase; (2) The failure of such word, statement, or information to appear on two or more parts or panels of the label, each of which has sufficient space therefor, and each of which is so designed as to render it likely to be, under customary conditions of purchase, the part or panel displayed; (3) The failure of the label to extend over the area of the container or package available for such extension, so as to provide sufficient label space for the prominent placing of such word, statement, or information; (4) Insufficiency of label space for the prominent placing of such word, statement, or information, resulting from the use of label space for any word, statement, design, or device which is not required by or under authority of the act to appear on the label; (5) Insufficiency of label space for the prominent placing of such word, statement, or information, resulting from the use of label space to give materially greater conspicuousness to any other word, statement, or information, or to any design or device; or (6) Smallness or style of type in which such word, statement, or information appears, insufficient background contrast, obscuring designs or vignettes, or crowding with other written, printed, or graphic matter. (b) No exemption depending on insufficiency of label space, as prescribed in regulations promulgated under section 502 (b) or (e) of the act, shall apply if such insufficiency is caused by: (1) The use of label space for any word, statement, design, or device which is not required by or under authority of the act to appear on the label; (2) The use of label space to give greater conspicuousness to an… | |||
| 21:21:4.0.1.1.2.1.1.7 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | A | Subpart A—General Labeling Provisions | § 201.16 Drugs; Spanish-language version of certain required statements. | FDA | [67 FR 4906, Feb. 1, 2002] | An increasing number of medications restricted to prescription use only are being labeled solely in Spanish for distribution in the Commonwealth of Puerto Rico where Spanish is the predominant language. Such labeling is authorized under § 201.15(c). One required warning, the wording of which is fixed by law in the English language, could be translated in various ways, from literal translation to loose interpretation. The statutory nature of this warning requires that the translation convey the meaning properly to avoid confusion and dilution of the purpose of the warning. Section 503(b)(4) of the Federal Food, Drug, and Cosmetic Act requires, at a minimum, that the label bear the statement “Rx only.” The Spanish-language version of this must be “Solamente Rx”. | |||
| 21:21:4.0.1.1.2.1.1.8 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | A | Subpart A—General Labeling Provisions | § 201.17 Drugs; location of expiration date. | FDA | [43 FR 45076, Sept. 29, 1978] | When an expiration date of a drug is required, e.g., expiration dating of drug products required by § 211.137 of this chapter, it shall appear on the immediate container and also the outer package, if any, unless it is easily legible through such outer package. However, when single-dose containers are packed in individual cartons, the expiration date may properly appear on the individual carton instead of the immediate product container. | |||
| 21:21:4.0.1.1.2.1.1.9 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | A | Subpart A—General Labeling Provisions | § 201.18 Drugs; significance of control numbers. | FDA | The lot number on the label of a drug should be capable of yielding the complete manufacturing history of the package. An incorrect lot number may be regarded as causing the article to be misbranded. | ||||
| 21:21:4.0.1.1.2.2.1.1 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | B | Subpart B—Labeling Requirements for Prescription Drugs and/or Insulin | § 201.50 Statement of identity. | FDA | [40 FR 13998, Mar. 27, 1975, as amended at 63 FR 26698, May 13, 1998] | (a) The label of prescription and insulin-containing drugs in package form shall bear as one of its principal features a statement of the identity of the drug. (b) Such statement of identity shall be in terms of the established name of the drug. In the case of a prescription drug that is a mixture and that has no established name, the requirement for statement of identity shall be deemed to be satisfied by a listing of the quantitative ingredient information as prescribed by § 201.10. (c) The statement of identity of a prescription drug shall also comply with the placement, size and prominence requirements of § 201.10. | |||
| 21:21:4.0.1.1.2.2.1.2 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | B | Subpart B—Labeling Requirements for Prescription Drugs and/or Insulin | § 201.51 Declaration of net quantity of contents. | FDA | [40 FR 13998, Mar. 27, 1975, as amended at 89 FR 51768, June 18, 2024] | (a) The label of a prescription or insulin-containing drug in package form shall bear a declaration of the net quantity of contents. This shall be expressed in the terms of weight, measure, numerical count, or a combination of numerical count and weight or measure. The statement of quantity of drugs in tablet, capsule, ampule, or other unit dosage form shall be expressed in terms of numerical count; the statement of quantity for drugs in other dosage forms shall be in terms of weight if the drug is solid, semi-solid, or viscous, in terms of fluid measure if the drug is liquid, or in terms of volume measure if the drug is a designated medical gas (as defined in § 201.161(c)(1)) or a medically appropriate combination of designated medical gases in a gaseous state. When the drug quantity statement is in terms of the numerical count of the drug units, it shall be augmented to give the weight or measure of the drug units or the quantity of each active ingredient in each drug unit or, when quantity does not accurately reflect drug potency, a statement of the drug potency. (b) Statements of weight of the contents shall in the case of prescription drugs be expressed in terms of avoirdupois pound, ounce, and grain or of kilogram, gram, and subdivisions thereof. A statement of liquid measure of the contents shall in the case of prescription drugs other than designated medical gases and medically appropriate combinations thereof be expressed in terms of the U.S. gallon of 231 cubic inches and quart, pint, fluid-ounce, and fluid-dram subdivisions thereof, or of the liter and milliliter, or cubic centimeter, and shall express the volume at 68 °F (20 °C). A statement of the liquid measure of the contents in the case of insulin-containing drugs shall be expressed in terms of the liter and milliliter, or cubic centimeter, and shall express the volume at 68 °F (20 °C). A statement of the measure of the contents shall in the case of designated medical gases (as defined in § 201.161(c)(1)) and medically appropriate combinations … | |||
| 21:21:4.0.1.1.2.2.1.3 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | B | Subpart B—Labeling Requirements for Prescription Drugs and/or Insulin | § 201.55 Statement of dosage. | FDA | Section 201.100(b)(2) requires that labels for prescription drugs bear a statement of the recommended or usual dosage. Since the dosage for some prescription drugs varies within extremely wide limits, depending upon the conditions being treated, it may not be possible in all cases to present an informative or useful statement of the recommended or usual dosage in the space available on the label or carton of the package. It is the view of the Food and Drug Administration that when such a situation prevails, compliance with this requirement would be met by a statement such as “See package insert for dosage information”, where the detailed information is contained in such insert. However, if an informative, realistic, recommended or usual dosage can readily be set forth on the label, it should appear thereon. | ||||
| 21:21:4.0.1.1.2.2.1.4 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | B | Subpart B—Labeling Requirements for Prescription Drugs and/or Insulin | § 201.56 Requirements on content and format of labeling for human prescription drug and biological products. | FDA | [71 FR 3986, Jan. 24, 2006, as amended at 79 FR 72101, Dec. 4, 2014] | (a) General requirements. Prescription drug labeling described in § 201.100(d) must meet the following general requirements: (1) The labeling must contain a summary of the essential scientific information needed for the safe and effective use of the drug. (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. (3) The labeling must be based whenever possible on data derived from human experience. No implied claims or suggestions of drug use may be made if there is inadequate evidence of safety or a lack of substantial evidence of effectiveness. Conclusions based on animal data but necessary for safe and effective use of the drug in humans must be identified as such and included with human data in the appropriate section of the labeling. (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: (i) Prescription drug products for which a new drug application (NDA), biologics license application (BLA), or efficacy supplement was approved by the Food and Drug Administration (FDA) between June 30, 2001 and June 30, 2006; (ii) Prescription drug products for which an NDA, BLA, or efficacy supplement is pending on June 30, 2006; or (iii) Prescription drug products for which an NDA, BLA, or efficacy supplement is submitted anytime on or after June 30, 2006. (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 … | |||
| 21:21:4.0.1.1.2.2.1.5 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | B | Subpart B—Labeling Requirements for Prescription Drugs and/or Insulin | § 201.57 Specific requirements on content and format of labeling for human prescription drug and biological products described in § 201.56(b)(1). | FDA | [71 FR 3988, Jan. 24, 2006, as amended at 79 FR 72101, Dec. 4, 2014] | The requirements in this section apply only to prescription drug products described in § 201.56(b)(1) and must be implemented according to the schedule specified in § 201.56(c), except for the requirement in paragraph (c)(18) of this section to reprint any FDA-approved patient labeling at the end of prescription drug labeling or accompany the prescription drug labeling, which must be implemented no later than June 30, 2007. (a) Highlights of prescribing information. The following information must appear in all prescription drug labeling: (1) Highlights limitation statement. The verbatim statement “These highlights do not include all the information needed to use ( insert name of drug product ) safely and effectively. See full prescribing information for (insert name of drug product).” (2) Drug names, dosage form, route of administration, and controlled substance symbol. The proprietary name and the established name of the drug, if any, as defined in section 502(e)(3) of the Federal Food, Drug, and Cosmetic Act (the act) or, for biological products, the proper name (as defined in § 600.3 of this chapter) including any appropriate descriptors. This information must be followed by the drug's dosage form and route of administration. For controlled substances, the controlled substance symbol designating the schedule in which the controlled substance is listed must be included as required by § 1302.04 of this chapter. (3) Initial U.S. approval. The verbatim statement “Initial U.S. Approval” followed by the four-digit year in which FDA initially approved a new molecular entity, new biological product, or new combination of active ingredients. The statement must be placed on the line immediately beneath the established name or, for biological products, proper name of the product. (4) Boxed warning. A concise summary of any boxed warning required by paragraph (c)(1) of this section, not to exceed a length of 20 lines. The summary must be preceded by a heading, in upper-case letters, containing the word “WAR… | |||
| 21:21:4.0.1.1.2.2.1.6 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | B | Subpart B—Labeling Requirements for Prescription Drugs and/or Insulin | § 201.58 Waiver of labeling requirements. | FDA | [71 FR 3996, Jan. 24, 2006, as amended at 74 FR 13112, Mar. 26, 2009; 80 FR 18090, Apr. 3, 2015] | An applicant may ask the Food and Drug Administration to waive any requirement under §§ 201.56, 201.57, and 201.80. A waiver request must be submitted in writing to the Director (or the Director's designee), Center for Drug Evaluation and Research, Food and Drug Administration, Central Document Room, 5901-B Ammendale Rd., Beltsville, MD 20705-1266, or, if applicable, the Director (or the Director's designee), Food and Drug Administration, Center for Biologics Evaluation and Research, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G112, Silver Spring, MD 20993-0002. The waiver must be granted or denied in writing by the Director or the Director's designee. | |||
| 21:21:4.0.1.1.2.3.1.1 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | C | Subpart C—Labeling Requirements for Over-the-Counter Drugs | § 201.60 Principal display panel. | FDA | The term principal display panel, as it applies to over-the-counter drugs in package form and as used in this part, means the part of a label that is most likely to be displayed, presented, shown, or examined under customary conditions of display for retail sale. The principal display panel shall be large enough to accommodate all the mandatory label information required to be placed thereon by this part with clarity and conspicuousness and without obscuring designs, vignettes, or crowding. Where packages bear alternate principal display panels, information required to be placed on the principal display panel shall be duplicated on each principal display panel. For the purpose of obtaining uniform type size in declaring the quantity of contents for all packages of substantially the same size, the term area of the principal display panel means the area of the side or surface that bears the principal display panel, which area shall be: (a) In the case of a rectangular package where one entire side properly can be considered to be the principal display panel side, the product of the height times the width of that side; (b) In the case of a cylindrical or nearly cylindrical container, 40 percent of the product of the height of the container times the circumference; and (c) In the case of any other shape of container, 40 percent of the total surface of the container: Provided, however, That where such container presents an obvious “principal display panel” such as the top of a triangular or circular package, the area shall consist of the entire top surface. In determining the area of the principal display panel, exclude tops, bottoms, flanges at the tops and bottoms of cans, and shoulders and necks of bottles or jars. In the case of cylindrical or nearly cylindrical containers, information required by this part to appear on the principal display panel shall appear within that 40 percent of the circumference which is most likely to be displayed, presented, shown, or examined under customary conditions of disp… | ||||
| 21:21:4.0.1.1.2.3.1.10 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | C | Subpart C—Labeling Requirements for Over-the-Counter Drugs | § 201.72 Potassium labeling. | FDA | [69 FR 13734, Mar. 24, 2004] | (a) The labeling of over-the-counter (OTC) drug products intended for oral ingestion shall contain the potassium content per dosage unit (e.g., tablet, teaspoonful) if the potassium content of a single maximum recommended dose of the product (which may be one or more dosage units) is 5 milligrams or more. OTC drug products intended for oral ingestion include gum and lozenge dosage forms, but do not include dentifrices, mouthwashes, or mouth rinses. (b) The potassium content shall be expressed in milligrams or grams per dosage unit and shall include the total amount of potassium regardless of the source, i.e., from both active and inactive ingredients. If the dosage unit contains less than 1 gram of potassium, milligrams should be used. The potassium content shall be rounded-off to the nearest 5 milligrams (or nearest tenth of a gram if over 1 gram). The potassium content per dosage unit shall follow the heading “Other information” as stated in § 201.66(c)(7). (c) The labeling of OTC drug products intended for oral ingestion shall contain the following statement under the heading “Warning” (or “Warnings” if it appears with additional warning statements) if the amount of potassium present in the labeled maximum daily dose of the product is more than 975 milligrams: “Ask a doctor before use if you have [in bold type] [bullet] 1 kidney disease [bullet] a potassium-restricted diet”. The warnings in §§ 201.64(c), 201.70(c), 201.71(c), and 201.72(c) may be combined, if applicable, provided the ingredients are listed in alphabetical order, e.g., a magnesium or potassium-restricted diet. 1 See § 201.66(b)(4) of this chapter for definition of bullet symbol. (d) Any product subject to this paragraph that is not labeled as required by this paragraph and that is initially introduced or initially delivered for introduction into interstate commerce after the following dates is misbranded under sections 201(n) and 502(a) and (f) of the Federal Food, Drug, and Cosmetic Act. (1) As of the date of approval of the applic… | |||
| 21:21:4.0.1.1.2.3.1.11 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | C | Subpart C—Labeling Requirements for Over-the-Counter Drugs | § 201.80 Specific requirements on content and format of labeling for human prescription drug and biological products; older drugs not described in § 201.56(b)(1). | FDA | [44 FR 37462, June 26, 1979, as amended at 55 FR 11576, Mar. 29, 1990; 59 FR 64249, Dec. 13, 1994; 62 FR 45325, Aug. 27, 1997; 63 FR 66396, Dec. 1, 1998. Redesignated and amended at 71 FR 3988, 3996, Jan. 24, 2006; 79 FR 72103, Dec. 4, 2014] | Each section heading listed in § 201.56(d), if not omitted under § 201.56(d)(3), shall contain the following information in the following order: (a) Description. (1) Under this section heading, the labeling shall contain: (i) The proprietary name and the established name, if any, as defined in section 502(e)(2) of the act, of the drug; (ii) The type of dosage form and the route of administration to which the labeling applies; (iii) The same qualitative and/or quantitative ingredient information as required under § 201.100(b) for labels; (iv) If the product is sterile, a statement of that fact; (v) The pharmacological or therapeutic class of the drug; (vi) The chemical name and structural formula of the drug; (vii) If the product is radioactive, a statement of the important nuclear physical characteristics, such as the principal radiation emission data, external radiation, and physical decay characteristics. (2) If appropriate, other important chemical or physical information, such as physical constants, or pH, shall be stated. (b) Clinical Pharmacology. (1) Under this section heading, the labeling shall contain a concise factual summary of the clinical pharmacology and actions of the drug in humans. The summary may include information based on in vitro and/or animal data if the information is essential to a description of the biochemical and/or physiological mode of action of the drug or is otherwise pertinent to human therapeutics. Pharmacokinetic information that is important to safe and effective use of the drug is required, if known, e.g., degree and rate of absorption, pathways of biotransformation, percentage of dose as unchanged drug and metabolites, rate or half-time of elimination, concentration in body fluids associated with therapeutic and/or toxic effects, degree of binding to plasma proteins, degree of uptake by a particular organ or in the fetus, and passage across the blood brain barrier. Inclusion of pharmacokinetic information is restricted to that which relates to clinical use of t… | |||
| 21:21:4.0.1.1.2.3.1.2 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | C | Subpart C—Labeling Requirements for Over-the-Counter Drugs | § 201.61 Statement of identity. | FDA | (a) The principal display panel of an over-the-counter drug in package form shall bear as one of its principal features a statement of the identity of the commodity. (b) Such statement of identity shall be in terms of the established name of the drug, if any there be, followed by an accurate statement of the general pharmacological category(ies) of the drug or the principal intended action(s) of the drug. In the case of an over-the-counter drug that is a mixture and that has no established name, this requirement shall be deemed to be satisfied by a prominent and conspicuous statement of the general pharmacological action(s) of the mixture or of its principal intended action(s) in terms that are meaningful to the layman. Such statements shall be placed in direct conjunction with the most prominent display of the proprietary name or designation and shall employ terms descriptive of general pharmacological category(ies) or principal intended action(s); for example, “antacid,” “analgesic,” “decongestant,” “antihistaminic,” etc. The indications for use shall be included in the directions for use of the drug, as required by section 502(f)(1) of the act and by the regulations in this part. (c) The statement of identity shall be presented in bold face type on the principal display panel, shall be in a size reasonably related to the most prominent printed matter on such panel, and shall be in lines generally parallel to the base on which the package rests as it is designed to be displayed. | ||||
| 21:21:4.0.1.1.2.3.1.3 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | C | Subpart C—Labeling Requirements for Over-the-Counter Drugs | § 201.62 Declaration of net quantity of contents. | FDA | (a) The label of an over-the-counter drug in package form shall bear a declaration of the net quantity of contents. This shall be expressed in the terms of weight, measure, numerical count, or a combination or numerical count and weight, measure, or size. The statement of quantity of drugs in tablet, capsule, ampule, or other unit form and the quantity of devices shall be expressed in terms of numerical count; the statement of quantity for drugs in other dosage forms shall be in terms of weight if the drug is solid, semisolid, or viscous, or in terms of fluid measure if the drug is liquid. The drug quantity statement shall be augmented when necessary to give accurate information as to the strength of such drug in the package; for example, to differentiate between several strengths of the same drug “100 tablets, 5 grains each” or “100 capsules, 125 milligrams each” or “100 capsules, 250 milligrams each”: Provided, That: (1) In the case of a firmly established, general consumer usage and trade custom of declaring the quantity of a drug in terms of linear measure or measure of area, such respective term may be used. Such term shall be augmented when necessary for accuracy of information by a statement of the weight, measure, or size of the individual units or of the entire drug; for example, the net quantity of adhesive tape in package form shall be expressed in terms of linear measure augmented by a statement of its width. (2) Whenever the Commissioner determines for a specific packaged drug that an existing practice of declaring net quantity of contents by weight, measure, numerical count, or a combination of these does not facilitate value comparisons by consumers, he shall by regulation designate the appropriate term or terms to be used for such article. (b) Statements of weight of the contents shall be expressed in terms of avoirdupois pound and ounce. A statement of liquid measure of the contents shall be expressed in terms of the U.S. gallon of 231 cubic inches and quart, pint, and fluid-ounce subdivisio… | ||||
| 21:21:4.0.1.1.2.3.1.4 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | C | Subpart C—Labeling Requirements for Over-the-Counter Drugs | § 201.63 Pregnancy/breast-feeding warning. | FDA | [47 FR 54757, Dec. 3, 1982, as amended at 55 FR 27784, July 5, 1990; 59 FR 14364, Mar. 28, 1994; 64 FR 13286, Mar. 17, 1999; 68 FR 24879, May 9, 2003; 88 FR 45065, July 14, 2023] | (a) The labeling for all over-the-counter (OTC) drug products that are intended for systemic absorption, unless specifically exempted, shall contain a general warning under the heading “Warning” (or “Warnings” if it appears with additional warning statements) as follows: “If pregnant or breast-feeding, ask a health professional before use.” [first four words of this statement in bold type] In addition to the written warning, a symbol that conveys the intent of the warning may be used in labeling. (b) Where a specific warning relating to use during pregnancy or while nursing has been established for a particular drug product in a new drug application (NDA) or for a product covered by an OTC drug final monograph in part 330 of this chapter, the specific warning shall be used in place of the warning in paragraph (a) of this section, unless otherwise stated in the NDA or in the final OTC drug monograph. (c) The following OTC drugs are exempt from the provisions of paragraph (a) of this section: (1) Drugs that are intended to benefit the fetus or nursing infant during the period of pregnancy or nursing. (2) Drugs that are labeled exclusively for pediatric use. (d) The Food and Drug Administration will grant an exemption from paragraph (a) of this section where appropriate upon petition under the provisions of § 10.30 of this chapter. Decisions with respect to requests for exemptions shall be maintained in a permanent file for public review by the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. (e) The labeling of orally or rectally administered OTC aspirin and aspirin-containing drug products must bear a warning that immediately follows the general warning identified in paragraph (a) of this section. The warning shall be as follows: “It is especially important not to use” (select “aspirin” or “carbaspirin calcium,” as appropriate) “during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problem… | |||
| 21:21:4.0.1.1.2.3.1.5 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | C | Subpart C—Labeling Requirements for Over-the-Counter Drugs | § 201.64 Sodium labeling. | FDA | [61 FR 17806, Apr. 22, 1996, as amended at 62 FR 19925, Apr. 24, 1997; 64 FR 13286, Mar. 17, 1999; 69 FR 13724, Mar. 24, 2004; 69 FR 69280, Nov. 29, 2004] | (a) The labeling of over-the-counter (OTC) drug products intended for oral ingestion shall contain the sodium content per dosage unit (e.g., tablet, teaspoonful) if the sodium content of a single maximum recommended dose of the product (which may be one or more dosage units) is 5 milligrams or more. OTC drug products intended for oral ingestion include gum and lozenge dosage forms, but do not include dentifrices, mouthwashes, or mouth rinses. (b) The sodium content shall be expressed in milligrams per dosage unit and shall include the total amount of sodium regardless of the source, i.e., from both active and inactive ingredients. The sodium content shall be rounded-off to the nearest whole number. The sodium content per dosage unit shall follow the heading “Other information” as stated in § 201.66(c)(7). (c) The labeling of OTC drug products intended for oral ingestion shall contain the following statement under the heading “Warning” (or “Warnings” if it appears with additional warning statements) if the amount of sodium present in the labeled maximum daily dose of the product is more than 140 milligrams: “Ask a doctor before use if you have [in bold type] [bullet] 1 a sodium-restricted diet”. The warnings in §§ 201.64(c), 201.70(c), 201.71(c), and 201.72(c) may be combined, if applicable, provided the ingredients are listed in alphabetical order, e g., a calcium or sodium restricted diet. 1 See § 201 .66(b)(4) of this chapter for definition of bullet symbol. (d) The term sodium free may be used in the labeling of OTC drug products intended for oral ingestion if the amount of sodium in the labeled maximum daily dose is 5 milligrams or less and the amount of sodium per dosage unit is 0 milligram (when rounded-off in accord with paragraph (b) of this section). (e) The term very low sodium may be used in the labeling of OTC drug products intended for oral ingestion if the amount of sodium in the labeled maximum daily dose is 35 milligrams or less. (f) The term low sodium may be used in the labeli… | |||
| 21:21:4.0.1.1.2.3.1.6 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | C | Subpart C—Labeling Requirements for Over-the-Counter Drugs | § 201.66 Format and content requirements for over-the-counter (OTC) drug product labeling. | FDA | [64 FR 13286, Mar. 17, 1999, as amended at 65 FR 8, Jan. 3, 2000; 65 FR 48904, Aug. 10, 2000; 69 FR 13733, Mar. 24, 2004; 72 FR 71785, Dec. 19, 2007; 73 FR 403, Jan. 3, 2008; 74 FR 19407, Apr. 29, 2009; 76 FR 44487, July 26, 2011] | (a) Scope. This section sets forth the content and format requirements for the labeling of all OTC drug products. Where an OTC drug product is the subject of an applicable monograph or regulation that contains content and format requirements that conflict with this section, the content and format requirements in this section must be followed unless otherwise specifically provided in the applicable monograph or regulation. (b) Definitions. The following definitions apply to this section: (1) Act means the Federal Food, Drug, and Cosmetic Act (secs. 201 et seq. (21 U.S.C. 321 et seq. )). (2) Active ingredient means any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans. The term includes those components that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect. (3) Approved drug application means a new drug (NDA) or abbreviated new drug (ANDA) application approved under section 505 of the act (21 U.S.C. 355). (4) Bullet means a geometric symbol that precedes each statement in a list of statements. For purposes of this section, the bullet style is limited to solid squares or solid circles, in the format set forth in paragraph (d)(4) of this section. (5) Established name of a drug or ingredient thereof means the applicable official name designated under section 508 of the act (21 U.S.C. 358), or, if there is no designated official name and the drug or ingredient is recognized in an official compendium, the official title of the drug or ingredient in such compendium, or, if there is no designated official name and the drug or ingredient is not recognized in an official compendium, the common or usual name of the drug or ingredient. (6) FDA means the Food and Drug Administration. (7) Heading means the… | |||
| 21:21:4.0.1.1.2.3.1.7 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | C | Subpart C—Labeling Requirements for Over-the-Counter Drugs | § 201.67 Labeling requirements for a nonprescription drug product with an additional condition for nonprescription use (ACNU). | FDA | [89 FR 105329, Dec. 26, 2024] | (a) Scope. This section sets forth labeling requirements for a nonprescription drug product with an ACNU. (b) Definition. The following definition applies to this section: (1) Additional condition for nonprescription use (ACNU) means one or more FDA-approved conditions that an applicant of a nonprescription drug product must implement to ensure consumers' appropriate self-selection or appropriate actual use, or both, of the nonprescription drug product without the supervision of a practitioner licensed by law to administer such drug, if the applicant demonstrates and FDA determines that labeling alone is insufficient to ensure appropriate self-selection or appropriate actual use, or both. (2) [Reserved] (c) General labeling requirements. (1) A nonprescription drug product with an ACNU must comply with applicable labeling requirements for nonprescription drug products under this part, including the format and content requirements for nonprescription drug product labeling under § 201.66 and the statements specified in § 201.130(a) and (b). (2) A nonprescription drug product with an ACNU may also be approved with additional labeling that supplements the format and content requirements for nonprescription drug product labeling under § 201.66. (d) Format requirements for the required statement about the ACNU. The statement about the ACNU specified in § 201.130(b)(1) must meet all format requirements as follows: (1) The statement about the ACNU must appear on the principal display panel (see § 201.60) and the immediate container surface that the consumer is most likely to view when seeking information about the drug product. If the immediate container is a bottle, the statement about the ACNU must appear on the surface that the consumer is most likely to consider the front of the bottle. If the immediate container is a blister card (including a card that contains more than one blister unit), the statement about the ACNU must appear on the blister card surface that the consumer would most likely view wh… | |||
| 21:21:4.0.1.1.2.3.1.8 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | C | Subpart C—Labeling Requirements for Over-the-Counter Drugs | § 201.70 Calcium labeling. | FDA | [69 FR 13733, Mar. 24, 2004] | (a) The labeling of over-the-counter (OTC) drug products intended for oral ingestion shall contain the calcium content per dosage unit (e.g., tablet, teaspoonful) if the calcium content of a single maximum recommended dose of the product (which may be one or more dosage units) is 20 milligrams or more. OTC drug products intended for oral ingestion include gum and lozenge dosage forms, but do not include dentifrices, mouthwashes, or mouth rinses. (b) The calcium content shall be expressed in milligrams or grams per dosage unit and shall include the total amount of calcium regardless of the source, i.e., from both active and inactive ingredients. If the dosage unit contains less than 1 gram of calcium, milligrams should be used. The calcium content per dosage unit shall be rounded-off to the nearest 5 milligrams (or nearest tenth of a gram if over 1 gram). The calcium content per dosage unit shall follow the heading “Other information” as stated in § 201.66(c)(7). (c) The labeling of OTC drug products intended for oral ingestion shall contain the following statement under the heading “Warning” (or “Warnings” if it appears with additional warning statements) if the amount of calcium present in the labeled maximum daily dose of the product is more than 3.2 grams: “Ask a doctor before use if you have [in bold type] [bullet] 1 kidney stones [bullet] a calcium-restricted diet”. The warnings in §§ 201.64(c), 201.70(c), 201.71(c), and 201.72(c) may be combined, if applicable, provided the ingredients are listed in alphabetical order, e.g., a calcium or sodium restricted diet. 1 See § 201.66(b)(4) of this chapter for definition of bullet symbol. (d) Any product subject to this paragraph that is not labeled as required by this paragraph and that is initially introduced or initially delivered for introduction into interstate commerce after the following dates is misbranded under sections 201(n) and 502(a) and (f) of the Federal Food, Drug, and Cosmetic Act. (1) As of the date of approval of the application for an… | |||
| 21:21:4.0.1.1.2.3.1.9 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | C | Subpart C—Labeling Requirements for Over-the-Counter Drugs | § 201.71 Magnesium labeling. | FDA | [69 FR 13734, Mar. 24, 2004] | (a) The labeling of over-the-counter (OTC) drug products intended for oral ingestion shall contain the magnesium content per dosage unit (e.g., tablet, teaspoonful) if the magnesium content of a single maximum recommended dose of the product (which may be one or more dosage units) is 8 milligrams or more. OTC drug products intended for oral ingestion include gum and lozenge dosage forms, but do not include dentifrices, mouthwashes, or mouth rinses. (b) The magnesium content shall be expressed in milligrams or grams per dosage unit and shall include the total amount of magnesium regardless of the source, i.e., from both active and inactive ingredients. If the dosage unit contains less than 1 gram of magnesium, milligrams should be used. The magnesium content shall be rounded-off to the nearest 5 milligrams (or nearest tenth of a gram if over 1 gram). The magnesium content per dosage unit shall follow the heading “Other information” as stated in § 201.66(c)(7). (c) The labeling of OTC drug products intended for oral ingestion shall contain the following statement under the heading “Warning” (or “Warnings” if it appears with additional warning statements) if the amount of magnesium present in the labeled maximum daily dose of the product is more than 600 milligrams: “Ask a doctor before use if you have [in bold type] [bullet] 1 kidney disease [bullet] a magnesium-restricted diet”. The warnings in §§ 201.64(c), 201.70(c), 201.71(c), and 201.72(c) may be combined, if applicable, provided the ingredients are listed in alphabetical order, e.g., a magnesium or potassium-restricted diet. 1 See § 201.66(b)(4) of this chapter for definition of bullet symbol. (d) Any product subject to this paragraph that is not labeled as required by this paragraph and that is initially introduced or initially delivered for introduction into interstate commerce after the following dates is misbranded under sections 201(n) and 502(a) and (f) of the Federal Food, Drug, and Cosmetic Act. (1) As of the date of approval of the applic… | |||
| 21:21:4.0.1.1.2.4.1.1 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | D | Subpart D—Exemptions From Adequate Directions for Use | § 201.100 Prescription drugs for human use. | FDA | [40 FR 13998, Mar. 27, 1975, as amended at 40 FR 58799, Dec. 18, 1975; 42 FR 15674, Mar. 22, 1977; 43 FR 37989, Aug. 25, 1978; 44 FR 20659, Apr. 6, 1979; 44 FR 37467, June 26, 1979; 45 FR 25777, Apr. 15, 1980; 63 FR 26698, May 13, 1998; 64 FR 400, Jan. 5, 1999; 67 FR 4906, Feb. 1, 2002; 71 FR 3996, Jan. 24, 2006] | A drug subject to the requirements of section 503(b)(1) of the act shall be exempt from section 502(f)(1) if all the following conditions are met: (a) The drug is: (1)(i) In the possession of a person (or his agents or employees) regularly and lawfully engaged in the manufacture, transportation, storage, or wholesale distribution of prescription drugs; or (ii) In the possession of a retail, hospital, or clinic pharmacy, or a public health agency, regularly and lawfully engaged in dispensing prescription drugs; or (iii) In the possession of a practitioner licensed by law to administer or prescribe such drugs; and (2) It is to be dispensed in accordance with section 503(b) (b) The label of the drug bears: (1) The statement “Rx only” and (2) The recommended or usual dosage and (3) The route of administration, if it is not for oral use; and (4) The quantity or proportion of each active ingredient, as well as the information required by section 502 (d) and (e); and (5) If it is for other than oral use, the names of all inactive ingredients, except that: (i) Flavorings and perfumes may be designated as such without naming their components. (ii) Color additives may be designated as coloring without naming specific color components unless the naming of such components is required by a color additive regulation prescribed in subchapter A of this chapter. (iii) Trace amounts of harmless substances added solely for individual product identification need not be named. If it is intended for administration by parenteral injection, the quantity or proportion of all inactive ingredients, except that ingredients added to adjust the pH or to make the drug isotonic may be declared by name and a statement of their effect; and if the vehicle is water for injection it need not be named. (6) An identifying lot or control number from which it is possible to determine the complete manufacturing history of the package of the drug. (7) A statement directed to the pharmacist specifying the type of container to be used in dis… | |||
| 21:21:4.0.1.1.2.4.1.10 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | D | Subpart D—Exemptions From Adequate Directions for Use | § 201.127 Drugs; expiration of exemptions. | FDA | [41 FR 6911, Feb. 13, 1976] | (a) If a shipment or delivery, or any part thereof, of a drug which is exempt under the regulations in this section is made to a person in whose possession the article is not exempt, or is made for any purpose other than those specified, such exemption shall expire, with respect to such shipment or delivery or part thereof, at the beginning of that shipment or delivery. The causing of an exemption to expire shall be considered an act which results in such drug being misbranded unless it is disposed of under circumstances in which it ceases to be a drug or device. (b) The exemptions conferred by §§ 201.117, 201.119, 201.120, 201.122, and 201.125 shall continue until the drugs are used for the purposes for which they are exempted, or until they are relabeled to comply with section 502(f)(1) of the act. If, however, the drug is converted, compounded, or manufactured into a dosage form limited to prescription dispensing, no exemption shall thereafter apply to the article unless the dosage form is labeled as required by section 503(b) and §§ 201.100 or 201.105. | |||
| 21:21:4.0.1.1.2.4.1.11 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | D | Subpart D—Exemptions From Adequate Directions for Use | § 201.128 Meaning of “intended uses”. | FDA | [86 FR 41401, Aug. 2, 2021] | The words intended uses or words of similar import in §§ 201.5, 201.115, 201.117, 201.119, 201.120, 201.122, and 1100.5 of this chapter refer to the objective intent of the persons legally responsible for the labeling of an article (or their representatives). The intent may be shown by such persons' expressions, the design or composition of the article, or by the circumstances surrounding the distribution of the article. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives. Objective intent may be shown, for example, by circumstances in which the article is, with the knowledge of such persons or their representatives, offered or used for a purpose for which it is neither labeled nor advertised; provided, however, that a firm would not be regarded as intending an unapproved new use for an approved drug based solely on that firm's knowledge that such drug was being prescribed or used by health care providers for such use. The intended uses of an article may change after it has been introduced into interstate commerce by its manufacturer. If, for example, a packer, distributor, or seller intends an article for different uses than those intended by the person from whom he or she received the article, such packer, distributor, or seller is required to supply adequate labeling in accordance with the new intended uses. | |||
| 21:21:4.0.1.1.2.4.1.12 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | D | Subpart D—Exemptions From Adequate Directions for Use | § 201.129 Drugs; exemption for radioactive drugs for research use. | FDA | [41 FR 6911, Feb. 13, 1976] | A radioactive drug intended for administration to human research subjects during the course of a research project intended to obtain basic research information regarding metabolism (including kinetics, distribution, and localization) of a radioactively labeled drug or regarding human physiology, pathophysiology, or biochemistry (but not intended for immediate therapeutic, diagnostic, or similar purposes), under the conditions set forth in § 361.1 of this chapter, shall be exempt from section 502(f)(1) of the act if the packaging, label, and labeling are in compliance with § 361.1(f) of this chapter. | |||
| 21:21:4.0.1.1.2.4.1.13 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | D | Subpart D—Exemptions From Adequate Directions for Use | § 201.130 Exemption from adequate directions for use for a nonprescription drug product with an additional condition for nonprescription use (ACNU). | FDA | [89 FR 105329, Dec. 26, 2024] | A nonprescription drug product approved under section 505(c) or 505(j) of the Federal Food, Drug, and Cosmetic Act with an ACNU as defined in § 201.67(b)(1) is exempt from section 502(f)(1) only if all the following conditions are met: (a) The label of the drug must include instructions for the ACNU as follows: (1) Content of instructions for the ACNU must either be: (i) ACNU Instructions, which read as follows: “To check if this drug is safe for you, go to [insert where or how consumers can find information about the ACNU; for example, applicant's website, applicant's phone number, or specific retail location] and [insert action to be taken by consumer]. Do not take this drug without completing this step”; or (ii) Alternative ACNU Instructions: FDA may approve an NDA applicant's revisions to the ACNU Instructions when the revisions are appropriate for a specific drug product and the applicant supports the revisions with adequate data or other information that demonstrate sufficient consumer understanding of the revised statement. (2) The locations of instructions for the ACNU are as follows: (i) If the purpose of the ACNU is for self-selection, the instructions for the ACNU must appear under the “Use” or “Uses” heading required in § 201.66(c)(4) as the first statement, followed by the other information required in § 201.66(c)(4); (ii) If the purpose of the ACNU is for actual use, the instructions for the ACNU must appear under the “Directions” heading required in § 201.66(c)(6) as the first direction, followed by the other information required in § 201.66(c)(6); or (iii) If the purpose of the ACNU is for both self-selection and actual use, the instructions for the ACNU must appear under the “Use” or “Uses” heading as the first statement, followed by the other information required in § 201.66(c)(4) and may also appear under the “Directions” heading as the first direction, followed by the other information required in § 201.66(c)(6). (b) The label of the drug must include a statement about the ACNU as fol… | |||
| 21:21:4.0.1.1.2.4.1.2 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | D | Subpart D—Exemptions From Adequate Directions for Use | § 201.105 Veterinary drugs. | FDA | [40 FR 13998, Mar. 27, 1975, as amended at 42 FR 15674, Mar. 22, 1977; 57 FR 54300, Nov. 18, 1992; 72 FR 69119, Dec. 6, 2007; 89 FR 51768, June 18, 2024] | A drug subject to the requirements of section 503(f)(1) of the act shall be exempt from section 502(f)(1) of the act if it is a designated medical gas (as defined in § 201.161(c)(1)) or a medically appropriate combination of designated medical gases and is in compliance with § 201.161, or if all the following conditions are met: (a) The drug is: (1)(i) In the possession of a person (or his agents or employees) regularly and lawfully engaged in the manufacture, transportation, storage, or wholesale distribution of drugs that are to be used only by or on the prescription or other order of a licensed veterinarian; or (ii) In the possession of a retail, hospital, or clinic pharmacy, or other person authorized under State law to dispense veterinary prescription drugs, who is regularly and lawfully engaged in dispensing drugs that are to be used only by or on the prescription or other order of a licensed veterinarian; or (iii) In the possession of a licensed veterinarian for use in the course of his professional practice; and (2) To be dispensed in accordance with section 503(f) of the act. (b) The label of the drug bears: (1) The statement “Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian”; and (2) The recommended or usual dosage; and (3) The route of administration, if it is not for oral use; and (4) The quantity or proportion of each active ingredient as well as the information required by section 502(e) of the act; and (5) If it is for other than oral use, the names of all inactive ingredients, except that: (i) Flavorings and perfumes may be designated as such without naming their components. (ii) Color additives may be designated as coloring without naming specific color components unless the naming of such components is required by a color additive regulation prescribed in subchapter A of this chapter. (iii) Trace amounts of harmless substances added solely for individual product identification need not be named. If it is intended for administration by p… | |||
| 21:21:4.0.1.1.2.4.1.3 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | D | Subpart D—Exemptions From Adequate Directions for Use | § 201.115 New drugs or new animal drugs. | FDA | [40 FR 13998, Mar. 27, 1975, as amended at 72 FR 69119, Dec. 6, 2007] | A new drug shall be exempt from section 502(f)(1) of the act: (a) To the extent to which such exemption is claimed in an approved application with respect to such drug under section 505 or 512 of the act or an index listing with respect to such drug under section 572 of the act; or (b) If no application under section 505 or 512 of the act is approved and no request for addition to the index is granted under section 572 with respect to such drug but it complies with section 505(i), 512(j), or 572(g) of the act and regulations thereunder. No exemption shall apply to any other drug which would be a new drug if its labeling bore representations for its intended uses. | |||
| 21:21:4.0.1.1.2.4.1.4 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | D | Subpart D—Exemptions From Adequate Directions for Use | § 201.116 Drugs having commonly known directions. | FDA | [41 FR 6910, Feb. 13, 1976] | A drug shall be exempt from section 502(f)(1) of the act insofar as adequate directions for common uses thereof are known to the ordinary individual. | |||
| 21:21:4.0.1.1.2.4.1.5 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | D | Subpart D—Exemptions From Adequate Directions for Use | § 201.117 Inactive ingredients. | FDA | A harmless drug that is ordinarily used as an inactive ingredient, such as a coloring, emulsifier, excipient, flavoring, lubricant, preservative, or solvent, in the preparation of other drugs shall be exempt from section 502(f)(1) of the act. This exemption shall not apply to any substance intended for a use which results in the preparation of a new drug, unless an approved new-drug application provides for such use. | ||||
| 21:21:4.0.1.1.2.4.1.6 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | D | Subpart D—Exemptions From Adequate Directions for Use | § 201.119 In vitro diagnostic products. | FDA | [41 FR 6910, Feb. 13, 1976] | (a) “In vitro diagnostic products” are those reagents, instruments and systems intended for use in the diagnosis of disease or in the determination of the state of health in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation and examination of specimens taken from the human body. These products are drugs or devices as defined in section 201(g) and 201(h), respectively, of the Federal Food, Drug, and Cosmetic Act (the act) or are a combination of drugs and devices, and may also be a biological product subject to section 351 of the Public Health Service Act. (b) A product intended for use in the diagnosis of disease and which is an in vitro diagnostic product as defined in paragraph (a) of this section shall be deemed to be in compliance with the requirements of this section and section 502(f)(1) of the act if it meets the requirements of § 809.10 of this chapter. | |||
| 21:21:4.0.1.1.2.4.1.7 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | D | Subpart D—Exemptions From Adequate Directions for Use | § 201.120 Prescription chemicals and other prescription components. | FDA | [40 FR 13998, Mar. 27, 1975, as amended at 67 FR 4906, Feb. 1, 2002] | A drug prepared, packaged, and primarily sold as a prescription chemical or other component for use by registered pharmacists in compounding prescriptions or for dispensing in dosage unit form upon prescriptions shall be exempt from section 502(f)(1) of the act if all the following conditions are met: (a) The drug is an official liquid acid or official liquid alkali, or is not a liquid solution, emulsion, suspension, tablet, capsule, or other dosage unit form; and (b) The label of the drug bears: (1) The statement “For prescription compounding”; and (2) If in substantially all dosage forms in which it may be dispensed it is subject to section 503(b)(1) of the act, the statement “Rx only”; or (3) If it is not subject to section 503(b)(1) of the act and is by custom among retail pharmacists sold in or from the interstate package for use by consumers, “adequate directions for use” in the conditions for which it is so sold. Provided, however, That the information referred to in paragraph (b)(3) of this section may be contained in the labeling on or within the package from which it is to be dispensed. (c) This exemption shall not apply to any substance intended for use in compounding which results in a new drug, unless an approved new-drug application covers such use of the drug in compounding prescriptions. | |||
| 21:21:4.0.1.1.2.4.1.8 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | D | Subpart D—Exemptions From Adequate Directions for Use | § 201.122 Drugs for processing, repacking, or manufacturing. | FDA | [41 FR 6911, Feb. 13, 1976, as amended at 41 FR 15844, Apr. 15, 1976; 50 FR 7492, Feb. 22, 1985; 55 FR 11576, Mar. 29, 1990; 57 FR 54301, Nov. 18, 1992; 67 FR 4906, Feb. 1, 2002; 72 FR 69119, Dec. 6, 2007] | A drug in a bulk package, except tablets, capsules, or other dosage unit forms, intended for processing, repacking, or use in the manufacture of another drug shall be exempt from section 502(f)(1) of the act if its label bears the statement “Caution: For manufacturing, processing, or repacking”; and if in substantially all dosage forms in which it may be dispensed it is subject to section 503(b)(1) of the act, the statement “Rx only”, or if in substantially all dosage forms in which it may be dispensed it is subject to section 503(f)(1) of the act, the statement “Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian”. This exemption and the exemption under § 201.120 may be claimed for the same article. However, the exemption shall not apply to a substance intended for a use in manufacture, processing, or repacking which causes the finished article to be a new drug or new animal drug, unless: (a) An approved new drug application or new animal drug application or a new animal drug index listing covers the production and delivery of the drug substance to the application or index listing holder by persons named in the application or in the request for determination of eligibility for indexing, and, for a new drug substance, the export of it by such persons under § 314.410 of this chapter; or (b) If no application is approved with respect to such new drug or new animal drug, and it is not listed in the index, the label statement “Caution: For manufacturing, processing, or repacking” is immediately supplemented by the words “in the preparation of a new drug or new animal drug limited by Federal law to investigational use”, and the delivery is made for use only in the manufacture of such new drug or new animal drug limited to investigational use as provided in part 312 or § 511.1 or § 516.125 of this chapter; or (c) A new drug application or new animal drug application or a request for addition to the index covering the use of the drug substance in the production and marketing … | |||
| 21:21:4.0.1.1.2.4.1.9 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | D | Subpart D—Exemptions From Adequate Directions for Use | § 201.125 Drugs for use in teaching, law enforcement, research, and analysis. | FDA | [41 FR 6911, Feb. 13, 1976] | A drug subject to § 201.100 or § 201.105, shall be exempt from section 502(f)(1) of the act if shipped or sold to, or in the possession of, persons regularly and lawfully engaged in instruction in pharmacy, chemistry, or medicine not involving clinical use, or engaged in law enforcement, or in research not involving clinical use, or in chemical analysis, or physical testing, and is to be used only for such instruction, law enforcement, research, analysis, or testing. | |||
| 21:21:4.0.1.1.2.5.1.1 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | E | Subpart E—Other Exemptions | § 201.150 Drugs; processing, labeling, or repacking. | FDA | [41 FR 6911, Feb. 13, 1976, as amended at 64 FR 400, Jan. 5, 1999] | (a) Except as provided by paragraphs (b) and (c) of this section, a shipment or other delivery of a drug which is, in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantity at an establishment other than that where originally processed or packed, shall be exempt, during the time of introduction into and movement in interstate commerce and the time of holding in such establishment, from compliance with the labeling and packaging requirements of sections 501(b) and 502 (b), (d), (e), (f), and (g) of the act if: (1) The person who introduced such shipment or delivery into interstate commerce is the operator of the establishment where such drug is to be processed, labeled, or repacked; or (2) In case such person is not such operator, such shipment or delivery is made to such establishment under a written agreement, signed by and containing the post-office addresses of such person and such operator, and containing such specifications for the processing, labeling, or repacking, as the case may be, of such drug in such establishment as will insure, if such specifications are followed, that such drug will not be adulterated or misbranded within the meaning of the act upon completion of such processing, labeling, or repacking. Such person and such operator shall each keep a copy of such agreement until 2 years after the final shipment or delivery of such drug from such establishment, and shall make such copies available for inspection at any reasonable hour to any officer or employee of the Department who requests them. (b) An exemption of a shipment or other delivery of a drug under paragraph (a)(1) of this section shall, at the beginning of the act of removing such shipment or delivery, or any part thereof, from such establishment, become void ab initio if the drug comprising such shipment, delivery, or part is adulterated or misbranded within the meaning of the act when so removed. (c) An exemption of a shipment or other delivery of a drug under paragraph (a)(2) of … | |||
| 21:21:4.0.1.1.2.5.1.2 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | E | Subpart E—Other Exemptions | § 201.161 Medical gases. | FDA | [89 FR 51768, June 18, 2024] | (a) The requirements of sections 503(b)(4) and 502(f) of the Federal Food, Drug, and Cosmetic Act are deemed to have been met for a designated medical gas or a medically appropriate combination of designated medical gases if the labeling on its final use container bears the following: (1) In the case of oxygen: (i) A warning statement providing that uninterrupted use of high concentrations of oxygen over a long duration, without monitoring its effect on oxygen content of arterial blood, may be harmful; that oxygen should not be used on patients who have stopped breathing unless used in conjunction with resuscitative equipment; and, in the case of oxygen that may be provided without a prescription for use in the event of depressurization or other environmental oxygen deficiency, or for oxygen deficiency or for use in emergency resuscitation when administered by properly trained personnel, a warning statement providing that oxygen may be used for emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation, and that for all other medical applications a prescription is required. (ii) A clear and prominent warning containing the statements “No Smoking” and “No Vaping” and a graphic symbol conveying that smoking, vaping, and open flames near oxygen are dangerous. (2) In the case of a designated medical gas other than oxygen, and in the case of medically appropriate combinations of any designated medical gases: (i) A warning statement providing that the administration of the gas or gas combination (as applicable) may be hazardous or contraindicated; and that the gas or gas combination (as applicable) should be used only by or under the supervision of a licensed practitioner who is experienced in the use and administration of the gas or gas combination (as applicable) and is familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and with the hazards, contraindications, and side effects and the precautions to be taken. (i… | |||
| 21:21:4.0.1.1.2.6.1.1 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | F | Subpart F—Labeling Claims for Drugs in Drug Efficacy Study | § 201.200 Disclosure of drug efficacy study evaluations in labeling and advertising. | FDA | [40 FR 13998, Mar. 27, 1975, as amended at 55 FR 11576, Mar. 29, 1990] | (a)(1) The National Academy of Sciences—National Research Council, Drug Efficacy Study Group, has completed an exhaustive review of labeling claims made for drugs marketed under new-drug and antibiotic drug procedures between 1938 and 1962. The results are compiled in “Drug Efficacy Study, A Report to the Commissioner of Food and Drugs from the National Academy of Sciences (1969).” As the report notes, this review has made “an audit of the state of the art of drug usage that has been uniquely extensive in scope and uniquely intensive in time” and is applicable to more than 80 percent of the currently marketed drugs. The report further notes that the quality of the evidence of efficacy, as well as the quality of the labeling claims, is poor. Labeling and other promotional claims have been evaluated as “effective,” “probably effective,” “possibly effective,” “ineffective,” “ineffective as a fixed combination,” and “effective but,” and a report for each drug in the study has been submitted to the Commissioner. (2) The Food and Drug Administration is processing the reports, seeking voluntary action on the part of the drug manufacturers and distributors in the elimination or modification of unsupported promotional claims, and initiating administrative actions as necessary to require product and labeling changes. (3) Delays have been encountered in bringing to the attention of the prescribers of prescription items the conclusions of the expert panels that reviewed the promotional claims. (b) The Commissioner of Food and Drugs concludes that: (1) The failure to disclose in the labeling of a drug and in other promotional material the conclusions of the Academy experts that a claim is “ineffective,” “possibly effective,” “probably effective,” or “ineffective as a fixed combination,” while labeling and promotional material bearing any such claim are being used, is a failure to disclose facts that are material in light of the representations made and causes the drug to be misbranded. (2) The Academy classification of a… | |||
| 21:21:4.0.1.1.2.7.1.1 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | G | Subpart G—Specific Labeling Requirements for Specific Drug Products | § 201.300 Notice to manufacturers, packers, and distributors of glandular preparations. | FDA | (a) Under date of December 4, 1941, in a notice to manufacturers of glandular preparations, the Food and Drug Administration expressed the opinion that preparations of inert glandular materials intended for medicinal use should, in view of the requirement of section 201(n) of the Federal Food, Drug, and Cosmetic Act (52 Stat. 1041; 21 U.S.C. 321(n)), be labeled with a statement of the material fact that there is no scientific evidence that the articles contain any therapeutic or physiologically active constituents. Numerous preparations of such inert glandular materials were subsequently marketed with disclaimers of the type suggested. The term inert glandular materials means preparations incapable of exerting an action or effect of some significant or measurable benefit in one way or another, i.e., in the diagnosis, cure, mitigation, treatment, or prevention of disease, or in affecting the structure or any function of the body. (b) Manufacturers have heretofore taken advantage of § 201.100 permitting omission of directions for use when the label bears the prescription legend. Section 201.100(c) requires that the labeling of the drug, which may include brochures readily available to licensed practitioners, bear information as to the use of the drug by practitioners licensed by law to administer it. Obviously, information adequate for the use of an inert glandular preparation is not available to practitioners licensed by law. (c) The Department of Health and Human Services is of the opinion that inert glandular materials may not be exempted from the requirements of section 502(f)(1) of the act that they bear adequate directions for use; and, accordingly, that their labeling must include among other things, representations as to the conditions for which such articles are intended to be used or as to the structure or function of the human body that they are intended to affect. Since any such representations offering these articles for use as drugs would be false or misleading, such articles will be considered to… | ||||
| 21:21:4.0.1.1.2.7.1.10 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | G | Subpart G—Specific Labeling Requirements for Specific Drug Products | § 201.309 Acetophenetidin (phenacetin)-containing preparations; necessary warning statement. | FDA | (a) In 1961, the Food and Drug Administration, pursuant to its statutory responsibility for the safety and effectiveness of drugs shipped in interstate commerce, began an active investigation of reports of possible toxic effects and renal damage due to misuse of the drug acetophenetidin. This study led to the decision that there was probable cause to conclude that misuse and prolonged use of the drug were in fact responsible for kidney lesions and disease. The Commissioner of Food and Drugs, in December 1963, appointed an ad hoc Advisory Committee of Inquiry on Possible Nephrotoxicity Associated With the Abuse of Acetophenetidin (Phenacetin)-Containing Preparations. This committee, composed of scientists in the fields of pharmacology and medicine, on April 23, 1964, submitted its findings and conclusions in the matter and recommended that all acetophenetidin (phenacetin)-containing preparations bear a warning as provided in section 502(f)(2) of the Federal Food, Drug, and Cosmetic Act. (b) On the basis of the studies made by the Food and Drug Administration and the report of the Advisory Committee, the Commissioner of Food and Drugs has concluded that it is necessary for the protection of users that the label and labeling of all acetophenetidin (phenacetin)-containing preparations bear a warning statement to the following effect: “Warning—This medication may damage the kidneys when used in large amounts or for a long period of time. Do not take more than the recommended dosage, nor take regularly for longer than 10 days without consulting your physician.” | ||||
| 21:21:4.0.1.1.2.7.1.11 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | G | Subpart G—Specific Labeling Requirements for Specific Drug Products | § 201.310 Phenindione; labeling of drug preparations intended for use by man. | FDA | (a) Reports in the medical literature and data accumulated by the Food and Drug Administration indicate that phenindione, a synthetic anticoagulant drug, has caused a number of cases of agranulocytosis (with two fatalities). There are also reports implicating the drug in cases of hepatitis and hypersensitivity reactions. In view of the potentially serious effects found to be associated with preparations of this drug intended for use by man, the Commissioner of Food and Drugs will regard such preparations as misbranded within the meaning of section 502(f) (1) and (2) of the Federal Food, Drug, and Cosmetic Act, unless the label and labeling on or within the package from which the drug is to be dispensed, and any other labeling furnishing or purporting to furnish information for use of the drug, bear a conspicuous warning statement to the following effect: “Warning: Agranulocytosis and hepatitis have been associated with the use of phenindione. Patients should be instructed to report promptly prodromal symptoms such as marked fatigue, chill, fever, and sore throat. Periodic blood studies and liver function tests should be performed. Use of the drug should be discontinued if leukopenia occurs or if evidence of hypersensitivity, such as dermatitis or fever, appears.” (b) Regulatory action may be initiated with respect to preparations of phenindione intended for use by man found within the jurisdiction of the act on or after November 25, 1961, unless such preparations are labeled in accordance with paragraph (a) of this section. | ||||
| 21:21:4.0.1.1.2.7.1.12 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | G | Subpart G—Specific Labeling Requirements for Specific Drug Products | § 201.311 [Reserved] | FDA | |||||
| 21:21:4.0.1.1.2.7.1.13 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | G | Subpart G—Specific Labeling Requirements for Specific Drug Products | § 201.312 Magnesium sulfate heptahydrate; label declaration on drug products. | FDA | Magnesium sulfate heptahydrate should be listed on the label of a drug product as epsom salt, which is its common or usual name. | ||||
| 21:21:4.0.1.1.2.7.1.14 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | G | Subpart G—Specific Labeling Requirements for Specific Drug Products | § 201.313 Estradiol labeling. | FDA | The article presently recognized in The National Formulary under the heading “Estradiol” and which is said to be “17-cis-beta estradiol” is the same substance formerly recognized in the United States Pharmacopeia under the designation “Alpha Estradiol.” The substance should no longer be referred to in drug labeling as “Alpha Estradiol.” The Food and Drug Administration would not object to label references to the article as simply “Estradiol”; nor would it object if the label of a preparation containing this substance referred to the presence of “Estradiol (formerly known as Alpha Estradiol).” | ||||
| 21:21:4.0.1.1.2.7.1.15 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | G | Subpart G—Specific Labeling Requirements for Specific Drug Products | § 201.314 Labeling of drug preparations containing salicylates. | FDA | [40 FR 13998, Mar. 27, 1985, as amended at 51 FR 8182, Mar. 7, 1986; 53 FR 21637, June 9, 1988; 53 FR 24830, June 30, 1988; 64 FR 13291, Mar. 17, 1999; 65 FR 8, Jan. 3, 2000; 68 FR 18869, Apr. 17, 2003] | (a) The label of any oral drug preparation intended for sale without prescription and which contains any salicylate ingredient (including aspirin, salicylamide, other salicylates, and combinations) must conspicuously bear, on a clearly contrasting background, the warning statement: “Keep out of reach of children [highlighted in bold type]. In case of overdose, get medical help or contact a Poison Control Center right away,” or “Keep out of reach of children [highlighted in bold type],” except that if the article is an aspirin preparation, it shall bear the first of these warning statements. Such a warning statement is required for compliance with section 502(f)(2) of the Federal Food, Drug, and Cosmetic Act and is intended to guard against accidental poisonings. Safety closures that prevent access to the drug by young children are also recommended to guard against accidental poisonings. (b) Effervescent preparations and preparations containing para-aminosalicylate as the only salicylate ingredient are exempted from this labeling requirement. (c) Aspirin tablets sold as such and containing no other active ingredients, except tablets which cannot be readily subdivided into a child's dose because of their coating or size, should always bear dosage directions for each age group down to 3 years of age, with a statement such as “For children under 3 years of age, consult your physician.” It is recommended that: (1) Aspirin tablets especially made for pediatric use be produced only in 1 1/4 -grain size to reduce the hazard of errors in dosage; (2) By June 1, 1967, manufacturers and distributors of 1 1/4 -grain size aspirin tablets discontinue the distribution of such tablets in retail containers containing more than 36 tablets, to reduce the hazard of accidental poisoning; (3) The flavoring of 5-grain aspirin tablets or other “adult aspirin tablets” be discontinued; and (4) Labeling giving undue emphasis to the pleasant flavor of flavored aspirin tablets be discontinued. (d) Salicylate preparations other than a… | |||
| 21:21:4.0.1.1.2.7.1.16 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | G | Subpart G—Specific Labeling Requirements for Specific Drug Products | § 201.315 Over-the-counter drugs for minor sore throats; suggested warning. | FDA | The Food and Drug Administration has studied the problem of the labeling of lozenges or troches containing a local anesthetic, chewing gum containing aspirin, various mouth washes and gargles and other articles sold over the counter for the relief of minor irritations of the mouth or throat. It will not object to the labeling of suitable articles of this type “For the temporary relief of minor sore throats”, provided this is immediately followed in the labeling with a warning statement in prominent type essentially as follows: “Warning—Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by physician.” | ||||
| 21:21:4.0.1.1.2.7.1.17 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | G | Subpart G—Specific Labeling Requirements for Specific Drug Products | § 201.316 Drugs with thyroid hormone activity for human use; required warning. | FDA | [43 FR 22009, May 23, 1978] | (a) Drugs with thyroid hormone activity have been promoted for, and continue to be dispensed and prescribed for, use in the treatment of obesity, although their safety and effectiveness for that use have never been established. (b) Drugs for human use with thyroid hormone activity are misbranded within the meaning of section 502 of the Federal Food, Drug, and Cosmetic Act unless their labeling bears the following boxed warning at the beginning of the “Warnings” section: Drugs with thyroid hormone activity, alone or together with other therapeutic agents, have been used for the treatment of obesity. In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction. Larger doses may produce serious or even life-threatening manifestations of toxicity, particularly when given in association with sympathomimetic amines such as those used for their anorectic effects. | |||
| 21:21:4.0.1.1.2.7.1.18 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | G | Subpart G—Specific Labeling Requirements for Specific Drug Products | § 201.317 Digitalis and related cardiotonic drugs for human use in oral dosage forms; required warning. | FDA | [43 FR 22009, May 23, 1978, as amended at 85 FR 72907, Nov. 16, 2020] | (a) Digitalis and related cardiotonic drugs for human use in oral dosage forms have been promoted for, and continue to be dispensed and prescribed for, use in the treatment of obesity, although their safety and effectiveness for that use have never been established. (b) Digitalis and related cardiotonic drugs for human use in oral dosage forms are misbranded within the meaning of section 502 of the Federal Food, Drug, and Cosmetic Act unless their labeling bears the following boxed warning at the beginning of the “Warnings” section: Digitalis alone or with other drugs has been used in the treatment of obesity. This use of digoxin or other digitalis glycosides is unwarranted. Moreover, since they may cause potentially fatal arrhythmias or other adverse effects, the use of these drugs in the treatment of obesity is dangerous. (c) This section does not apply to digoxin products for oral use. | |||
| 21:21:4.0.1.1.2.7.1.19 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | G | Subpart G—Specific Labeling Requirements for Specific Drug Products | § 201.319 Water-soluble gums, hydrophilic gums, and hydrophilic mucilloids (including, but not limited to agar, alginic acid, calcium polycarbophil, carboxymethylcellulose sodium, carrageenan, chondrus, glucomannan ((B-1,4 linked) polymannose acetate), guar gum, karaya gum, kelp, methylcellulose, plantago seed (psyllium), polycarbophil tragacanth, and xanthan gum) as active ingredients; required warnings and directions. | FDA | [58 FR 45201, Aug. 26, 1993, as amended at 64 FR 13292, Mar. 17, 1999; 72 FR 14674, Mar. 29, 2007] | (a) Reports in the medical literature and data accumulated by the Food and Drug Administration indicate that esophageal obstruction and asphyxiation have been associated with the ingestion of water-soluble gums, hydrophilic gums, and hydrophilic mucilloids including, but not limited to, agar, alginic acid, calcium polycarbophil, carboxymethylcellulose sodium, carrageenan, chondrus, glucomannan ((B-1,4 linked) polymannose acetate), guar gum, karaya gum, kelp, methylcellulose, plantago seed (psyllium), polycarbophil, tragacanth, and xanthan gum. Esophageal obstruction and asphyxiation due to orally-administered drug products containing water-soluble gums, hydrophilic gums, and hydrophilic mucilloids as active ingredients are significant health risks when these products are taken without adequate fluid or when they are used by individuals with esophageal narrowing or dysfunction, or with difficulty in swallowing. Additional labeling is needed for the safe and effective use of any OTC drug product for human use containing a water-soluble gum, hydrophilic gum, or hydrophilic mucilloid as an active ingredient when marketed in a dry or incompletely hydrated form to include, but not limited to, the following dosage forms: Capsules, granules, powders, tablets, and wafers. Granular dosage forms containing psyllium are not generally recognized as safe and effective as OTC laxatives (see § 310.545(a)(12)(i)(B) of this chapter) and may not be marketed without an approved new drug application because the warnings and directions in paragraph (b) of this section have been found inadequate for these products. (b) Any drug products for human use containing a water-soluble gum, hydrophilic gum, or hydrophilic mucilloid as an active ingredient in an oral dosage form when marketed in a dry or incompletely hydrated form as described in paragraph (a) of this section are misbranded within the meaning of section 502 of the Federal Food, Drug, and Cosmetic Act unless their labeling bears the following warnings (under the subheading “Chok… | |||
| 21:21:4.0.1.1.2.7.1.2 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | G | Subpart G—Specific Labeling Requirements for Specific Drug Products | § 201.301 Notice to manufacturers, packers, and distributors of estrogenic hormone preparations. | FDA | Some drug preparations fabricated wholly or in part from estradiol and labeled as to potency in terms of international units or in terms of international units of estrone activity have been marketed. The international unit of the estrus-producing hormone was established by the International Conference on the Standardization of Sex Hormones at London, England, on August 1, 1932. This unit was defined as “the specific estrus-producing activity contained in 0.1 gamma ( = 0.0001 mg.) of the standard” hydroxyketonic hormone found in urine (estrone). The International Conference declared that it did not recommend the determination of the activity of nonhydroxyketonic forms of estrogenic hormones in units of estrone because of the varying ratios between the activity of such nonhydroxyketonic estrogenic hormones and estrone, when measured by different methods on test animals. There is no international unit for measuring the activity of estradiol and no accepted relationship between its activity and that of estrone, either in test animals or in humans. The declaration of potency of estradiol in terms of international units or in terms of international units of estrone activity is therefore considered misleading, within the meaning of 21 U.S.C. 352(a). The declaration of the estradiol content of an estrogenic hormone preparation in terms of weight is considered appropriate. | ||||
| 21:21:4.0.1.1.2.7.1.20 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | G | Subpart G—Specific Labeling Requirements for Specific Drug Products | § 201.320 Warning statements for drug products containing or manufactured with chlorofluorocarbons or other ozone-depleting substances. | FDA | [61 FR 20100, May 3, 1996] | (a)(1) All drug products containing or manufactured with chlorofluorocarbons, halons, carbon tetrachloride, methyl chloride, or any other class I substance designated by the Environmental Protection Agency (EPA) shall, except as provided in paragraph (b) or (c) of this section, bear the following warning statement: Warning: Contains [or Manufactured with, if applicable] [ insert name of substance ], a substance which harms public health and the environment by destroying ozone in the upper atmosphere. Warning: Contains [or Manufactured with, if applicable] [ insert name of substance ], a substance which harms public health and the environment by destroying ozone in the upper atmosphere. (2) The warning statement shall be clearly legible and conspicuous on the product, its immediate container, its outer packaging, or other labeling in accordance with the requirements of 40 CFR part 82 and appear with such prominence and conspicuousness as to render it likely to be read and understood by consumers under normal conditions of purchase. (b)(1) For prescription drug products for human use, the following alternative warning statement may be used: The indented statement below is required by the Federal government's Clean Air Act for all products containing or manufactured with chlorofluorocarbons (CFC's) [or name of other class I substance, if applicable]: This product contains [or is manufactured with, if applicable] [ insert name of substance ], a substance which harms the environment by destroying ozone in the upper atmosphere. Your physician has determined that this product is likely to help your personal health. USE THIS PRODUCT AS DIRECTED, UNLESS INSTRUCTED TO DO OTHERWISE BY YOUR PHYSICIAN. If you have any questions about alternatives, consult with your physician. (2) The warning statement shall be clearly legible and conspicuous on the product, its immediate container, its outer packaging, or other labeling in accordance with the requirements of 40 CFR part 82 and appear with such prominence and conspic… | |||
| 21:21:4.0.1.1.2.7.1.21 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | G | Subpart G—Specific Labeling Requirements for Specific Drug Products | § 201.323 Aluminum in large and small volume parenterals used in total parenteral nutrition. | FDA | [65 FR 4110, Jan. 26, 2000, as amended at 67 FR 70691, Nov. 26, 2002; 68 FR 32981, June 3, 2003] | (a) The aluminum content of large volume parenteral (LVP) drug products used in total parenteral nutrition (TPN) therapy must not exceed 25 micrograms per liter (µg/L). (b) The package insert of LVP's used in TPN therapy must state that the drug product contains no more than 25 µg/L of aluminum. This information must be contained in the “Precautions” section of the labeling of all large volume parenterals used in TPN therapy. (c) Except as provided in paragraph (d) of this section, the maximum level of aluminum present at expiry must be stated on the immediate container label of all small volume parenteral (SVP) drug products and pharmacy bulk packages (PBPs) used in the preparation of TPN solutions. The aluminum content must be stated as follows: “Contains no more than __ µg/L of aluminum.” The immediate container label of all SVP's and PBP's that are lyophilized powders used in the preparation of TPN solutions must contain the following statement: “When reconstituted in accordance with the package insert instructions, the concentration of aluminum will be no more than __ µg/L.” This maximum level of aluminum must be stated as the highest of: (1) The highest level for the batches produced during the last 3 years; (2) The highest level for the latest five batches, or (3) The maximum historical level, but only until completion of production of the first five batches after July 26, 2004. (d) If the maximum level of aluminum is 25 µg/L or less, instead of stating the exact amount of aluminum as required in paragraph (c) of this section, the immediate container label may state: “Contains no more than 25 µg/L of aluminum.” If the SVP or PBP is a lyophilized powder, the immediate container label may state: “When reconstituted in accordance with the package insert instructions, the concentration of aluminum will be no more than 25 µg/L”. (e) The package insert for all LVP's, all SVP's, and PBP's used in TPN must contain a warning statement. This warning must be contained in the “Warnings” section of the labeling.… | |||
| 21:21:4.0.1.1.2.7.1.22 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | G | Subpart G—Specific Labeling Requirements for Specific Drug Products | § 201.325 Over-the-counter drugs for vaginal contraceptive and spermicide use containing nonoxynol 9 as the active ingredient; required warnings and labeling information. | FDA | [72 FR 71785, Dec. 19, 2007] | (a) Studies indicate that use of vaginal contraceptive drug products containing nonoxynol 9 does not protect against infection from the human immunodeficiency virus (HIV), the virus that causes acquired immunodeficiency syndrome (AIDS), or against the transmission of other sexually transmitted diseases (STDs). Studies also indicate that use of vaginal contraceptive drug products containing nonoxynol 9 can increase vaginal irritation, such as the disruption of the vaginal epithelium, and also can cause epithelial disruption when used in the rectum. These effects may increase the risk of transmission of the AIDS virus (HIV) from an infected partner. Therefore, consumers should be warned that these products do not protect against the transmission of the AIDS virus (HIV) or other STDs, that use of these products can increase vaginal and rectal irritation, which may increase the risk of getting the AIDS virus (HIV) from an HIV infected partner, and that the products are not for rectal use. Consumers should also be warned that these products should not be used by persons who have HIV/AIDS or are at high risk for HIV/AIDS. (b) The labeling of OTC vaginal contraceptive and spermicide drug products containing nonoxynol 9 as the active ingredient, whether subject to the ongoing OTC drug review or an approved drug application, must contain the following warnings under the heading “Warnings,” in accordance with 21 CFR 201.66. (1) “[bullet] For vaginal use only [bullet] Not for rectal (anal) use” [both warnings in bold type]. (2) “Sexually transmitted diseases (STDs) alert [in bold type]: This product does not [word “not” in bold type] protect against HIV/AIDS or other STDs and may increase the risk of getting HIV from an infected partner”. (3) “Do not use” [in bold type] if you or your sex partner has HIV/AIDS. If you do not know if you or your sex partner is infected, choose another form of birth control”. (4) “When using this product [in bold type] [optional, bullet] you may get vaginal irritation (burning, itching, o… | |||
| 21:21:4.0.1.1.2.7.1.23 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | G | Subpart G—Specific Labeling Requirements for Specific Drug Products | § 201.326 Over-the-counter drug products containing internal analgesic/antipyretic active ingredients; required warnings and other labeling. | FDA | [74 FR 19407, Apr. 29, 2009, as amended at 74 FR 31180, June 30, 2009; 74 FR 61514, Nov. 25, 2009] | (a) Labeling. The labeling for all over-the-counter (OTC) drug products containing any internal analgesic/antipyretic active ingredients (including, but not limited to, acetaminophen, aspirin, carbaspirin calcium, choline salicylate, ibuprofen, ketoprofen, magnesium salicylate, naproxen sodium, and sodium salicylate) alone or in combination must bear the following labeling in accordance with §§ 201.60, 201.61, and 201.66. (1) Acetaminophen —(i) Statement of identity. The statement of identity appears in accord with §§ 201.61 and 299.4 of this chapter. The ingredient name “acetaminophen” must appear highlighted (e.g., fluorescent or color contrast) or in bold type, be in lines generally parallel to the base on which the package rests as it is designed to be displayed, and be in one of the following sizes, whichever is greater: (A) At least one-quarter as large as the size of the most prominent printed matter on the principal display panel (PDP), or (B) At least as large as the size of the “Drug Facts” title, as required in § 201.66(d)(2). The presence of acetaminophen must appear as part of the established name of the drug, as defined in § 299.4 of this chapter. Combination products containing acetaminophen and a nonanalgesic ingredient(s) (e.g., cough-cold) must include the name “acetaminophen” and the name(s) of the other active ingredient(s) in the product on the PDP in accord with this paragraph. Only the name “acetaminophen” must appear highlighted or in bold type, and in a prominent print size, as described in this paragraph. (ii) Active Ingredient and Purpose Headings. The information required under § 201.66(c)(2) and (c)(3) of this chapter must be included under these headings. The information under these headings, but not the headings, may appear highlighted. (iii) For products labeled for adults only. The labeling of the product states the following warnings under the heading “Warnings”: (A) The liver warning states “Liver warning [heading in bold type]: This product contains acetaminophen… | |||
| 21:21:4.0.1.1.2.7.1.24 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | G | Subpart G—Specific Labeling Requirements for Specific Drug Products | § 201.327 Over-the-counter sunscreen drug products; required labeling based on effectiveness testing. | FDA | [76 FR 35660, June 17, 2011, as amended at 76 FR 38975, July 5, 2011] | The following provisions apply to sunscreen products containing aminobenzoic acid, avobenzone, cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, oxybenzone, padimate O, sulisobenzone, titanium dioxide, trolamine salicylate, or zinc oxide, alone or in combination. The provisions do not apply to sunscreen products marketed under approved new drug applications or abbreviated new drug applications. (a) Principal display panel. In addition to the statement of identity in paragraph (b) of this section, the following labeling shall be prominently placed on the principal display panel: (1) Effectiveness claim —(i) For products that pass the broad spectrum test in paragraph (j) of this section. (A) The labeling states “Broad Spectrum SPF [insert numerical SPF value resulting from testing under paragraph (i) of this section]”. (B) Prominence. The Broad Spectrum SPF statement shall appear as continuous text with no intervening text or graphic. The entire text shall appear in the same font style, size, and color with the same background color. (ii) For sunscreen products that do not pass the broad spectrum test in paragraph (j) of this section. The labeling states “SPF [insert numerical SPF value resulting from testing under paragraph (i) of this section]”. The entire text shall appear in the same font style, size, and color with the same background color. (2) Water resistance statements —(i) For products that provide 40 minutes of water resistance according to the test in paragraph (i)(7)(i) of this section. The labeling states “Water Resistant (40 minutes)”. (ii) For products that provide 80 minutes of water resistance according to the test in paragraph (i)(7)(ii) of this section. The labeling states “Water Resistant (80 minutes)”. (b) Statement of identity. The labeling of the product contains the established name of the drug, if any, and identifies the drug as a “sunscreen.” (c) Indications. The labeling of the product states, under the heading “Use… | |||
| 21:21:4.0.1.1.2.7.1.25 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | G | Subpart G—Specific Labeling Requirements for Specific Drug Products | § 201.328 Labeling of medical gas containers. | FDA | [81 FR 81696, Nov. 18, 2016, as amended at 89 FR 51769, June 18, 2024] | (a) Portable cryogenic medical gas containers. For the purposes of this section a portable cryogenic medical gas container is one that is capable of being transported and is intended to be attached to a medical gas supply system within a hospital, health care entity, nursing home, other facility, or home health care setting, or is used to fill small cryogenic gas containers for use by individual patients. The term excludes cryogenic containers that are not designed to be connected to a medical gas supply system, e.g., tank trucks, trailers, rail cars, or small cryogenic gas containers for use by individual patients (including portable liquid oxygen units as defined at § 868.5655 of this chapter). (1) Each portable cryogenic medical gas container must be conspicuously marked with a 360° wraparound label identifying its contents. Such label must meet the requirements of § 213.94(e)(3) of this chapter and the following additional requirements. (i) If the container holds a single gas, the name of the gas held in the container must be printed on the label in one of the following ways: (A) Using lettering that appears in the color designated for the gas in paragraph (c) of this section and that is printed against a white background, or (B) Using lettering that appears in white against a background that is painted in the color for the gas designated in paragraph (c) of this section. (ii) The lettering for the name of the gas on the label must be at least 2 inches high. (iii) The name of the gas must be printed continuously around the label and be capable of being read around the entire container. (iv) The label must be on the sidewall of the container, as close to the top of the container as possible but below the top weld seam. (v) A portable cryogenic medical gas container may only be colored in the color or colors designated in paragraph (c) of this section if the gas or gases held within the container correspond to that color or those colors. (2) A label on the container (either the 360° wraparound la… | |||
| 21:21:4.0.1.1.2.7.1.3 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | G | Subpart G—Specific Labeling Requirements for Specific Drug Products | § 201.302 Notice to manufacturers, packers, and distributors of drugs for internal use which contain mineral oil. | FDA | (a) In the past few years research studies have altered medical opinion as to the usefulness and harmfulness of mineral oil in the human body. These studies have indicated that when mineral oil is used orally near mealtime it interferes with absorption from the digestive tract of provitamin A and the fat-soluble vitamins A, D, and K, and consequently interferes with the utilization of calcium and phosphorus, with the result that the user is left liable to deficiency diseases. When so used in pregnancy it predisposes to hemorrhagic disease of the newborn. (b) There is accumulated evidence that the indiscriminate administration of mineral oil to infants may be followed by aspiration of the mineral oil and subsequent “lipoid pneumonia.” (c) In view of these facts, the Department of Health and Human Services will regard as misbranded under the provisions of the Federal Food, Drug, and Cosmetic Act a drug for oral administration consisting in whole or in part of mineral oil, the labeling of which encourages its use in pregnancy or indicates or implies that such drug is for administration to infants. (d) It is also this Department's view that the act requires the labelings of such drugs to bear a warning against consumption other than at bedtime and against administration to infants. The following form of warning is suggested: “Caution: To be taken only at bedtime. Do not use at any other time or administer to infants, except upon the advice of a physician.” (e) This statement of interpretation does not in any way exempt mineral oil or preparations containing mineral oil from complying in all other respects with the requirements of the Federal Food, Drug, and Cosmetic Act. | ||||
| 21:21:4.0.1.1.2.7.1.4 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | G | Subpart G—Specific Labeling Requirements for Specific Drug Products | § 201.303 Labeling of drug preparations containing significant proportions of wintergreen oil. | FDA | (a) Because methyl salicylate (wintergreen oil) manifests no toxicity in the minute amounts in which it is used as a flavoring, it is mistakenly regarded by the public as harmless even when taken in substantially larger amounts. Actually, it is quite toxic when taken in quantities of a teaspoonful or more. Wintergreen oil and preparations containing it have caused a number of deaths through accidental misuse by both adults and children. Children are particularly attracted by the odor and are likely to swallow these products when left within reach. (b) To safeguard against fatalities from this cause, the Department of Health and Human Services will regard as misbranded under the provisions of the Federal Food, Drug, and Cosmetic Act any drug containing more than 5 percent methyl salicylate (wintergreen oil), the labeling of which fails to warn that use otherwise than as directed therein may be dangerous and that the article should be kept out of reach of children to prevent accidental poisoning. (c) This statement of interpretation in no way exempts methyl salicylate (wintergreen oil) or its preparations from complying in all other respects with the requirements of the Federal Food, Drug, and Cosmetic Act. | ||||
| 21:21:4.0.1.1.2.7.1.5 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | G | Subpart G—Specific Labeling Requirements for Specific Drug Products | § 201.304 Tannic acid and barium enema preparations. | FDA | (a) It has become a widespread practice for tannic acid to be added to barium enemas to improve X-ray pictures. Tannic acid is capable of causing diminished liver function and severe liver necrosis when absorbed in sufficient amounts. The medical literature reports a number of deaths associated with the addition of tannic acid to barium enemas. There is a lack of scientific evidence to establish the conditions, if any, under which tannic acid is safe and effective for use in enemas. Tannic acid for rectal use to enhance X-ray visualization is regarded as a new drug within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act. (b) In view of the hazards involved when tannic acid is used in barium enemas, any shipments of tannic acid labeled to come within the exemptions under 502(f) of the Act containing such phrases as: “Caution: For manufacturing, processing, or repackaging,” “For prescription compounding,” or “Diagnostic reagent—For professional use only” will be regarded by the Commissioner of Food and Drugs as misbranded within the meaning of section 502(f) of the Federal Food, Drug, and Cosmetic Act unless the label and the labeling bear conspicuously a warning to the effect: “ Warning— Not for use in enemas.” (c) Any tannic acid intended for use by man and found within the jurisdiction of the Federal Food, Drug, and Cosmetic Act labeled contrary to this section after 60 days from the date of its publication in the Federal Register may be made the subject of regulatory proceedings. | ||||
| 21:21:4.0.1.1.2.7.1.6 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | G | Subpart G—Specific Labeling Requirements for Specific Drug Products | § 201.305 Isoproterenol inhalation preparations (pressurized aerosols, nebulizers, powders) for human use; warnings. | FDA | [40 FR 13998, Mar. 27, 1975, as amended at 55 FR 11576, Mar. 29, 1990] | (a) Accumulating reports have been received by the Food and Drug Administration and have appeared in the medical literature of severe paradoxical bronchoconstriction associated with repeated, excessive use of isoproterenol inhalation preparations in the treatment of bronchial asthma and other chronic bronchopulmonary disorders. The cause of this paradoxical reaction is unknown; it has been observed, however, that patients have not responded completely to other forms of therapy until use of the isoproterenol inhalation preparation was discontinued. In addition, sudden unexpected deaths have been associated with the excessive use of isoproterenol inhalation preparations. The mechanism of these deaths and their relationship, if any, to the cases of severe paradoxical bronchospasm are not clear. Cardiac arrest was noted in several of these cases of sudden death. (b) On the basis of the above information and after discussion with and concurrence of the Respiratory and Anesthetic Drugs Advisory Committee for Food and Drug Administration, the Commissioner of Food and Drugs concludes that in order for the labeling of such drugs to bear adequate information for their safe use, as required by § 201.100, such labeling must include the following: Warning: Occasional patients have been reported to develop severe paradoxical airway resistance with repeated, excessive use of isoproterenol inhalation preparations. The cause of this refractory state is unknown. It is advisable that in such instances the use of this preparation be discontinued immediately and alternative therapy instituted, since in the reported cases the patients did not respond to other forms of therapy until the drug was withdrawn. Deaths have been reported following excessive use of isoproterenol inhalation preparations and the exact cause is unknown. Cardiac arrest was noted in several instances. Warning: Occasional patients have been reported to develop severe paradoxical airway resistance with repeated, excessive use of isoproterenol inhalation prep… | |||
| 21:21:4.0.1.1.2.7.1.7 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | G | Subpart G—Specific Labeling Requirements for Specific Drug Products | § 201.306 Potassium salt preparations intended for oral ingestion by man. | FDA | [40 FR 13998, Mar. 27, 1975, as amended at 55 FR 11576, Mar. 29, 1990; 67 FR 4906, Feb. 1, 2002] | (a) The Food and Drug Administration will initiate no regulatory action with respect to the continued marketing of coated tablets containing potassium chloride or other potassium salts which supply 100 milligrams or more of potassium per tablet provided all the following conditions are met: (1) Within 30 days from the date of publication of this statement of policy in the Federal Register: (i) The labeling of the drug bears the prescription caution statement quoted in section 503(b)(4) of the Federal Food, Drug, and Cosmetic Act; (ii) The labeling on or within the package from which the drug is to be dispensed bears adequate information for its use by practitioners in accord with the “full disclosure” labeling requirements of § 201.100 of this chapter, including the following warning statement: Warning —There have been several reports, published and unpublished, concerning nonspecific small-bowel lesions consisting of stenosis, with or without ulceration, associated with the administration of enteric-coated thiazides with potassium salts. These lesions may occur with enteric-coated potassium tablets alone or when they are used with nonenteric-coated thiazides, or certain other oral diuretics. These small-bowel lesions have caused obstruction, hemorrhage, and perforation. Surgery was frequently required and deaths have occurred. Based on a large survey of physicians and hospitals, both United States and foreign, the incidence of these lesions is low, and a causal relationship in man has not been definitely established. Available information tends to implicate enteric-coated potassium salts, although lesions of this type also occur spontaneously. Therefore, coated potassium-containing formulations should be administered only when indicated, and should be discontinued immediately if abdominal pain, distention, nausea, vomiting, or gastrointestinal bleeding occur. Coated potassium tablets should be used only when adequate dietary supplementation is not practicable. Warning —There have been several reports, publ… | |||
| 21:21:4.0.1.1.2.7.1.8 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | G | Subpart G—Specific Labeling Requirements for Specific Drug Products | § 201.307 Sodium phosphates; package size limitation, warnings, and directions for over-the-counter sale. | FDA | [63 FR 27843, May 21, 1998] | (a) Reports in the medical literature and data accumulated by the Food and Drug Administration indicate that multiple container sizes of sodium phosphates oral solution available in the marketplace have caused consumer confusion and appear to have been involved in several consumer deaths. Sodium phosphates oral solution has been marketed in 45-milliliter (mL), 90-mL, and 240-mL container sizes. The 45-mL and 90-mL container sizes of sodium phosphates oral solution are often recommended and prescribed by physicians for bowel cleansing prior to surgery and diagnostic procedures of the colon. Sodium phosphates oral solution (adult dose 20 mL to 45 mL) is also used as an over-the-counter (OTC) laxative for the relief of occasional constipation. Accidental overdosing and deaths have occurred because the 240-mL container was mistakenly used instead of the 45-mL or 90-mL container. The Food and Drug Administration is limiting the amount of sodium phosphates oral solution to not more than 90 mL (3 ounces (oz)) per OTC container because of the serious health risks associated with the ingestion of larger than intended doses of this product. Further, because an overdose of either oral or rectal enema sodium phosphates can cause an electrolyte imbalance, additional warning and direction statements are required for the safe use of any OTC laxative drug product containing sodium phosphates. (b) Any OTC drug product for laxative or bowel cleansing use containing sodium phosphates as an active ingredient when marketed as described in paragraph (a) of this section is misbranded within the meaning of section 502 of the Federal Food, Drug, and Cosmetic Act unless packaged and labeled as follows: (1) Package size limitation for sodium phosphates oral solution: Container shall not contain more than 90 mL (3 oz). (2) Warnings. The following sentences shall appear in boldface type as the first statement under the heading “Warnings.” (i) Oral dosage forms. “Taking more than the recommended dose in 24 hours can be harmful.” (ii) Rec… | |||
| 21:21:4.0.1.1.2.7.1.9 | 21 | Food and Drugs | I | C | 201 | PART 201—LABELING | G | Subpart G—Specific Labeling Requirements for Specific Drug Products | § 201.308 Ipecac syrup; warnings and directions for use for over-the-counter sale. | FDA | (a) It is estimated that each year about 500,000 accidental poisonings occur in the United States and result in approximately 1,500 deaths, of which over 400 are children. In the emergency treatment of these poisonings, ipecac syrup is considered the emetic of choice. The immediate availability of this drug for use in such situations is critical, since rapid treatment may be the difference between life and death. The restriction of this drug to prescription sale limits its availability in emergencies. On the other hand, it is the consensus of informed medical opinion that ipecac syrup should be used only under medical supervision in the emergency treatment of poisonings. In view of these facts, the question of whether ipecac syrup labeled as an emergency treatment for use in poisonings should be available over the counter has been controversial. (b) In connection with its study of this problem, the Food and Drug Administration has obtained the views of medical authorities. It is the unanimous recommendation of the American Academy of Pediatrics, the American Association of Poison Control Centers, the American Medical Association, and the Medical Advisory Board of the Food and Drug Administration that ipecac syrup in 1 fluid ounce containers be permitted to be sold without prescription so that it will be readily available in the household for emergency treatment of poisonings, under medical supervision, and that the drug be appropriately packaged and labeled for this purpose. (c) In view of the above recommendations, the Commissioner of Food and Drugs has determined that it is in the interest of the public health for ipecac syrup to be available for sale without prescription, provided that it is packaged in a quantity of 1 fluid ounce (30 milliliters), and its label bears, in addition to other required label information, the following, in a prominent and conspicuous manner: (1) A statement conspicuously boxed and in red letters, to the effect: “For emergency use to cause vomiting in poisoning. Before using, cal… |
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