(3) Laboratory tests. In the interest of uniformity of presentation, FDA strongly reccommends that the Drug Facts labeling be presented using the graphic specifications set forth in appendix A to part 201. (A) A specific geriatric indication, if any, that is supported by adequate and well-controlled studies in the geriatric population must be described under the Indications and Usage section, and appropriate geriatric dosage must be stated under the Dosage and Administration section. Labeling and Label Approval. 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. If there is an outer and immediate container of a retail package, this warning must appear on both the outer and immediate containers. 201.119 - In vitro diagnostic products. The declaration in terms of the largest whole units shall be in parentheses following the declaration in terms of inches and any remainder shall be in terms of inches or common or decimal fractions of the foot or yard; if applicable, as in the case of adhesive tape, the initial declaration in linear inches shall be preceded by a statement of the width. This section must discuss those clinical studies that facilitate an understanding of how to use the drug safely and effectively. FDAs labeling resources for human prescription drugs are primarily directed to industry staff who develop human prescription drug labeling. (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 reagentFor 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.. In addition, a minimum of 5 measurements of spectral irradiance transmitted for each wavelength through the PMMA plate covered with the sunscreen product will be similarly obtained after pre-irradiation of the sunscreen product [P1(), P2(), P3(), P4(), and P5()]. The presence of a sulfite(s) in this product should not deter administration of the drug for treatment of serious allergic or other emergency situations. This statement shall appear in the Warnings section of the labeling. 27, 1975, as amended at 42 FR 15674, Mar. (f) Reminder labeling which calls attention to the name of the drug product but does not include indications or dosage recommendations for use of the drug product is exempted from the provisions of paragraph (d) of this section. There are, however, no adequate and well-controlled studies in pregnant women. (3) Burns moderately; tans gradually (light brown) (normal). (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. Using more than one enema in 24 hours can be harmful., (i) The labeling of all orally or rectally administered OTC drug products containing sodium phosphates shall contain the following directions in boldface type immediately preceding the dosage information: Do not (take or use) more unless directed by a doctor. A drug product is deemed to be a listed drug on the date of approval for the NDA or ANDA for that drug product. Mix well. As appropriate, this information shall also be contained in Contraindications, Warnings, and elsewhere in Precautions.. (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. (E) The optimal method of titrating dosage. If you are a healthcare professional, patient, or caregiver, visit Frequently Asked Questions about Labeling for Prescription Medicines. The chance is higher if your child [bullet] has had stomach ulcers or bleeding problems [bullet] takes a blood thinning (anticoagulant) or steroid drug [bullet] takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) [bullet] takes more or for a longer time than directed. (bb) Human cell, tissue, or cellular or tissue-based product (HCT/P) regulated as a device means an HCT/P as defined in 1271.3(d) of this chapter that does not meet the criteria in 1271.10(a) and that is also regulated as a device. (2) The same information concerning the ingredients of the drug as appears on the label and labeling on or within the package from which the drug is to be dispensed. Pipet 5.0 mL of the preparation into a 50-mL volumetric flask and dilute to volume with isopropanol. 9, 2011; 80 FR 18090, Apr. (h) Drug Abuse and Dependence. A clinical study or reference may be cited in prescription drug labeling only under the following conditions: (i) If the clinical study is cited in the labeling in place of a detailed discussion of data and information concerning an indication for use of the drug, the clinical study must constitute an adequate and well-controlled study as described in 314.126(b) of this chapter, except for biological products, and must not imply or suggest indications or uses or dosing regimens not stated in the Indications and Usage or Dosage and Administration section. (b) Statement of identity. (12) Total surface area available to bear labeling means all surfaces of the outside container of the retail package or, if there is no such outside container, all surfaces of the immediate container or container wrapper except for the flanges at the tops and bottoms of cans and the shoulders and necks of bottles and jars. (B) Clinical considerations. (aa) Verification means confirmation by examination and provision of objective evidence that specified requirements have been fulfilled. Information on therapeutic drug concentration monitoring (TDM) must also be included in this section when TDM is necessary. (ii) For biological products, all indications listed in this section must be supported by substantial evidence of effectiveness. The labeling states Water Resistant (80 minutes). Repack or repackage means the act of taking a finished drug product or unfinished drug from the container in which it was placed in commercial distribution and placing it into a different container without manipulating, changing, or affecting the composition or formulation of the drug. Electronic Code of Federal Regulations (eCFR). [40 FR 13998, Mar. For more information on labeling, including Physician Labeling Rule (PLR) requirements, guidances, presentations, sample templates and format tools, and established pharmacologic class (EPC . (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. The provisions do not apply to sunscreen products marketed under approved new drug applications or abbreviated new drug applications. The sample holder should be a thin, flat plate with a suitable aperture through which UV radiation can pass. (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. (2) To be dispensed in accordance with section 503(f) of the act. (i) Statement of identity. (12) Drug interactions. Navigate by entering citations or phrases 201.56 Requirements on content and format of labeling for human prescription drug and biological products. (2) Include a representation of the proposed labeling, including any outserts, panel extensions, or other graphical or packaging techniques intended to be used with the product. 29, 1990; 57 FR 54301, Nov. 18, 1992; 67 FR 4906, Feb. 1, 2002; 72 FR 69119, Dec. 6, 2007]. Commonly for a drug that has been marketed for a long time, and in rare cases for a new drug, chronic animal toxicity studies have not been performed or completed for a drug that is administered over prolonged periods or is implanted in the body. However, the headings Active Ingredient and Purpose may not appear highlighted. 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. 201.10 Drugs; statement of ingredients. Each test site should be a minimum of 30 square centimeters and outlined with indelible ink. 201.1 - Drugs; name and place of business of manufacturer, packer, or distributor. (J) Efficacious or toxic concentration ranges and therapeutic concentration windows of the drug or its metabolites, if established and clinically significant. Determine that each subject is not taking topical or systemic medication that is known to alter responses to UV radiation. (e) After 270 days following expiration of said 90 days, regulatory proceedings based on section 505(a) of the Federal Food, Drug, and Cosmetic Act may be initiated with regard to any such drug shipped within the jurisdiction of the act for which an approved new-drug application is not in effect. Company, Incorporated, etc., may be abbreviated or omitted and The may be omitted. The waiver must be granted or denied in writing by the Director or the Director's designee. (1) A declaration of 112 pounds weight shall be expressed as Net wt. (iv) The drug, if used for a particular indication only in conjuction with a primary mode of therapy, e.g., diet, surgery, or some other drug, is an adjunct to the mode of therapy. When a drug is approved for pediatric use based on adequate and well-controlled studies in adults with other information supporting pediatric use, the Pediatric use subsection of the labeling shall contain either the following statement, or a reasonable alternative: The safety and effectiveness of (drug name) have been established in the age groups _ to _ (note any limitations, e.g., no data for pediatric patients under 2, or only applicable to certain indications approved in adults). 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. (15) 14 Clinical studies. 201.16 Drugs; Spanish-language version of certain required statements. This subsection must contain information necessary for patients to use the drug safely and effectively (e.g., precautions concerning driving or the concomitant use of other substances that may have harmful additive effects). In addition, the name shall meet the requirements of paragraph (g) of this section. CFR - Code of Federal Regulations Title 21 - Food and Drug Administration Meat and Poultry Labeling Terms - Food Safety and Inspection Service (i) General. This section must contain information necessary for patients to use the drug safely and effectively (e.g., precautions concerning driving or the concomitant use of other substances that may have harmful additive effects). (q) The declaration of net quantity of contents shall express an accurate statement of the quantity of contents of the package. The Broad Spectrum SPF statement shall appear as continuous text with no intervening text or graphic. [45 FR 25775, Apr. A concise summary of any boxed warning required by paragraph (c)(1) of this section, not to exceed a length of 20 lines. A specific warning relating to a use not provided for under the Indications and Usage section may be required by FDA in accordance with sections 201(n) and 502(a) of the act if the drug is commonly prescribed for a disease or condition and such usage is associated with a clinically significant risk or hazard. 201.105 - Veterinary drugs. 5 and/or FD&C Yellow No. (2) Letter heights pertain to upper case or capital letters. 201.127 - Drugs; expiration of exemptions. The diffuser will be constructed from any UV radiation transparent material (e.g., Teflon or quartz). 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: (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), (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. (ii) All applicable warnings listed in paragraphs (c)(5)(ii)(A) through (c)(5)(ii)(G) of this section with the appropriate subheadings highlighted in bold type: (A) Reye's syndrome warning for drug products containing salicylates set forth in 201.314(h)(1). This section must list the adverse reactions that occur with the drug and with drugs in the same pharmacologically active and chemically related class, if applicable. (13) Use in specific populations. 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. (2) If the clinical study or reference is cited in the labeling in the place of a detailed discussion of data and information concerning a risk or risks from the use of the drug, the risk or risks shall also be identified or discussed in the appropriate section of the labeling for the drug. (7) Dosage and administration. (e) Labeling requirements for older prescription drug products. (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. (4) Description of animal data. This term includes, but is not limited to, control laboratories, contract laboratories, contract manufacturers, contract packers, contract labelers, and other entities that manufacture a drug, or an animal feed bearing or containing a new animal drug, as defined in this paragraph. Pharmaceutical alternatives are drug products that contain the identical therapeutic moiety, or its precursor, but not necessarily in the same amount or dosage form or as the same salt or ester. 201.2 Drugs and devices; National Drug Code numbers. 6, 1979; 44 FR 37467, June 26, 1979; 45 FR 25777, Apr. [1] See 201 .66(b)(4) of this chapter for definition of bullet symbol. This subsection of the labeling may be omitted only if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. (Alternatively, the labeling may state the total number of subjects included in the studies who were 65 and over and 75 and over.) 6. The regulations affecting special dietary foods ( 105.3(e) of this chapter) define an infant as a child not more than 12 months old. (1) [bullet] For vaginal use only [bullet] Not for rectal (anal) use [both warnings in bold type]. (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: WarningThere 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. Potassium salt preparations intended for oral ingestion by man. (B) At least as large as the size of the Drug Facts title, as required in 201.66(d)(2). (3) Stop use and ask a doctor if [bullet] child experiences any of the following signs of stomach bleeding: [add the following as second level of statements: [bullet] feels faint [bullet] vomits blood [bullet] has bloody or black stools [bullet] has stomach pain that does not get better]. The Stomach bleeding warning must appear after the Reye's syndrome and Allergy alert warnings in 201.66(c)(5)(ii)(A) and (c)(5)(ii)(B). Subpart A - General Labeling Provisions The solar simulator output should be measured before and after each phototest or, at a minimum, at the beginning and end of each test day. (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. (viii) If the drug product contains one or more inactive ingredients that present an increased risk of toxic effects to neonates or other pediatric subgroups, a special note of this risk shall be made, generally in the Contraindications, Warnings, or Precautions section. The total finished design output consists of the device, its packaging and labeling, and the device master record. Center for Devices and Radiological Health, An official website of the United States government, : 201.51 - Declaration of net quantity of contents. 201.55 - Statement of dosage. (f) If an ingredient is a derivative or preparation of a substance specifically named in section 502(e) of the act and the established name of such ingredient does not indicate that it is a derivative or preparation of the parent substance named in section 502(e) of the act, the labeling shall, in conjunction with the listing of the established name of such ingredient, declare that such article is a derivative or preparation of such parent substance. 201.307 Sodium phosphates; package size limitation, warnings, and directions for over-the-counter sale. In the interim, these products should continue to be labeled with the previous Reye's syndrome warning that appears in paragraph (h)(1) of this section. (i) Preparation. (ii) Specific statements on geriatric use of the drug for an indication approved for adults generally, as distinguished from a specific geriatric indication, shall be contained in the Geriatric use subsection and shall reflect all information available to the sponsor that is relevant to the appropriate use of the drug in elderly patients. If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.. If the immediate container is a blister card, the warning must appear on the blister card and remain intact and readable when drug product is removed from the blister card. 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. (9) Subheading means the required statements in quotation marks listed in paragraphs (c)(5)(ii) through (c)(5)(vii) of this section. 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. If such information is available for the population(s) for which the drug is labeled, it must also be included. 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. The information is set in 6 point Helvetica Regular with 6.5 point leading, left justified. This subsection must be based primarily on human data and human experience, but pertinent animal data may also be used. (21 U.S.C. Dosing recommendations based on clinically significant factors that change the product's pharmacokinetics (e.g., age, gender, race, hepatic or renal dysfunction, concomitant therapy) that appear in other sections (e.g., Warnings and Precautions, Dosage and Administration or Use in Specific Populations) must not be repeated in this subsection, but the location of such recommendations must be referenced. A single port or multiport solar simulator should be filtered so that it provides a continuous emission spectrum from 290 to 400 nanometers (nm) with a limit of 1,500 Watts per square meter (W/m2) on total irradiance for all wavelengths between 250 and 1,400 nm. (2) A production identifier - a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of the device: (i) The lot or batch within which a device was manufactured; (ii) The serial number of a specific device; (iii) The expiration date of a specific device; (iv) The date a specific device was manufactured. (f) If the labeling or advertising of a salicylate preparation offers it for use in arthritis or rheumatism, the label and labeling should clearly state that the beneficial effects claimed are limited to: For the temporary relief of minor aches and pains of arthritis and rheumatism. The qualifying phrase for the temporary relief of minor aches and pains should appear with the same degree of prominence and conspicuousness as the phrase arthritis and rheumatism. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives. Appropriate pediatric dosage must be given under the Dosage and Administration section. 27, 1975, as amended at 55 FR 11576, Mar. (3) When fractions are used, each component numeral shall meet one-half the minimum height standards. 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. A solar simulator should have no significant time-related fluctuations (within 20 percent) in radiation emissions after an appropriate warm-up time and demonstrate good beam uniformity (within 20 percent) in the exposure plane. (6) Pregnancy. 201.308 Ipecac syrup; warnings and directions for use for over-the-counter sale. (f) A prescription drug intended for both human and veterinary use shall comply with paragraphs (e) and (f) of this section and 201.100. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.. Contents must also contain any additional subheading(s) included in the full prescribing information preceded by the identifying number assigned in accordance with 201.56(d)(2). (f) The Center Director may grant an exception or alternative under this section to the following provisions of this chapter, to the extent that the requirements in these provisions are not explicitly required by statute: (1) 201.1(h)(1) through (h)(2), (h)(5) through (h)(6), and (i); (2) 201.10(a), (d)(2), (f), (g)(1), and (h)(1); (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. 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. (5) 4 Contraindications. (16) 15 References. The immediate availability of this drug for use in such situations is critical, since rapid treatment may be the difference between life and death. 1. The verbatim statement These highlights do not include all the information needed to use (insert name of drug product) safely and effectively. 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. For all other drugs, this subsection of the labeling shall contain the following information: (i) Teratogenic effects. If unable to submit comments online, please mail written comments to: Dockets Management For products described in paragraph (b)(1) of this section, labeling conforming to the requirements in paragraph (d) of this section and 201.57 must be submitted according to the following schedule: (1) For products for which an NDA, BLA, or efficacy supplement is submitted for approval on or after June 30, 2006, proposed conforming labeling must be submitted as part of the application. 7. (5) Any risk information that is required under 201.57(c)(9)(iv) is considered appropriate pediatric contraindications, warnings, or precautions within the meaning of section 505A(l)(2) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. All written comments should be identified with this document's docket number: FDA-2020-D-0957. 6 in certain drugs for human use. Adverse reactions important for other reasons (e.g., because they are serious or frequently lead to discontinuation or dosage adjustment) must not be repeated under this heading in Highlights if they are included elsewhere in Highlights (e.g., Warnings and Precautions, Contraindications). FDA or Agency is the Food and Drug Administration. Private label distribution means commercial distribution of a drug under the label or trade name of a person who did not manufacture, repack, relabel, or salvage that drug. Instructions for Downloading Viewers and Players. Active ingredient is 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 man or other animals.