Detailed dosing or monitoring recommendations based on pharmacodynamic information that appear in other sections (e.g., Warnings and Precautions or Dosage and Administration) must not be repeated in this subsection, but the location of such recommendations must be referenced. (a) It has become a widespread practice for tannic acid to be added to barium enemas to improve X-ray pictures. 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. In order that the person who evaluates the test subsites is not biased, he/she should not be the same person who applied the sunscreen drug product to the test site or administered the UV doses. 201.20 - Declaration of presence of FD&C Yellow No. 201.5 - Drugs; adequate directions for use. If the pertinent animal data cannot be appropriately incorporated into other sections of the labeling, this section may be used. (k) Paragraphs (b), (c), (d), (e), and (f) of this section, do not apply to the labeling of drug components. [61 FR 17806, Apr. (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. Labeling and Label Approval. (11) 10 Overdosage. The Electronic Code of Federal Regulations (eCFR) is a continuously updated online version of the CFR. 5 (tartrazine) as a color additive or Contains color additives including FD&C Yellow No. Note: If you need help accessing information in different file formats, see Combination products containing an NSAID and a nonanalgesic ingredient(s) (e.g., cough-cold) must include the name of the NSAID ingredient and the word (NSAID) in accordance with this paragraph, and the name(s) of the other active ingredient(s) in the product on the PDP. (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). Spreading should be done with a very light spreading action for approximately 30 seconds followed by spreading with greater pressure for approximately 30 seconds. Examples of specific sulfites used to inhibit this oxidation process include sodium bisulfite, sodium metabisulfite, sodium sulfite, potassium bisulfite, and potassium metabisulfite. (2) A declaration of three-fourths pound avoirdupois weight shall be expressed as Net wt. (2) Letter heights pertain to upper case or capital letters. In cases where the immediate container is not the retail package, the retail package also must bear the warning statement. A concise summary of the information required under paragraph (c)(8) of this section, with any appropriate subheadings. Enhanced content is provided to the user to provide additional context. (1) Weigh 0.50 gram (g) of oxybenzone USP reference standard into a 250-mL volumetric flask. The Risk Summary must describe the effects of the drug and/or its active metabolite(s) on milk production. NDA holder is the applicant that owns an approved NDA. 201.325 - Over-the-counter drugs for vaginal contraceptive and spermicide use containing nonoxynol 9 as the active ingredient; required warnings and labeling information. (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. For postmarks documenting an electronic event, the date of transmission is the date (in a particular time zone) that FDA sends the electronic transmission on its host system as evidenced by a verifiable record. (4) Boxed warning. Foreign for the purposes of registration and listing under this part: (1) When used to modify the term "manufacturer," "repacker," "relabeler," or "salvager," refers to a manufacturer, repacker, relabeler, or salvager, who is located in a foreign country and who manufactures, repacks, relabels, or salvages a drug, or an animal feed bearing or containing a new animal drug, that is imported or offered for import into the United States. Taking more than the recommended dose in 24 hours can be harmful., (ii) Rectal enema dosage forms. For products with an expected SPF from 8 to 15, administer UV doses that increase by 20 percent with each successive dose (i.e., 0.69X, 0.83X, 1.00X, 1.20X, and 1.44X). (ii) Effects of drug on the breast-fed child. (b) Effervescent preparations and preparations containing para-aminosalicylate as the only salicylate ingredient are exempted from this labeling requirement. 201.116 - Drugs having commonly known directions. This paragraph does not apply to any drug or drug product dispensed in accordance with section 503(b)(1) of the act. 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. If reproduction studies or other data in animals reveal a problem or potential problem concerning mutagenesis or impairment of fertility in either males or females, the information shall be described. The continuation of the required content and format onto multiple panels must retain the required order and flow of headings, subheadings, and information. [1] See 201 .66(b)(4) of this chapter for definition of bullet symbol. To the extent applicable, the labeling must describe the types of studies or reports, number of subjects and the duration of each study, exposure information, and limitations of the data. (3) The labeling must be based whenever possible on data derived from human experience. The Office of the Federal Register publishes documents on behalf of Federal agencies but does not have any authority over their programs. Examples of Graphic Enhancements Used by FDA. Pharmacologic information based on in vitro data using human biomaterials or pharmacologic animal models, or relevant details about in vivo study designs or results (e.g., drug interaction studies), may be included in this section if essential to understand dosing or drug interaction information presented in other sections of the labeling. For products that contain both acetaminophen and aspirin, this Liver warning must appear after the Reye's syndrome and Allergy alert warnings in 201.66(c)(5)(ii)(A) and (c)(5)(ii)(B) and before the Stomach bleeding warning in paragraph (a)(2)(iii)(A) of this section. Subpart FLabeling Claims for Drugs in Drug Efficacy Study. (ii) by including in the package a printed warning with instructions to pharmacists to place the warning on the container prior to dispensing. (i) The statement of the place of business shall include the street address, city, State, and ZIP Code. (2) Dose adjustments during pregnancy and the postpartum period. A devices labeling misbrands the product if: Note: Previously, it was a prohibited act to have the premarket approval application (PMA) number on the device labeling. Unless otherwise noted, information contained in the Geriatric use subsection must pertain to use of the drug in persons 65 years of age and older. 24 oz (1.5 lb). (c) Content requirements. The sample holder should be a thin, flat plate with a suitable aperture through which UV radiation can pass. (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 active ingredients and purposes shall be aligned under the appropriate headings such that the heading and information required under paragraph (c)(2) of this section shall be left justified and the heading and information required under paragraph (c)(3) of this section shall be right justified. (1) Each portable cryogenic medical gas container must be conspicuously marked with a 360 wraparound label identifying its contents. Drug Facts is set in 9 point Helvetica Bold Italic, left justified. For water resistant sunscreen products, proceed with the water resistance testing procedure described in paragraph (i)(7) of this section after waiting at least 15 minutes. For all OTC drug products under an approved drug application whose packaging does not include a toll-free number through which consumers can report complaints to the manufacturer or distributor of the drug product, the following text shall immediately follow the subheading: [Bullet] side effects occur. (iv) Paragraph (d)(4) of this section shall apply except that if more than one bulleted statement is placed on the same horizontal line, the additional bulleted statements may continue to the next line of text, and except that the bullets under each heading or subheading need not be vertically aligned. (3) FDA shall grant a full or partial waiver, as appropriate, if the agency finds that there is a reasonable basis on which to conclude that one or more of the grounds for waiver specified in paragraphs (c)(2) or (c)(3) of this section have been met. (2) The declaration may appear in more than one line. If there is a serious known or potential risk to the pregnant woman and/or the embryo/fetus associated with the disease or condition for which the drug is indicated to be used, the labeling must describe the risk. [64 FR 13286, Mar. 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. Any precautionary statement on these topics must include practical, relevant advice to the prescriber on the significance of these animal findings. 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).. (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 certain susceptible persons. Particularly susceptible patient populations shall be identified. (1) The stomach bleeding warning states Stomach bleeding warning [heading in bold type]: This product contains an NSAID, which may cause severe stomach bleeding. Newly acquired information is data, analyses, or other information not previously submitted to the Agency, which may include (but is not limited to) data derived from new clinical studies, reports of adverse events, or new analyses of previously submitted data (e.g., meta-analyses) if the studies, events, or analyses reveal risks of a different type or greater severity or frequency than previously included in submissions to FDA. (10) Drug facts labeling means the title, headings, subheadings, and information required under or otherwise described in paragraph (c) of this section. The drug labeling and other information has been reformatted to make it easier to read but its content has neither been altered nor . 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. (l) A drug product is misbranded under section 502(a) of the act if its labeling identifies a person as manufacturer, packer, or distributor, and that identification does not meet the requirements of this section. Drug substance is an active ingredient 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 human body, but does not include intermediates used in the synthesis of such ingredient. This guidance was written prior to the February 27, 1997 implementation of FDA's Good Guidance Practices, GGP's. Title 21 was last amended 6/22/2023. contact the publishing agency. Understanding the FDA regulations governing advertising and promotion This section must briefly note information on any known interference by the product with laboratory tests and reference the section where the detailed information is presented (e.g., Drug Interactions section). The statement of identity appears in accord with 201.61 and 299.4 of this chapter. (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 web site is designed for the current versions of An NDA or ANDA for which FDA issued a complete response letter, but which was withdrawn before approval and later submitted again, is not a resubmission. When (insert name of antibacterial drug product) is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. (g) The requirement for declaration of the name of the manufacturer, packer, or distributor shall be deemed to be satisfied, in the case of a corporate person, only by the actual corporate name, except that the corporate name may be the name of a parent, subsidiary, or affiliate company where the related companies are under common ownership and control. 5 and/or FD&C Yellow No. (3) OTC drug products that are dispensed pursuant to an order and are commonly used in hospitals. (15.56 C.). (2) Nonsteroidal anti-inflammatory analgesic/antipyretic active ingredientsincluding, but not limited to, aspirin, carbaspirin calcium, choline salicylate, ibuprofen, ketoprofen, magnesium salicylate, naproxen sodium, and sodium salicylate. (E) If the requirements for a finding of substantial evidence to support a pediatric indication or a pediatric use statement have not been met for a particular pediatric population, the Pediatric use subsection must contain an appropriate statement such as Safety and effectiveness in pediatric patients below the age of (__) have not been established. If use of the drug in this pediatric population is associated with a specific hazard, the hazard must be described in this subsection, or, if appropriate, the hazard must be stated in the Contraindications or Warnings and Precautions section and this subsection must refer to it. These operations include: (e) A person performs an operation listed in paragraph (b) of this section only if the operation is performed, including the performance of the appropriate in-process quality control operations, except laboratory testing of samples taken during processing, as follows: (1) By individuals, a majority of whom are employees of the person and, throughout the performance of the operation, are subject to the person's direction and control; (2) On premises that are continuously owned or leased by the person and subject to the person's direction and control; and. (d) If a manufacturer fails to submit a supplemental application containing the information or request for approval of a pediatric formulation described in paragraph (a) of this section within the time specified by FDA, the drug product may be considered misbranded or an unapproved new drug or unlicensed biologic. The street address may be omitted if it is shown in a current city directory or telephone directory. 29, 2009, as amended at 74 FR 31180, June 30, 2009; 74 FR 61514, Nov. 25, 2009]. 201.66 - Format and content requirements for over-the-counter (OTC) drug product labeling. (E) The optimal method of titrating dosage. 6. Moderate changes (e.g., adding or strengthening a warning or adverse reaction) in a Changes Being Effected (CBE) labeling supplement that is undergoing FDA review. (iv) Input optics. (5) 4 Contraindications. 201.150 - Drugs; processing, labeling, or repacking. (d) The declaration shall be located on the principal display panel of the label, and with respect to packages bearing alternate principal panels it shall be duplicated on each principal display panel. 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. (p) Manufacturing material means any material or substance used in or used to facilitate the manufacturing process, a concomitant constituent, or a byproduct constituent produced during the manufacturing process, which is present in or on the finished device as a residue or impurity not by design or intent of the manufacturer. (G) If the sponsor believes that none of the statements described in paragraphs (c)(9)(iv)(B) through (c)(9)(iv)(F) of this section are appropriate or relevant to the labeling of a particular drug, the sponsor must provide reasons for omission of the statements and may propose alternative statement(s). For purposes of this paragraph, person, when it identifies a corporation, includes a parent, subsidiary, or affiliate company where the related companies are under common ownership and control. 201.301 Notice to manufacturers, packers, and distributors of estrogenic hormone preparations. [65 FR 4110, Jan. 26, 2000, as amended at 67 FR 70691, Nov. 26, 2002; 68 FR 32981, June 3, 2003]. (ii) HPLC assay. (7) A statement directed to the pharmacist specifying the type of container to be used in dispensing the drug product to maintain its identity, strength, quality, and purity. (18) 17 Patient counseling information. The title and headings shall be in bold italic, and the subheadings shall be in bold type, except that the word (continued) in the title Drug Facts (continued) shall be regular type. (B) At least as large as the size of the Drug Facts title, as required in 201.66(d)(2). (3) For products that satisfy the water resistance test in paragraph (i)(7) of this section. 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. Sponsors of a product marketed under an approved drug application shall also submit a single copy of the exemption request to their application. When not modified by "domestic" or "foreign," the term includes both domestic manufacturers and foreign manufacturers. (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. This section must be based on human data. (4) Calculation of mean transmittance values. (h) Design review means a documented, comprehensive, systematic examination of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems. 201.323 Aluminum in large and small volume parenterals used in total parenteral nutrition. Specific requirements on content and format of labeling for human prescription drug and biological products; older drugs not described in 201.56(b)(1). Excess hair on the back is acceptable if the hair is clipped. (5) Rarely burns; tans profusely (dark brown) (insensitive). In addition, with the implementation of NFI's Seafood Economic Integrity Initiative, NFI members have pledged to adhere to all FDA labeling laws. (g) The declaration of net quantity of contents shall express an accurate statement of the quantity of contents of the package. (7) The identifying numbers required by 201.56(d) and paragraphs (c)(1) through (c)(18) of this section must be presented in bold print and must precede the heading or subheading by at least two square em's (i.e., two squares of the size of the letter m in 8 point type). (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). Meat and Poultry Labeling Terms - Food Safety and Inspection Service (2) 1 Indications and usage. (ix) The pregnancy/breast-feeding warning set forth in 201.63(a); the third trimester warning set forth in 201.63(e) for products containing aspirin or carbaspirin calcium; the third trimester warning set forth in approved drug applications for products containing ketoprofen, naproxen sodium, and ibuprofen (not intended exclusively for use in children). The approximate frequency of each adverse reaction shall be expressed in rough estimates or orders of magnitude essentially as follows: The most frequent adverse reaction(s) to (name of drug) is (are) (list reactions). Private label distributor means, with respect to a particular drug, a person who did not manufacture, repack, relabel, or salvage the drug but under whose label or trade name the drug is commercially distributed. In addition, the solar simulator must be recalibrated if there is any change in the lamp bulb or the optical filtering components (i.e., filters, mirrors, lenses, collimating devices, or focusing devices). (ii) Remain intact under normal conditions of use. 201.200 - Disclosure of drug efficacy study evaluations in labeling and advertising. (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. (4) If the person performs all applicable operations listed in paragraph (b) of this section except for those operations listed in paragraph (d) of this section. This warning shall follow the subheading Sexually transmitted diseases (STDs) alert:. (B) If there is a specific pediatric indication different from those approved for adults that is supported by adequate and well-controlled studies in the pediatric population, it must be described under the Indications and Usage section, and appropriate pediatric dosage information must be given under the Dosage and Administration section. 201.323 - Aluminum in large and small volume parenterals used in total parenteral nutrition. Labeling Claims for Drugs in Drug Efficacy Study. is available with paragraph structure matching the official CFR (i) If a drug is absorbed systemically, this subsection of the labeling shall contain, if known, information about excretion of the drug in human milk and effects on the nursing infant. (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. (h) The declaration shall be in letters and numerals in a type size established in relationship to the area of the principal display panel of the package and shall be uniform for all packages of substantially the same size by complying with the following type specifications: (1) Not less than one-sixteenth inch in height on packages the principal display panel of which has an area of 5 square inches or less. If the drug is associated with serious adverse reactions or if the drug has a known tumorigenic potential, the labeling shall state: Because of the potential for serious adverse reactions in nursing infants from (name of drug) (or, Because of the potential for tumorigenicity shown for (name of drug) in (animal or human) studies), a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. If the drug is not associated with serious adverse reactions and does not have a known tumorigenic potential, the labeling shall state: Caution should be exercised when (name of drug) is administered to a nursing woman., (iii) If a drug is absorbed systemically and information on excretion in human milk is unknown, this subsection of the labeling shall contain one of the following statements, as appropriate. 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. (2) Drug absorbed systemically. 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. A horizontal hairline extending within two spaces on either side of the Drug Facts box or similar enclosure shall immediately follow the title and shall immediately precede each of the subheadings set forth in paragraph (c)(5) of this section, except the subheadings in paragraphs (c)(5)(ii)(A) through (c)(5)(ii)(G) of this section. 201.26 Exceptions or alternatives to labeling requirements for human drug products held by the Strategic National Stockpile. The new warnings information statement must remain on the PDP of the drug product for at least 1 year from the date the product is initially introduced into interstate commerce. (D) If information on limitations of use or uncertainty about anticipated clinical benefits is relevant to the recommended intervals between doses, to the appropriate duration of treatment when such treatment should be limited, or to any modification of dosage, a concise description of the information with reference to the more detailed information in the Dosage and Administration section.
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