cfr_sections
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10 rows where agency = "FDA" and part_number = 330 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 21:21:5.0.1.1.11.1.1.1 | 21 | Food and Drugs | I | D | 330 | PART 330—OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED | A | Subpart A—General Provisions | § 330.1 General conditions for general recognition as safe, effective and not misbranded. | FDA | [39 FR 11741, Mar. 29, 1974, as amended at 40 FR 11718, Mar. 13, 1975; 40 FR 13496, Mar. 27, 1975; 42 FR 15674, Mar. 22, 1977; 46 FR 8459, Jan. 27, 1981; 50 FR 8996, Mar. 6, 1985; 51 FR 16266, May 1, 1986; 55 FR 11581, Mar. 29, 1990; 59 FR 4000, Jan. 28, 1994; 59 FR 14365, Mar. 28, 1994; 64 FR 13294, Mar. 17, 1999; 68 FR 24879, May 9, 2003; 88 FR 45066, July 14, 2023] | An over-the-counter (OTC) drug listed in this subchapter is generally recognized as safe and effective and is not misbranded if it meets each of the conditions contained in this part and each of the conditions contained in any applicable monograph. Any product which fails to conform to each of the conditions contained in this part and in an applicable monograph is liable to regulatory action. (a) The product is manufactured in compliance with current good manufacturing practices, as established by parts 210 and 211 of this chapter. (b) The establishment(s) in which the drug product is manufactured is registered, and the drug product is listed, in compliance with part 207 of this chapter. It is requested but not required that the number assigned to the product pursuant to part 207 of this chapter appear on all drug labels and in all drug labeling. If this number is used, it shall be placed in the manner set forth in part 207 of this chapter. (c)(1) The product is labeled in compliance with chapter V of the Federal Food, Drug, and Cosmetic Act (the act) and subchapter C et seq. of this chapter, including the format and content requirements in § 201.66 of this chapter. An OTC drug product that is not in compliance with chapter V and subchapter C, including § 201.66 of this chapter, is subject to regulatory action. For purposes of § 201.61(b) of this chapter, the statement of identity of the product shall be the term or phrase used in the applicable OTC drug monograph established in this part. (2) The “Uses” section of the label and labeling of the product shall contain the labeling describing the “Indications” that have been established in an applicable OTC drug monograph or alternative truthful and nonmisleading statements describing only those indications for use that have been established in an applicable monograph, subject to the provisions of section 502 of the act relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate… | |||
| 21:21:5.0.1.1.11.1.1.2 | 21 | Food and Drugs | I | D | 330 | PART 330—OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED | A | Subpart A—General Provisions | § 330.2 Pregnancy-nursing warning. | FDA | [47 FR 54758, Dec. 3, 1982] | A pregnancy-nursing warning for OTC drugs is set forth under § 201.63 of this chapter. | |||
| 21:21:5.0.1.1.11.1.1.3 | 21 | Food and Drugs | I | D | 330 | PART 330—OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED | A | Subpart A—General Provisions | § 330.3 Imprinting of solid oral dosage form drug products. | FDA | [58 FR 47959, Sept. 13, 1993] | A requirement to imprint an identification code on solid oral dosage form drug products is set forth under part 206 of this chapter. | |||
| 21:21:5.0.1.1.11.1.1.4 | 21 | Food and Drugs | I | D | 330 | PART 330—OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED | A | Subpart A—General Provisions | § 330.5 Drug categories. | FDA | Monographs promulgated pursuant to the provisions of this part shall be established in this part 330 and following parts and shall cover the following designated categories: (a) Antacids. (b) Laxatives. (c) Antidiarrheal products. (d) Emetics. (e) Antiemetics. (f) Antiperspirants. (g) Sunburn prevention and treatment products. (h) Vitamin-mineral products. (i) Antimicrobial products. (j) Dandruff products. (k) Oral hygiene aids. (l) Hemorrhoidal products. (m) Hematinics. (n) Bronchodilator and antiasthmatic products. (o) Analgesics. (p) Sedatives and sleep aids. (q) Stimulants. (r) Antitussives. (s) Allergy treatment products. (t) Cold remedies. (u) Antirheumatic products. (v) Ophthalmic products. (w) Contraceptive products. (x) Miscellaneous dermatologic products. (y) Dentifrices and dental products such as analgesics, antiseptics, etc. (z) Miscellaneous (all other OTC drugs not falling within one of the above therapeutic categories). | ||||
| 21:21:5.0.1.1.11.2.1.1 | 21 | Food and Drugs | I | D | 330 | PART 330—OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED | B | Subpart B—Administrative Procedures | § 330.10 Procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded, and for establishing monographs. | FDA | [39 FR 11741, Mar. 29, 1974, as amended at 39 FR 39556, Nov. 8, 1974; 42 FR 19141, Apr. 12, 1977; 42 FR 54800, Oct. 11, 1977; 46 FR 8460, 8955, Jan. 27, 1981; 46 FR 14340, Feb. 27, 1981; 46 FR 21360, Apr. 10, 1981; 46 FR 47738, Sept. 29, 1981; 50 FR 7516, Feb. 22, 1985; 55 FR 11581, Mar. 29, 1990; 63 FR 5253, Feb. 2, 1998; 67 FR 3073, Jan. 23, 2002; 88 FR 45066, July 14, 2023] | For purposes of classifying over-the-counter (OTC) drugs as drugs generally recognized among qualified experts as safe and effective for use and as not misbranded drugs, the following regulations shall apply: (a) Procedure for establishing OTC drug monographs —(1) Advisory review panels. The Commissioner shall appoint advisory review panels of qualified experts to evaluate the safety and effectiveness of OTC drugs, to review OTC drug labeling, and to advise him on the promulgation of monographs establishing conditions under which OTC drugs are generally recognized as safe and effective and not misbranded. A single advisory review panel shall be established for each designated category of OTC drugs and every OTC drug category will be considered by a panel. The members of a panel shall be qualified experts (appointed by the Commissioner) and may include persons from lists submitted by organizations representing professional, consumer, and industry interests. The Commissioner shall designate the chairman of each panel. Summary minutes of all meetings shall be made. (2) Request for data and views. The Commissioner will publish a notice in the Federal Register requesting interested persons to submit, for review and evaluation by an advisory review panel, published and unpublished data and information pertinent to a designated category of OTC drugs. Data and information submitted pursuant to a published notice, and falling within the confidentiality provisions of 18 U.S.C. 1905, 5 U.S.C. 552(b), or 21 U.S.C. 331(j), shall be handled by the advisory review panel and the Food and Drug Administration as confidential until publication of a proposed monograph and the full report(s) of the panel or until the Commissioner places the panel's recommendations on public display at the office of the Dockets Management Staff. Thirty days thereafter such data and information shall be made publicly available and may be viewed at the office of the Dockets Management Staff of the Food and Drug Administration, except to the ext… | |||
| 21:21:5.0.1.1.11.2.1.2 | 21 | Food and Drugs | I | D | 330 | PART 330—OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED | B | Subpart B—Administrative Procedures | § 330.11 NDA deviations from applicable monograph. | FDA | [39 FR 11741, Mar. 29, 1974, as amended at 55 FR 11581, Mar. 29, 1990] | A new drug application requesting approval of an OTC drug deviating in any respect from a monograph that has become final shall be in the form required by § 314.50 of this chapter, but shall include a statement that the product meets all conditions of the applicable monograph except for the deviation for which approval is requested and may omit all information except that pertinent to the deviation. | |||
| 21:21:5.0.1.1.11.2.1.3 | 21 | Food and Drugs | I | D | 330 | PART 330—OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED | B | Subpart B—Administrative Procedures | § 330.12 Status of over-the-counter (OTC) drugs previously reviewed under the Drug Efficacy Study (DESI). | FDA | (a) There were 420 OTC drugs reviewed in the Drug Efficacy Study (a review of drugs introduced to the market through new drug procedures between 1938 and 1962). A careful review has been made of the reports on these drugs to determine those drugs for which implementation may be deferred without significant risk to the public health, pending review by appropriate OTC drug advisory review panels and promulgation of a monograph. (b) On and after April 20, 1972, a number of notices were published in the Federal Register concerning previously unpublished OTC drugs reviewed by the National Academy of Sciences-National Research Council Drug Efficacy Study Group. Only the evaluations and comments of the panels were published, with no conclusions of the Commissioner of Food and Drugs. Those publications were for the purpose of giving interested persons the benefit of the Academy's opinions. For those products, and also for OTC drug products previously published with the Commissioner's conclusions (except for the products listed in paragraphs (b) (1) and (2) of this section, all requests for data, revised labeling, requests for new drug applications, abbreviated new drug applications, updating supplements, data to support less than effective claims, if any, etc., are deferred, and such OTC drug products are instead subject to the OTC drug review in their appropriate classes pursuant to the procedures established in this subpart. (1) The requirements of the following DESI announcements are not deferred (the reference document may also pertain to prescription drugs): (i) Certain Surgical Sutures (DESI 4725), published in the Federal Register of November 11, 1971 (36 FR 21612). (ii) Absorbable Dusting Powder (DESI 6264), published in the Federal Register of May 25, 1971 (36 FR 9475). (iii) Certain Insulin Preparations (DESI 4286), published in the Federal Register of April 9, 1971 (36 FR 6842). (iv) Sulfo-Van Ointment (DESI 2230), published in the Federal Register of October 8, 1970 (35 FR 15860). (v) Antiper… | ||||
| 21:21:5.0.1.1.11.2.1.4 | 21 | Food and Drugs | I | D | 330 | PART 330—OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED | B | Subpart B—Administrative Procedures | § 330.13 Conditions for marketing ingredients recommended for over-the-counter (OTC) use under the OTC drug review. | FDA | [41 FR 32582, Aug. 4, 1976, as amended at 47 FR 17739, Apr. 23, 1982; 50 FR 8996, Mar. 6, 1985; 55 FR 11581, Mar. 29, 1990; 67 FR 3074, Jan. 23, 2002] | (a) Before the publication in the Federal Register of an applicable proposed monograph, an OTC drug product that contains: (1) An active ingredient limited, on or after May 11, 1972, to prescription use for the indication and route of administration under consideration by an OTC advisory review panel, and not thereafter exempted from such limitation pursuant to § 310.200 of this chapter, or (2) An active ingredient at a dosage level higher than that available in an OTC drug product on December 4, 1975, shall be regarded as a new drug within the meaning of section 201(p) of the act for which an approved new drug application is required. (b)(1) An OTC drug product that contains: (i) An active ingredient limited, on or after May 11, 1972, to prescription use for the indication and route of administration under consideration by an OTC advisory review panel, and not thereafter exempted from such limitation pursuant to § 310.200 of this chapter, or (ii) An active ingredient at a dosage level higher than that available in an OTC drug product on December 4, 1975, which ingredient and/or dosage level is classified by the panel in category I (conditions subject to § 330.10(a)(6)(i)) shall be regarded as a new drug within the meaning of section 201(p) of the act for which an approved new drug application is required if marketed for OTC use prior to the date of publication in the Federal Register of a proposed monograph. (2) An OTC drug product covered by paragraph (b)(1) of this section which is marketed after the date of publication in the Federal Register of a proposed monograph but prior to the effective date of a final monograph shall be subject to the risk that the Commissioner may not accept the panel's recommendation and may instead adopt a different position that may require relabeling, recall, or other regulatory action. The Commissioner may state such position at any time by notice in the Federal Register, either separately or as part of another document; appropriate regulatory action will commence imm… | |||
| 21:21:5.0.1.1.11.2.1.5 | 21 | Food and Drugs | I | D | 330 | PART 330—OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED | B | Subpart B—Administrative Procedures | § 330.14 Additional criteria and procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded. | FDA | [67 FR 3074, Jan. 23, 2002, as amended at 81 FR 84475, Nov. 23, 2016; 88 FR 45066, July 14, 2023] | This section sets forth additional criteria and procedures by which over-the-counter (OTC) drugs initially marketed in the United States after the OTC drug review began in 1972 and OTC drugs without any U.S. marketing experience can be considered in the OTC drug monograph system. This section also addresses conditions regulated as a cosmetic or dietary supplement in a foreign country that would be regulated as OTC drugs in the United States. Section 330.15 sets forth timelines for FDA review and action. (a) Definitions. The definitions and interpretations contained in section 201 of the Federal Food, Drug, and Cosmetic Act and the following definitions of terms apply to this section and to § 330.15. (1) Botanical drug substance means a drug substance derived from one or more plants, algae, or macroscopic fungi, but does not include a highly purified or chemically modified substance derived from such a source. (2) Condition means an active ingredient or botanical drug substance (or a combination of active ingredients or botanical drug substances), dosage form, dosage strength, or route of administration, marketed for a specific OTC use, except as excluded in paragraph (b)(2) of this section. (3) Date of filing means the date of the notice from FDA stating that FDA has made a threshold determination that the safety and effectiveness data submission is sufficiently complete to permit a substantive review; or, if the submission is filed over protest in accordance with paragraph (j)(3) of this section, the date of filing is the date of the notice from FDA stating that FDA has filed the submission over protest (this date will be no later than 30 days after the request that FDA file the submission over protest). (4) Feedback letter means a letter issued by the agency in accordance with paragraph (g)(4) of this section that informs the sponsor and other interested persons who have submitted data under paragraph (f) of this section that a condition is initially determined not to be generally recognized as s… | |||
| 21:21:5.0.1.1.11.2.1.6 | 21 | Food and Drugs | I | D | 330 | PART 330—OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED | B | Subpart B—Administrative Procedures | § 330.15 Timelines for FDA review and action on time and extent applications and safety and effectiveness data submissions. | FDA | [81 FR 84477, Nov. 23, 2016] | (a) Applicability. This section applies to the review of a condition in a time and extent application (TEA) submitted under § 330.14 for consideration in the over-the-counter (OTC) drug monograph system. This section does not apply to: (1) A sunscreen active ingredient or combination of sunscreen active ingredients, and other conditions for such ingredients; or (2) A non-sunscreen active ingredient or combination of non-sunscreen active ingredients, and other conditions for such ingredients submitted in a TEA under § 330.14 before November 27, 2014, subject to section 586F(a)(1)(C) of the Federal Food, Drug, and Cosmetic Act. (b) Metrics. FDA will maintain and update annually, a publicly available posting of metrics for the review of TEAs and safety and effectiveness data submissions that are subject to the timelines in this section. The posting will contain the following information for tracking the extent to which the timelines set forth in paragraph (c) of this section were met during the previous calendar year. (1) Number and percent of eligibility notices or ineligibility letters issued within 180 days of submission of a TEA; (2) Number and percent of filing determinations issued within 90 days of submission of a safety and effectiveness data submission; (3) If applicable, number and percent of feedback letters issued within 730 days from the date of filing; (4) Number and percent of notices for proposed rulemaking issued within 1,095 days from the date of filing; (5) Number and percent of final rules issued within 912 days of closing of the docket of the proposed rulemaking; and (6) Total number of TEAs submitted under § 330.14. (c) Timelines for FDA review and action. FDA will review and take an action within the following timelines: (1) Within 180 days of submission of a TEA under § 330.14(c), FDA will issue a notice of eligibility or post to the docket a letter of ineligibility, in accordance with § 330.14(d) and (e). (2) Within 90 days of submission of a safety and effectiveness data s… |
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CREATE TABLE cfr_sections (
section_id TEXT PRIMARY KEY,
title_number INTEGER,
title_name TEXT,
chapter TEXT,
subchapter TEXT,
part_number TEXT,
part_name TEXT,
subpart TEXT,
subpart_name TEXT,
section_number TEXT,
section_heading TEXT,
agency TEXT,
authority TEXT,
source_citation TEXT,
amendment_citations TEXT,
full_text TEXT
);
CREATE INDEX idx_cfr_title ON cfr_sections(title_number);
CREATE INDEX idx_cfr_part ON cfr_sections(part_number);
CREATE INDEX idx_cfr_agency ON cfr_sections(agency);