title_number stringclasses 48
values | title_name stringclasses 51
values | subtitle_code stringclasses 6
values | subtitle_name stringclasses 73
values | chapter_number stringclasses 28
values | chapter_name stringclasses 153
values | subchapter_number stringclasses 26
values | subchapter_name stringclasses 649
values | part_number stringlengths 0 27 | part_name stringlengths 0 371 | subpart_code stringlengths 0 272 | subpart_name stringlengths 0 329 | section_number stringlengths 0 163 | section_subject stringlengths 0 958 | section_text stringlengths 0 2.43M | section_type stringclasses 2
values | subsections stringlengths 0 3.93M | authority_citation stringlengths 0 1.64k | usc_reference stringlengths 0 2.57k | cfr_cross_references stringlengths 0 1.74k | original_citation stringlengths 0 2.19k | effective_date stringlengths 0 17 | revision_date stringclasses 44
values | amendment_date stringclasses 266
values | omb_control_number stringlengths 0 9 | editorial_notes stringlengths 0 2.54M | contains_table stringclasses 2
values | table_data stringlengths 0 2.63M | contains_definitions stringclasses 2
values | defined_terms stringlengths 0 4.14k | numerical_values stringlengths 0 869 | has_penalty_amount stringclasses 2
values | penalty_amount stringclasses 353
values | has_deadline stringclasses 2
values | deadline_period stringlengths 0 348 | source stringclasses 1
value | year stringdate 1996-01-01 00:00:00 2003-01-01 00:00:00 | xml_file stringlengths 24 26 | source_url stringclasses 330
values | rag_id stringlengths 16 183 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | 300 | GENERAL | Subpart B | Combination Drugs | 300.50 | Fixed-combination prescription drugs for humans. | The Food and Drug Administration's policy in administering the new-drug, antibiotic, and other regulatory provisions of the Federal Food, Drug, and Cosmetic Act regarding fixed combination dosage form prescription drugs for humans is as follows:
(a) Two or more drugs may be combined in a single dosage form when each c... | regulation | [{"label": "(a)", "text": "Two or more drugs may be combined in a single dosage form when each component makes a contribution to the claimed effects and the dosage of each component (amount, frequency, duration) is such that the combination is safe and effective for a significant patient population requiring such concu... | [40 FR 13496, Mar. 27, 1975] | Mar. 27, 1975 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:300:300.50 | |||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | 300 | GENERAL | Subpart C | Substances Generally Prohibited From Drugs | 300.100 | Chlorofluorocarbon propellants. | The use of chlorofluorocarbons in human drugs as propellants in self-pressurized containers is generally prohibited except as provided by § 2.125 of this chapter. | regulation | § 2.125 | [43 FR 11317, Mar. 17, 1978] | Mar. 17, 1978 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:300:300.100 | |||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | Pt. 310 | NEW DRUGS | Subpart A | General Provisions | 310.3 | Definitions and interpretations. | As used in this part:
(a) The term act means the Federal Food, Drug, and Cosmetic Act, as amended (secs. 201-902, 52 Stat. 1040 et seq., as amended; 21 U.S.C. 321-392).
(b) Department means the Department of Health and Human Services.
(c) Secretary means the Secretary of Health and Human Services.
(d) Commissioner ... | regulation | [{"label": "(a)", "text": "The term act means the Federal Food, Drug, and Cosmetic Act, as amended (secs. 201-902, 52 Stat. 1040 et seq., as amended; 21 U.S.C. 321-392).", "source": null}, {"label": "(b)", "text": "Department means the Department of Health and Human Services.", "source": null}, {"label": "(c)", "text":... | 21 U.S.C. 321 | § 600.3 | [39 FR 11680, Mar. 29, 1974, as amended at 39 FR 20484, June 11, 1974; 40 FR 31307, July 25, 1975; 46 FR 8952, Jan. 27, 1981; 50 FR 7492, Feb. 22, 1985] | Mar. 29, 1974 | (Revised as of April 1, 1996) | False | True | The term act; The term radioactive drug; The term sponsor; New drug substance | 5 years | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:Pt._310:310.3 | |||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | Pt. 310 | NEW DRUGS | Subpart A | General Provisions | 310.4 | Biologics; products subject to license control. | (a) Except for radioactive biological products intended for human use, a new drug shall not be deemed to be subject to section 505 of the act if it is a drug licensed under the Public Health Service Act of July 1, 1944 (58 Stat. 682, as amended (42 U.S.C. 201 et seq.)) or under the animal virus, serum, and toxin law of... | regulation | [{"label": "(a)", "text": "Except for radioactive biological products intended for human use, a new drug shall not be deemed to be subject to section 505 of the act if it is a drug licensed under the Public Health Service Act of July 1, 1944 (58 Stat. 682, as amended (42 U.S.C. 201 et seq.)) or under the animal virus, ... | 42 U.S.C. 201; 21 U.S.C. 151 | § 600.3 | [40 FR 31312, July 25, 1975] | July 25, 1975 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:Pt._310:310.4 | |||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | Pt. 310 | NEW DRUGS | Subpart A | General Provisions | 310.6 | Applicability of “new drug” or safety or effectiveness findings in drug efficacy study implementation notices and notices of opportunity for hearing to identical, related, and similar drug products. | (a) The Food and Drug Administration's conclusions on the effectiveness of drugs are currently being published in the Federal Register as Drug Efficacy Study Implementation (DESI) Notices and as Notices of Opportunity for Hearing. The specific products listed in these notices include only those that were introduced int... | regulation | [{"label": "(a)", "text": "The Food and Drug Administration's conclusions on the effectiveness of drugs are currently being published in the Federal Register as Drug Efficacy Study Implementation (DESI) Notices and as Notices of Opportunity for Hearing. The specific products listed in these notices include only those t... | § 330.10 | [39 FR 11680, Mar. 29, 1974, as amended at 48 FR 2755, Jan. 21, 1983; 50 FR 8996, Mar. 6, 1985; 55 FR 11578, Mar. 29, 1990] | Mar. 29, 1974 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:Pt._310:310.6 | ||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | Pt. 310 | NEW DRUGS | Subpart B | Specific Administrative Rulings and Decisions | 310.100 | New drug status opinions; statement of policy. | (a) Over the years since 1938 the Food and Drug Administration has given informal advice to inquirers as to the new drug status of preparations. These drugs have sometimes been identified only by general statements of composition. Generally, such informal opinions were incorporated in letters that did not explicitly re... | regulation | [{"label": "(a)", "text": "Over the years since 1938 the Food and Drug Administration has given informal advice to inquirers as to the new drug status of preparations. These drugs have sometimes been identified only by general statements of composition. Generally, such informal opinions were incorporated in letters tha... | Pub. L. 87-781 | [39 FR 11680, Mar. 29, 1974] | Mar. 29, 1974 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:Pt._310:310.100 | ||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | Pt. 310 | NEW DRUGS | Subpart B | Specific Administrative Rulings and Decisions | 310.101 | FD&C Red No. 4; procedure for discontinuing use in new drugs for ingestion; statement of policy. | (a) Section 81.10(d) of this chapter published December 11, 1964 (29 FR 16983), terminated the provisional listing of FD&C Red No. 4 for use in drugs that may be ingested and canceled the effectiveness of certificates for this color additive and mixtures containing it as of June 9, 1965 (§ 81.30(c) of this chapter), in... | regulation | [{"label": "(a)", "text": "Section 81.10(d) of this chapter published December 11, 1964 (29 FR 16983), terminated the provisional listing of FD&C Red No. 4 for use in drugs that may be ingested and canceled the effectiveness of certificates for this color additive and mixtures containing it as of June 9, 1965 (§ 81.30(... | § 81.30; § 81.25; § 81.1 | [39 FR 11680, Mar. 29, 1974, as amended at 42 FR 15674, Mar. 22, 1977] | Mar. 29, 1974 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:Pt._310:310.101 | ||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | Pt. 310 | NEW DRUGS | Subpart B | Specific Administrative Rulings and Decisions | 310.103 | New drug substances intended for hypersensitivity testing. | (a) The Food and Drug Administration is aware of the need in the practice of medicine for the ingredients of a new drug to be available for tests of hypersensitivity to such ingredients and therefore will not object to the shipment of a new drug substance, as defined in § 310.3(g), for such purpose if all of the follow... | regulation | [{"label": "(a)", "text": "The Food and Drug Administration is aware of the need in the practice of medicine for the ingredients of a new drug to be available for tests of hypersensitivity to such ingredients and therefore will not object to the shipment of a new drug substance, as defined in § 310.3(g), for such purpo... | § 310.3 | [39 FR 11680, Mar. 29, 1974, as amended at 55 FR 11578, Mar. 29, 1990] | Mar. 29, 1974 | (Revised as of April 1, 1996) | False | False | 2 years | False | True | 2 years | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:Pt._310:310.103 | ||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | Pt. 310 | NEW DRUGS | Subpart C | New Drugs Exempted From Prescription-Dispensing Requirements | 310.200 | Prescription-exemption procedure. | (a) Duration of prescription requirement. Any drug limited to prescription use under section 503(b)(1)(C) of the act remains so limited until it is exempted as provided in paragraph (b) or (e) of this section.
(b) Prescription-exemption procedure for drugs limited by a new drug application. Any drug limited to prescri... | regulation | [{"label": "(a)", "text": "Duration of prescription requirement. Any drug limited to prescription use under section 503(b)(1)(C) of the act remains so limited until it is exempted as provided in paragraph (b) or (e) of this section.", "source": null}, {"label": "(b)", "text": "Prescription-exemption procedure for drugs... | § 330.13 | [39 FR 11680, Mar. 29, 1974, as amended at 41 FR 32582, Aug. 4, 1976; 42 FR 4714, Jan. 25, 1977; 42 FR 15674, Mar. 22, 1977] | Mar. 29, 1974 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:Pt._310:310.200 | ||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | Pt. 310 | NEW DRUGS | Subpart C | New Drugs Exempted From Prescription-Dispensing Requirements | 310.201 | Exemption for certain drugs limited by new-drug applications to prescription sale. | (a) The prescription-dispensing requirements of section 503(b)(1)(C) of the Federal Food, Drug, and Cosmetic Act are not necessary for the protection of the public health with respect to the following drugs subject to new drug applications:
(1) N-Acetyl-p-aminophenol (acetaminophen, p-hydroxy-acetanilid) preparations ... | regulation | [{"label": "(a)", "text": "The prescription-dispensing requirements of section 503(b)(1)(C) of the Federal Food, Drug, and Cosmetic Act are not necessary for the protection of the public health with respect to the following drugs subject to new drug applications:", "source": null}, {"label": "(1)", "text": "N-Acetyl-p-... | [39 FR 11680, Mar. 29, 1974, as amended at 42 FR 36994, July 19, 1977; 52 FR 15892, Apr. 30, 1987; 52 FR 30055, Aug. 12, 1987; 55 FR 31779, Aug. 3, 1990; 57 FR 58374, Dec. 9, 1992; 58 FR 49898, Sept. 23, 1993; 59 FR 4218, Jan. 28, 1994] | Mar. 29, 1974 | (Revised as of April 1, 1996) | False | False | 1 week; 3 years; 3 days; 6 years; 10 days; 4 days; 1 year; 4 years; 12 years; 2 years | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:Pt._310:310.201 | ||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | Pt. 310 | NEW DRUGS | Subpart D | Records and Reports | 310.303 | Continuation of long-term studies, records, and reports on certain drugs for which new drug applications have been approved. | (a) A new drug may not be approved for marketing unless it has been shown to be safe and effective for its intended use(s). After approval, the applicant is required to establish and maintain records and make reports related to clinical experience or other data or information necessary to make or facilitate a determina... | regulation | [{"label": "(a)", "text": "A new drug may not be approved for marketing unless it has been shown to be safe and effective for its intended use(s). After approval, the applicant is required to establish and maintain records and make reports related to clinical experience or other data or information necessary to make or... | § 310.304. | [39 FR 11680, Mar. 29, 1974, as amended at 41 FR 4714, Jan. 25, 1976; 42 FR 15674, Mar. 22, 1977] | Mar. 29, 1974 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:Pt._310:310.303 | ||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | Pt. 310 | NEW DRUGS | Subpart D | Records and Reports | 310.304 | Drugs that are subjects of approved new drug applications and that require special studies, records, and reports. | Listed below are the new drugs and requirements referred to in § 310.303:
(a) [Reserved]
(b) Methadone. Methadone may be used as an analgesic in severe pain, for the detoxification of narcotic addicts, and as an oral substitute for heroin or other morphine-like drugs, in the maintenance treatment of narcotic addicts,... | regulation | [{"label": "(a)", "text": "[Reserved]", "source": null}, {"label": "(b)", "text": "Methadone. Methadone may be used as an analgesic in severe pain, for the detoxification of narcotic addicts, and as an oral substitute for heroin or other morphine-like drugs, in the maintenance treatment of narcotic addicts, pursuant to... | § 310.303; § 291.505.; § 291.505 | [39 FR 11680, Mar. 29, 1974, as amended at 41 FR 9546, Mar. 5, 1976; 41 FR 28263, July 9, 1976; 42 FR 46710, Sept. 16, 1977] | Mar. 29, 1974 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:Pt._310:310.304 | ||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | Pt. 310 | NEW DRUGS | Subpart D | Records and Reports | 310.305 | Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications. | (a) Scope. FDA is requiring manufacturers, packers, and distributors of marketed prescription drug products that are not the subject of an approved new drug or abbreviated new drug application to establish and maintain records and make reports to FDA of:
(1) All serious, unexpected adverse drug experiences associated ... | regulation | [{"label": "(a)", "text": "Scope. FDA is requiring manufacturers, packers, and distributors of marketed prescription drug products that are not the subject of an approved new drug or abbreviated new drug application to establish and maintain records and make reports to FDA of:", "source": null}, {"label": "(1)", "text"... | § 211.198 | [51 FR 24779, July 3, 1986, as amended at 52 FR 37936, Oct. 13, 1987; 55 FR 11578, Mar. 29, 1990; 57 FR 17980, Apr. 28, 1993] | July 3, 1986 | (Revised as of April 1, 1996) | False | True | Adverse drug experience; Increased frequency | 10 years | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:Pt._310:310.305 | ||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | Pt. 310 | NEW DRUGS | Subpart E | Requirements for Specific New Drugs or Devices | 310.500 | Digoxin products for oral use; conditions for marketing. | (a) Studies have shown evidence of clinically significant differences in bio-availability in different batches of certain marketed digoxin products for oral use from single manufacturers as well as in batches of these products produced by different manufacturers. These differences were observed despite the fact that th... | regulation | [{"label": "(a)", "text": "Studies have shown evidence of clinically significant differences in bio-availability in different batches of certain marketed digoxin products for oral use from single manufacturers as well as in batches of these products produced by different manufacturers. These differences were observed d... | § 314.50 | [39 FR 11680, Mar. 29, 1974, as amended at 41 FR 43137, Sept. 30, 1976; 41 FR 49482, Nov. 3, 1976; 50 FR 8996, Mar. 6, 1985; 55 FR 11578, Mar. 29, 1990] | Mar. 29, 1974 | (Revised as of April 1, 1996) | False | False | 8 hour; 36 hours; 2 hours; 180 days; 1 month; 30 days; 10 years; 7 days; 2 years; 8 hours; 3 hours | False | True | 180 days; at least 2 year; within 180 day; within 30 day; 30 days | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:Pt._310:310.500 | ||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | Pt. 310 | NEW DRUGS | Subpart E | Requirements for Specific New Drugs or Devices | 310.501 | Patient package inserts for oral contraceptives. | (a) Requirement for a patient package insert. The safe and effective use of oral contraceptive drug products requires that patients be fully informed of the benefits and the risks involved in their use. An oral contraceptive drug product that does not comply with the requirements of this section is misbranded under sec... | regulation | [{"label": "(a)", "text": "Requirement for a patient package insert. The safe and effective use of oral contraceptive drug products requires that patients be fully informed of the benefits and the risks involved in their use. An oral contraceptive drug product that does not comply with the requirements of this section ... | § 10.90; § 314.70 | [54 FR 22587, May 25, 1989] | May 25, 1989 | (Revised as of April 1, 1996) | False | False | 30 days | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:Pt._310:310.501 | |||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | Pt. 310 | NEW DRUGS | Subpart E | Requirements for Specific New Drugs or Devices | 310.502 | Intrauterine devices for human use for the purpose of contraception. | (a) New drug status of certain intrauterine devices for human use for the purpose of contraception. (1) The Food and Drug Administration has become aware of the increased clinical use for the purpose of contraception of intrauterine devices (IUD's) that incorporate heavy metals, drugs, or other active substances. The a... | regulation | [{"label": "(a)", "text": "New drug status of certain intrauterine devices for human use for the purpose of contraception. (1) The Food and Drug Administration has become aware of the increased clinical use for the purpose of contraception of intrauterine devices (IUD's) that incorporate heavy metals, drugs, or other a... | § 801.427; § 314.70 | [42 FR 23777, May 10, 1977; 42 FR 25854, May 20, 1977; 42 FR 35155, July 8, 1977; 55 FR 11578, Mar. 29. 1990] | May 10, 1977 | (Revised as of April 1, 1996) | True | [{"title": "", "headers": [{"text": "12 mo", "level": "1"}, {"text": "Parous", "level": "2"}, {"text": "Nulliparous", "level": "2"}, {"text": "24 mo", "level": "1"}, {"text": "Parous", "level": "2"}, {"text": "Nulliparous", "level": "2"}], "rows": [[{"text": "Pregnancy", "indent": "01"}, {"text": "", "indent": null}, {... | False | 24 months; 48 hours; 12 months; 3 months | False | True | within 3 month; 3 months | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:Pt._310:310.502 | |||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | Pt. 310 | NEW DRUGS | Subpart E | Requirements for Specific New Drugs or Devices | 310.503 | Requirements regarding certain radioactive drugs. | (a) On January 8, 1963 (28 FR 183), the Commissioner of Food and Drugs exempted investigational radioactive new drugs from part 312 of this chapter provided they were shipped in complete conformity with the regulations issued by the Nuclear Regulatory Commission. This exemption also applied to investigational radioacti... | regulation | [{"label": "(a)", "text": "On January 8, 1963 (28 FR 183), the Commissioner of Food and Drugs exempted investigational radioactive new drugs from part 312 of this chapter provided they were shipped in complete conformity with the regulations issued by the Nuclear Regulatory Commission. This exemption also applied to in... | 10 CFR 35.11 | [39 FR 11680, Mar. 29, 1974, as amended at 40 FR 31307, July 25, 1975; 40 FR 44543, Sept. 29, 1975; 41 FR 35171, Aug. 20, 1976; 41 FR 42947, Sept. 29, 1976; 50 FR 8996, Mar. 6, 1985; 55 FR 11578, Mar. 29, 1990] | Mar. 29, 1974 | (Revised as of April 1, 1996) | True | [{"title": "", "headers": [{"text": "Isotope", "level": "1"}, {"text": "Chemical form", "level": "1"}, {"text": "Use", "level": "1"}], "rows": [[{"text": "Chromium 51", "indent": "01"}, {"text": "Chromate", "indent": null}, {"text": "Spleen scans.", "indent": null}], [{"text": "Do", "indent": "01"}, {"text": "......do"... | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:Pt._310:310.503 | |||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | Pt. 310 | NEW DRUGS | Subpart E | Requirements for Specific New Drugs or Devices | 310.504 | Amphetamines (amphetamine, dextroamphetamine, and their salts and levamfetamine and its salts) for human use. | (a) Amphetamine and dextroamphetamine and their salts. (1) Pursuant to the drug efficacy requirements of the Federal Food, Drug, and Cosmetic Act, the National Academy of Sciences-National Research Council, Drug Efficacy Study Group, has evaluated certain dosage forms of amphetamines and other sympathomimetic stimulant... | regulation | [{"label": "(a)", "text": "Amphetamine and dextroamphetamine and their salts. (1) Pursuant to the drug efficacy requirements of the Federal Food, Drug, and Cosmetic Act, the National Academy of Sciences-National Research Council, Drug Efficacy Study Group, has evaluated certain dosage forms of amphetamines and other sy... | Pub. L. 87-781 | § 314.55; § 300.50 | [39 FR 11680, Mar. 29, 1974, as amended at 41 FR 10885, Mar. 15, 1976; 55 FR 11578, Mar. 29, 1990] | Mar. 29, 1974 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:Pt._310:310.504 | |||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | Pt. 310 | NEW DRUGS | Subpart E | Requirements for Specific New Drugs or Devices | 310.506 | Use of vinyl chloride as an ingredient, including propellant, of aerosol drug products. | (a) Vinyl chloride has been used as a propellant in aerosol drug preparations. Evidence indicates that vinyl chloride inhalation can result in acute toxicity manifested by dizziness, headache, disorientation, and unconsciousness where inhaled at high concentrations. Cardiac effects, bone changes, and degenerative chang... | regulation | [{"label": "(a)", "text": "Vinyl chloride has been used as a propellant in aerosol drug preparations. Evidence indicates that vinyl chloride inhalation can result in acute toxicity manifested by dizziness, headache, disorientation, and unconsciousness where inhaled at high concentrations. Cardiac effects, bone changes,... | [39 FR 30830, Aug. 26, 1974, as amended at 55 FR 11578, Mar. 29, 1990] | Aug. 26, 1974 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:Pt._310:310.506 | |||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | Pt. 310 | NEW DRUGS | Subpart E | Requirements for Specific New Drugs or Devices | 310.507 | Aerosol drug products for human use containing 1,1,1-trichloroethane. | (a) Trichloroethane has been used in aerosol drug products as a solvent for the active ingredients and to reduce the vapor pressure of the propellants. It is potentially toxic to the cardiovascular system, i.e., can sensitize the heart to epinephrine. At a sufficiently large concentration, it is a potent anesthetic age... | regulation | [{"label": "(a)", "text": "Trichloroethane has been used in aerosol drug products as a solvent for the active ingredients and to reduce the vapor pressure of the propellants. It is potentially toxic to the cardiovascular system, i.e., can sensitize the heart to epinephrine. At a sufficiently large concentration, it is ... | [42 FR 63387, Dec. 16, 1977, as amended at 55 FR 11578, Mar. 29, 1990] | Dec. 16, 1977 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:Pt._310:310.507 | |||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | Pt. 310 | NEW DRUGS | Subpart E | Requirements for Specific New Drugs or Devices | 310.508 | Use of certain halogenated salicylanilides as an inactive ingredient in drug products. | (a) Halogenated salicylanilides (tribromsalan (TBS, 3,4′,5-tribromosalicylanilide), dibromsalan (DBS, 4′, 5-dibromosalicylanilide), metabromsalan (MBS, 3, 5-dibromosalicylanilide), and 3,3′, 4,5′-tetrachlorosalicylanilide (TC-SA)) have been used as active or inactive ingredients in a number of over-the-counter (OTC) dr... | regulation | [{"label": "(a)", "text": "Halogenated salicylanilides (tribromsalan (TBS, 3,4′,5-tribromosalicylanilide), dibromsalan (DBS, 4′, 5-dibromosalicylanilide), metabromsalan (MBS, 3, 5-dibromosalicylanilide), and 3,3′, 4,5′-tetrachlorosalicylanilide (TC-SA)) have been used as active or inactive ingredients in a number of ov... | [40 FR 50530, Oct. 30, 1975, as amended at 55 FR 11578, Mar. 29, 1990] | Oct. 30, 1975 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:Pt._310:310.508 | |||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | Pt. 310 | NEW DRUGS | Subpart E | Requirements for Specific New Drugs or Devices | 310.509 | Parenteral drug products in plastic containers. | (a) Any parenteral drug product packaged in a plastic immediate container is not generally recognized as safe and effective, is a new drug within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act, and requires an approved new drug application as a condition for marketing. A “Investigational New ... | regulation | [{"label": "(a)", "text": "Any parenteral drug product packaged in a plastic immediate container is not generally recognized as safe and effective, is a new drug within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act, and requires an approved new drug application as a condition for marketing. ... | 42 U.S.C. 201 | § 314.70 | [43 FR 58562, Dec. 15, 1978, as amended at 50 FR 8996, Mar. 6, 1985; 55 FR 11578, Mar. 29, 1990] | Dec. 15, 1978 | (Revised as of April 1, 1996) | False | False | 24 months; 9 months | False | True | 9 months; within 24 month | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:Pt._310:310.509 | |||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | Pt. 310 | NEW DRUGS | Subpart E | Requirements for Specific New Drugs or Devices | 310.510 | Use of aerosol drug products containing zirconium. | (a) Aerosol products containing zirconium have been used in over-the-counter drug products as antiperspirants. Based upon the lack of toxicological data adequate to establish a safe level for use and the adverse benefit-to-risk ratio, such aerosol products containing zirconium cannot be considered generally recognized ... | regulation | [{"label": "(a)", "text": "Aerosol products containing zirconium have been used in over-the-counter drug products as antiperspirants. Based upon the lack of toxicological data adequate to establish a safe level for use and the adverse benefit-to-risk ratio, such aerosol products containing zirconium cannot be considere... | [42 FR 41376, Aug. 16, 1977, as amended at 55 FR 11579, Mar. 29, 1990] | Aug. 16, 1977 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:Pt._310:310.510 | |||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | Pt. 310 | NEW DRUGS | Subpart E | Requirements for Specific New Drugs or Devices | 310.513 | Chloroform, use as an ingredient (active or inactive) in drug products. | (a) Chloroform has been used as an ingredient in drug products, such as cough preparations, liniments, and toothpastes. Although considered safe for many years, recent information has become available associating chloroform with carcinogenic effects in animals. Studies conducted by the National Cancer Institute have de... | regulation | [{"label": "(a)", "text": "Chloroform has been used as an ingredient in drug products, such as cough preparations, liniments, and toothpastes. Although considered safe for many years, recent information has become available associating chloroform with carcinogenic effects in animals. Studies conducted by the National C... | § 314.70 | [41 FR 26845, June 29, 1976, as amended at 55 FR 11579, Mar. 29, 1990] | June 29, 1976 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:Pt._310:310.513 | ||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | Pt. 310 | NEW DRUGS | Subpart E | Requirements for Specific New Drugs or Devices | 310.515 | Patient package inserts for estrogens. | (a) Requirement for a patient package insert. FDA concludes that the safe and effective use of drug products containing estrogens requires that patients be fully informed of the benefits and risks involved in the use of these drugs. Accordingly, except as provided in paragraph (e) of this section, each estrogen drug pr... | regulation | [{"label": "(a)", "text": "Requirement for a patient package insert. FDA concludes that the safe and effective use of drug products containing estrogens requires that patients be fully informed of the benefits and risks involved in the use of these drugs. Accordingly, except as provided in paragraph (e) of this section... | § 310.501.; § 10.90; § 314.70 | [55 FR 18723, May 4, 1990] | May 4, 1990 | (Revised as of April 1, 1996) | False | False | 30 days | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:Pt._310:310.515 | |||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | Pt. 310 | NEW DRUGS | Subpart E | Requirements for Specific New Drugs or Devices | 310.516 | Progestational drug products; labeling directed to the patient. | (a) The Commissioner of Food and Drugs concludes that the safe and effective use of any progestational drug product requires that patients be informed that there is an increased risk of birth defects in children whose mothers have taken this drug during the first 4 months of pregnancy. Accordingly, except as provided b... | regulation | [{"label": "(a)", "text": "The Commissioner of Food and Drugs concludes that the safe and effective use of any progestational drug product requires that patients be informed that there is an increased risk of birth defects in children whose mothers have taken this drug during the first 4 months of pregnancy. Accordingl... | § 310.501.; § 310.6; § 314.70 | [43 FR 47181, Oct. 13, 1978, as amended at 46 FR 53657, Oct. 30, 1981; 54 FR 1163, Jan. 12, 1989] | Oct. 13, 1978 | (Revised as of April 1, 1996) | False | False | 30 days; 4 months | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:Pt._310:310.516 | |||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | Pt. 310 | NEW DRUGS | Subpart E | Requirements for Specific New Drugs or Devices | 310.517 | Labeling for oral hypoglycemic drugs of the sulfonylurea class. | (a) The University Group Diabetes Program clinical trial has reported an association between the administration of tolbutamide and increased cardiovascular mortality. The Food and Drug Administration has concluded that this reported association provides adequate basis for a warning in the labeling. In view of the simil... | regulation | [{"label": "(a)", "text": "The University Group Diabetes Program clinical trial has reported an association between the administration of tolbutamide and increased cardiovascular mortality. The Food and Drug Administration has concluded that this reported association provides adequate basis for a warning in the labelin... | [49 FR 14331, Apr. 11, 1984] | Apr. 11, 1984 | (Revised as of April 1, 1996) | False | False | 8 years | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:Pt._310:310.517 | ||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | Pt. 310 | NEW DRUGS | Subpart E | Requirements for Specific New Drugs or Devices | 310.519 | Drug products marketed as over-the-counter (OTC) daytime sedatives. | (a) Antihistamines, bromides, and scopolamine compounds, either singly or in combinations, have been marketed as ingredients in over-the-counter (OTC) drug products for use as daytime sedatives. The following claims have been made for daytime sedative products: “occasional simple nervous tension,” “nervous irritability... | regulation | [{"label": "(a)", "text": "Antihistamines, bromides, and scopolamine compounds, either singly or in combinations, have been marketed as ingredients in over-the-counter (OTC) drug products for use as daytime sedatives. The following claims have been made for daytime sedative products: “occasional simple nervous tension,... | [44 FR 36380, June 22, 1979; 45 FR 47422, July 15, 1980, as amended at 55 FR 11579, Mar. 29, 1990] | June 22, 1979 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:Pt._310:310.519 | |||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | Pt. 310 | NEW DRUGS | Subpart E | Requirements for Specific New Drugs or Devices | 310.525 | Sweet spirits of nitre drug products. | (a) Historically, sweet spirits of nitre has been present as an ingredient in over-the-counter (OTC) drug products for various uses. Based upon the lack of adequate data to establish effectiveness for any use and the adverse benefit-to-risk ratio, sweet spirits of nitre drug products cannot be considered generally reco... | regulation | [{"label": "(a)", "text": "Historically, sweet spirits of nitre has been present as an ingredient in over-the-counter (OTC) drug products for various uses. Based upon the lack of adequate data to establish effectiveness for any use and the adverse benefit-to-risk ratio, sweet spirits of nitre drug products cannot be co... | [45 FR 43401, June 27, 1980, as amended at 55 FR 11579, Mar. 29, 1990] | June 27, 1980 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:Pt._310:310.525 | |||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | Pt. 310 | NEW DRUGS | Subpart E | Requirements for Specific New Drugs or Devices | 310.526 | Camphorated oil drug products. | (a) Historically, camphorated oil (also known as camphor liniment), a solution of 20 percent camphor in cottonseed oil, has been marketed as an over-the-counter (OTC) drug product for various uses, primarily as a topical counterirritant or liniment. A large number of accidental ingestions of camphorated oil, often mist... | regulation | [{"label": "(a)", "text": "Historically, camphorated oil (also known as camphor liniment), a solution of 20 percent camphor in cottonseed oil, has been marketed as an over-the-counter (OTC) drug product for various uses, primarily as a topical counterirritant or liniment. A large number of accidental ingestions of camp... | [47 FR 41720, Sept. 21, 1982, as amended at 55 FR 11579, Mar. 29, 1990] | Sept. 21, 1982 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:Pt._310:310.526 | |||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | Pt. 310 | NEW DRUGS | Subpart E | Requirements for Specific New Drugs or Devices | 310.527 | Drug products containing active ingredients offered over-the-counter (OTC) for external use as hair growers or for hair loss prevention. | (a) Amino acids, aminobenzoic acid, ascorbic acid, benzoic acid, biotin and all other B-vitamins, dexpanthenol, estradiol and other topical hormones, jojoba oil, lanolin, nucleic acids, polysorbate 20, polysorbate 60, sulfanilamide, sulfur 1 percent on carbon in a fraction of paraffinic hydrocarbons, tetracaine hydroch... | regulation | [{"label": "(a)", "text": "Amino acids, aminobenzoic acid, ascorbic acid, benzoic acid, biotin and all other B-vitamins, dexpanthenol, estradiol and other topical hormones, jojoba oil, lanolin, nucleic acids, polysorbate 20, polysorbate 60, sulfanilamide, sulfur 1 percent on carbon in a fraction of paraffinic hydrocarb... | [54 FR 28777, July 7, 1989] | July 7, 1989 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:Pt._310:310.527 | |||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | Pt. 310 | NEW DRUGS | Subpart E | Requirements for Specific New Drugs or Devices | 310.528 | Drug products containing active ingredients offered over-the-counter (OTC) for use as an aphrodisiac. | (a) Any product that bears labeling claims that it will arouse or increase sexual desire, or that it will improve sexual performance, is an aphrodisiac drug product. Anise, cantharides, don qual, estrogens, fennel, ginseng, golden seal, gotu kola, Korean ginseng, licorice, mandrake, methyltestosterone, minerals, nux vo... | regulation | [{"label": "(a)", "text": "Any product that bears labeling claims that it will arouse or increase sexual desire, or that it will improve sexual performance, is an aphrodisiac drug product. Anise, cantharides, don qual, estrogens, fennel, ginseng, golden seal, gotu kola, Korean ginseng, licorice, mandrake, methyltestost... | [54 FR 28786, July 7, 1989] | July 7, 1989 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:Pt._310:310.528 | |||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | Pt. 310 | NEW DRUGS | Subpart E | Requirements for Specific New Drugs or Devices | 310.529 | Drug products containing active ingredients offered over-the-counter (OTC) for oral use as insect repellents. | (a) Thiamine hydrochloride (vitamin B-1) has been marketed as an ingredient in over-the-counter (OTC) drug products for oral use as an insect repellent (an orally administered drug product intended to keep insects away). There is a lack of adequate data to establish the effectiveness of this, or any other ingredient fo... | regulation | [{"label": "(a)", "text": "Thiamine hydrochloride (vitamin B-1) has been marketed as an ingredient in over-the-counter (OTC) drug products for oral use as an insect repellent (an orally administered drug product intended to keep insects away). There is a lack of adequate data to establish the effectiveness of this, or ... | [40 FR 25171, June 17, 1985, as amended at 55 FR 11579, Mar. 29, 1990] | June 17, 1985 | (Revised as of April 1, 1996) | False | False | 24 hours | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:Pt._310:310.529 | ||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | Pt. 310 | NEW DRUGS | Subpart E | Requirements for Specific New Drugs or Devices | 310.530 | Topically applied hormone-containing drug products for over-the-counter (OTC) human use. | (a) The term “hormone” is used broadly to describe a chemical substance formed in some organ of the body, such as the adrenal glands or the pituitary, and carried to another organ or tissue, where it has a specific effect. Hormones include, for example, estrogens, progestins, androgens, anabolic steroids, and adrenal c... | regulation | [{"label": "(a)", "text": "The term “hormone” is used broadly to describe a chemical substance formed in some organ of the body, such as the adrenal glands or the pituitary, and carried to another organ or tissue, where it has a specific effect. Hormones include, for example, estrogens, progestins, androgens, anabolic ... | [58 FR 47610, Sept. 9, 1993] | Sept. 9, 1993 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:Pt._310:310.530 | |||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | Pt. 310 | NEW DRUGS | Subpart E | Requirements for Specific New Drugs or Devices | 310.531 | Drug products containing active ingredients offered over-the-counter (OTC) for the treatment of boils. | (a) Aminacrine hydrochloride, benzocaine, bismuth subnitrate, calomel, camphor, cholesterol, ergot fluid extract, hexachlorophene, ichthammol, isobutamben, juniper tar (oil of cade), lanolin, magnesium sulfate, menthol, methyl salicylate, oxyguinoline sulfate, petrolatum, phenol, pine tar, rosin, rosin cerate, sassafra... | regulation | [{"label": "(a)", "text": "Aminacrine hydrochloride, benzocaine, bismuth subnitrate, calomel, camphor, cholesterol, ergot fluid extract, hexachlorophene, ichthammol, isobutamben, juniper tar (oil of cade), lanolin, magnesium sulfate, menthol, methyl salicylate, oxyguinoline sulfate, petrolatum, phenol, pine tar, rosin,... | [58 FR 60336, Nov. 15, 1993] | Nov. 15, 1993 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:Pt._310:310.531 | |||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | Pt. 310 | NEW DRUGS | Subpart E | Requirements for Specific New Drugs or Devices | 310.532 | Drug products containing active ingredients offered over-the-counter (OTC) to relieve the symptoms of benign prostatic hypertrophy. | (a) The amino acids glycine, alanine, and glutamic acid (alone or in combination) and the ingredient sabal have been present in over-the-counter (OTC) drug products to relieve the symptoms of benign prostatic hypertrophy, e.g., urinary urgency and frequency, excessive urinating at night, and delayed urination. There is... | regulation | [{"label": "(a)", "text": "The amino acids glycine, alanine, and glutamic acid (alone or in combination) and the ingredient sabal have been present in over-the-counter (OTC) drug products to relieve the symptoms of benign prostatic hypertrophy, e.g., urinary urgency and frequency, excessive urinating at night, and dela... | [55 FR 6930, Feb. 27, 1990] | Feb. 27, 1990 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:Pt._310:310.532 | |||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | Pt. 310 | NEW DRUGS | Subpart E | Requirements for Specific New Drugs or Devices | 310.533 | Drug products containing active ingredients offered over-the-counter (OTC) for human use as an anticholinergic in cough-cold drug products. | (a) Atropine sulfate, belladonna alkaloids, and belladonna alkaloids as contained in Atropa belladonna and Datura stramonium have been present as ingredients in cough-cold drug products for use as an anticholinergic. Anticholinergic drugs have been marketed OTC in cough-cold drug products to relieve excessive secretion... | regulation | [{"label": "(a)", "text": "Atropine sulfate, belladonna alkaloids, and belladonna alkaloids as contained in Atropa belladonna and Datura stramonium have been present as ingredients in cough-cold drug products for use as an anticholinergic. Anticholinergic drugs have been marketed OTC in cough-cold drug products to reli... | [50 FR 46587, Nov. 8, 1985, as amended at 55 FR 11579, Mar. 29, 1990] | Nov. 8, 1985 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:Pt._310:310.533 | |||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | Pt. 310 | NEW DRUGS | Subpart E | Requirements for Specific New Drugs or Devices | 310.534 | Drug products containing active ingredients offered over-the-counter (OTC) for human use as oral wound healing agents. | (a) Allantoin, carbamide peroxide in anhydrous glycerin, water soluble chlorophyllins, and hydrogen peroxide in aqueous solution have been present in oral mucosal injury drug products for use as oral wound healing agents. Oral wound healing agents have been marketed as aids in the healing of minor oral wounds by means ... | regulation | [{"label": "(a)", "text": "Allantoin, carbamide peroxide in anhydrous glycerin, water soluble chlorophyllins, and hydrogen peroxide in aqueous solution have been present in oral mucosal injury drug products for use as oral wound healing agents. Oral wound healing agents have been marketed as aids in the healing of mino... | [51 FR 26114, July 18, 1986, as amended at 55 FR 11579, Mar. 29, 1990] | July 18, 1986 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:Pt._310:310.534 | |||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | Pt. 310 | NEW DRUGS | Subpart E | Requirements for Specific New Drugs or Devices | 310.536 | Drug products containing active ingredients offered over-the-counter (OTC) for use as a nailbiting or thumbsucking deterrent. | (a) Denatonium benzoate and sucrose octaacetate have been present in OTC nailbiting and thumbsucking deterrent drug products. There is a lack of adequate data to establish general recognition of the safety and effectiveness of these and any other ingredients (e.g., cayenne pepper) for OTC use as a nailbiting or thumbsu... | regulation | [{"label": "(a)", "text": "Denatonium benzoate and sucrose octaacetate have been present in OTC nailbiting and thumbsucking deterrent drug products. There is a lack of adequate data to establish general recognition of the safety and effectiveness of these and any other ingredients (e.g., cayenne pepper) for OTC use as ... | [58 FR 46754, Sept. 2, 1993] | Sept. 2, 1993 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:Pt._310:310.536 | |||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | Pt. 310 | NEW DRUGS | Subpart E | Requirements for Specific New Drugs or Devices | 310.537 | Drug products containing active ingredients offered over-the-counter (OTC) for oral administration for the treatment of fever blisters and cold sores. | (a) l-lysine (lysine, lysine hydrochloride), Lactobacillus acidophilus, and Lactobacillus bulgaricus have been present in orally administered OTC drug products to treat fever blisters and cold sores. There is a lack of adequate data to establish general recognition of the safety and effectiveness of these or any other ... | regulation | [{"label": "(a)", "text": "l-lysine (lysine, lysine hydrochloride), Lactobacillus acidophilus, and Lactobacillus bulgaricus have been present in orally administered OTC drug products to treat fever blisters and cold sores. There is a lack of adequate data to establish general recognition of the safety and effectiveness... | [57 FR 29173, June 30, 1992] | June 30, 1992 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:Pt._310:310.537 | |||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | Pt. 310 | NEW DRUGS | Subpart E | Requirements for Specific New Drugs or Devices | 310.538 | Drug products containing active ingredients offered over-the-counter (OTC) for use for ingrown toenail relief. | (a) Any product that bears labeling claims such as for “temporary relief of discomfort from ingrown toenails,” or “ingrown toenail relief product,” or “ingrown toenail reliever,” or similar claims is considered an ingrown toenail relief drug product. Benzocaine, chlorobutanol, chloroxylenol, dibucaine, sodium sulfide, ... | regulation | [{"label": "(a)", "text": "Any product that bears labeling claims such as for “temporary relief of discomfort from ingrown toenails,” or “ingrown toenail relief product,” or “ingrown toenail reliever,” or similar claims is considered an ingrown toenail relief drug product. Benzocaine, chlorobutanol, chloroxylenol, dibu... | [58 FR 47605, Sept. 9, 1993] | Sept. 9, 1993 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:Pt._310:310.538 | |||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | Pt. 310 | NEW DRUGS | Subpart E | Requirements for Specific New Drugs or Devices | 310.540 | Drug products containing active ingredients offered over-the-counter (OTC) for use as stomach acidifiers. | (a) Betaine hydrochloride, glutamic acid hydrochloride, diluted hydrochloric acid, and pepsin have been present as ingredients in over-the-counter (OTC) drug products for use as stomach acidifiers. Because of the lack of adequate data to establish the effectiveness of these or any other ingredients for use in treating ... | regulation | [{"label": "(a)", "text": "Betaine hydrochloride, glutamic acid hydrochloride, diluted hydrochloric acid, and pepsin have been present as ingredients in over-the-counter (OTC) drug products for use as stomach acidifiers. Because of the lack of adequate data to establish the effectiveness of these or any other ingredien... | [53 FR 31271, Aug. 17, 1988] | Aug. 17, 1988 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:Pt._310:310.540 | |||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | Pt. 310 | NEW DRUGS | Subpart E | Requirements for Specific New Drugs or Devices | 310.541 | Over-the-counter (OTC) drug products containing active ingredients offered for use in the treatment of hypophosphatemia. | (a) Hypophosphatemia is a condition in which an abnormally low plasma level of phosphate occurs in the blood. This condition is not amenable to self-diagnosis or self-treatment. Treatment of this condition should be restricted to the supervision of a physician. For this reason, any drug product containing ingredients o... | regulation | [{"label": "(a)", "text": "Hypophosphatemia is a condition in which an abnormally low plasma level of phosphate occurs in the blood. This condition is not amenable to self-diagnosis or self-treatment. Treatment of this condition should be restricted to the supervision of a physician. For this reason, any drug product c... | [55 FR 19858, May 11, 1990] | May 11, 1990 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:Pt._310:310.541 | |||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | Pt. 310 | NEW DRUGS | Subpart E | Requirements for Specific New Drugs or Devices | 310.542 | Over-the-counter (OTC) drug products containing active ingredients offered for use in the treatment of hyperphosphatemia. | (a) Hyperphosphatemia is a condition in which an abnormally high plasma level of phosphate occurs in the blood. This condition in not amenable to self-diagnosis or self-treatment. Treatment of this condition should be restricted to the supervision of a physician. For this reason, any drug product containing ingredients... | regulation | [{"label": "(a)", "text": "Hyperphosphatemia is a condition in which an abnormally high plasma level of phosphate occurs in the blood. This condition in not amenable to self-diagnosis or self-treatment. Treatment of this condition should be restricted to the supervision of a physician. For this reason, any drug product... | [55 FR 19858, May 11, 1990] | May 11, 1990 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:Pt._310:310.542 | |||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | Pt. 310 | NEW DRUGS | Subpart E | Requirements for Specific New Drugs or Devices | 310.543 | Drug products containing active ingredients offered over-the-counter (OTC) for human use in exocrine pancreatic insufficiency. | (a) Hemicellulase, pancreatin, and pancrelipase have been present as ingredients in exocrine pancreatic insufficiency drug products. Pancreatin and pancrelipase are composed of enzymes: amylase, trypsin (protease), and lipase. Significant differences have been shown in the bioavailability of marketed exocrine pancreati... | regulation | [{"label": "(a)", "text": "Hemicellulase, pancreatin, and pancrelipase have been present as ingredients in exocrine pancreatic insufficiency drug products. Pancreatin and pancrelipase are composed of enzymes: amylase, trypsin (protease), and lipase. Significant differences have been shown in the bioavailability of mark... | [60 FR 20165, Apr. 24, 1995] | Apr. 24, 1995 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:Pt._310:310.543 | |||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | Pt. 310 | NEW DRUGS | Subpart E | Requirements for Specific New Drugs or Devices | 310.544 | Drug products containing active ingredients offered over-the-counter (OTC) for use as a smoking deterrent. | (a) Any product that bears labeling claims that it “helps stop or reduce the cigarette urge,” “helps break the cigarette habit,” “helps stop or reduce smoking,” or similar claims is a smoking deterrent drug product. Cloves, coriander, eucalyptus oil, ginger (Jamaica), lemon oil (terpeneless), licorice root extract, lob... | regulation | [{"label": "(a)", "text": "Any product that bears labeling claims that it “helps stop or reduce the cigarette urge,” “helps break the cigarette habit,” “helps stop or reduce smoking,” or similar claims is a smoking deterrent drug product. Cloves, coriander, eucalyptus oil, ginger (Jamaica), lemon oil (terpeneless), lic... | [58 FR 31241, June 1, 1993] | June 1, 1993 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:Pt._310:310.544 | |||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | Pt. 310 | NEW DRUGS | Subpart E | Requirements for Specific New Drugs or Devices | 310.545 | Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses. | (a) A number of active ingredients have been present in OTC drug products for various uses, as described below. However, based on evidence currently available, there are inadequate data to establish general recognition of the safety and effectiveness of these ingredients for the specified uses:
(1) Topical acne drug p... | regulation | [{"label": "(a)", "text": "A number of active ingredients have been present in OTC drug products for various uses, as described below. However, based on evidence currently available, there are inadequate data to establish general recognition of the safety and effectiveness of these ingredients for the specified uses:",... | § 358.710; § 355.10 | [55 FR 46919, Nov. 7, 1990] | Nov. 7, 1990 | (Revised as of April 1, 1996) | Editorial Note: For Federal Register citations affecting § 310.545, see the List of CFR Sections Affected in the Finding Aids section of this volume. | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:Pt._310:310.545 | |||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | Pt. 310 | NEW DRUGS | Subpart E | Requirements for Specific New Drugs or Devices | 310.546 | Drug products containing active ingredients offered over-the-counter (OTC) for the treatment and/or prevention of nocturnal leg muscle cramps. | (a) Quinine sulfate alone or in combination with vitamin E has been present in over-the-counter (OTC) drug products for the treatment and/or prevention of nocturnal leg muscle cramps, i.e., a condition of localized pain in the lower extremities usually occurring in middle life and beyond with no regular pattern concern... | regulation | [{"label": "(a)", "text": "Quinine sulfate alone or in combination with vitamin E has been present in over-the-counter (OTC) drug products for the treatment and/or prevention of nocturnal leg muscle cramps, i.e., a condition of localized pain in the lower extremities usually occurring in middle life and beyond with no ... | [59 FR 43252, Aug. 22, 1994] | Aug. 22, 1994 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:Pt._310:310.546 | |||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | 312 | INVESTIGATIONAL NEW DRUG APPLICATION | Subpart A | General Provisions | 312.1 | Scope. | (a) This part contains procedures and requirements governing the use of investigational new drugs, including procedures and requirements for the submission to, and review by, the Food and Drug Administration of investigational new drug applications (IND's). An investigational new drug for which an IND is in effect in a... | regulation | [{"label": "(a)", "text": "This part contains procedures and requirements governing the use of investigational new drugs, including procedures and requirements for the submission to, and review by, the Food and Drug Administration of investigational new drug applications (IND's). An investigational new drug for which a... | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:312:312.1 | |||||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | 312 | INVESTIGATIONAL NEW DRUG APPLICATION | Subpart A | General Provisions | 312.2 | Applicability. | (a) Applicability. Except as provided in this section, this part applies to all clinical investigations of products that are subject to section 505 or 507 of the Federal Food, Drug, and Cosmetic Act or to the licensing provisions of the Public Health Service Act (58 Stat. 632, as amended (42 U.S.C. 201 et seq.)).
(b) ... | regulation | [{"label": "(a)", "text": "Applicability. Except as provided in this section, this part applies to all clinical investigations of products that are subject to section 505 or 507 of the Federal Food, Drug, and Cosmetic Act or to the licensing provisions of the Public Health Service Act (58 Stat. 632, as amended (42 U.S.... | 42 U.S.C. 201 | § 312.7.; § 312.160.; § 320.31. | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:312:312.2 | |||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | 312 | INVESTIGATIONAL NEW DRUG APPLICATION | Subpart A | General Provisions | 312.3 | Definitions and interpretations. | (a) The definitions and interpretations of terms contained in section 201 of the Act apply to those terms when used in this part:
(b) The following definitions of terms also apply to this part:
Act means the Federal Food, Drug, and Cosmetic Act (secs. 201-902, 52 Stat. 1040 et seq., as amended (21 U.S.C. 301-392)).
... | regulation | [{"label": "(a)", "text": "The definitions and interpretations of terms contained in section 201 of the Act apply to those terms when used in this part:", "source": null}, {"label": "(b)", "text": "The following definitions of terms also apply to this part:", "source": null}] | 21 U.S.C. 301 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:312:312.3 | ||||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | 312 | INVESTIGATIONAL NEW DRUG APPLICATION | Subpart A | General Provisions | 312.6 | Labeling of an investigational new drug. | (a) The immediate package of an investigational new drug intended for human use shall bear a label with the statement “Caution: New Drug—Limited by Federal (or United States) law to investigational use.”
(b) The label or labeling of an investigational new drug shall not bear any statement that is false or misleading i... | regulation | [{"label": "(a)", "text": "The immediate package of an investigational new drug intended for human use shall bear a label with the statement “Caution: New Drug—Limited by Federal (or United States) law to investigational use.”", "source": null}, {"label": "(b)", "text": "The label or labeling of an investigational new ... | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:312:312.6 | |||||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | 312 | INVESTIGATIONAL NEW DRUG APPLICATION | Subpart A | General Provisions | 312.7 | Promotion and charging for investigational drugs. | (a) Promotion of an investigational new drug. A sponsor or investigator, or any person acting on behalf of a sponsor or investigator, shall not represent in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation or otherwise promote the drug. Thi... | regulation | [{"label": "(a)", "text": "Promotion of an investigational new drug. A sponsor or investigator, or any person acting on behalf of a sponsor or investigator, shall not represent in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation or otherwis... | § 312.31. | [52 FR 8831, Mar. 19, 1987, as amended at 52 FR 19476, May 22, 1987] | Mar. 19, 1987 | (Revised as of April 1, 1996) | False | False | 30 days | False | True | 30 days | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:312:312.7 | ||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | 312 | INVESTIGATIONAL NEW DRUG APPLICATION | Subpart A | General Provisions | 312.10 | Waivers. | (a) A sponsor may request FDA to waive applicable requirement under this part. A waiver request may be submitted either in an IND or in an information amendment to an IND. In an emergency, a request may be made by telephone or other rapid communication means. A waiver request is required to contain at least one of the ... | regulation | [{"label": "(a)", "text": "A sponsor may request FDA to waive applicable requirement under this part. A waiver request may be submitted either in an IND or in an information amendment to an IND. In an emergency, a request may be made by telephone or other rapid communication means. A waiver request is required to conta... | [52 FR 8831, Mar. 19, 1987, as amended at 52 FR 23031, June 17, 1987] | Mar. 19, 1987 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:312:312.10 | |||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | 312 | INVESTIGATIONAL NEW DRUG APPLICATION | Subpart B | Investigational New Drug Application (IND) | 312.20 | Requirement for an IND. | (a) A sponsor shall submit an IND to FDA if the sponsor intends to conduct a clinical investigation with an investigational new drug that is subject to § 312.2(a).
(b) A sponsor shall not begin a clinical investigation subject to § 312.2(a) until the investigation is subject to an IND which is in effect in accordance ... | regulation | [{"label": "(a)", "text": "A sponsor shall submit an IND to FDA if the sponsor intends to conduct a clinical investigation with an investigational new drug that is subject to § 312.2(a).", "source": null}, {"label": "(b)", "text": "A sponsor shall not begin a clinical investigation subject to § 312.2(a) until the inves... | § 312.2; § 312.40. | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:312:312.20 | ||||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | 312 | INVESTIGATIONAL NEW DRUG APPLICATION | Subpart B | Investigational New Drug Application (IND) | 312.21 | Phases of an investigation. | An IND may be submitted for one or more phases of an investigation. The clinical investigation of a previously untested drug is generally divided into three phases. Although in general the phases are conducted sequentially, they may overlap. These three phases of an investigation are a follows:
(a) Phase 1. (1) Phase ... | regulation | [{"label": "(a)", "text": "Phase 1. (1) Phase 1 includes the initial introduction of an investigational new drug into humans. Phase 1 studies are typically closely monitored and may be conducted in patients or normal volunteer subjects. These studies are designed to determine the metabolism and pharmacologic actions of... | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:312:312.21 | |||||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | 312 | INVESTIGATIONAL NEW DRUG APPLICATION | Subpart B | Investigational New Drug Application (IND) | 312.22 | General principles of the IND submission. | (a) FDA's primary objectives in reviewing an IND are, in all phases of the investigation, to assure the safety and rights of subjects, and, in Phase 2 and 3, to help assure that the quality of the scientific evaluation of drugs is adequate to permit an evaluation of the drug's effectiveness and safety. Therefore, altho... | regulation | [{"label": "(a)", "text": "FDA's primary objectives in reviewing an IND are, in all phases of the investigation, to assure the safety and rights of subjects, and, in Phase 2 and 3, to help assure that the quality of the scientific evaluation of drugs is adequate to permit an evaluation of the drug's effectiveness and s... | § 312.23 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:312:312.22 | ||||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | 312 | INVESTIGATIONAL NEW DRUG APPLICATION | Subpart B | Investigational New Drug Application (IND) | 312.23 | IND content and format. | (a) A sponsor who intends to conduct a clinical investigation subject to this part shall submit an “Investigational New Drug Application” (IND) including, in the following order:
(1) Cover sheet (Form FDA-1571). A cover sheet for the application containing the following:
(i) The name, address, and telephone number of... | regulation | [{"label": "(a)", "text": "A sponsor who intends to conduct a clinical investigation subject to this part shall submit an “Investigational New Drug Application” (IND) including, in the following order:", "source": null}, {"label": "(1)", "text": "Cover sheet (Form FDA-1571). A cover sheet for the application containing... | § 25.24; § 312.30; § 25.31.; § 312.55; § 312.32 | [52 FR 8831, Mar. 19, 1987, as amended at 52 FR 23031, June 17, 1987; 53 FR 1918, Jan. 25, 1988] | Mar. 19, 1987 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:312:312.23 | ||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | 312 | INVESTIGATIONAL NEW DRUG APPLICATION | Subpart B | Investigational New Drug Application (IND) | 312.30 | Protocol amendments. | Once an IND is in effect, a sponsor shall amend it as needed to ensure that the clinical investigations are conducted according to protocols included in the application. This section sets forth the provisions under which new protocols may be submitted and changes in previously submitted protocols may be made.
(a) New ... | regulation | [{"label": "(a)", "text": "New protocol. Whenever a sponsor intends to conduct a study that is not covered by a protocol already contained in the IND, the sponsor shall submit to FDA a protocol amendment containing the protocol for the study. Such study may begin provided two conditions are met: (1) The sponsor has sub... | § 56.104; § 312.23; § 312.34. | [52 FR 8831, Mar. 19, 1987, as amended at 52 FR 23031, June 17, 1987; 53 FR 1918, Jan. 25, 1988] | Mar. 19, 1987 | (Revised as of April 1, 1996) | False | False | 30 days | False | True | within 30 day | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:312:312.30 | ||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | 312 | INVESTIGATIONAL NEW DRUG APPLICATION | Subpart B | Investigational New Drug Application (IND) | 312.31 | Information amendments. | (a) Requirement for information amendment. A sponsor shall report in an information amendment essential information on the IND that is not within the scope of a protocol amendment, IND safety reports, or annual report. Examples of information requiring an information amendment include:
(1) New toxicology, chemistry, o... | regulation | [{"label": "(a)", "text": "Requirement for information amendment. A sponsor shall report in an information amendment essential information on the IND that is not within the scope of a protocol amendment, IND safety reports, or annual report. Examples of information requiring an information amendment include:", "source"... | [52 FR 8831, Mar. 19, 1987, as amended at 52 FR 23031, June 17, 1987; 53 FR 1918, Jan. 25, 1988] | Mar. 19, 1987 | (Revised as of April 1, 1996) | False | False | 30 days | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:312:312.31 | ||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | 312 | INVESTIGATIONAL NEW DRUG APPLICATION | Subpart B | Investigational New Drug Application (IND) | 312.32 | IND safety reports. | (a) Definitions. The following definitions of terms apply to this section:
Associated with the use of the drug means that there is a reasonable possibility that the experience may have been caused by the drug.
Serious adverse experience means any experience that suggests a significant hazard, contraindication, side e... | regulation | [{"label": "(a)", "text": "Definitions. The following definitions of terms apply to this section:", "source": null}, {"label": "(b)", "text": "Review of safety information. The sponsor shall promptly review all information relevant to the safety of the drug obtained or otherwise received by the sponsor from any source,... | [52 FR 8831, Mar. 19, 1987, as amended at 52 FR 23031, June 17, 1987; 55 FR 11579, Mar. 29, 1990] | Mar. 19, 1987 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:312:312.32 | |||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | 312 | INVESTIGATIONAL NEW DRUG APPLICATION | Subpart B | Investigational New Drug Application (IND) | 312.33 | Annual reports. | A sponsor shall within 60 days of the anniversary date that the IND went into effect, submit a brief report of the progress of the investigation that includes:
(a) Individual study information. A brief summary of the status of each study in progress and each study completed during the previous year. The summary is req... | regulation | [{"label": "(a)", "text": "Individual study information. A brief summary of the status of each study in progress and each study completed during the previous year. The summary is required to include the following information for each study:", "source": null}, {"label": "(1)", "text": "The title of the study (with any a... | § 312.23 | [52 FR 8831, Mar. 19, 1987, as amended at 52 FR 23031, June 17, 1987] | Mar. 19, 1987 | (Revised as of April 1, 1996) | False | False | 1 year; 60 days | False | True | within 60 day | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:312:312.33 | ||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | 312 | INVESTIGATIONAL NEW DRUG APPLICATION | Subpart B | Investigational New Drug Application (IND) | 312.34 | Treatment use of an investigational new drug. | (a) General. A drug that is not approved for marketing may be under clinical investigation for a serious or immediately life-threatening disease condition in patients for whom no comparable or satisfactory alternative drug or other therapy is available. During the clinical investigation of the drug, it may be appropria... | regulation | [{"label": "(a)", "text": "General. A drug that is not approved for marketing may be under clinical investigation for a serious or immediately life-threatening disease condition in patients for whom no comparable or satisfactory alternative drug or other therapy is available. During the clinical investigation of the dr... | 21 CFR part 50; § 312.42.; 21 CFR part 56 | [52 FR 19476, May 22, 1987, as amended at 57 FR 13248, Apr. 15, 1992] | May 22, 1987 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:312:312.34 | ||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | 312 | INVESTIGATIONAL NEW DRUG APPLICATION | Subpart B | Investigational New Drug Application (IND) | 312.35 | Submissions for treatment use. | (a) Treatment protocol submitted by IND sponsor. Any sponsor of a clinical investigation of a drug who intends to sponsor a treatment use for the drug shall submit to FDA a treatment protocol under § 312.34 if the sponsor believes the criteria of § 312.34 are satisfied. If a protocol is not submitted under § 312.34, bu... | regulation | [{"label": "(a)", "text": "Treatment protocol submitted by IND sponsor. Any sponsor of a clinical investigation of a drug who intends to sponsor a treatment use for the drug shall submit to FDA a treatment protocol under § 312.34 if the sponsor believes the criteria of § 312.34 are satisfied. If a protocol is not submi... | § 312.34.; § 312.23; § 312.34; § 312.32.; 21 CFR part 50; § 312.23. | [52 FR 19477, May 22, 1987, as amended at 57 FR 13249, Apr. 15, 1992] | May 22, 1987 | (Revised as of April 1, 1996) | False | False | 30 days | False | True | 30 days | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:312:312.35 | ||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | 312 | INVESTIGATIONAL NEW DRUG APPLICATION | Subpart B | Investigational New Drug Application (IND) | 312.36 | Emergency use of an investigational new drug. | Need for an investigational drug may arise in an emergency situation that does not allow time for submission of an IND in accordance with § 312.23 or § 312.34. In such a case, FDA may authorize shipment of the drug for a specified use in advance of submission of an IND. A request for such authorization may be transmitt... | regulation | § 312.34.; § 312.23 | [52 FR 8831, Mar. 19, 1987, as amended at 52 FR 23031, June 17, 1987; 55 FR 11579, Mar. 29, 1990] | Mar. 19, 1987 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:312:312.36 | |||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | 312 | INVESTIGATIONAL NEW DRUG APPLICATION | Subpart B | Investigational New Drug Application (IND) | 312.38 | Withdrawal of an IND. | (a) At any time a sponsor may withdraw an effective IND without prejudice.
(b) If an IND is withdrawn, FDA shall be so notified, all clinical investigations conducted under the IND shall be ended, all current investigators notified, and all stocks of the drug returned to the sponsor or otherwise disposed of at the req... | regulation | [{"label": "(a)", "text": "At any time a sponsor may withdraw an effective IND without prejudice.", "source": null}, {"label": "(b)", "text": "If an IND is withdrawn, FDA shall be so notified, all clinical investigations conducted under the IND shall be ended, all current investigators notified, and all stocks of the d... | § 312.59. | [52 FR 8831, Mar. 19, 1987, as amended at 52 FR 23031, June 17, 1987] | Mar. 19, 1987 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:312:312.38 | ||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | 312 | INVESTIGATIONAL NEW DRUG APPLICATION | Subpart C | Administrative Actions | 312.40 | General requirements for use of an investigational new drug in a clinical investigation. | (a) An investigational new drug may be used in a clinical investigation if the following conditions are met:
(1) The sponsor of the investigation submits an IND for the drug to FDA; the IND is in effect under paragraph (b) of this section; and the sponsor complies with all applicable requirements in this part and part... | regulation | [{"label": "(a)", "text": "An investigational new drug may be used in a clinical investigation if the following conditions are met:", "source": null}, {"label": "(1)", "text": "The sponsor of the investigation submits an IND for the drug to FDA; the IND is in effect under paragraph (b) of this section; and the sponsor ... | § 312.42 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:312:312.40 | ||||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | 312 | INVESTIGATIONAL NEW DRUG APPLICATION | Subpart C | Administrative Actions | 312.41 | Comment and advice on an IND. | (a) FDA may at any time during the course of the investigation communicate with the sponsor orally or in writing about deficiencies in the IND or about FDA's need for more data or information.
(b) On the sponsor's request, FDA will provide advice on specific matters relating to an IND. Examples of such advice may incl... | regulation | [{"label": "(a)", "text": "FDA may at any time during the course of the investigation communicate with the sponsor orally or in writing about deficiencies in the IND or about FDA's need for more data or information.", "source": null}, {"label": "(b)", "text": "On the sponsor's request, FDA will provide advice on specif... | § 312.42 | [52 FR 8831, Mar. 19, 1987, as amended at 52 FR 23031, June 17, 1987] | Mar. 19, 1987 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:312:312.41 | ||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | 312 | INVESTIGATIONAL NEW DRUG APPLICATION | Subpart C | Administrative Actions | 312.42 | Clinical holds and requests for modification. | (a) General. A clinical hold is an order issued by FDA to the sponsor to delay a proposed clinical investigation or to suspend an ongoing investigation. The clinical hold order may apply to one or more of the investigations covered by an IND. When a proposed study is placed on clinical hold, subjects may not be given t... | regulation | [{"label": "(a)", "text": "General. A clinical hold is an order issued by FDA to the sponsor to delay a proposed clinical investigation or to suspend an ongoing investigation. The clinical hold order may apply to one or more of the investigations covered by an IND. When a proposed study is placed on clinical hold, subj... | § 312.35; § 312.45.; § 312.23; § 312.34; § 312.48. | [52 FR 8831, Mar. 19, 1987, as amended at 52 FR 19477, May 22, 1987; 57 FR 13249, Apr. 15, 1992] | Mar. 19, 1987 | (Revised as of April 1, 1996) | False | False | 1 year; 30 days | False | True | 30 days | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:312:312.42 | ||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | 312 | INVESTIGATIONAL NEW DRUG APPLICATION | Subpart C | Administrative Actions | 312.44 | Termination. | (a) General. This section describes the procedures under which FDA may terminate an IND. If an IND is terminated, the sponsor shall end all clinical investigations conducted under the IND and recall or otherwise provide for the disposition of all unused supplies of the drug. A termination action may be based on deficie... | regulation | [{"label": "(a)", "text": "General. This section describes the procedures under which FDA may terminate an IND. If an IND is terminated, the sponsor shall end all clinical investigations conducted under the IND and recall or otherwise provide for the disposition of all unused supplies of the drug. A termination action ... | § 312.23; § 312.7.; § 312.42; § 312.42.; § 312.32; § 312.33. | [52 FR 8831, Mar. 19, 1987, as amended at 52 FR 23031, June 17, 1987; 55 FR 11579, Mar. 29, 1990; 57 FR 13249, Apr. 15, 1992] | Mar. 19, 1987 | (Revised as of April 1, 1996) | False | False | 30 days; 5 years; 10 days | False | True | within 10 day | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:312:312.44 | ||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | 312 | INVESTIGATIONAL NEW DRUG APPLICATION | Subpart C | Administrative Actions | 312.45 | Inactive status. | (a) If no subjects are entered into clinical studies for a period of 2 years or more under an IND, or if all investigations under an IND remain on clinical hold for 1 year or more, the IND may be placed by FDA on inactive status. This action may be taken by FDA either on request of the sponsor or on FDA's own initiativ... | regulation | [{"label": "(a)", "text": "If no subjects are entered into clinical studies for a period of 2 years or more under an IND, or if all investigations under an IND remain on clinical hold for 1 year or more, the IND may be placed by FDA on inactive status. This action may be taken by FDA either on request of the sponsor or... | § 312.30; § 312.44.; § 312.130.; § 312.42; § 312.59. | [52 FR 8831, Mar. 19, 1987, as amended at 52 FR 23031, June 17, 1987] | Mar. 19, 1987 | (Revised as of April 1, 1996) | False | False | 2 years; 30 days; 1 year; 5 years | False | True | 30 days | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:312:312.45 | ||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | 312 | INVESTIGATIONAL NEW DRUG APPLICATION | Subpart C | Administrative Actions | 312.47 | Meetings. | (a) General. Meetings between a sponsor and the agency are frequently useful in resolving questions and issues raised during the course of a clinical investigation. FDA encourages such meetings to the extent that they aid in the evaluation of the drug and in the solution of scientific problems concerning the drug, to t... | regulation | [{"label": "(a)", "text": "General. Meetings between a sponsor and the agency are frequently useful in resolving questions and issues raised during the course of a clinical investigation. FDA encourages such meetings to the extent that they aid in the evaluation of the drug and in the solution of scientific problems co... | § 10.65 | [52 FR 8831, Mar. 19, 1987, as amended at 52 FR 23031, June 17, 1987; 55 FR 11580, Mar. 29, 1990] | Mar. 19, 1987 | (Revised as of April 1, 1996) | False | False | 1 month | False | True | at least 1 month | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:312:312.47 | ||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | 312 | INVESTIGATIONAL NEW DRUG APPLICATION | Subpart C | Administrative Actions | 312.48 | Dispute resolution. | (a) General. The Food and Drug Administration is committed to resolving differences between sponsors and FDA reviewing divisions with respect to requirements for IND's as quickly and amicably as possible through the cooperative exchange of information and views.
(b) Administrative and procedural issues. When administr... | regulation | [{"label": "(a)", "text": "General. The Food and Drug Administration is committed to resolving differences between sponsors and FDA reviewing divisions with respect to requirements for IND's as quickly and amicably as possible through the cooperative exchange of information and views.", "source": null}, {"label": "(b)"... | § 312.47 | [52 FR 8831, Mar. 19, 1987, as amended at 55 FR 11580, Mar. 29, 1990] | Mar. 19, 1987 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:312:312.48 | ||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | 312 | INVESTIGATIONAL NEW DRUG APPLICATION | Subpart D | Responsibilities of Sponsors and Investigators | 312.50 | General responsibilities of sponsors. | Sponsors are responsibile for selecting qualified investigators, providing them with the information they need to conduct an investigation properly, ensuring proper monitoring of the investigation(s), ensuring that the investigation(s) is conducted in accordance with the general investigational plan and protocols conta... | regulation | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:312:312.50 | ||||||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | 312 | INVESTIGATIONAL NEW DRUG APPLICATION | Subpart D | Responsibilities of Sponsors and Investigators | 312.52 | Transfer of obligations to a contract research organization. | (a) A sponsor may transfer responsibility for any or all of the obligations set forth in this part to a contract research organization. Any such transfer shall be described in writing. If not all obligations are transferred, the writing is required to describe each of the obligations being assumed by the contract resea... | regulation | [{"label": "(a)", "text": "A sponsor may transfer responsibility for any or all of the obligations set forth in this part to a contract research organization. Any such transfer shall be described in writing. If not all obligations are transferred, the writing is required to describe each of the obligations being assume... | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:312:312.52 | |||||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | 312 | INVESTIGATIONAL NEW DRUG APPLICATION | Subpart D | Responsibilities of Sponsors and Investigators | 312.53 | Selecting investigators and monitors. | (a) Selecting investigators. A sponsor shall select only investigators qualified by training and experience as appropriate experts to investigate the drug.
(b) Control of drug. A sponsor shall ship investigational new drugs only to investigators participating in the investigation.
(c) Obtaining information from the i... | regulation | [{"label": "(a)", "text": "Selecting investigators. A sponsor shall select only investigators qualified by training and experience as appropriate experts to investigate the drug.", "source": null}, {"label": "(b)", "text": "Control of drug. A sponsor shall ship investigational new drugs only to investigators participat... | § 312.64 | [52 FR 8831, Mar. 19, 1987, as amended at 52 FR 23031, June 17, 1987] | Mar. 19, 1987 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:312:312.53 | ||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | 312 | INVESTIGATIONAL NEW DRUG APPLICATION | Subpart D | Responsibilities of Sponsors and Investigators | 312.55 | Informing investigators. | (a) Before the investigation begins, a sponsor (other than a sponsor-investigator) shall give each participating clinical investigator an investigator brochure containing the information described in § 312.23(a)(5).
(b) The sponsor shall, as the overall investigation proceeds, keep each participating investigator info... | regulation | [{"label": "(a)", "text": "Before the investigation begins, a sponsor (other than a sponsor-investigator) shall give each participating clinical investigator an investigator brochure containing the information described in § 312.23(a)(5).", "source": null}, {"label": "(b)", "text": "The sponsor shall, as the overall in... | § 312.32.; § 312.23 | [52 FR 8831, Mar. 19, 1987, as amended at 52 FR 23031, June 17, 1987] | Mar. 19, 1987 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:312:312.55 | ||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | 312 | INVESTIGATIONAL NEW DRUG APPLICATION | Subpart D | Responsibilities of Sponsors and Investigators | 312.56 | Review of ongoing investigations. | (a) The sponsor shall monitor the progress of all clinical investigations being conducted under its IND.
(b) A sponsor who discovers that an investigator is not complying with the signed agreement (Form FDA-1572), the general investigational plan, or the requirements of this part or other applicable parts shall prompt... | regulation | [{"label": "(a)", "text": "The sponsor shall monitor the progress of all clinical investigations being conducted under its IND.", "source": null}, {"label": "(b)", "text": "A sponsor who discovers that an investigator is not complying with the signed agreement (Form FDA-1572), the general investigational plan, or the r... | § 312.33.; § 312.59; § 312.32. | [52 FR 8831, Mar. 19, 1987, as amended at 52 FR 23031, June 17, 1987] | Mar. 19, 1987 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:312:312.56 | ||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | 312 | INVESTIGATIONAL NEW DRUG APPLICATION | Subpart D | Responsibilities of Sponsors and Investigators | 312.57 | Recordkeeping and record retention. | (a) A sponsor shall maintain adequate records showing the receipt, shipment, or other disposition of the investigational drug. These records are required to include, as appropriate, the name of the investigator to whom the drug is shipped, and the date, quantity, and batch or code mark of each such shipment.
(b) A spo... | regulation | [{"label": "(a)", "text": "A sponsor shall maintain adequate records showing the receipt, shipment, or other disposition of the investigational drug. These records are required to include, as appropriate, the name of the investigator to whom the drug is shipped, and the date, quantity, and batch or code mark of each su... | § 320.63; § 320.38.; § 320.38 | [52 FR 8831, Mar. 19, 1987, as amended at 52 FR 23031, June 17, 1987; 58 FR 25926, Apr. 28, 1993] | Mar. 19, 1987 | (Revised as of April 1, 1996) | False | False | 2 years | False | True | 2 years | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:312:312.57 | ||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | 312 | INVESTIGATIONAL NEW DRUG APPLICATION | Subpart D | Responsibilities of Sponsors and Investigators | 312.58 | Inspection of sponsor's records and reports. | (a) FDA inspection. A sponsor shall upon request from any properly authorized officer or employee of the Food and Drug Administration, at reasonable times, permit such officer or employee to have access to and copy and verify any records and reports relating to a clinical investigation conducted under this part. Upon w... | regulation | [{"label": "(a)", "text": "FDA inspection. A sponsor shall upon request from any properly authorized officer or employee of the Food and Drug Administration, at reasonable times, permit such officer or employee to have access to and copy and verify any records and reports relating to a clinical investigation conducted ... | 21 U.S.C. 801 | 21 CFR part 1308 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:312:312.58 | |||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | 312 | INVESTIGATIONAL NEW DRUG APPLICATION | Subpart D | Responsibilities of Sponsors and Investigators | 312.59 | Disposition of unused supply of investigational drug. | The sponsor shall assure the return of all unused supplies of the investigational drug from each individual investigator whose participation in the investigation is discontinued or terminated. The sponsor may authorize alternative disposition of unused supplies of the investigational drug provided this alternative disp... | regulation | § 312.57. | [52 FR 8831, Mar. 19, 1987, as amended at 52 FR 23031, June 17, 1987] | Mar. 19, 1987 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:312:312.59 | |||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | 312 | INVESTIGATIONAL NEW DRUG APPLICATION | Subpart D | Responsibilities of Sponsors and Investigators | 312.60 | General responsibilities of investigators. | An investigator is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator's care; and for the control of drugs under investigation.... | regulation | § 50.23. | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:312:312.60 | |||||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | 312 | INVESTIGATIONAL NEW DRUG APPLICATION | Subpart D | Responsibilities of Sponsors and Investigators | 312.61 | Control of the investigational drug. | An investigator shall administer the drug only to subjects under the investigator's personal supervision or under the supervision of a subinvestigator responsible to the investigator. The investigator shall not supply the investigational drug to any person not authorized under this part to receive it. | regulation | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:312:312.61 | ||||||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | 312 | INVESTIGATIONAL NEW DRUG APPLICATION | Subpart D | Responsibilities of Sponsors and Investigators | 312.62 | Investigator recordkeeping and record retention. | (a) Disposition of drug. An investigator is required to maintain adequate records of the disposition of the drug, including dates, quantity, and use by subjects. If the investigation is terminated, suspended, discontinued, or completed, the investigator shall return the unused supplies of the drug to the sponsor, or ot... | regulation | [{"label": "(a)", "text": "Disposition of drug. An investigator is required to maintain adequate records of the disposition of the drug, including dates, quantity, and use by subjects. If the investigation is terminated, suspended, discontinued, or completed, the investigator shall return the unused supplies of the dru... | § 312.59. | [52 FR 8831, Mar. 19, 1987, as amended at 52 FR 23031, June 17, 1987] | Mar. 19, 1987 | (Revised as of April 1, 1996) | False | False | 2 years | False | True | 2 years | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:312:312.62 | ||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | 312 | INVESTIGATIONAL NEW DRUG APPLICATION | Subpart D | Responsibilities of Sponsors and Investigators | 312.64 | Investigator reports. | (a) Progress reports. The investigator shall furnish all reports to the sponsor of the drug who is responsible for collecting and evaluating the results obtained. The sponsor is required under § 312.33 to submit annual reports to FDA on the progress of the clinical investigations.
(b) Safety reports. An investigator s... | regulation | [{"label": "(a)", "text": "Progress reports. The investigator shall furnish all reports to the sponsor of the drug who is responsible for collecting and evaluating the results obtained. The sponsor is required under § 312.33 to submit annual reports to FDA on the progress of the clinical investigations.", "source": nul... | § 312.33 | [52 FR 8831, Mar. 19, 1987, as amended at 52 FR 23031, June 17, 1987] | Mar. 19, 1987 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:312:312.64 | ||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | 312 | INVESTIGATIONAL NEW DRUG APPLICATION | Subpart D | Responsibilities of Sponsors and Investigators | 312.66 | Assurance of IRB review. | An investigator shall assure that an IRB that complies with the requirements set forth in Part 56 will be responsible for the initial and continuing review and approval of the proposed clinical study. The investigator shall also assure that he or she will promptly report to the IRB all changes in the research activity ... | regulation | [52 FR 8831, Mar. 19, 1987, as amended at 52 FR 23031, June 17, 1987] | Mar. 19, 1987 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:312:312.66 | ||||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | 312 | INVESTIGATIONAL NEW DRUG APPLICATION | Subpart D | Responsibilities of Sponsors and Investigators | 312.68 | Inspection of investigator's records and reports. | An investigator shall upon request from any properly authorized officer or employee of FDA, at reasonable times, permit such officer or employee to have access to, and copy and verify any records or reports made by the investigator pursuant to § 312.62. The investigator is not required to divulge subject names unless t... | regulation | § 312.62. | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:312:312.68 | |||||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | 312 | INVESTIGATIONAL NEW DRUG APPLICATION | Subpart D | Responsibilities of Sponsors and Investigators | 312.69 | Handling of controlled substances. | If the investigational drug is subject to the Controlled Substances Act, the investigator shall take adequate precautions, including storage of the investigational drug in a securely locked, substantially constructed cabinet, or other securely locked, substantially constructed enclosure, access to which is limited, to ... | regulation | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:312:312.69 | ||||||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | 312 | INVESTIGATIONAL NEW DRUG APPLICATION | Subpart D | Responsibilities of Sponsors and Investigators | 312.70 | Disqualification of a clinical investigator. | (a) If FDA has information indicating that an investigator has repeatedly or deliberately failed to comply with the requirements of this part, Part 50, or part 56, or has submitted to the sponsor false information in any required report, the Center for Drug Evaluation and Research or the Center for Biologics Evaluation... | regulation | [{"label": "(a)", "text": "If FDA has information indicating that an investigator has repeatedly or deliberately failed to comply with the requirements of this part, Part 50, or part 56, or has submitted to the sponsor false information in any required report, the Center for Drug Evaluation and Research or the Center f... | [52 FR 8831, Mar. 19, 1987, as amended at 52 FR 23031, June 17, 1987; 55 FR 11580, Mar. 29, 1990] | Mar. 19, 1987 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:312:312.70 | |||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | 312 | INVESTIGATIONAL NEW DRUG APPLICATION | Subpart E | Drugs Intended to Treat Life-threatening and Severely-debilitating Illnesses | 312.80 | Purpose. | The purpose of this section is to establish procedures designed to expedite the development, evaluation, and marketing of new therapies intended to treat persons with life-threatening and severely-debilitating illnesses, especially where no satisfactory alternative therapy exists. As stated § 314.105(c) of this chapter... | regulation | § 314.105 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:312:312.80 | |||||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | 312 | INVESTIGATIONAL NEW DRUG APPLICATION | Subpart E | Drugs Intended to Treat Life-threatening and Severely-debilitating Illnesses | 312.81 | Scope. | This section applies to new drug, antibiotic, and biological products that are being studied for their safety and effectiveness in treating life-threatening or severely-debilitating diseases.
(a) For purposes of this section, the term “life-threatening” means:
(1) Diseases or conditions where the likelihood of death ... | regulation | [{"label": "(a)", "text": "For purposes of this section, the term “life-threatening” means:", "source": null}, {"label": "(1)", "text": "Diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted; and", "source": null}, {"label": "(2)", "text": "Diseases or conditions w... | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:312:312.81 | |||||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | 312 | INVESTIGATIONAL NEW DRUG APPLICATION | Subpart E | Drugs Intended to Treat Life-threatening and Severely-debilitating Illnesses | 312.82 | Early consultation. | For products intended to treat life-threatening or severely-debilitating illnesses, sponsors may request to meet with FDA-reviewing officials early in the drug development process to review and reach agreement on the design of necessary preclinical and clinical studies. Where appropriate, FDA will invite to such meetin... | regulation | [{"label": "(a)", "text": "Pre-investigational new drug (IND) meetings. Prior to the submission of the initial IND, the sponsor may request a meeting with FDA-reviewing officials. The primary purpose of this meeting is to review and reach agreement on the design of animal studies needed to initiate human testing. The m... | § 312.47 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:312:312.82 | ||||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | 312 | INVESTIGATIONAL NEW DRUG APPLICATION | Subpart E | Drugs Intended to Treat Life-threatening and Severely-debilitating Illnesses | 312.83 | Treatment protocols. | If the preliminary analysis of phase 2 test results appears promising, FDA may ask the sponsor to submit a treatment protocol to be reviewed under the procedures and criteria listed in §§ 312.34 and 312.35. Such a treatment protocol, if requested and granted, would normally remain in effect while the complete data nece... | regulation | § 312.34; § 312.42 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:312:312.83 | |||||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | 312 | INVESTIGATIONAL NEW DRUG APPLICATION | Subpart E | Drugs Intended to Treat Life-threatening and Severely-debilitating Illnesses | 312.84 | Risk-benefit analysis in review of marketing applications for drugs to treat life-threatening and severely-debilitating illnesses. | (a) FDA's application of the statutory standards for marketing approval shall recognize the need for a medical risk-benefit judgment in making the final decision on approvability. As part of this evaluation, consistent with the statement of purpose in § 312.80, FDA will consider whether the benefits of the drug outweig... | regulation | [{"label": "(a)", "text": "FDA's application of the statutory standards for marketing approval shall recognize the need for a medical risk-benefit judgment in making the final decision on approvability. As part of this evaluation, consistent with the statement of purpose in § 312.80, FDA will consider whether the benef... | § 312.80; § 314.101; § 312.82; § 314.120 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:312:312.84 | ||||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | 312 | INVESTIGATIONAL NEW DRUG APPLICATION | Subpart E | Drugs Intended to Treat Life-threatening and Severely-debilitating Illnesses | 312.85 | Phase 4 studies. | Concurrent with marketing approval, FDA may seek agreement from the sponsor to conduct certain postmarketing (phase 4) studies to delineate additional information about the drug's risks, benefits, and optimal use. These studies could include, but would not be limited to, studying different doses or schedules of adminis... | regulation | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:312:312.85 | ||||||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | 312 | INVESTIGATIONAL NEW DRUG APPLICATION | Subpart E | Drugs Intended to Treat Life-threatening and Severely-debilitating Illnesses | 312.86 | Focused FDA regulatory research. | At the discretion of the agency, FDA may undertake focused regulatory research on critical rate-limiting aspects of the preclinical, chemical/manufacturing, and clinical phases of drug development and evaluation. When initiated, FDA will undertake such research efforts as a means for meeting a public health need in fac... | regulation | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:312:312.86 | ||||||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | 312 | INVESTIGATIONAL NEW DRUG APPLICATION | Subpart E | Drugs Intended to Treat Life-threatening and Severely-debilitating Illnesses | 312.87 | Active monitoring of conduct and evaluation of clinical trials. | For drugs covered under this section, the Commissioner and other agency officials will monitor the progress of the conduct and evaluation of clinical trials and be involved in facilitating their appropriate progress. | regulation | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:312:312.87 | ||||||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | 312 | INVESTIGATIONAL NEW DRUG APPLICATION | Subpart E | Drugs Intended to Treat Life-threatening and Severely-debilitating Illnesses | 312.88 | Safeguards for patient safety. | All of the safeguards incorporated within parts 50, 56, 312, 314, and 600 of this chapter designed to ensure the safety of clinical testing and the safety of products following marketing approval apply to drugs covered by this section. This includes the requirements for informed consent (part 50 of this chapter) and in... | regulation | § 314.50; § 312.32; § 312.23; § 314.80 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:312:312.88 | |||||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | 312 | INVESTIGATIONAL NEW DRUG APPLICATION | Subpart F | Miscellaneous | 312.110 | Import and export requirements. | (a) Imports. An investigational new drug offered for import into the United States complies with the requirements of this part if it is subject to an IND that is in effect for it under § 312.40 and: (1) The consignee in the United States is the sponsor of the IND; (2) the consignee is a qualified investigator named in ... | regulation | [{"label": "(a)", "text": "Imports. An investigational new drug offered for import into the United States complies with the requirements of this part if it is subject to an IND that is in effect for it under § 312.40 and: (1) The consignee in the United States is the sponsor of the IND; (2) the consignee is a qualified... | § 312.40 | [52 FR 8831, Mar. 19, 1987, as amended at 52 FR 23031, June 17, 1987] | Mar. 19, 1987 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:312:312.110 | ||||||||||||
21 | Food and Drugs | I | Food and Drug Administration, Department of Health and Human Services (Continued) | D | DRUGS FOR HUMAN USE | 312 | INVESTIGATIONAL NEW DRUG APPLICATION | Subpart F | Miscellaneous | 312.120 | Foreign clinical studies not conducted under an IND. | (a) Introduction. This section describes the criteria for acceptance by FDA of foreign clinical studies not conducted under an IND. In general, FDA accepts such studies provided they are well designed, well conducted, performed by qualified investigators, and conducted in accordance with ethical principles acceptable t... | regulation | [{"label": "(a)", "text": "Introduction. This section describes the criteria for acceptance by FDA of foreign clinical studies not conducted under an IND. In general, FDA accepts such studies provided they are well designed, well conducted, performed by qualified investigators, and conducted in accordance with ethical ... | § 314.126.; § 314.106. | [52 FR 8831, Mar. 19, 1987, as amended at 52 FR 23031, June 17, 1987; 56 FR 22113, May 14, 1991] | Mar. 19, 1987 | (Revised as of April 1, 1996) | False | False | False | False | CFR | 1996 | CFR-1996-title21-vol5.xml | https://www.govinfo.gov/bulkdata/CFR/1996/title-21 | cfr:1996:21:312:312.120 |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.