Datasets:

Azzindani
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US_Regulation_CFR_20260101

title_number stringclasses 48 values	title_name stringclasses 51 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	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	contains_table stringclasses 2 values	contains_definitions stringclasses 2 values	defined_terms stringlengths 0 4.14k	numerical_values stringlengths 0 869	has_penalty_amount stringclasses 2 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

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US Regulation CFR 2026-01-01 Dataset

This repository contains a structured version of the Code of Federal Regulations (CFR), captured as of January 1, 2026. This dataset is designed for use in Retrieval-Augmented Generation (RAG) systems, legal analysis, and Large Language Model (LLM) fine-tuning.

Dataset Description

The dataset provides a snapshot of federal administrative law across all available titles. It has been processed from raw government sources into a format suitable for high-performance indexing and semantic search.

Source: GovInfo Bulk Data (CFR)
Snapshot Date: 2026-01-01
Format: [Specify format, e.g., JSONL, Parquet, or CSV]
Coverage: All 50 Titles of the CFR (where available in bulk format)

Data Acquisition & Integrity

This dataset was compiled using legitimate developer-sanctioned methods. Rather than employing traditional bot-based web scraping, the data was retrieved through official government bulk data endpoints and APIs provided by the U.S. Government Publishing Office (GPO). This ensures:

High Fidelity: Data is pulled directly from the source XML/JSON structures, preserving the original hierarchy of Titles, Chapters, Parts, and Sections.
Compliance: Retrieval adheres to the "Developer Hub" guidelines provided by GovInfo.
Cleanliness: The ingestion process filters out transport-level artifacts common in scraped data, resulting in cleaner text for embedding models.

Potential Use Cases

Legal RAG Pipelines: Powering AI assistants that need to cite specific federal regulations accurately.
Compliance Monitoring: Tracking regulatory changes by comparing this snapshot against previous or future versions.
Knowledge Graphs: Mapping the relationships between different federal agencies and the regulations they enforce.
Academic Research: Large-scale linguistic or structural analysis of administrative law.

Structure

The data is organized to reflect the legal hierarchy of the CFR:

Title: The broad subject area of the regulation.
Volume/Chapter: The specific agency or sub-topic.
Part/Section: The granular regulatory text.
Metadata: Includes original file references and publication dates.

Disclaimer

This dataset is provided for informational and developmental purposes. While every effort is made to ensure the accuracy of the conversion process, users should consult the official version of the CFR at GovInfo.gov for legal proceedings or formal compliance.

Acknowledgment

This data is sourced from the U.S. Government Publishing Office (GPO) Bulk Data repository. We credit the GPO for providing public access to these vital legal records.

License

This dataset is licensed under the Creative Commons Attribution 4.0 International (CC BY 4.0).

Attribution

If you use this dataset in your research or applications, please provide attribution to:

Original Source: The U.S. Government Publishing Office (GPO) GovInfo Bulk Data.
Dataset Curator: Azzindani (via Hugging Face Datasets).

Government Works Public Domain Notice

Note that the underlying regulatory text contained within this dataset is a work of the U.S. Government and is not subject to copyright protection within the United States. This license applies to the specific curation, structuring, and formatting provided in this repository.

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