21 cfr part 1

Requirements To Submit Prior Notice of Imported Food General Requirements Section 1308.03 Administration Controlled Substances Code Number. § 1.21 - Failure to reveal material facts. 3885, 3889. Source: 69 FR 71651, Dec. 9, 2004, unless otherwise noted. § 1.78 - Biological products, HCT/Ps, and related drugs and medical devices. Electronic Code of Federal Regulations (e-CFR) Title 21. The Code of Federal Regulations (CFR) annual edition is the codification of the general and permanent rules published in the Federal Register by the departments and agencies of the Federal Government.. Section 1308.11 Schedule I. § 1.24 - Exemptions from required label statements. § 1.227 - What definitions apply to this subpart? § 1.613 - What protections against conflicts of interest must an accreditation body have to qualify for recognition? Part 11 has a total of 19 requirements. 6, 2016, unless otherwise noted. § 1.71 - Definitions. § 1.508 - What corrective actions must I take under my FSVP? Title 21 Code of Federal Regulations.    § 1.337 - What information must nontransporters establish and maintain to identify the nontransporter and transporter immediate previous sources of food?    § 1.914 - Under what circumstances will we waive a requirement of this subpart? § 1.715 - When must a user fee required by this subpart be submitted? GENERAL; Part 1. Subpart O - Sanitary Transportation of Human and Animal Food.    § 1.670 - How do I apply to FDA for direct accreditation or renewal of direct accreditation? PART 21—REPORTING OF DEFECTS AND NONCOMPLIANCE. 21.3 Definitions.    § 1.630 - How do I apply to FDA for recognition or renewal of recognition? Title 21 of the CFR or the Code of Federal Regulations deals with governing of food and drugs in the United States for three of its governing bodies: The FDA (Food and Drug Administration), DEA (Drug Enforcement Agency) and ONDCP (Office of National Drug Control Policy). PART 1308 — SCHEDULES OF CONTROLLED SUBSTANCES GENERAL INFORMATION. CFR Title 21 Part 11 sets requirements to ensure that electronic records and signatures are trustworthy, reliable, and equivalent substitutes for paper records and handwritten signatures.    § 1.345 - What information must nontransporters establish and maintain to identify the nontransporter and transporter immediate subsequent recipients of food? It also offers guidelines to improve the security of computer systems in FDA-regulated industries. § 1.513 - What FSVP may I have if I am importing certain food from a country with an officially recognized or equivalent food safety system? '; Toggle navigation eCFR. regulations (21 CFR Part 211), the Quality System regulation (21 CFR Part 820), and the Good Laboratory Practice for Nonclinical Laboratory Studies regulations (21 CFR Part 58). Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP). § 1.633 - How will FDA monitor recognized accreditation bodies? § 1.665 - What if I want to voluntarily relinquish accreditation or do not want to renew accreditation? § 1.233 - Are there optional items included in the registration form? Records § 1.3 - Definitions.    § 1.908 - What requirements apply to transportation operations? § 1.327 - Who is excluded from all or part of the regulations in this subpart? 1333, … § 1.643 - What protections against conflicts of interest must a third-party certification body have to qualify for accreditation? Food and Drugs; Chapter I. Section 1313.02 Definitions. § 1.231 - How and where do you register or renew your registration?    § 1.500 - What definitions apply to this subpart? § 1.75 - Animal drugs. § 1.632 - What is the duration of recognition? It is divided into 50 titles that represent broad areas subject to Federal regulation. Electronic Code of Federal Regulations (eCFR). § 1.692 - How do I request internal agency review of a denial of an application or waiver request upon reconsideration? Training § 1.666 - How do I request reaccreditation? Requirements for User Fees Under This Subpart How do I check if One-drive and Sharepoint is compliant with 21 CFR Part 11, ICH R2, HIPAA, etc...? § 1.96 - Granting of authorization to relabel and recondition.    § 1.610 - Who is eligible to seek recognition? 2.    § 1.240 - What other registration requirements apply? § 1.664 - When would FDA withdraw accreditation? § 1.652 - What must an accredited third-party certification body include in food safety audit reports? Note: If you need help accessing information in different file formats, see § 1.73 - Food. Section 1313.01 Scope. § 1.655 - How must an accredited third-party certification body monitor its own performance? For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). § 1.720 - Are user fees under this subpart refundable? § 1.21 - Failure to reveal material facts. § 1.651 - How must an accredited third-party certification body conduct a food safety audit of an eligible entity? Food and Drugs; Chapter I. § 1.631 - How will FDA review my application for recognition or renewal of recognition and what happens once FDA decides on my application? This final rule amended Title 14 Code of Federal Regulations (14 CFR) parts 1, 21, 43 and 45. § 1.381 - May a detained article of food be delivered to another entity or transferred to another location? § 1.392 - Who receives a copy of the detention order? General Provisions § 1.401 - Who is entitled to appeal? Subpart I - Prior Notice of Imported Food. General Provisions    § 1.83 - Definitions. § 1.363 - What are the consequences of failing to establish or maintain records or make them available to FDA as required by this subpart? PART 1303 - QUOTAS. § 1.918 - What must be included in the Statement of Grounds in a petition requesting a waiver? L. 111-353, 124 Stat. § 1.80 - Cosmetics. § 1.382 - What labeling or marking requirements apply to a detained article of food? § 1.661 - What is the duration of accreditation by a recognized accreditation body? § 1.622 - How must a recognized accreditation body monitor its own performance?    § 1.620 - How must a recognized accreditation body evaluate third-party certification bodies seeking accreditation? This information is current as of April 1, 2020.. General Provisions 1490, 1491; 21 U.S.C. Subpart K - Administrative Detention of Food for Human or Animal Consumption. Title 21 Code of Federal Regulations. § 1.74 - Human drugs. 802, 827(h), 830, 871(b) 890. § 1.924 - What process applies to a petition requesting a waiver? § 1.285 - What happens to food that is imported or offered for import from unregistered facilities that are required to register under subpart H of this part? § 1.378 - What criteria does FDA use to order a detention? Source: 54 FR 31665, Aug. 1, 1989, unless otherwise noted. 21.4 Interpretations. Requirements for Third-Party Certification Bodies That Have Been Accredited Under This Subpart § 1.245 - Waiver request. New Search Compliance Dates § 1.623 - What reports and notifications must a recognized accreditation body submit to FDA? § 1.284 - What are the other consequences of failing to submit adequate prior notice or otherwise failing to comply with this subpart?    § 1.368 - What are the compliance dates for this subpart? 594, 668-69; Pub. 21 CFR Part 11 includes 36 pages out of which only 3 pages constitute the rule itself , the other 33 pages are a preamble with comments from the FDA on feedback from the industry. § 1.504 - What hazard analysis must I conduct? § 1.23 - Procedures for requesting variations and exemptions from required label statements. § 1.281 - What information must be in a prior notice? (b) Records established or maintained to satisfy the requirements of this subpart that meet the definition of electronic records in § 11.3(b)(6) (21 CFR 11.3 (b)(6)) of this chapter are exempt from the requirements of part 11 of this chapter. § 1.402 - What are the requirements for submitting an appeal? General Provisions.    § 1.352 - What information must transporters establish and maintain? Title 21: Food and Drugs List of Subjects revised as of January 4, 2021. General Provisions 3885', 'cleanpath': 'https://www.law.cornell.edu/rio/citation/124_Stat._3885'}, {'Volume': '124', 'Page': '3889', 'headtext': '124 Stat. Procedures for Registration of Food Facilities The information on this page is current as of April 1 2020. § 1.510 - How must I maintain records of my FSVP? CFR › Title 21 › Volume 1 › Chapter I › Subchapter A › Part 2. § 1.383 - What expedited procedures apply when FDA initiates a seizure action against a detained perishable food? § 1.243 - Is food registration information available to the public? § 1.277 - What is the scope of this subpart? § 1.76 - Medical devices. § 1.95 - Application for authorization to relabel and recondition. PART 1304 — RECORDS AND REPORTS OF REGISTRANTS CONTINUING RECORDS §1304.21 General requirements for continuing records. § 1.509 - How must the importer be identified at entry? § 1.512 - What FSVP may I have if I am a very small importer or I am importing certain food from certain small foreign suppliers? § 1.226 - Who does not have to register under this subpart? Recognition of Accreditation Bodies Under This Subpart Title 21 PART 1 SUBPART o. CFR › Title 21 › Volume 1 › Chapter I › Subchapter A › Part 1 › Subpart o. Subpart O - Sanitary Transportation of Human and Animal Food. It is divided into three chapters: Chapter I — Food and Drug Administration § 1.403 - What requirements apply to an informal hearing? § 1.662 - How will FDA monitor accredited third-party certification bodies? § 1.934 - What procedures apply if we determine that a waiver should be modified or revoked? L. 107-188, 116 Stat. § 1.285 What happens to food that is imported or offered for import from unregistered facilities that are required to register under subpart H of this part? FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES; Subchapter A. § 1.77 - Radiation-emitting electronic products.    § 1.660 - Where do I apply for accreditation or renewal of accreditation by a recognized accreditation body and what happens once the recognized accreditation body decides on my application? § 1.621 - How must a recognized accreditation body monitor the performance of third-party certification bodies it accredited? The regulations in this part establish procedures and requirements for implementation of section 206 of the Energy Reorganization Act of 1974. § 1.404 - Who serves as the presiding officer for an appeal and for an informal hearing? § 1.615 - What records procedures must an accreditation body have to qualify for recognition? § 1.4 - Authority citations.    § 1.20 - Presence of mandatory label information. 594', 'cleanpath': 'https://www.law.cornell.edu/rio/citation/116_Stat._594'}, {'Volume': '116', 'Page': '668--669', 'headtext': '116 Stat.    § 1.700 - Who is subject to a user fee under this subpart? Additional Procedures for Direct Accreditation of Third-Party Certification Bodies Under This Subpart § 1.24 - Exemptions from required label statements. Hi, Few questions about Office 365 E3 plan (sharepoint & one-drive): 1. § 1.501 - To what foods do the requirements in this subpart apply? Requirements for Eligible Entities Under This Subpart Accreditation of Third-Party Certification Bodies Under This Subpart The 21 CFR and its recommendations are very important in today's pharmaceutical industry. § 1.94 - Hearing on refusal of admission or destruction.    § 1.650 - How must an accredited third-party certification body ensure its audit agents are competent and objective? § 1.710 - How will FDA notify the public about the fee schedule? Records that satisfy the requirements of part 1, subpart J of this chapter, but that also are required under other applicable statutory provisions or regulations, remain subject to this part. § 1.644 - What quality assurance procedures must a third-party certification body have to qualify for accreditation? 321, 331, 332, 333, 334, 335a, 342, 343, 350c, 350d, 350e, 350j, 350k, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 371, 373, 374, 379j-31, 381, 382, 384, 384a, 384b, 384d, 387, 387a, 387c, 393; 42 U.S.C. Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP).. GENERAL ENFORCEMENT REGULATIONS; Subpart H. Registration of Food Facilities    § 1.980 - Administrative detention of drugs. § 1.672 - What is the duration of direct accreditation? Full Text Version (44.99 KB). § 1.653 - What must an accredited third-party certification body do when issuing food or facility certifications? The CFR is organized like this: Title > Chapter > Subchapter > Part. Authority: 21 U.S.C. § 1.505 - What evaluation for foreign supplier approval and verification must I conduct? Title 21, part 2 of the Electronic Code of Federal Regulations. § 1.611 - What legal authority must an accreditation body have to qualify for recognition?    § 1.912 - What record retention and other records requirements apply to shippers, receivers, loaders, and carriers engaged in transportation operations? Subpart A - General Provisions § 1.1 - General. 14 CFR Parts 1, 21, 43, & 45 Amendments Part 21 Briefing Material - 2009 Rule Change.    § 1.690 - How will FDA make information about recognized accreditation bodies and accredited third-party certification bodies available to the public? For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). § 1.241 - What are the consequences of failing to register, update, renew, or cancel your registration? Home; Title 21 PART 2. General Provisions § 1.235 - How and when do you cancel your facility's registration information? § 1.671 - How will FDA review my application for direct accreditation or renewal of direct accreditation and what happens once FDA decides on my application? Electronic Code of Federal Regulations (e-CFR) Title 21 - Food and Drugs; CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES; SUBCHAPTER A - GENERAL; PART 1 - GENERAL ENFORCEMENT REGULATIONS; Subpart L - Foreign Supplier Verification Programs for Food Importers § 1.500 What definitions apply to this subpart? Subpart L - Foreign Supplier Verification Programs for Food Importers 216, 241, 243, 262, 264, 271; Pub. What Is the Appeal Process for a Detention Order? Requirements for Nontransporters To Establish and Maintain Records To Identify the Nontransporter and Transporter Immediate Subsequent Recipients of Food § 1.624 - How must a recognized accreditation body protect against conflicts of interest? GENERAL ENFORCEMENT REGULATIONS § 1.379 - How long may FDA detain an article of food? 21.1 Purpose. § 1.625 - What records requirements must an accreditation body that has been recognized meet? § 1.328 - What definitions apply to this subpart? § 1.506 - What foreign supplier verification and related activities must I conduct? 1333, 1453, 1454, 1455, 4402; 19 U.S.C. Section 1308.01 Scope of this part. Part 2 - General Administrative Rulings And Decisions. § 1.3 - Definitions.    § 1.326 - Who is subject to this subpart? § 1.232 - What information is required in the registration? Subpart B - General Labeling Requirements § 1.904 - What definitions apply to this subpart? § 1.242 - What does assignment of a registration number mean? Practically speaking, Part 11 applies to drug makers, medical device Authority: 15 U.S.C.    § 1.283 - What happens to food that is imported or offered for import without adequate prior notice? Sec. § 1.663 - How do I request an FDA waiver or waiver extension for the 13-month limit for audit agents conducting regulatory audits? regulations (21 CFR Part 211), the Quality System regulation (21 CFR Part 820), and the Good Laboratory Practice for Nonclinical Laboratory Studies regulations (21 CFR Part 58). PART 1313 — IMPORTATION AND EXPORTATION OF LIST I AND LIST II CHEMICALS. The most significant changes affected part 21, Certification Procedures for Products, Articles, and Parts, and part 45, Identification and Registration Marking. This online reference for CFR Title 21 is updated once a year. § 1.725 - What are the consequences of not paying a user fee under this subpart on time? § 1.902 - How do the criteria and definitions in this subpart apply under the Federal Food, Drug, and Cosmetic Act? Given that, the “21 CFR Part 11” name leaves out a couple of details: • Chapter 1: Part 11 falls under “Chapter I,” which applies to the Food and Drug Administration (FDA) and is largely based on the Food, Drug, and … Can they be validated for Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records.    § 1.680 - How and when will FDA monitor eligible entities? Additional Provisions Administrative practice and procedure Cosmetics Drugs Foods 21 CFR Part 3_Product jurisdiction. § 1.503 - Who must develop my FSVP and perform FSVP activities? § 1.384 - When does a detention order terminate? Procedures for Accreditation of Third-Party Certification Bodies Under This Subpart § 1.926 - Under what circumstances may we deny a petition requesting a waiver? Subpart B - General Labeling Requirements, Subpart L - Foreign Supplier Verification Programs for Food Importers, Subpart Q - Administrative Detention of Drugs Intended for Human or Animal Use, Instructions for Downloading Viewers and Players. § 1.636 - How do I request reinstatement of recognition? Section 1308.02 Definitions. Requirements for Accreditation Bodies That Have Been Recognized Under This Subpart § 1.634 - When will FDA revoke recognition? 6, 2016, unless otherwise noted. Title 21 PART 1 SUBPART o. CFR › Title 21 › Volume 1 › Chapter I › Subchapter A › Part 1 › Subpart o. Subpart O - Sanitary Transportation of Human and Animal Food. § 1.23 - Procedures for requesting variations and exemptions from required label statements. Source: 69 FR 71651, Dec. 9, 2004, unless otherwise noted. Title 21 PART 1 SUBPART j. CFR › Title 21 › Volume 1 › Chapter I › Subchapter A › Part 1 › Subpart j. Subpart J - Establishment, Maintenance, and Availability of Records.    § 1.70 - Scope. § 1.79 - Tobacco products. Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration regulations on electronic records and electronic signatures. § 1.930 - When will a waiver that we grant become effective?    § 1.910 - What training requirements apply to carriers engaged in transportation operations? Title 21 Part 2 of the Electronic Code of Federal Regulations. Some of them are specific to Part 11, others are … § 1.681 - How frequently must eligible entities be recertified? General Requirements of This Subpart § 1.511 - What FSVP must I have if I am importing a food subject to certain requirements in the dietary supplement current good manufacturing practice regulation? 14 CFR Parts 1, 21, 43, & 45 Amendments Part 21 Briefing Material - 2009 Rule Change. § 1.280 - How must you submit prior notice? FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES; Subchapter A. § 1.614 - What quality assurance procedures must an accreditation body have to qualify for recognition? This online version is updated according to the Electronic Code of Federal Regulations (e-CFR) PART 1300 - DEFINITIONS. § 1.691 - How do I request reconsideration of a denial by FDA of an application or a waiver request? PART 1304 - RECORDS … Title 21 Part 1 of the Electronic Code of Federal Regulations. § 1.705 - What user fees are established under this subpart? Section 1310.21 Sale by Federal departments or agencies of chemicals which could be used to manufacture controlled substances. § 1.693 - How do I request a regulatory hearing on a revocation of recognition or withdrawal of accreditation? SCHEDULES. § 1.635 - What if I want to voluntarily relinquish recognition or do not want to renew recognition? § 1.502 - What foreign supplier verification program (FSVP) must I have? GENERAL; Part 1. 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