For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). It's easier to search, find, read, and apply all of our favorite regulations. § 610.46 - Human immunodeficiency virus (HIV) "lookback" requirements. 21 CFR 11, 58, 210/211, 600, 601, 610, 820 - Multi-US GMPs. Although manufacturers of live virus vaccines and inactivated virus vaccines § 610.13 - Purity. Electronic Code of Federal Regulations (e-CFR) Title 21. Food and Drugs; Chapter I.
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§ 610.61 - Package label. April 1, 2014 GENERAL BIOLOGICAL PRODUCTS STANDARDS A description is not available for this item.
The information on this page is current as of April 1 2020.
I (4–1–08 Edition) 610.53 Dating periods for licensed biological .
Therefore, under the Federal Food, Drug, and Cosmetic Act, and the Food and Drug Administration Modernization Act, and under authority delegated to the Commissioner of Food and Drugs, it is proposed that chapter I of Title 21 be amended as follows: § 610.60 - Container label. FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES, Subpart A - Release Requirements (§§ 610.1 - 610.2), Subpart B - General Provisions (§§ 610.9 - 610.18), Subpart E - Testing Requirements for Relevant Transfusion-Transmitted Infections (§§ 610.39 - 610.48), Subpart F - Dating Period Limitations (§§ 610.50 - 610.53), Subpart G - Labeling Standards (§§ 610.60 - 610.68), Part 610. § 610.53 - Dating periods for Whole Blood and blood components. 610.48 Hepatitis C virus (HCV) ‘‘lookback’’ requirements based on review of histor ical testing records. § 610.47 - Hepatitis C virus (HCV) "lookback" requirements. § 610.68 - Exceptions or alternatives to labeling requirements for biological products held by the Strategic National Stockpile. Subpart F—Dating Period Limitations . 216, 262, 263, 263a, 264. Published by FAA …
Biologics Labeling Reporting and recordkeeping requirements 21 CFR Part 630_Requirements for blood and blood components intended for transfusion of for further manufacturing use. § 610.61 - Package label.
The regulations in this part establish procedures and requirements for implementation of section 206 of the Energy Reorganization Act of 1974. § 610.42 - Restrictions on use for further manufacture of medical devices. § 610.16 - Total solids in serums.
GENERAL BIOLOGICAL PRODUCTS STANDARDS.
610…
211.22 Responsibilities of quality control unit.211.25 Personnel qualifications.211.28 Personnel responsibilities.211.34 Consultants. § 610.14 - Identity. Collapse to view only § 610.61 - Package label.
For U.S. Customs Service regulations relating to viruses, serums, and toxins, see 19 CFR …
needs to be filled on a regular, full- or part-time basis.
For U.S. Customs Service regulations relating to viruses, serums, and toxins, see 19 CFR 12.21-12.23.For U.S. Title 21 CFR Part 610.12 amends previous sterility test requirements for biological products.
§ 610.40 - Test requirements. § 610.1 - Tests prior to release required for each lot.
§ 610.2 - Requests for samples and protocols; official release. 21 CFR PART 610. 610.50 Date of manufacture. Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English, The information on this page is current as of. (1) An applicant of a biological product, other than blood or blood components for transfusion, which is licensed under section 351 of the Public Health Service Act, and which may be dispensed only under prescription under section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
The course provides a breakdown of the FDA requirements in 21 CFR 600, 601, and 610. Subpart G—Labeling Standards .
§ 610.20-610.21 - [Reserved]. {'United States Code': [{'Title': '42', 'Section': '216', 'headtext': ' Regulations', 'cleanpath': '/uscode/text/42/216'}, {'Title': '42', 'Section': '262', 'headtext': ' Regulation of biological products', 'cleanpath': '/uscode/text/42/262'}, {'Title': '42', 'Section': '263', 'headtext': ' Preparation of biological products by Service', 'cleanpath': '/uscode/text/42/263'}, {'Title': '42', 'Section': '263a', 'headtext': ' Certification of laboratories', 'cleanpath': '/uscode/text/42/263a'}, {'Title': '42', 'Section': '264', 'headtext': ' Regulations to control communicable diseases', 'cleanpath': '/uscode/text/42/264'}, {'Title': '21', 'Section': '321', 'headtext': ' Definitions; generally', 'cleanpath': '/uscode/text/21/321'}, {'Title': '21', 'Section': '331', 'headtext': ' Prohibited acts', 'cleanpath': '/uscode/text/21/331'}, {'Title': '21', 'Section': '351', 'headtext': ' Adulterated drugs and devices', 'cleanpath': '/uscode/text/21/351'}, {'Title': '21', 'Section': '352', 'headtext': ' Misbranded drugs and devices', 'cleanpath': '/uscode/text/21/352'}, {'Title': '21', 'Section': '353', 'headtext': ' Exemptions and consideration for certain drugs, devices, and biological products', 'cleanpath': '/uscode/text/21/353'}, {'Title': '21', 'Section': '355', 'headtext': ' New drugs', 'cleanpath': '/uscode/text/21/355'}, {'Title': '21', 'Section': '360', 'headtext': ' Registration of producers of drugs or devices', 'cleanpath': '/uscode/text/21/360'}, {'Title': '21', 'Section': '360c', 'headtext': ' Classification of devices intended for human use', 'cleanpath': '/uscode/text/21/360c'}, {'Title': '21', 'Section': '360d', 'headtext': ' Performance standards', 'cleanpath': '/uscode/text/21/360d'}, {'Title': '21', 'Section': '360h', 'headtext': ' Notification and other remedies', 'cleanpath': '/uscode/text/21/360h'}, {'Title': '21', 'Section': '360i', 'headtext': ' Records and reports on devices', 'cleanpath': '/uscode/text/21/360i'}, {'Title': '21', 'Section': '371', 'headtext': ' Regulations and hearings', 'cleanpath': '/uscode/text/21/371'}, {'Title': '21', 'Section': '372', 'headtext': ' Examinations and investigations', 'cleanpath': '/uscode/text/21/372'}, {'Title': '21', 'Section': '374', 'headtext': ' Inspection', 'cleanpath': '/uscode/text/21/374'}, {'Title': '21', 'Section': '381', 'headtext': ' Imports and exports', 'cleanpath': '/uscode/text/21/381'}], 'Statutes at Large': [], 'Public Laws': [], 'Presidential Documents': []}, Electronic Code of Federal Regulations (e-CFR), Chapter I.
Federal Regulations (CFR) 610.30, Subpart D (21 CFR 610.30 or the 610.30 Test for Mycoplasma). SUMMARY: The Food and Drug Administration (FDA, the Agency, or … Testing for Communicable Diseases: 21CFR Part 610 The critical elements of Part 610 General Biological Products Standards relate to testing for communicable disease agents.
§ 610.67 - Bar code label requirements. Cook v. Army, 18 MSPR 610 (1984).
FDA regulations are perfect for viewing on Apple and Android devices. (a) Storage and maintenance. U.S. Code of Federal Regulations. 21 CFR Part 610 Biologics, Labeling, Reporting and recordkeeping requirements. Regulations most recently checked for updates: Jan 20, 2021 All Titles Title 21 Chapter I Part 610 Subpart B - General Provisions. Terms Used In 21 CFR 610.14. filling: refers to a group of final containers identical in all respects, which have been filled with the same product from the same bulk lot without any change that will affect the integrity of the filling assembly.See 21 CFR 600.3; Lot: means that quantity of uniform material identified by the manufacturer as having been thoroughly mixed in a single vessel. § 610.41 - Donor deferral.
21 CFR Part 610_General biological products standards.
Authority: 21 U.S.C. § 610.9 - Equivalent methods and processes.
title 21 chapter I-i6 part 610 subpart F § 610.50 Collapse to view only § 610.50 - Date of manufacture for biological products. CITE AS: 21 CFR 610.9 § 610.10 - Potency. 610.1 Tests prior to release required for each lot.
§ 610.39 - Definitions. § 610.15 - Constituent materials. 610.2 Requests for samples and protocols; official release.
1-933734-55-8.
ACTION: Final rule. § 610.60 - Container label. § 610.44 - Use of reference panels by manufacturers of test kits. Official Publications from the U.S. Government Publishing Office. This document references: 19 CFR PART 12 - SPECIAL CLASSES OF MERCHANDISE. It provides manufacturers of biological products greater flexibility, as appropriate, and encourages the use of the most appropriate and state-of-the-art testing methods for assuring the safety of biological products. [Code of Federal Regulations] [Title 21, Volume 7] [Revised as of April 1, 2020] [CITE: 21CFR610] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER F - BIOLOGICS : PART 610: GENERAL BIOLOGICAL PRODUCTS STANDARDS Sec.
Current as of: 2019 | Check for updates | Other versions (a) Storage and maintenance. Postal Service regulations relating to the admissibility to the United States mails see parts 124 and 125 of the Domestic Mail Manual, that is incorporated by reference in 39 CFR part 111. GENERAL BIOLOGICAL PRODUCTS STANDARDS; Subpart G. Labeling Standards
Instructions for Downloading Viewers and Players. Subpart F - Dating Period Limitations
§ 610.64 - Name and address of distributor. Postal Service regulations relating to the admissibility to the United States mails see parts 124 and 125 of the Domestic Mail Manual, that is incorporated by reference in 39 CFR part 111.
§ 610.17 - Permissible combinations. U.S. Code of Federal Regulations. (This course does not include blood and blood products, 21 CFR part 606.)
These FDA requirements are important and support your business and compliance drivers. It also offers guidelines to improve the security of computer systems in FDA-regulated industries. All Titles Title 21 Chapter I Part 610 Subpart B - General Provisions Collapse to view only § 610.18 - Cultures. § 610.63 - Divided manufacturing responsibility to be shown.
21 CFR Ch. § 610.62 - Proper name; package label; legible type. CFR > Title 21 > Chapter I > Subchapter F > Part 610 > Subpart B > § 610.18 21 CFR 610.18 – Cultures.
Subpart A - Release Requirements
Note: If you need help accessing information in different file formats, see
Source: 38 FR 32056, Nov. 20, 1973, unless otherwise noted. Subpart A - Release Requirements § 610.1 - Tests prior to release required for each lot. 21 CFR Part 607 Establishment Registration And Product Listing For Manufacturers Of Human Blood And Blood Products And Licensed Devices 21 CFR Part 610 General Biological Products Standards 21 CFR Part 630 Requirements For Blood And Blood Components Intended For Transfusion Or For Further Manufacturing Use § 610.12 - Sterility. § 610.48 - [Reserved].
§ 610.9 - Equivalent methods and processes. FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES; Subchapter F. BIOLOGICS; Part 610. § 610.18 - Cultures. View Less.
For U.S. Customs Service regulations relating to viruses, serums, and toxins, see 19 CFR 12.21-12.23.
US FDA Title 21 CFR Parts. See also McCauley v. Interior, 116 MSPR 484 (2011), holding that a charge of Excessive Leave may include sick leave, annual leave, LWOP, and AWOL but may never be based on FMLA leave. Part 11 - Electronic Records/Electronic Signatures (ERES) with Scope and Application Part 58 - Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies While 21 CFR Parts 210 and 211 both apply to GMP of drug products, each part addresses a different set of guidelines. Major topic areas covered are general requirements, licensing, and biologics standards. 21 CFR, Pt 610 TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER F--BIOLOGICS PART 610--GENERAL BIOLOGICAL PRODUCTS STANDARDS Subpart A--Release Requirements Sec. § 610.11-610.11a - … View all text of Subpart B [§ 610.9 - § 610.18] § 610.18 - Cultures.
§ 610.10 - Potency.
FDA-2018-N-4757] RIN 0910-AH95 Revocation of the Test for Mycoplasma is overly restrictive in that it identifies only one test AGENCY: Food and Drug Administration, HHS.
Biologics Licensure 4 • Title 21 of the Code of Federal regulations (CFR) contains the regulations through which FDA implements the PHS Act and the FD& C Act Legal definitions for safety, purity and potency are stated in 21 CFR 600.3 Ø Safety is defined as “…the relative freedom from harmful effect to persons affected, directly or indirectly, by a product when prudently
§ 610.50 - Date of manufacture for biological products. (a) Notification of a permanent discontinuance or an interruption in manufacturing.
Subpart G - Labeling Standards
21 CFR 11, 210/211, 820 - Electronic Records with Drug and Device GMPs 21 CFR 11, 58, 210/211, 600, 601, 610, 820 - Multi-US GMPs 21 CFR 11, 210/211, 820, ICH Q7 - Good Manufacturing Practice Handbook CITE AS: 21 CFR 610.50 § 610.53 - Dating periods for Whole Blood and blood components.
§ 610.2 - Requests for samples and protocols; official release.. Subpart B - General Provisions § 610.9 - Equivalent methods and processes.
610.60 Container label. 21 CFR Part 610 [Docket No. Electronic Code of Federal Regulations (eCFR).
Subpart E - Testing Requirements for Relevant Transfusion-Transmitted Infections
(a) General. Note that only the following tests are currently required, although additional testing (eg, Chagas and West Nile Virus) may be … § 610.65 - Products for export.
For U.S. 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. Tests for potency shall consist of either in vitro or in vivo tests, or both, which have been specifically designed for each product so as to indicate its potency in a …
References.
The final rule removes § 610.30 (21 CFR 610.30), which details the method for Mycoplasma testing of samples of the virus harvest pool and control fluid pool of live virus vaccines and inactivated virus vaccines produced from in vitro living cell cultures. CFR Title 21 Section 610.53 Dating periods for Whole Blood and blood components of the Electronic Code of Federal Regulations
Title 21 - Food and Drugs Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) Subchapter F - BIOLOGICS Part 610 - GENERAL BIOLOGICAL PRODUCTS STANDARDS Subpart D - Mycoplasma Section 610.30 - Test for Mycoplasma. § 610.10 - Potency. Subpart B - General Provisions
Regulations most recently checked for updates: Jan 20, 2021 All Titles Title 21 Chapter I Part 610 Subpart G - Labeling Standards.
§ 610.10 - Potency.
§ 610.11-610.11a - [Reserved]
Subpart E - Testing Requirements for Relevant Transfusion-Transmitted Infections, Instructions for Downloading Viewers and Players.
321, 331, 351, 352, 353, 355, 360, 360c, 360d, 360h, 360i, 371, 372, 374, 381; 42 U.S.C.