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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER F--BIOLOGICS
 
PART 610GENERAL BIOLOGICAL PRODUCTS STANDARDS
 

Subpart A--Release Requirements
   § 610.1 - Tests prior to release required for each lot.
   § 610.2 - Requests for samples and protocols; official release.

Subpart B--General Provisions
   § 610.9 - Equivalent methods and processes.
   § 610.10 - Potency.
   § 610.11 - General safety.
   § 610.11a - Inactivated influenza vaccine, general safety test.
   § 610.12 - Sterility.
   § 610.13 - Purity.
   § 610.14 - Identity.
   § 610.15 - Constituent materials.
   § 610.16 - Total solids in serums.
   § 610.17 - Permissible combinations.
   § 610.18 - Cultures.

Subpart C--Standard Preparations and Limits of Potency
   § 610.20 - Standard preparations.
   § 610.21 - Limits of potency.

Subpart D--Mycoplasma
   § 610.30 - Test for Mycoplasma.

Subpart E--Testing Requirements for Communicable Disease Agents
   § 610.40 - Test requirements.
   § 610.41 - Donor deferral.
   § 610.42 - Restrictions on use for further manufacture of medical devices.
   § 610.44 - Use of reference panels by manufacturers of test kits.
   § 610.46 - Human immunodeficiency virus (HIV) "lookback" requirements.
   § 610.47 - Hepatitis C virus (HCV) "lookback" requirements.
   § 610.48 - Hepatitis C virus (HCV) "lookback" requirements based on review of historical testing records.

Subpart F--Dating Period Limitations
   § 610.50 - Date of manufacture.
   § 610.53 - Dating periods for licensed biological products.

Subpart G--Labeling Standards
   § 610.60 - Container label.
   § 610.61 - Package label.
   § 610.62 - Proper name; package label; legible type.
   § 610.63 - Divided manufacturing responsibility to be shown.
   § 610.64 - Name and address of distributor.
   § 610.65 - Products for export.
   § 610.67 - Bar code label requirements.
   § 610.68 - Exceptions or alternatives to labeling requirements for biological products held by the Strategic National Stockpile.

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360c, 360d, 360h, 360i, 371, 372, 374, 381; 42 U.S.C. 216, 262, 263, 263a, 264.
Source: 38 FR 32056, Nov. 20, 1973, unless otherwise noted.

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