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21 C.F.R. PART 610--GENERAL BIOLOGICAL PRODUCTS STANDARDS

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

�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

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

''Lookback'' requirements.

�610.47

''Lookback'' notification requirements for transfusion services.

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.