Production Requirements for Biological Products

  1. Law
  2. CFR 9
  3. Animals and Animal Products
  4. Animal and Plant Health Inspection Service, Department of Agriculture
  5. Viruses, Serums, Toxins, and Analogous Products; Organisms and Vectors
  6. Production Requirements for Biological Products

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Section
114.1

Applicability.

Section
114.2

Products not prepared under license.

Section
114.3

Separation of establishments.

Section
114.4

Identification of biological products.

Section
114.5

Micro-organisms used as seed.

Section
114.6

Mixing biological products.

Section
114.7

Personnel at licensed establishments.

Section
114.8

Outline of Production required.

Section
114.9

Outline of Production guidelines.

Section
114.10

Antibiotics as preservatives.

Section
114.11

Storage and handling.

Section
114.12

Expiration date required for a serial.

Section
114.13

Determination of the dating period of a product.

Section
114.14

Extension of expiration date for a serial or subserial.

Section
114.15

Disposal of unsatisfactory products and byproducts.

Section
114.16

Producing subsidiaries.

Section
114.17

Rebottling of biological products.

Section
114.18

Reprocessing of biological products.