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This policy manual represents the Center for Veterinary Biologics (CVB) current thinking on these topics. It does not create or confer any rights for, or on any person, and does not operate to bind CVB or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the CVB staff responsible for implementing these policies.
1. INTRODUCTION
2. AUTHORITIES FOR THE BIOLOGICS PROGRAM
3. INSPECTION OF ESTABLISHMENTS - Principles (In process)
4. INVESTIGATION AND PROCESSING ALLEGED VIOLATIONS OF THE VIRUS-SERUM-TOXIN ACT CVB-SOP-0037 (July 21, 2020)
5. PHARMACOVIGILANCE OF VETERINARY BIOLOGICAL PRODUCTS
6. PROCESSING SERIAL RECORDS
7. PRODUCT SAMPLING CVB-SOP-0040 (formerly numbered ICSOP0022) (January 13, 2020)
8. PRODUCT DESTRUCTION ICSOP0005 (June 27, 2011)
9. PROCESSING FACILITY DOCUMENTS ICSOP0018 (October 6, 2017)
10. PROCESSING AUDITS FOR APHIS FORMS 2008 and 2071 (In process)
11. INSPECTION OF A FOREIGN ESTABLISHMENT (In process)
12. DEPOSITION, SUBPOENAS, INFORMAL CONFERENCE AND LEGISLATIVE INQUIRY PROCEDURES
13. SAFETY AND HEALTH
14. INSPECTION AND COMPLIANCE POLICIES
15. GENERAL OFFICE GUIDELINES
16. REFUSAL OF ENTRY, ASSAULT AND BRIBERY PROCEDURES
17. GENERAL COMPUTER GUIDELINES
18. EXPORT ACTIVITIES
19. MISCELLANEOUS