Post-renovation BioPort Production | Pre-Renovation Lots

FDA Lot-Release Authorizations
These memos show the authority for the manufacturer to release anthrax vaccine from the manufacturing plant. Each lot of every vaccine produced in the United States must be individually released in this way, after having been tested for sterility, purity, potency, and general safety. Lot-release tests are performed by the manufacturer and audited by FDA.

FAV114 PDF  17 Mar 05   FAV113 PDF  22 Feb 05   FAV112 PDF  15 Feb 05   FAV111 PDF  17 Mar 05   FAV110 PDF  30 Dec 04    more...  *For Anthrax vaccine released after January 2002 (Lots FAV063 and higher)

General Vaccine Vaccine Info   Cold Chain Management Processes and Procedures for all Medical Temperature Sensitive Products   USAMMA   DoD Vaccine, Skin Test & Antibody Price List  [PDF]  [XLS]  01 Aug 08   This summary list will help identify quantity breaks, and other efficiencies when you purchase vaccines.   Monitoring Temperatures on Refrigerator/Freezer Units Storing Temperature Sensitive Medical Products PDF  04 Feb 05   Operations Management Bulletin, No. 01-05   Recommended Adult Immunization Schedule — United States, October 2007–September 2008   Advisory Committee on Immunization Practices, the American Academy of Family Physicians, the American College of Obstetricians and Gynecologists, and the American College of Physicians.   Thimerosal Content in Some US Licensed Vaccines   Institute for Vaccine Safety - Johns Hopkins   Vaccine Management: Recommendations for Storage & Handling of Selected Biologicals   Centers for Disease Control and Prevention   Vaccine Summary PDF  25 Jan 06   List of all Vaccines Licensed in the US Anthrax Vaccine Info   Anthrax Immune Globulin (AIG) Letter PDF  30 Jun 04   FAV158 PDF  22 Aug 06   FAV163 PDF  12 Sep 06   FAV173 PDF  07 Dec 06   FAV174 PDF  19 Dec 06   FAV175 PDF  31 Aug 06   FAV176 PDF  22 Aug 06   FAV177 PDF  19 Dec 06   FAV178 PDF  19 Sep 06   FAV181 PDF  22 Feb 07   FAV182 PDF  22 Feb 07   FAV183 PDF  04 Apr 07   FAV184 PDF  07 Feb 07   FAV186 PDF  01 Mar 07   FAV187 PDF  06 Feb 07   FAV188 PDF  13 Mar 07 Haemophilus B Vaccine Info   CDC Q&A;'s; Voluntary Recall of Certain Lots of Haemophilus influenza type b (Hib) Vaccine Produced by Merck & Co., Inc.:   Information for Public Health Agencies and Healthcare Providers   Voluntary Recall of Certain Lots of PedvaxHIB® and COMVAX®   Merck Letter on Voluntary Recall of Certain Lots of Vaccine / NDC 0006-4897-00 and 0006-4898-00 Hepatitis B Vaccine Info   New reformulated Energix-B available to order form GlaxoSmithKline PDF  01 Apr 07   New NDC for GSK Hepatitis B Vaccine (Recombinant) in Prefilled Tip-Lok® Syringe Influenza (pandemic) Vaccine Info   Draft Guidance on Allocating and Targeting Pandemic Influenza Vaccine   US Government Influenza (seasonal) Vaccine Info   FDA Product Approval Information - Licensing Action   FluMist (2-49 y.o.) Approval   FluMist Dosage and Administration   Video Instructions, produced by MILVAX, length (3:18) Smallpox Vaccine Info   ACAM2000 Expiration Chart PDF  29 Feb 08   Conversion table detailing 17 months expiration dating from date of shipment   ACAM2000 Vial Stopper Raw Material Content PDF  14 Mar 08   Latex-free Stopper Information Letter   Dryvax (Wyeth)   Package Insert   Dryvax/ACAM2000 Comparison Chart PDF  11 Jan 08   Expected Appearance of Dryvax-brand Smallpox Vaccine PDF  05 Mar 03   Author: Col. John D. Grabenstein, Maj Patrick Garman   FDA Product Approval Letter   Smallpox (Vaccinia) Vaccine, Live - ACAM2000   FDA Questions and Answers   ACAM2000TM Smallpox (Vaccinia) Vaccine, Live   Intra-Venous Vaccinia Immune Globulin (IV-VIG) PDF  09 Nov 07   Information Paper   Lot Release Information for Dryvax Lot 4020071  PDF  25 Oct 02   Medication Guide - ACAM2000™ PDF  16 Jan 08   Smallpox (Vaccinia) Vaccine, Live   Notice to Readers:   Guidelines for Maintaining and Managing the Vaccine Cold Chain   Revised Stability Information PDF  13 Feb 03   Dryvax is stable for 90 days after reconstitution, if refrigerated.   Risk Communication Plan for Health Care Facilities PDF  29 Dec 03   Smallpox Vaccine Extension of Dating PDF  21 Dec 07   Lot # 4020072 Lot # 4020074 Lot # 4020075 Lot # 4020076 Lot # 4020077 Lot # 4030013 Lot # 4030014 Lot # 4030020 The dating will be extended from 31 Dec 07 until 29 Feb 08 at which time Wyeth intends to withdraw all vaccine from the field. Dryvax is stable for 90 days after reconstitution, if refrigerated.   Smallpox Vaccine Storage and Handling   An interactive, Internet-based training course sponsored by the CDC's National Immunization Program (NIP)   Vaccine Deployment Guidance - ACAM2000 PDF  24 Mar 08   Vaccinia Immune Globulin (VIG)   Contact the Vaccine Healthcare Center Network for clinical consultation and instructions for obtaining VIG. For 24/7 clinical consultation support for you, your family, or your healthcare provider: DoD Vaccine Clinical Call Center - 1-866-210-6469   Vaccinia Immune Globulin Intravenous (Human) (VIGIV) (Cangene)   Package Insert Yellow Fever Vaccine Info   Yellow Fever Vaccine Shipping Change PDF  01 Aug 05