| Title: | FDA Product Codes Changes |
|---|---|
| Date: | 2010-06-10 |
| To: | abi |
| Links: | previous, next |
TO: All ABI Filers
FROM: Food And Drug Administration
SUBJECT: End-Dating of Industry 57 - Biological Products Product Codes
FDA has previously advised the trade the following product codes will be end-dated. See CSMS message 09-000337 dated 10/30/2009.
The codes will be end-dated on Monday, June 14, 2010, and will no longer be acceptable for transmission over the CBP/FDA Interface. Filers are encouraged to use the new product codes listed in CSMS message 09-000337 in place of those that have been end-dated.
FDA's Center for Biologic Evaluation and Research (CBER) has published two searchable product code lists to assist filers in selecting the appropriate product code:
CBER Import Product Codes Sorted Alphabetically by Manufacturer Name
http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ComplianceActivities/BiologicsImportingExporting/UCM196892.pdf
CBER Import Product Codes Sorted by Product Class
http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ComplianceActivities/BiologicsImportingExporting/UCM196894.pdf
Class F is end-dated, effective 6/14/10 and replaced with new Class V.
Class O is end-dated, effective 6/14/10.
The following subclasses are end-dated, effective 6/14/10:
Subclass B - Bacterial Antigens
Subclass C - Bacterial Vaccines
Subclass D - Mod Bacterial Vaccine
Subclass E - Sens Bacterial Vaccine
Subclass F - Thera Immune Serums
Subclass G - Blood Grouping Serum
Subclass J - For Non-Clinical Research Use
Subclass K - For Educational Purposes
Subclass Y - Not Elsewhere Classified (NEC)
The following product codes are end-dated, effective 6/14/10:
57 A 01 B.Oedematiens Antitoxin
57 A 03 Diphtheria Antitoxin
57 A 04 Gas Gangrene Polyvalent Antitoxin
57 A 05 Perfringens Antitoxin
57 A 06 Staphylococcus Antitoxin
57 A 07 Tetanus Antitoxin
57 A 08 Tetanus and Gas Gangrene Polyvalent Antitoxin
57 A 12 Cobra Venom Solution
57 A 13 Cobra Venom with Silicic and Formic Acid
57 A 14 Collagenase
57 A 15 Russell Viper Venom
57 A 16 Streptokinase
57 A 17 Streptokinase-Streptodornase
57 A 18 Urokinase
57 A 19 Asparaginase Antitoxin/Antivenin/Enzyme/Venom
57 B 02 Diphtheria Toxoid, Absorbed
57 B 03 Staphylococcus Toxoid
57 B 06 Tetanus Toxoid, Absorbed
57 C 01 Adenovirus Vaccine
57 C 04 Measle, Mumps, Rubella Virus Vaccine, Live
57 C 05 Measle, Rubella Virus Vaccine, Live
57 C 06 Measle-Smallpox Vaccine, Live
57 C 07 Mumps Vaccine
57 C 10 Poliomyelitis Vaccine, Absorbed
57 C 11 Poliovirus Vaccine, Live, Oral, Trivalent
57 C 12 Poliovirus Vaccine, Live, Oral, Type 1
57 C 13 Poliovirus Vaccine, Live, Oral, Type 2
57 C 14 Poliovirus Vaccine, Live, Oral, Type 3
57 C 16 Rocky Mountain Spotted Fever Vaccine
57 C 17 Rubella and Mumps Virus Vaccine, Live
57 C 20 Typhus Vaccine
57 C 22 Measle and Mumps Virus Vaccine, Live
57 C 23 Adenovirus Vaccine, Live, Oral, Type 4
57 C 24 Adenovirus Vaccine, Live, Oral, Type 7
57 D 02 Anti-Inhibitor Coagulant Complex (Blood and Blood Derivatives)
57 D 03 Antihemophilic Factor (Human) (Blood and Blood Derivatives)
57 D 04 Antihemophilic Plasma (Human) (Blood and Blood Derivatives)
57 D 06 Factor IX Complex (Human) (Blood and Blood Derivatives)
57 D 07 Fibrinogen (Human) (Blood and Blood Derivatives)
57 D 08 Fibrinogen with Antihemophilic Factor (Human) (Blood and Blood Derivatives)
57 D 09 Fibrinolysin (Human) (Blood and Blood Derivatives)
57 D 10 Fibrinolysin and Desoxyribonuclease Combined (Bovine) (Blood and Blood Derivatives)
57 D 11 Fibrinolysin and Desoxyribonuclease Combined (Bovine) with ChloramPhenicol (Blood and Blood Derivati
57 D 12 Histamine Azoprotein (Blood and Blood Derivatives)
57 D 13 Pepsin-Modified Immune Serum Globulin (Human) (Blood and Blood Derivatives)
57 D 14 Immune Serum Globulin (Human) (Blood and Blood Derivatives)
57 D 15 Measles Immune Globulin (Human) (Blood and Blood Derivatives)
57 D 16 Modified Plasma (Bovine) (Blood and Blood Derivatives)
57 D 17 Mumps Immune Globulin (Human) (Blood and Blood Derivatives)
57 D 19 Normal Human Plasma (Blood and Blood Derivatives)
57 D 21 Normal Rabbit Serum (Blood and Blood Derivatives)
57 D 22 Normal Serum Albumin (Human) (Blood and Blood Derivatives)
57 D 23 Pertussis Immune Globulin (Human)
57 D 24 Plasma Protein Fraction (Human) (Blood and Blood Derivatives)
57 D 25 Profibrinolysin (Human) (Blood and Blood Derivatives)
57 D 30 Red Blood Cells (Human) Frozen (Blood and Blood Derivatives)
57 D 31 Rho (D) Immune Globulin (Human) (Blood and Blood Derivatives)
57 D 33 Tetanus Immune Globulin (Human) (Blood and Blood Derivatives)
57 D 34 Thrombin, as a Drug (Blood and Blood Derivatives)
57 D 35 Vaccinia Immune Globulin (Human) (Blood and Blood Derivatives)
57 D 37 Whole Blood (Human) CPD (Blood and Blood Derivatives)
57 D 38 Whole Blood (Human) Heparin (Blood and Blood Derivatives)
57 D 39 Whole Blood (Human) Modified without Antihemophilic Factor (Blood and Blood Derivatives)
57 D 40 Blood Group Specific Substance A (Blood and Blood Derivatives)
57 D 41 Blood Group Specific Substance B (Blood and Blood Derivatives)
57 D 42 Blood Group Specific Substances A and B (Blood and Blood Derivatives)
57 D 43 Rabies Immune Globulin (Human) (Blood and Blood Derivatives)
57 D 46 Red Blood Cells (Human) Deglycerolized (Blood and Blood Derivatives)
57 D 47 Blood Group Specific Substance AB (Blood and Blood Derivatives)
57 D 48 Whole Blood Modified - Platelets Removed (Blood and Blood Derivatives)
57 D 49 Human Serum Albumin (Blood and Blood Derivatives)
57 D 50 Hepatitus Immune Globulin (Human) (Blood and Blood Derivatives)
57 D 51 Whole Blood (Human) CPDA-1 (Blood and Blood Derivatives)
57 D 52 Single Donor Plasma (Human) Platelet Rich (Blood and Blood Derivatives)
57 D 53 Single Donor Plasma (Human) Fresh/Frozen (Blood and Blood Derivatives)
57 D 54 Single Donor Plasma (Human) Liquid (Blood and Blood Derivatives)
57 D 56 Red Blood Cells (Human) Leukocytes Removed (Blood and Blood Derivatives)
57 D 57 Whole Blood (Human) Modified - Leukocytes Removed (Blood and Blood Derivatives)
57 D 58 Varicella-Zoster Immune Globln (Blood and Blood Derivatives)
57 D 59 Red Blood Cells (Human) Frozen Rejuvenated (Blood and Blood Derivatives)
57 D 60 Red Blood Cells (Human) Rejuvenated Deglycerolized (Blood and Blood Derivatives)
57 D 61 Red Blood Cells (Human) Washed (Blood and Blood Derivatives)
57 D 62 Thrombin Impregnated Pad (Blood and Blood Derivatives)
57 E 01 Blastomycin (In-Vivo Diagnostic Products)
57 E 03 Coccidioidin (In-Vivo Diagnostic Products)
57 E 04 Diphtheria Toxin for Schick Test (In-Vivo Diagnostic Products)
57 E 05 Histoplasmin (In-Vivo Diagnostic Products)
57 E 06 Lymphogranuloma Venereum Antigen (In-Vivo Diagnostic Products)
57 E 07 Mumps Skin Test Antigen (In-Vivo Diagnostic Products)
57 E 08 Schick Test Control (In-Vivo Diagnostic Products)
57 E 09 Tuberculin, Old (In-Vivo Diagnostic Products)
57 E 11 Albumin (Human) Aggregated Radio-Iodinated (I-131) (In-Vivo Diagnostic Products)
57 E 12 Albumin Microspheres (Human) (In-Vivo Diagnostic Products)
57 E 13 Serum Albumin (Human), Radio- Chromated (Cr-51) (In-Vivo Diagnostic Products)
57 E 14 Serum Albumin (Human), Radio-Iodinated (I-125) (In-Vivo Diagnostic Products)
57 E 15 Serum Albumin (Human), Radio-Iodinated (I-131) (In-Vivo Diagnostic Products)
57 E 16 Albumin (Human), Aggregated Technetated (99mTc) (In-Vivo Diagnostic Products)
57 E 17 Trichinella Extract (In-Vivo Diagnostic Products)
57 E 18 Albumin (Human), Aggregated (In-Vivo Diagnostic Products)
57 E 19 Diphtheria Toxoid-Schick Test Control (In-Vivo Diagnostic Products)
57 E 20 Iodine 123 (In-Vivo Diagnostic Products)
57 F 99 In-Vitro Diagnostic Products, N.E.C
57 F 01 Anti-A1 (Blood Grouping Serum)
57 F 02 Anti-A (Blood Grouping Serum)
57 F 03 Anti-B (Blood Grouping Serum)
57 F 04 Anti-A,B (Blood Grouping Serum)
57 F 05 Anti-Dia (Blood Grouping Serum)
57 F 06 Anti-Fya (Blood Grouping Serum)
57 F 07 Anti-Fyb (Blood Grouping Serum)
57 F 08 Anti-Human Chorionic Gonadotrop Serum (In-Vitro Diagnostic Products)
57 F 09 Anti-Human Serum (In-Vitro Diagnostic Products)
57 F 10 Anti-Influenza Virus Serum (Hemagglutination Inhibition Test) (In-Vitro Diagnostic Products)
57 F 11 Anti-I (Blood Grouping Serum)
57 F 12 Anti-Jka (Blood Grouping Serum)
57 F 13 Anti-Jkb (Blood Grouping Serum)
57 F 14 Anti-Jsb (Blood Grouping Serum)
57 F 15 Anti-k (Small K) (Blood Grouping Serum)
57 F 16 Anti-K (Capital K) (Blood Grouping Serum)
57 F 17 Anti-Kpa (Blood Grouping Serum)
57 F 18 Anti-Kpb (Blood Grouping Serum)
57 F 19 Anti-Lea (Human) (Blood Grouping Serum)
57 F 20 Anti-Leb (Human) (Blood Grouping Serum)
57 F 21 Anti-Lua (Blood Grouping Serum)
57 F 22 Anti-M (Human) (Blood Grouping Serum)
57 F 23 Anti-Mg (Blood Grouping Serum)
57 F 24 Anti-Mia (Blood Grouping Serum)
57 F 25 Anti-N (Human) (Blood Grouping Serum)
57 F 26 Anti-P1 (Human) (Blood Grouping Serum)
57 F 27 Anti-Cob (Human) (Blood Grouping Serum)
57 F 28 Anti-D (High Protein) (Blood Grouping Serum)
57 F 29 Anti-CD (High Protein) (Blood Grouping Serum)
57 F 30 Anti-DE (High Protein) (Blood Grouping Serum)
57 F 31 Anti-CDE (High Protein) (Blood Grouping Serum)
57 F 32 Anti-C (High Protein) (Blood Grouping Serum)
57 F 33 Anti-E (High Protein) (Blood Grouping Serum)
57 F 34 Anti-c (Small C)(High Protein) (Blood Grouping Serum)
57 F 35 Anti-e (Small E)(High Protein) (Blood Grouping Serum)
57 F 36 Anti-V (Blood Grouping Serum)
57 F 37 Anti-Cw (High Protein) (Blood Grouping Serum)
57 F 38 Anti-S (Blood Grouping Serum)
57 F 39 Anti-s (Small S) (Blood Grouping Serum)
57 F 40 Anti-U (Blood Grouping Serum)
57 F 41 Anti-Xga (Blood Grouping Serum)
57 F 42 Anti-A For Automated Systems (Blood Grouping Serum)
57 F 43 Anti-B For Automated Systems (Blood Grouping Serum)
57 F 44 Anti-A,B For Automated Systems (Blood Grouping Serum)
57 F 45 Anti-D For Automated Systems (Blood Grouping Serum)
57 F 46 Anti-Cd For Automated Systems (Blood Grouping Serum)
57 F 47 Anti-De For Autmd Sys
57 F 48 Anti-CDE For Automated Systems (Blood Grouping Serum)
57 F 49 Anti-c (Small C) For Automated Systems (Blood Grouping Serum)
57 F 50 Haemophilus Influenzae Typing Serum (In-Vitro Diagnostic Products)
57 F 51 Hepatitis Associated Antibody (Anti-Australia Antigen) (In-Vitro Diagnostic Products)
57 F 52 Influenzae Virus Hemagglutinating Antigen (In-Vitro Diagnostic Products)
57 F 53 Reagent Red Blood Cells (In-Vitro Diagnostic Products)
57 F 54 Leukocyte Typing Serum (In-Vitro Diagnostic Products)
57 F 55 Anti-Carcinoembryo Antigenic Serum (In-Vitro Diagnostic Products)
57 F 56 Hepatitis B Surface Antigen (In-Vitro Diagnostic Products)
57 F 57 Reagent Red Blood Cells for Automated Systems (In-Vitro Diagnostic Products)
57 F 58 Limulus Amchocyte Lysate (In-Vitro Diagnostic Products)
57 F 60 Anti-D (Saline Active) (Blood Grouping Serum)
57 F 61 Anti-C (Saline Active) (Blood Grouping Serum)
57 F 62 Anti-E (Saline Active) (Blood Grouping Serum)
57 F 63 Anti-c (Small C) (Saline Active) (Blood Grouping Serum)
57 F 64 Anti-e (Small E) (Saline Active) (Blood Grouping Serum)
57 F 65 Anti-Cw (Saline Active) (Blood Grouping Serum)
57 F 66 Anti-Lea (Goat) (Blood Grouping Serum)
57 F 67 Anti-Leb (Goat) (Blood Grouping Serum)
57 F 68 Anti-M (Rabbit) (Blood Grouping Serum)
57 F 69 Anti-N (Rabbit) (Blood Grouping Serum)
57 F 70 Anti_P1 (Goat) (Blood Grouping Serum)
57 F 71 Anti-Human Serum, Anti-IgG (In-Vitro Diagnostic Products)
57 F 73 Anti-Mg (Saline Active) (Blood Grouping Serum)
57 F 74 Anti-Human Serum, Anti C3d (Mouse Hybridoma) (Blood Grouping Serum)
57 F 87 Antibody to Hepatitis A Virus (In-Vitro Diagnostic Products)
57 F 88 Antibody to Hepatitis B Core Antigen (In-Vitro Diagnostic Product)
57 F 89 Hepatitis B Core Antigen (In-Vitro Diagnostic Products)
57 F 90 Hepatitis A Virus (In-Vitro Diagnostic Products)
57 F 91 Blood Grouping Reagent(s)
57 G 02 Allergenic Extracts Alum Precipitated (Allergenic Products)
57 G 12 Poison Ivy Extract (Allergenic Products)
57 G 13 Poison Ivy Extract Alum Precipitated (Allergenic Products)
57 G 14 Poison Ivy-Oak-Sumac Extracts Combined (Allergenic Products)
57 G 15 Poison Ivy-Oak Extracst Combined (Allergenic Products)
57 G 16 Poison Oak Extract (Allergenic Products)
57 G 17 Poison Sumac Extract (Allergenic Products)
57 G 60 Anti-D(Saline Active)
57 H 33 Cholera Vaccine (Bacterial Vaccines)
57 H 13 Pseudomonas Polysaccaride (Bacterial Antigen)
57 H 34 Pertussis Vaccine (Bacterial Vaccines)
57 H 35 Pertussis Vaccine, Adsorbed (Bacterial Vaccines)
57 H 40 Meningococcal Polysaccharide Vaccine, Group A (Bacterial Vaccines)
57 H 41 Meningococcal Polysaccharide Vaccine, Groups A,C (Bacterial Vaccines)
57 H 43 Meningococcal Polysaccharide Vaccine, Group Y (Bacterial Vaccines)
57 H 51 Polyvalent Modified Bacterial Antigen (No U.S. Standard Potency)
57 H 81 Anti-Hemophilus Influenzae Type b (Small B) Serum (Therapeutic Immune Serums)
57 H 82 Antirabies Serum (Therapeutic Immune Serums)
57 H 83 Streptococuss Vaccine (Therapeutic Immune Serums)
57 I 01 Adenovirus and Influenzae Virus Vaccines Combined, Aluminum Phosphate Adsorbed
57 I 02 Diphtheria and Tetanus Toxoid (Multiple Antigen Preparations)
57 I 03 Diphtheria and Tetanus Toxoid, Adsorbed (Multiple Antigen Preparations)
57 I 04 Diphtheria, Tetanus and Pertussis Vaccine (Multiple Antigen Preparations)
57 I 06 Diptheria, Tetanus and Pertussis Vaccine and Polio (Multiple Antigen Preparations)
57 I 07 Diphtheria, Tetanus, Pertussis and Polio Vaccine, Absorbed (Multiple Antigen Preparations)
57 I 08 Diphtheria Toxoid and Pertussis Vaccine, Adsorbed (Multiple Antigen Preparations)
57 I 09 Staph Toxoid and Bacterial Antigen made from Staph (Albus and Aureus)
57 J 01 Fascia (Human Musculoskeletal Tissues)
57 J 02 Cartilage (Human Musculoskeletal Tissues)
57 J 04 Ligaments (Human Musculoskeletal Tissues)
57 J 05 Tendons (Human Musculoskeletal Tissues)
57 J 06 Vascular Graft (Human Musculoskeletal Tissues)
57 L 01 Cornea (Human Ocular Tissues)
57 L 02 Sclera (Human Ocular Tissues)
57 N 01 Somatic Cells (Human Tissue, Cellular Therapies)
57 N 02 Cell & Gene Therapies (Human Tissue, Cellular Therapies)
57 O 01 Skin (Human Tissue, Other Tissues)
57 O 02 Pericardium (Human Tissue, Other Tissues)