# copyright
US government funded - content free to use by all

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Surveillance, Epidemiology, and End Results Program

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Union for International Cancer Control Stage

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Stage 0 Childhood Retinoblastoma by Toronto Guidelines v2

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International Germ Cell Consensus Risk Classification

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International Neuroblastoma Risk Group Staging System

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Low Risk Mantle Cell Lymphoma International Prognostic Index Combined Biologic Index

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Low-Intermediate Risk Mantle Cell Lymphoma International Prognostic Index Combined Biologic Index

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High-Intermediate Risk Mantle Cell Lymphoma International Prognostic Index Combined Biologic Index

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High Risk Mantle Cell Lymphoma International Prognostic Index Combined Biologic Index

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Lugano Classification Adult Non-Hodgkin Lymphoma by AJCC v8 Stage

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Lugano Classification Hodgkin Lymphoma by AJCC v8 Stage

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Lugano Classification Childhood Hodgkin Lymphoma by AJCC v8 Stage

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Lugano Classification Adult Hodgkin Lymphoma by AJCC v8 Stage

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Chronic Lymphocytic Leukemia- Modified Rai Staging System

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Veterans Administration Lung Study Group Clinical Classification

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Mediastinal Malignant Germ Cell Tumor Stage

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Intergroup Rhabdomyosarcoma Study Group Clinical Staging and Grouping System

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Non-Seminomatous Germ Cell Tumor International Germ Cell Consensus Risk Classification

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Seminoma International Germ Cell Tumor Consensus Risk Classification

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Malignant Germ Cell International Collaborative Risk Classification

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Atypical Teratoid/Rhabdoid Tumor Staging System

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Embryonal Tumor with Multilayered Rosettes Staging System

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Modified Chang Staging System for Medulloblastoma

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FIGO Staging System and Modified World Health Organization [WHO] Prognostic Scoring System for Gestational Trophoblastic Neoplasms

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Blood and lymphatic system disorders - Other, specify

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Congenital, familial and genetic disorders - Other, specify

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Ear and labyrinth disorders - Other, specify

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Gastrointestinal disorders - Other, specify

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General disorders and administration site conditions - Other, specify

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Hepatobiliary disorders - Other, specify

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Immune system disorders - Other, specify

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Infections and infestations - Other, specify

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Injury, poisoning and procedural complications - Other, specify

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Activated partial thromboplastin time prolonged

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Carbon monoxide diffusing capacity decreased

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Metabolism and nutrition disorders - Other, specify

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Joint range of motion decreased cervical spine

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Joint range of motion decreased lumbar spine

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Musculoskeletal and connective tissue disorder - Other, specify

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Leukemia secondary to oncology chemotherapy

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Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify

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Nervous system disorders - Other, specify

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Pregnancy, puerperium and perinatal conditions - Other, specify

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Renal and urinary disorders - Other, specify

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Reproductive system and breast disorders - Other, specify

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Respiratory, thoracic and mediastinal disorders - Other, specify

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Skin and subcutaneous tissue disorders - Other, specify

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Surgical and medical procedures - Other, specify

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Life Threatening or Disabling Adverse Event

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Grade 4 Life Threatening or Disabling Adverse Event

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Results In Persistent Or Significant Disability

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Required Intervention to Prevent Permanent Impairment/damage

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Manufactures human prescription drug products

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Distributes human prescription drug products

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Distributes human over-the-counter drug products

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Intent to compound 506E (drug shortage) drugs

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No intent to compound 506E (drug shortage) drugs

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Manufactures animal prescription drug products

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Manufactures veterinary feed directive Type A medicated article drug products

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Manufactures animal over-the-counter Type A medicated article drug products

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Warehouses human prescription drug products

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Manufactures Human Over-the-Counter Drug Products Produced Under a Monograph

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Manufactures Human Over-the-Counter Drug Products Produced Under an Approved Drug Application

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Manufactures Human Over-the-Counter Drug Products Neither Produced Under an Approved Application nor Under a Monograph

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Contract Manufacturing for human over-the-counter drug products produced under a monograph

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Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

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Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)

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Type 4: Device Coated/Impregnated/Otherwise Combined with Drug

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Type 5: Device Coated or Otherwise Combined with Biologic

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Type 7: Separate Products Requiring Cross Labeling

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Type 8: Possible Combination Based on Cross Labeling of Separate Products (Temporary Type)

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Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)

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LINEAR STRUCTURAL REPEAT UNIT CONNECTION POINTS

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STRUCTURAL REPEAT UNIT SUBSTITUTION POINT

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NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER

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Designate a Healthcare Setting Representative

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Have Necessary Healthcare Personnel or Equipment

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Review Training or Educational Materials

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Establish Processes and Procedures to Verify REMS Safe Use Conditions

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Assess Patient Condition, Health Status, or Adverse Event

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Do Not Distribute, Transfer, Loan, or Sell Product

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Adhere to REMS Patient Safe Use Conditions

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Report Treatment Discontinuation or Transfer of Care

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Establish Processes and Procedures to Notify

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Establish Processes and Procedures to Provide

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Do Not Dispense Outside of Specified Facility

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Patient Must have a Specified Item or Intervention

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Distribute Only to Certified Healthcare Provider or Setting

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Hospital Transfusion Service - Approved Medicare

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Hospital Transfusion Service - Not Approved Medicare

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Product Testing Laboratory - Associated with Community or Hospital Blood Bank

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Product Testing Laboratory - Independent

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Platelets PAS (Platelets Additive Solution)

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Red Blood Cells Rejuvenated Frozen Deglycerolized

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Testing for Relevant Communicable Disease Agents and Diseases

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Hospital based cell or tissue processing facility

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Non-hospital based cell or tissue processing facility

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Organ and tissue procurement organization

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Human Peripheral And Cord Blood Cell Product

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Other Human, Cell and Tissue Products (HCT/Ps)

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CLINICAL BIOEQUIVALENCE OR BIOAVALABILITY STUDY

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IN VITRO BIOEQUIVALENCE OR BIOANALYTICAL TESTING

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UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE

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SPL Lot Distribution Data - Distribution Codes

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Human Drug Compounding Outsourcing Facility

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Approved Drug Product Manufactured Under Contract

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OTC Monograph Drug Product Manufactured Under Contract

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Unapproved Drug Product Manufactured Under Contract

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Outsourcing Facility Compounded Human Drug Product (Exempt From Approval Requirements)

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Outsourcing Facility Compounded Human Drug Product (Not Marketed - Not Distributed)

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PATCH, EXTENDED RELEASE, ELECTRICALLY CONTROLLED

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GRANULE, FOR SUSPENSION, EXTENDED RELEASE

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INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION, EXTENDED RELEASE

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INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

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INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION

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INJECTION, POWDER, LYOPHILIZED, FOR LIPOSOMAL SUSPENSION

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INJECTION, POWDER, FOR SUSPENSION, EXTENDED RELEASE

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TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE

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Distributes drug products under own private label

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UNAPPROVED DRUG OTHER MARKETING CATEGORY

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POSITRON EMISSION TOMOGRAPHY DRUG PRODUCTION

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LEGALLY MARKETED UNAPPROVED NEW ANIMAL DRUGS FOR MINOR SPECIES

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APPROVED DRUG PRODUCT MANUFACTURED EXCLUSIVELY FOR PRIVATE LABEL DISTRIBUTOR

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OTC MONOGRAPH DRUG PRODUCT MANUFACTURED EXCLUSIVELY FOR PRIVATE LABEL DISTRIBUTOR

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UNAPPROVED DRUG PRODUCT MANUFACTURED EXCLUSIVELY FOR PRIVATE LABEL DISTRIBUTOR

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BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING

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BULK INGREDIENT FOR ANIMAL PRESCRIPTION COMPOUNDING

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BULK INGREDIENT FOR ANIMAL DRUG COMPOUNDING

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Child Resistant Plastic Container Closure

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Continuous Thread Metal Container Closure

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Continuous Thread Plastic Container Closure

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Tamper Evident Plastic Container Closure

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Tamper Evident Composite Container Closure

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Vacuum Sealed Composite Container Closure

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Flip-Top Dispensing Plastic Container Closure

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Hinged Dispensing Plastic Container Closure

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Pump Dispensing Plastic Container Closure

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Push-Pull Dispensing Plastic Container Closure

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Snip-Tip Dispensing Plastic Container Closure

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Trigger Spray Dispensing Plastic Container Closure

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Twist Open/Close Dispensing Plastic Container Closure

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Valved Dispensing Plastic Container Closure

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Simplified Molecular Input Line Entry Specification

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Master File or Application Approved Indicator

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Cell and Gene Therapy Product Characterization Assay

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Dose Orifice Diameter Drilled Measurement

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In Process Control Content Uniformity Tests

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In Vitro or In Vivo Test for Viral Contaminants

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Individual Substance Fill Weight Measurement

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Single or Double Drilled Side Assessment

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Target Group Product Weight Gain Percentage

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Total Product Impurity above Threshold Assay

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Unspecified Product Impurity below ICH Identification Threshold

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Identified Impurity under IT, Monitored as Unspecified

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Average Fill Substance Weight Measurement

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Generic Investigational New Animal Drug File