№ lp_1_2_58470
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This document provides detailed labelling requirements for biological products and HCT materials under the Therapeutic Goods Order (TGO) 107.
Year: 2021
Region / City: Australia
Subject: Biologicals, Labelling Requirements
Document Type: Regulatory Guidelines
Organization / Institution: Therapeutic Goods Administration (TGA)
Author: Therapeutic Goods Administration (TGA)
Target Audience: Manufacturers and sponsors of biologicals
Effective Period: From 30 September 2021
Approval Date: May 2021
Revision Date: Not specified
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ARGB Appendix 12 - Guidance on TGO 108: Standard for Human Cell or Tissue Products – Donor Screening Requirements
Year: 2021
Region / City: Australia
Topic: Biologicals, Human Cell and Tissue Products, Donor Screening
Document Type: Guideline
Agency: Therapeutic Goods Administration (TGA)
Author: Therapeutic Goods Administration (TGA)
Target Audience: Manufacturers and Sponsors of Biological Products
Effective Period: 2021
Approval Date: May 2021
Amendment Date: N/A
Drugs and Biologicals – JW and JZ Modifier Policy
Year: 2023
Note: Region / City
Subject: Billing Requirements for Drugs and Biologicals with Discarded Amounts
Document Type: Policy
Organization / Institution: SummaCare, Apex Summa Health Management Company, Summa Insurance Company
Target Audience: Providers, Healthcare Administrators, Claims Department
Effective Period: From 01/01/2017
Approval Date: 08/15/2023
Review Date: Every 2 years or as necessary
Compliance Statement: All members of the workforce are responsible for compliance with this policy.
Monitoring and Auditing: Claims Department
Documentation Retention: Minimum of 10 years
Purpose: To outline the billing requirements for drugs and biologicals with unused and discarded amounts from single-dose containers or single-use packages.
Description: Guidelines on proper billing procedures for drugs and biologicals, including the use of JW and JZ modifiers for discarded drug amounts or no wastage in single-dose vials, applicable to providers and insurers.
Supporting Statement – Part A Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biologicals and Supporting Regulations in 42 CFR 414.800-806 (CMS-10110, OMB 0938-0921)
Year: 2025
Region / City: USA
Subject: Medicare Part B Drugs and Biologicals ASP Data Reporting
Document Type: Regulatory
Organization / Institution: Centers for Medicare & Medicaid Services (CMS)
Author: Centers for Medicare & Medicaid Services (CMS)
Target Audience: Manufacturers of Medicare Part B Drugs and Biologicals
Period of Effect: From January 1, 2022
Approval Date: Not specified
Amendment Date: November 5, 2025
Boundary and combination products - medicines, medical devices, and biologicals
Year: 2022
Region / city: Australia
Topic: Therapeutic Goods Regulation
Document type: Guidance
Organization: Therapeutic Goods Administration (TGA)
Author: Commonwealth of Australia
Target audience: Sponsors, manufacturers, and regulatory professionals
Validity period: Not specified
Approval date: October 2022
Date of changes: Not specified
Therapeutic Goods (Standard for Biologicals) (TGO 109) Order 2021
Year: 2021
Jurisdiction: Australia
Document type: Regulatory order
Subject: Standards for biological therapeutic goods
Authority: Minister for Health and Aged Care
Responsible body: Department of Health
Commencement date: 30 September 2021
Scope: Human musculoskeletal, cardiovascular, ocular, skin, and amnion tissue products
Legal basis: Therapeutic Goods Act 1989
Status: Draft at the time of excerpt, not for signature
Therapeutic Goods (Standard for Vaporiser Nicotine) (TGO 110) Order 2021
Year: 2021
Region / City: Australia
Topic: Vaporiser Nicotine Product Standards
Document Type: Legislative Instrument
Organization / Institution: Department of Health
Author: [Name of delegate]
Target Audience: Manufacturers, Health Authorities, Regulatory Bodies
Period of Validity: From 1 October 2021
Approval Date: 1 October 2021
Amendment Date: Not specified
ARGB Appendix 12 - Guidance on TGO 108: Standard for Human Cell or Tissue Products – Donor Screening Requirements
Year: 2021
Region / City: Australia
Topic: Biologicals, Human Cell and Tissue Products, Donor Screening
Document Type: Guideline
Agency: Therapeutic Goods Administration (TGA)
Author: Therapeutic Goods Administration (TGA)
Target Audience: Manufacturers and Sponsors of Biological Products
Effective Period: 2021
Approval Date: May 2021
Amendment Date: N/A
Therapeutic Goods (Standard for Biologicals) (TGO 109) Order 2021
Year: 2021
Jurisdiction: Australia
Document type: Regulatory order
Subject: Standards for biological therapeutic goods
Authority: Minister for Health and Aged Care
Responsible body: Department of Health
Commencement date: 30 September 2021
Scope: Human musculoskeletal, cardiovascular, ocular, skin, and amnion tissue products
Legal basis: Therapeutic Goods Act 1989
Status: Draft at the time of excerpt, not for signature
TGO 110 – Standard for Vaporiser Nicotine Consultation paper
Year: 2021
Region / city: Australia
Topic: Vaporiser nicotine regulation
Document type: Consultation paper
Agency / institution: Therapeutic Goods Administration (TGA)
Author: Commonwealth of Australia
Target audience: Industry stakeholders, health professionals, general public
Period of validity: Until TGO 110 is finalized
Approval date: Expected April or May 2021
Amendment date: Not specified
Note: Context
Topics: ARGB Biologicals TGO