№ lp_1_2_22594
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Character count: 2789
File size: 64 KB
The document outlines the considerations for leaders of covered entities when developing a request for proposal (RFP) to solicit independent 340B compliance audit proposals.
Year:
2025
Region / City:
Not specified
Topic:
340B Compliance Audit
Document Type:
Instructional Guide
Organization / Institution:
Apexus LLC
Author:
Not specified
Target Audience:
Covered Entity Leaders
Period of Action:
Not specified
Approval Date:
Not specified
Amendment Date:
Not specified
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Year:
2023
Region / City:
United States
Topic:
Medicaid, 340B Program
Document Type:
Instructional Form
Organization:
HRSA (Health Resources and Services Administration)
Author:
HRSA
Target Audience:
Covered entities, contract pharmacies, Medicaid providers
Effective Period:
Ongoing
Approval Date:
March 5, 2010
Modification Date:
December 12, 2014
Year:
2025
Region / City:
United States
Topic:
340B Program Financial Impact
Document Type:
Tool / Guide
Organization / Institution:
Apexus
Author:
Apexus
Target Audience:
340B Covered Entities, Medicaid Agencies
Period of Validity:
2025
Approval Date:
2025
Modification Date:
Not specified
Year:
2024
Region / City:
United States
Subject:
340B Contract Pharmacy Policy Changes
Document Type:
Internal Memo
Organization:
Bausch Health
Author:
Bausch Health
Target Audience:
Internal employees of Bausch Health
Effective Date:
June 6, 2024
Amendment Date:
June 20, 2024
Start Date of Policy Change:
June 6, 2024
End Date of Policy Change:
October 1, 2025
Background:
In 1996, HHS issued guidance on 340B contract pharmacies.
Context:
This document provides detailed updates on Bausch Health’s evolving 340B contract pharmacy policies.
Year:
2021
Region / City:
Rockville, MD
Topic:
340B Drug Pricing Program
Document Type:
Guidance
Organization / Institution:
Health Resources and Services Administration (HRSA)
Author:
Apexus
Target Audience:
340B stakeholders, covered entities, health departments
Effective Period:
Ongoing
Approval Date:
2021
Date of Changes:
N/A
Year:
2026
Region / City:
United States
Theme:
Healthcare, Pharmaceutical Purchasing
Document Type:
Guidelines
Organization:
340B Program
Author:
Not specified
Target Audience:
Covered entities in 340B hospitals
Validity Period:
Ongoing
Approval Date:
Not specified
Amendment Date:
Not specified
Note:
Year
Theme:
Pharmaceutical industry
Document type:
Manufacturer communication
Organization / institution:
[Manufacturer]
Author:
[Manufacturer]
Target audience:
Covered entities, stakeholders in the 340B program
Year:
2024
Program:
340B Drug Pricing Program
Subject:
Compliance policy and self-disclosure procedures
Document Type:
Guidance framework
Issuing Organization:
Apexus
Related Authority:
Health Resources and Services Administration (HRSA)
Intended Audience:
340B covered entity leaders and stakeholders
Scope:
Definition of material breach and self-disclosure to HRSA and manufacturers
Key Components:
Threshold indicators, policy criteria, sample statement, review procedures
Compliance Focus:
Diversion and duplicate discounts
Copyright:
© 2024 Apexus
Usage Rights:
Permitted for use, copying, and distribution by 340B covered entities and Medicaid agencies
Year:
2023
Region / City:
United States
Topic:
340B Program, Children’s Hospitals, Healthcare
Document Type:
Registration Form
Organization / Institution:
Office of Pharmacy Affairs (OPA)
Author:
Not specified
Target Audience:
Healthcare Providers, Children’s Hospitals
Period of Validity:
Not specified
Approval Date:
Not specified
Modification Date:
Not specified
Year:
2026
Organization:
Department of Agriculture, Fisheries and Forestry (DAFF)
Document type:
Policy / Procedure Manual
Version:
7.3
Scope:
Biosecurity industry participants
Audit types:
Probationary Audit Rate, Low Audit Rate
Compliance categories:
Critical non-compliance, Major non-compliance, Minor non-compliance
Key arrangement outcomes:
Containment, Isolation, Security, Identification, Traceability, Hygiene, Movement, Release, Awareness, Inspection, Treatment, Arrangement compliance, Notification, Supporting functions
Target audience:
Biosecurity industry participants
Fee structure:
On site $62/15min, Off site $37/15min
Reference conditions:
Biosecurity containment level 2 (BC2), Microbiological Class 5.2
Documented procedures:
Audit checklist, Site mapping, Signage, Access control, Waste storage
Year:
2026
Region / City:
Not specified
Theme:
Compliance Monitoring, Training Organisations
Document Type:
Guidance
Authority / Institution:
Civil Aviation Authority (CAA)
Author:
Not specified
Target Audience:
Small non-complex ATOs offering LAPL, PPL and associated ratings training
Period of Validity:
Not specified
Approval Date:
Not specified
Modification Date:
Not specified
Year:
2024
Region / City:
Australia
Topic:
Medical devices, Regulatory requirements, Audits
Document type:
Guidance document
Organization / Institution:
Therapeutic Goods Administration (TGA)
Author:
Commonwealth of Australia
Target audience:
Sponsors of medical devices seeking inclusion in the Australian Register of Therapeutic Goods (ARTG)
Period of validity:
2024
Approval date:
December 2024
Date of changes:
N/A
Year:
2026
Region:
KwaZulu-Natal, South Africa
Subject:
Environmental compliance and water use licensing
Document Type:
Terms of Reference / Scope of Work
Organization:
UMngeni UThukela Water
Audience:
Professional service providers / auditors
Period of Activity:
12 months
Legislation:
National Water Act 36 of 1998
Scope:
Audit of 15 licensed operational sites for WUL compliance
Output:
Compliance Audit Report including non-applicable conditions register, recommendations, timelines, and cost estimates
Year:
2024
Region / City:
Online Agriculture Products Store
Topic:
Business Analysis Process and Strategy
Document Type:
Report
Organization / Institution:
CoEPD
Author:
Mr. Karthik
Target Audience:
Business Analysts, Project Managers, Stakeholders
Period of Validity:
N/A
Approval Date:
N/A
Modification Date:
N/A
Year:
2024-2025
Region / City:
Idaho
Subject:
Audits of Local Schools
Document Type:
Memorandum
Organization / Institution:
Idaho State Department of Education
Author:
Idaho State Department of Education
Target Audience:
Auditors of Idaho Public Schools
Period of Validity:
FY 2025
Approval Date:
Not specified
Amendment Date:
Not specified
Jurisdiction:
England
Legal framework:
Education Act 2002 (sections 175 and 157)
Related statutory guidance:
Keeping Children Safe in Education
Education settings covered:
Schools, colleges, post-16 education providers
Governing responsibility:
Governing bodies and proprietors
Issuing context:
Local authority safeguarding oversight
Associated organisations:
Department for Education, Hertfordshire Safeguarding Children Partnership
Primary focus:
Safeguarding and child welfare
Document type:
Guidance
Intended users:
School and college leadership and management
Audit scope:
Safeguarding practice standards and quality assurance
Regulatory context:
Ofsted, ISI, Department for Education
Related legislation:
Further and Higher Education Act 1992; Apprenticeships, Skills, Children and Learning Act 2009
Referenced roles:
Designated Safeguarding Lead, Child Protection School Liaison Officer
Year:
2023
Region / city:
Europe
Topic:
Hybrid audits, quality management systems, MDR/IVDR
Document type:
Position paper
Organ / institution:
Team-NB
Author:
Team-NB
Target audience:
Notified bodies, auditors, manufacturers
Validity period:
Indefinite
Approval date:
May 16th, 2023
Date of amendments:
Not specified
Year:
2024
Region / City:
Global
Topic:
Data Management, Financial Audits, Programmatic Advertising
Document Type:
Guidelines
Organization:
Cross-industry Programmatic Supply Chain Taskforce
Author:
Not specified
Target Audience:
Advertisers, Publishers, Auditors
Effective Period:
Ongoing
Approval Date:
4th July 2024
Date of Changes:
4th July 2024
Note:
Year
Theme:
Laboratory Safety
Document Type:
Checklist