№ lp_1_2_23037
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This document provides a comprehensive template and recommendations for communicating National Drug Code (NDC) changes to stakeholders, specifically regarding the transfer of accumulations from old NDCs to new NDCs in the 340B program.
Note:
Year
Theme:
Pharmaceutical industry
Document type:
Manufacturer communication
Organization / institution:
[Manufacturer]
Author:
[Manufacturer]
Target audience:
Covered entities, stakeholders in the 340B program
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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:
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
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
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
Note:
Study Summary 1.1 Please provide a brief summary of the study in the table below. A complete description of the study with detailed information should be provided in the body of the protocol. For sections not applicable to the study, mark them as N/A. Study Title Study Design Primary Objective/Purpose Secondary Objective(s)/Purposes Research Intervention(s) ClinicalTrials.gov NCT # Study Population Sample Size Study Duration for individual subjects Study Specific Abbreviations/ Definitions
Background 3.1 Provide the scientific or scholarly background for, rationale for, and significance of the research based on the existing literature and how will it add to existing knowledge. :
this section should be limited to only information directly related to the research questions and objectives. Do not include your full dissertation proposal. 3.2 Describe any relevant preliminary data (e.g. pilot data).
Procedures Involved 5.1 Describe and explain the study design. 5.2 Please select the methods that will be employed in this study (select all that apply):
☐ Audio/Video Recording ☐ Psychophysiological Recording ☐ Behavioral Interventions ☐ Record Review - Educational ☐ Behavioral Observations and Experimentations ☐ Record Review - Employee ☐ Deception ☐ Record Review- Medical ☐ Focus Groups ☐ Record Review - Other ☐ Interviews ☐ Specimen Collection or Analysis ☐ Investigational Medical Device – (e.g. Medical Mobile Applications) ☐ Surveys and/or Questionnaires ☐Psychometric Testing ☐ Other Social-Behavioral Procedures Provide a description of all research procedures being performed and when they are performed. (Upload any surveys, questionnaires, interview scripts, focus group scripts, debriefing scripts, psychometric tests, stimulus materials, intervention manuals, and data collection forms on the Local Site Documents page in the IRB application.) 5.3 Describe the procedures or interventions that are going to be conducted as part of the research project, but that would have been conducted anyway, even if the research was not occurring (i.e. standard of care procedures, activities that would occur in a classroom). 5.4 Describe the procedures performed to lessen the probability or magnitude of risks of items selected in 5.2.5. 5 If accessing or collecting existing data, describe: The data that will be collected during the study (e.g. demographics, medical history, etc.). Attach the data capture sheet(s) on the Local Site Documents page in the IRB application. How the data will be obtained, including how you have the authority to access the data. The source or location of the data (e.g. USF Epic, TGH Epic, Hillsborough County School records, CANVAS records, publicly available databases, etc.). 5.6 If collecting and/or analyzing biological specimens, describe: How the biological specimens will be or have been collected. How the biological specimens will be stored. How long the biological specimens will be stored. How the biological specimens will be used. The laboratories that will be used. Whether the collected biological specimens will undergo genetic testing. If so, indicate if this study is part of a Genome Wide Association Study (GWAS) and whether the data will be forwarded to the NIH dbGaP. 5.7 If there are plans for long-term follow-up (once all research related procedures are complete), what data will be collected during this period.
Data and Specimen Storage for Future Research 6.1 If data or specimens will be banked for future research studies, describe where the data or specimens will be stored, how long it/they will b:
the process to request a release, approvals required for release, who can obtain data or specimens, and the data to be provided with specimens.
Year:
2023
Region / City:
Bangalore
Topic:
Contact Information
Document Type:
Official Directory
Organization:
Stamps and Registration Department
Author:
Not mentioned
Target Audience:
Public, Government Officials
Period of Validity:
Not mentioned
Approval Date:
Not mentioned
Date of Changes:
Not mentioned
Year:
2026
Region / city:
Global
Theme:
African and Asian Studies, Migration, Law, Development
Document type:
Journal Index
Institution:
Various publishers
Target audience:
Researchers, Academics, Policy Makers
Effective period:
Ongoing
Approval date:
2026
Revision date:
Not specified
Context:
The document lists academic journals focusing on African and Asian studies, law, migration, and development, with their respective ISSN numbers and publisher details.
Note:
Year
Topic:
HVAC Systems, VRF Systems, Equipment Specifications
Document Type:
Guide Specifications
Organization / Institution:
LG
Target Audience:
Contractors, Engineers
Year:
2021
Region / City:
United States
Subject:
Copier rental agreements and service conditions
Document Type:
Contractual Agreement
Agency / Institution:
Government
Author:
Contractor
Target Audience:
Contractors and Government Agencies
Effective Period:
Until contract termination
Approval Date:
Not specified
Date of Modifications:
Not specified
Year:
2023
Region / City:
Toronto, Ontario
Topic:
School visitor policies for 2024 - 2025
Document Type:
Policy Document
Organization / Institution:
Various schools within Toronto
Author:
Not specified
Target Audience:
School staff, athletic directors, parents, students
Effective Period:
2024 - 2025
Approval Date:
Not specified
Modification Date:
Not specified
Context:
A collection of visitor policies for multiple schools in Toronto, detailing specific guidelines for spectators, students, and parents during athletic events and playoffs.
Note:
Year
Subject:
Health Services, Department Contact Information
Document Type:
Internal Resource
Organization / Institution:
Grady Health System
Author:
Grady Health System
Target Audience:
Employees and Healthcare Providers at Grady Health System
Effective Period:
Ongoing
Note:
Year
Note:
Year
Validity Period:
6 months
Page Number:
1 of 6
Year:
2023
Region / city:
Philippines
Topic:
E-mail and Mobile Contact Information Submission
Document Type:
Authorization Form
Organization / Institution:
Securities and Exchange Commission of the Philippines
Author:
Not specified
Target Audience:
Corporations, Partnerships, Individuals
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Jurisdiction:
Canada
Authority:
Health Canada
Directorate:
Medical Devices Directorate
Document type:
Regulatory guidance and administrative instructions
Regulatory framework:
Medical Devices Regulations
Regulations issued:
July 1998
Subject matter:
Amendments for non-significant additions or deletions of catalogue or model numbers
Application scope:
Sections 28 to 31 and Section 34 of the Medical Devices Regulations
Exclusions:
Private Label licences
Submission requirements:
Fax-back form with copy of page 1 of the applicable licence
Processing timeframe:
7 calendar days from receipt
Authorization effect:
Amended licence authorizes sale of listed devices and catalogue numbers
Related guidance:
Guidance for the Interpretation of Significant Change; Guidance for the Interpretation of Sections 28 to 31
Administrative source:
Medical Devices Directorate, Health Canada
Year:
2017
Region / City:
New South Wales
Subject:
Mathematics
Document Type:
Educational Curriculum
Organization / Institution:
NSW Education Standards Authority (NESA)
Author:
NSW Education Standards Authority (NESA)
Target Audience:
Students
Duration:
6 weeks
Prerequisite Knowledge:
Year 10 Mathematics 5.3, Year 11 Mathematics Advanced, Year 12 Mathematics Advanced
Assessment Methods:
Formative assessment, matching tasks, applet use
Date Approved:
2017
Contextual Description:
Educational curriculum document outlining the study of complex numbers for Year 12 Mathematics Extension 2, including goals, outcomes, and teaching strategies.