Inventory Management Best Practices for 340B Covered Entities in 2026
Inventory controls in 340B live or die on replenishment discipline, auditable records, and clean split-billing logic in 2026.
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compliance-guide
340b-program
340B contract pharmacy restrictions: how manufacturer policies, HRSA guidance, and covered-entity records govern access to discounted drugs
Manufacturer contract pharmacy restrictions turn on records, claim identification, and policy conflicts that covered entities can't afford to treat casually.
340b-program
340B patient definition: how HRSA defines covered outpatient drugs, dispensing eligibility, and the records that establish patient status
How patient status is established in 340B turns on documented care, outpatient drug use, and records that can survive audit review.
340b-program
340B split billing and replenishment: how covered entities map eligible claims to purchases and maintain auditable inventory records
How split billing and replenishment work in 340B, with practical guidance on claim mapping, accumulations, and inventory records that can stand up to audit.
compliance-guide
340B Medicaid exclusion file management: what records HRSA requires to prevent duplicate discounts
Medicaid exclusion file mistakes create duplicate discount risk. Here's what HRSA expects covered entities to document and reconcile.
340b-program
How 340B Manufacturers Use Electronic Data Portals (ESP) to Verify Contract Pharmacy Claims and Enforce Distribution Restrictions
Manufacturers' electronic portals like ESP redefine 340B oversight by verifying contract pharmacy claims and enforcing distribution limits.
compliance-guide
340B Inventory Replenishment Models: How HRSA Defines Virtual Inventory, Purchase Tracking, and Auditable Dispensing Records for Compliance
HRSA expects 340B entities to maintain auditable dispensing, replenishment, and purchase-tracking systems that prove compliant virtual inventory use.
340b-program
Insulin Dispensing Under 340B: How Covered Entities Document Eligibility, Contract Pharmacy Distribution, and Duplicate Discount Prevention
Covered entities face strict 340B documentation demands for insulin eligibility, contract pharmacy dispensing, and duplicate discount prevention.
340b-program
340B Orphan Drug Exclusion: how HRSA defines eligible use for disproportionate share hospitals and free-standing cancer centers
How HRSA applies the 340B orphan drug exclusion for DSH hospitals and freestanding cancer centers, and what counts as eligible use.
340b-program
340B Program Integrity Audits: How HRSA Verifies Drug Diversion, Patient Eligibility, and Contract Pharmacy Compliance During Site Reviews
How HRSA audits 340B covered entities for diversion, eligibility, and contract pharmacy compliance during site reviews in 2026.
340b-program
340B Child Sites and Off-Site Outpatient Facilities: HRSA’s Eligibility, Registration, and Auditable Service Relationships
How HRSA defines eligibility and registration for 340B child sites and off-site outpatient facilities in 2026, and what makes them auditable.
compliance-guide
Split-billing software configuration guide: aligning virtual inventory, purchase data, and dispensing records to maintain 340B audit compliance
Practical 340B compliance guide for setting up split-billing software to align virtual inventory, purchasing, and dispensing data.
340b-program
340B Ceiling Price Disputes: How HRSA Defines Overcharges, Validates Manufacturer Submissions, and Enforces Refund Obligations to Covered Entities
How HRSA defines 340B overcharges, validates manufacturer data, and compels refunds when ceiling prices are exceeded in 2026.
compliance-guide
HRSA 340B contract pharmacy registration process: documenting site eligibility, executing written agreements, and maintaining OPAIS accuracy
HRSA’s 340B contract pharmacy registration hinges on verified site eligibility, written agreements, and precise OPAIS records.
340b-program
Duplicate discount prohibition under 340B: how HRSA defines Medicaid overlap and what records covered entities must maintain
HRSA’s duplicate discount prohibition defines Medicaid overlap rules and recordkeeping expectations that every 340B covered entity must understand.
compliance-guide
Developing a 340B Compliance Guide for Community Health Centers: HRSA 2026 Audit Focus on Medicaid Exclusion File Accuracy and Duplicate Discount Prevention
HRSA’s 2026 audits are tightening around Medicaid Exclusion File accuracy and duplicate discount controls for FQHCs and community health centers.
compliance-guide
Developing a 340B Compliance Guide for Federally Qualified Health Centers: HRSA 2026 Audit Priorities on Eligibility Documentation, Medicaid Billing, and Contract Pharmacy Inventory Controls
FQHCs are under tighter HRSA audit scrutiny in 2026: eligibility records, Medicaid duplicate discount flags, and contract pharmacy inventory data are key.
340b-program
HRSA’s 2026 Enforcement of 340B Program Integrity in Health System Mergers: Covered Entity Re-Registration, Contract Pharmacy Continuity, and Eligibility Validation
HRSA’s 2026 enforcement push exposes how health system mergers disrupt 340B eligibility, contract pharmacy integrity, and re-registration.
compliance-guide
Developing a 340B Compliance Guide for Oncology Infusion Centers: HRSA 2026 Audit Focus on Drug Administration Documentation, Billing Alignment, and Contract Pharmacy Claims Matching
How HRSA’s 2026 audits are reshaping 340B compliance expectations for oncology infusion centers, from infusion notes to contract pharmacy claim matching.
340b-program
HRSA’s 2026 Oversight of 340B Drug Diversion Controls in Specialty Pharmacy Distribution: Patient Definition, Shipment Verification, and Contract Pharmacy Oversight
HRSA’s 2026 scrutiny of 340B diversion controls now targets specialty pharmacy shipments, patient definitions, and contract pharmacy oversight.
340b-program
HRSA’s 2026 Enforcement of 340B Contract Pharmacy Data Integrity: Handling Split-Billing Discrepancies and Prescription Origination Conflicts in Multi-Site Health Systems
HRSA’s 2026 audits now target 340B contract pharmacy data integrity across multi-site systems, forcing covered entities to confront split-billing mismatches and origination errors.
340b-program
HRSA’s 2026 Oversight of 340B Program Integrity in Mobile Health Units: Eligibility Verification, Dispensing Documentation, and Contract Pharmacy Integration
HRSA’s 2026 oversight of 340B program integrity in mobile health units now targets gaps in eligibility, dispensing records, and contract pharmacy tie-ins.
compliance-guide
Developing a 340B Compliance Guide for Dialysis Centers: HRSA 2026 Audit Priorities on Patient Eligibility, Inventory Replenishment, and Contract Pharmacy Coordination
Dialysis centers face new HRSA 2026 audit priorities on 340B patient eligibility, inventory control, and contract pharmacy oversight.
compliance-guide
Developing a 340B Compliance Guide for Behavioral Health Hospitals: HRSA 2026 Audit Priorities on Patient Definition, Dispensing Documentation, and Contract Pharmacy Oversight
Behavioral health hospitals face new HRSA 2026 audit priorities around patient definition, documentation, and contract pharmacy oversight.
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B. Braun Medical Inc. Issues Voluntary Nationwide Recall of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container Due to the Presence of Particulate Matter
FOR IMMEDIATE RELEASE – August 19, 2026– Bethlehem, PA, B. Braun Medical Inc (B. Braun) is voluntarily recalling three (3) lots of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Containe
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Moderna raises $2.6B to support cancer work; FDA clears updated COVID vaccines
Moderna's upsized note offering quickly followed a big win in a crucial study. Elsewhere, a biotech's shares tumbled after study data were "inadvertently" published ahead of a medical meeting.
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AstraZeneca, Ionis data spark debate about RNA drugs’ impact on deadly heart disease
Results published in NEJM raised questions about the benefits "silencer" medications provide on top of standard therapies for TTR cardiomyopathy and amplified investor pressure on Alnylam.
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This week in charts: Biotech’s rebound is undeniable
Not only is the XBI continuing to hover around a historic high, but drug companies can't seem to get enough of both large IPOs and big-ticket M&A.
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FDA green lights Priovant drug for rare skin disease
Lisraya's clearance marks the first approval of a drug the Roivant subsidiary licensed from Pfizer and has since positioned against multiple rare inflammatory conditions.
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Michael Polansky has a new, skin-focused biotech. Don’t call it a drug company.
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Revolution pancreatic cancer drug should quickly become a blockbuster, analysts say
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Revolution drug heralded as a pancreatic cancer breakthrough cleared by FDA
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ESC: AZ, Ionis' Wainua post-mortem throws water on silencer-plus-stabilizer approach in ATTR-CM
After a surprise washout in a recent phase 3 trial of AstraZeneca and Ionis’ antisense oligonucleotide Wainua, the likely reason for the miss is being laid bare, in a potential ill omen for others pur
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Takeda bolsters blood cancer portfolio with FDA nod for Mimrylo in polycythemia vera
The FDA has approved Takeda’s Mimrylo (rusfertide) for polycythemia vera, introducing a new mechanism to the nonmalignant rare blood cancer and handing CEO Julie Kim another major regulatory win since
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Lilly scores Novo-pressuring Mounjaro expansion to curb heart risks in diabetes patients
In their high-profile competition in the diabetes and obesity markets, Eli Lilly has proven adept at playing catch-up with Novo Nordisk. On Friday, Lilly checked another item off that list as it secur
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MrBeast, Snapchat, AI and more: Pharma marketing’s pulse check
In this week’s episode of “The Top Line,” Fierce’s Ben Adams and Zoey Becker discuss how pharma marketing is evolving across social media, creative work and agency strategy.
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