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Federal RequirementsApril 22, 2025

The 340B Program and Pharmacy Operations

A detailed look at the 340B drug pricing program and its impact on pharmacy operations for the PTCB exam.

How 340B Works

The 340B Drug Pricing Program, created by Section 340B of the Public Health Service Act, requires drug manufacturers participating in Medicaid to sell outpatient drugs at reduced prices to eligible covered entities. These discounts can be 25-50% below average wholesale price.

Eligible entities include federally qualified health centers (FQHCs), Ryan White HIV/AIDS program grantees, disproportionate share hospitals (DSH), and certain children's hospitals. These organizations use the savings to stretch limited resources and serve more patients.

Compliance Requirements

340B compliance requires careful inventory management to prevent diversion (using 340B drugs for ineligible patients) and duplicate discounts (claiming both a 340B price and a Medicaid rebate). Pharmacies use either a physical or virtual inventory model to track 340B drugs separately.

Audits by HRSA (Health Resources and Services Administration) verify compliance. Pharmacies must maintain accurate records of eligible patients and dispensed medications.

PTCB Exam Tips

340B knowledge demonstrates operational expertise. Study with our PTCB flashcards and mini exams.

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