Resource Center › Compliance
Federal Drug Samples Reporting
Learn who must report drug samples under ACA Section 6004, what the FDA requires and when annual reports are due.
U.S. Federal, FDA
Manufacturers and authorized distributors of record
April 1 each year
Drug samples requested by and distributed to HCPs
Overview
As part of the effort to provide greater transparency into how Life Sciences companies provide drug samples to Healthcare Professionals (HCPs), Section 6004 was included in the Affordable Care Act (ACA) when enacted by Congress in 2010. Starting on April 1, 2012 and on April 1 of each year thereafter, it mandates that manufacturers and authorized distributors of record (ADRs) of drugs annually report to the Secretary of the Department of Health and Human Services (HHS) the identity and quantity of drug samples that were requested and distributed to HCPs.
To facilitate the collection of this data, the HHS Secretary directed the Food and Drug Administration (FDA) to issue guidance on the data to be submitted and design and oversee a system for its collection and management. The FDA created a sophisticated XML format for data submission and leveraged the Electronic Submissions Gateway (ESG) to provide the means through which manufacturers and ADRs submit this data. Manufacturers and ADRs must report on the name, address, professional designation and signature of the HCP who requested the sample(s) and of the individual who requested or accepted delivery of the sample(s) on behalf of the HCP. Manufacturers and ADRs must register with the ESG, collect data related to sample distributions for the entire calendar year, format the data according to FDA requirements and submit the report by the following April 1.
For more information on Section 6004 of the ACA and the FDA ESG, visit the FDA’s ACA Section 6004 page.
How MedPro Systems Can Help
We help Life Sciences and Healthcare companies drive better health outcomes by reducing complexity across their compliance and commercial operations. With tailored data, solutions and service, our dedicated team of industry veterans simplifies each step and helps customers move forward with confidence and precision.
Our end-to-end global platform, MedPro Compliance Reporting ID®, is the single solution that equips you for the growing complexity and evolving nature of transparency obligations around the world.
Streamline your transparency data capture and reporting with holistic, scalable, integrated coverage enhanced by trusted data and a responsive, proactive team of industry veterans.
FAQ
Frequently Asked Questions
Global Transparency Guide
Navigating Global Transparency Compliance
Download MedPro’s comprehensive guide to global transparency compliance. Learn how leading Life Sciences organizations achieve end-to-end coverage across U.S. and international disclosure obligations in a single platform.
Related resources
-
Provider Verification Beyond Compounding Pharmacy Onboarding
How current provider and facility information supports documented decisions from account setup through order fulfillment.
-
Where Prescriber Verification Fits in the Specialty Pharmacy Workflow
A practical look at verification checkpoints from prescription intake through dispensing and the value of current provider data at each stage.
-
7 Workflow Gaps That Slow Down Life Sciences Compliance Teams
As compliance responsibilities grow, small gaps between data, systems and teams can create extra manual work. Here are 7 places to look first and practical steps your team can take to strengthen the workflow.
-
Two International Disclosure Dates to Plan For
Colombia’s biannual value-transfer filing is due September 30, and Japan’s annual disclosure window follows each company’s fiscal year end.
