Reminder: Drug Sample Compliance Reports Are Due

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April 1 is just around the corner. If your company has distributed drug samples over the past year, your drug sample compliance report is due to the FDA very soon.

The Affordable Care Act requires pharmaceutical companies that dispense drug samples to physicians and health care professionals to report annually on the details of the samples dispensed. The government mandated this electronic reporting of all drug samples annually, by April 1 each year. The intent of the legislation is to help FDA monitor prescription drug distribution activity and prevent abuse.

The key elements that must be reported are:

  • the name and quantity of drug samples distributed
  • the name, address, professional designation and signature of the person who makes or signs for the drug sample request

These submissions are often referred to as “ACA 6004 Drug Sample” submissions.  It is much like a Structured Product Labeling (SPL) submission, an Extensible Markup Language (XML) file.  The XML file should be arranged per the FDA specifications (please see the link below) and transmitted via the FDA Electronic Submission Gateway (ESG), choosing the “ACA 6004 Drug Samples” drop-down for Submission Type.

Please refer to the FDA’s web page on the topic, which includes a link to a draft guidance.

Please contact us at contactus@synchrogenix.com with questions or if you require assistance.

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Author: Rob Labriola

Rob Labriola has 20 plus years experience in regulatory operations for the pharmaceutical industry. Mr. Labriola has seen it all and truly understands the frustrations and rewards of moving to eCTD. He has worked on multiple application types (INDs, NDAs, BLAs, CTAs, NDSs, JNDAs and MAAs), and has extensive international experience, having submitted applications to the FDA, Canada, Europe, Switzerland, Australia, Israel, Japan, etc.

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