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.
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