Deadline for Mandatory Submission of Drug Sample Information to FDA Closes Soon
The US Food and Drug Administration (FDA) released updates this week (26 March) on submitting information required under the Patient Protection and Affordable Care Act (PPACA). Under the law, pharmaceutical companies are required to submit certain drug sample information to FDA before 1 April 2012 and every year thereafter.
Under the PPACA's Section 6004, "Prescription Drug Sample Transparency," manufacturers must submit:
- the identity and quantity of drug samples requested
- the identity and quantity of drug samples distributed
- the name, address, professional designation, and signature of any person who makes or signs for the request
- any other category of information determined appropriate by the Secretary.
To assist pharmaceutical manufacturers, FDA updated its webpage on the PPACA section 6004 submissions. The webpage now contains links to:
- ACA 6004 Legislation
- ACA 6004 Specifications User Guide (PDF - 231KB)
- ACA 6004 XML Schema and Sample (ZIP - 4KB)
- Practitioner Acronym Table (PDF - 51KB)
- Electronic Submissions Gateway
- ESG User Guide
Addition frequently asked questions and contact information will reportedly be available on the website shortly.
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