On March 23, 2010, the Affordable Care Act (ACA) was signed into law. Among other things, the ACA amends the Social Security Act, 42 U.S.C. 1301 et seq., by adding section 6004. This new section requires the submission of certain drug sample information to FDA on or before April 1, 2012.
At Masuu Global Solutions, we’re dedicated to promoting safety, transparency, and integrity in everything we do – especially when it comes to controlled substances. One of the most important pieces of legislation guiding this effort is Section 6004 of the Affordable Care Act (ACA). This provision helps ensure that medications, particularly in long-term care settings, are tracked responsibly and used appropriately.
What Is ACA Section 6004?Under section 6004 of the ACA, manufacturers and ADRs of applicable drugs must submit the identity and quantity of drug samples requested and the identity and quantity of drug samples distributed, aggregated by the name, address, professional designation, signature of the practitioner making the request, and signature.
The Affordable Care Act explicitly states that manufacturers and authorized distributors must submit the following information concerning drug sample distribution to FDA:
- 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, and
- any other category of information determined appropriate by the Secretary.
The misuse of opioids and other controlled substances continues to be a major public health challenge. ACA 6004 empowers regulators and healthcare organizations to work proactively in:
- Preventing drug diversion
- Tracking usage
- Safeguarding patient care environments, especially in long-term and assisted living facilities
By promoting transparency in the pharmaceutical distribution chain, this provision strengthens public trust and improves overall safety outcomes.
Our Commitment to ComplianceAt Masuu Global Solutions, we recognize the importance of ACA 6004 in ensuring responsible pharmaceutical practices. Our internal systems are designed to:
- Support accurate and timely reporting
- Provide full traceability and transparency in all controlled substance transactions
We work closely with our partners and stakeholders to maintain full compliance, reduce risk, and support better health outcomes for the communities we serve.
Want to Learn More?If you have questions about how ACA 6004 impacts your organization or how we can help you navigate compliance requirements, please contact us or speak with one of our compliance specialists.
Reference https://www.fda.gov/drugs/guidance-compliance-regulatory-information/affordable-care-act-aca-6004