AFFORDABLE CARE ACT (ACA)-6004

Enhancing Transparency in Drug Sample Distribution

Masuu Global Solutions recognizes the vital importance of adhering to Section 6004 of the Affordable Care Act (ACA). This provision though often overshadowed by other ACA mandates holds deep significance in ensuring responsible distribution of prescription drug samples across the United States.

Affordable Care Act (ACA)-6004[US]

FDA’s Reporting Requirements for Drug Samples Under ACA Section 6004 :
  • Enacted in 2010, Section 6004 amends the Social Security Act, introducing section 1128H.
  • Mandates annual reporting of drug sample distribution to the Department of Health and Human Services (HHS).
  • Reports are due by April 1 each year and must cover the previous calendar year
  • This applies to samples covered under sections 503(d)(2) and 503(d)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Applicable drug:

An applicable drug is a drug that is subject to section 503(b) of the FD&C Act (21 U.S.C. 353(b)) and for which payment is available under title XVIII of the Social Security Act (SSA) or a State plan under title XIX or XXI of the SSA (or a waiver of such a plan).

Authorized distributor of record (ADR):

“Those distributors with whom a manufacturer has established an ongoing relationship to distribute such manufacturer’s products.” 8 An entity that is an ADR under section 503(d) of the FD&C Act is also an ADR under section 1128H of the SSA.

Importance

  • Promotes transparency around drug promotion and sample distribution
  • Detects irregularities, such as excessive or suspicious dispensing
  • Reinforces regulatory compliance, complementing the Prescription Drug Marketing Act (PDMA)

Who Must Report?

Both manufacturers and ADR’S distributing “applicable drugs” must submit data to the Department of Health and Human Services (HHS) via the FDA’s Electronic Submissions Gateway

Applicable drugs” are:
  • Prescription drugs covered by Medicare or Medicaid
  • Drugs falling under Section 503(b) of the FD&C Act

Notably, if a drug sample distribution is reported by one party (manufacturer or ADR), the other doesn’t need to duplicate it.

What Data is Required?

The annual report must include detailed information for each drug sample transaction:

Identity and Quantity
  • Drug name, dosage, packaging, units requested and distributed
Practitioner Details
  • Full name, professional designation (e.g., M.D.), address, signature of both requestor and recipient
  • The individual making the request.
  • The individual receiving delivery (if different) a signature-on-file checkbox suffices
Additional Information
  • Any other data deemed necessary by HHS, as specified in FDA guidance
Drug specifics
  • Name, dosage, package size, units requested vs. Units delivered.

How to submit?: Technical pathway

  • Compliance hinges on a seamless XML-based electronic submission into the FDA’s
                      Electronic Submissions Gateway (ESG), guided by:
  • Detailed XML schema and sample submissions are available
  • Reports are submitted electronically via the Electronic Submissions Gateway (ESG)

Why Compliance Matters?

Regulatory Integrity

By aligning with ACA Section 6004, companies demonstrate their commitment to transparency and legal compliance.

Combating Sample Abuse

A structured, annual audit of sample distributions helps detect overuse, fraudulent activity, or diversion to non-clinical avenues.

Alignment with PDMA

Many data points are common to the Prescription Drug Marketing Act’s recordkeeping and labeling requirements, reducing duplication

Enhanced Trust with hcps and Payers

Meticulous reporting fosters confidence among healthcare practitioners, payers, and regulatory bodies underlining ethical practices

Compliance Excellence with Masuu

Masuu Global Solutions offers comprehensive expertise to guide pharmaceutical clients through ACA Section 6004 compliance:

  1. Data strategy assessment: We analyze your sample distribution model to ensure reportable data are accurately captured and grouped.
  2. XML conversion & schema validation: We translate raw data into FDA-compliant XML, testing each file before submission.
  3. ESG submission support: We assist with ESG registration, credentialing, and actual gateway submission.
  4. Process optimization: We design sops that integrate signature flags, transaction date stamping, and drug categorization in your sample systems.
  5. Year-round maintenance: Sample distributions don’t stop in April—our ongoing support ensures you’re ready early each year.
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