(NDC Labeller Registration & CARES Act Submissions)
Compounded drug products intended for the US market are subject to specific FDA requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the CARES Act. Our US Compounding Drug Registration services support 503A pharmacies and 503B outsourcing facilities with NDC Labeller Registration, product listing, and CARES Act submissions, ensuring accurate, timely, and compliant FDA filings.
We provide end-to-end regulatory support to help you meet FDA expectations, maintain ongoing compliance, and avoid enforcement risk.
Comprehensive US Compounding Regulatory Support
Our services cover the complete registration and listing lifecycle—initial setup, submission, maintenance, and FDA communication.
Scope of Services
- NDC Labeller Registration
- FDA Establishment Registration for compounding entities
- NDC Labeller Code application and confirmation
- Product listing and structured product data (SPL) preparation
- Updates for changes in products, labels, or facilities
- CARES Act Submissions
- Drug product reporting as required under the CARES Act
- Active ingredient, dosage form, route, and strength reporting
- Discontinued product notifications and updates
- Timely submissions aligned with FDA reporting schedules
- 503A / 503B Compliance Support
- Regulatory pathway assessment (503A vs 503B)
- Alignment with FDA compounding requirements
- Documentation readiness for inspections
- Support for outsourcing facility obligations
- Labelling & Data Accuracy
- Review of labelling content for regulatory alignment
- NDC structure and data consistency checks
- SPL validation and error resolution
- Ongoing data maintenance and lifecycle management
- FDA Communication & Ongoing Support
- Coordination of FDA correspondence
- Support for information requests and clarifications
- Change management and annual updates
- Integration with US Agent services (if required)
Regulatory Framework Covered
Our services are aligned with:
- US FDA Compounding Regulations (503A & 503B)
- NDC Labeller Registration & SPL Requirements
- CARES Act Drug Reporting Obligations
- 21 CFR Parts 207, 210, and 211 (as applicable)
- FDA Data Integrity & Submission Standards
This ensures full compliance with current FDA expectations for compounded drugs.
Risk-Based & Accuracy-Driven Approach
We follow a risk-based, data-accuracy-first approach to compounding registrations and listings. Correct classification, complete data, and timely updates are critical to avoiding FDA observations, product delistings, or enforcement actions.
Key Deliverables
- Confirmed NDC Labeller Registration
- FDA-compliant SPL files and product listings
- CARES Act submission confirmations
- Change and update tracking logs
- Inspection-ready regulatory records
Why Choose Our US Compounding Registration Services?
- Specialized US FDA Expertise
Deep understanding of compounding regulations and FDA systems. - Error-Free & Timely Submissions
Accurate data to prevent rejections and compliance gaps. - End-to-End Lifecycle Support
From initial registration to ongoing updates. - Integrated Regulatory Services
Seamless coordination with US Agent, DMF, and compliance support. - Confidential & Secure Handling
Protection of proprietary product and facility data.
Who We Support
- 503A Compounding Pharmacies
- 503B Outsourcing Facilities
- Non-US Companies Supplying Compounded Products
- Contract Compounding Organizations
- US Market Entrants and Growing Facilities
Stay Compliant in the US Compounding Landscape
With increased FDA oversight of compounded drugs and reporting under the CARES Act, accurate NDC Labeller Registration and product reporting are essential. Our structured, regulator-aligned approach ensures your compounding operations remain compliant, transparent, and inspection-ready.
