FDA Compounding Pharmacy Registration

Compounding pharmacies that operate as outsourcing facilities under Section 503B of the FD&C Act must register with FDA. LMG assists outsourcing facilities with FDA registration, drug listing, and compliance.

Section 503BOutsourcing FacilitiesAnnual Registration

Compounding Pharmacy Services

LMG assists 503B outsourcing facilities with FDA registration, drug reporting, inspection preparation, and ongoing compliance.

503B Outsourcing Facility Registration

FDA registration for compounding pharmacies operating under Section 503B of the FD&C Act. We handle the complete registration process, enabling you to compound drugs without individual prescriptions.

Compounded Product Reporting

503B outsourcing facilities must report all drugs they compound to FDA. LMG prepares and submits your drug product reports using the required format, ensuring compliance with FDA's semi-annual reporting requirements.

Compliance Support

Ongoing assistance with 503B regulatory obligations including registration maintenance, product reporting deadlines, and FDA correspondence management. LMG ensures your facility remains compliant throughout the year.

Annual Registration Renewal

503B registrations must be renewed annually between October 1 and December 31. LMG manages your complete renewal process, tracks critical deadlines, and ensures uninterrupted registration status year after year

How It Works

We manage the entire process from start to finish — so you can focus on your business.

503B Eligibility Review

We confirm your compounding pharmacy meets the requirements for registration as a 503B outsourcing facility.

Registration Preparation

We prepare your complete 503B outsourcing facility registration including all required facility and product information.

FDA Submission

We submit your registration to FDA and confirm assignment of your outsourcing facility registration number.

Drug Reporting & Compliance

We proceed with drug reporting submissions and provide ongoing compliance support for your 503B operations.

Frequently Asked Questions

Common questions about this FDA regulatory service.

What is a 503B outsourcing facility?

A 503B outsourcing facility is a compounding pharmacy that must registered with FDA under Section 503B of the FD&C Act. These facilities can compound drug products without patient-specific prescriptions and distribute to healthcare facilities.

What are the requirements for 503B registration?

503B outsourcing facilities must register with FDA, comply with cGMP requirements, report all compounded drug products, and report adverse events. They are subject to FDA inspection.

Is 503B registration required?

503B Outsourcing Facilities must register and comply with FDA’s cGMP requirements.

How does 503B differ from 503A?

503A covers traditional compounding pharmacies that compound based on patient-specific prescriptions. 503B covers outsourcing facilities that compound for healthcare facilities without patient-specific prescriptions.