Our 503B Facilities

McGuff Outsourcing Solutions operates within the FDA-registered, cGMP-compliant sterile drug manufacturing facility of McGuff Pharmaceuticals, Inc. (MPI) in Santa Ana, California.

This advanced pharmaceutical environment supports the production of ready-to-use sterile drug products for hospitals, surgery centers, physician practices, IV hydration clinics, and wellness/functional medicine providers in states where we are authorized to distribute.

Built on more than 50 years of sterile manufacturing experience, our facilities combine full pharmaceutical-grade production with the operational flexibility of a 503B outsourcing model—giving healthcare organizations a reliable source of high-quality, compliant sterile preparations.

Sterile Manufacturing Infrastructure

MOS operates inside a fully classified sterile manufacturing environment designed for repeatability, precision, and compliance:

• ISO-classified cleanrooms for sterile manufacturing
• ISO-5 aseptic work zones (biosafety cabinets and isolators)
• Dedicated compounding, aseptic filling, finishing, and API weighing suites
• Semi-automated and automated aseptic filling lines
• Terminal sterilization for eligible products
• Routine smoke studies to verify airflow patterns and aseptic process integrity

These capabilities support high-quality aseptic processing and scalable batch production for institutional providers.

503B Oversight & Regulatory Compliance

As a 503B outsourcing facility, MOS operates under strict regulatory expectations, including:

• 503B-required pharmacist oversight of sterile manufacturing
• Comprehensive batch record review and release by an independent Quality Unit
• Routine media fill simulations and operator qualifications
• Ongoing training and competency assessments for aseptic personnel
• Adherence to FDA, cGMP, and USP standards applicable to 503B operations

This structure ensures that each batch is produced, documented, and released with rigorous oversight.

In-House Microbiology & Chemistry Labs

On-site QC laboratories support product safety, consistency, and documentation requirements:

• Sterility, endotoxin, and particulate testing
• Chemical assay and identity testing
• In-process and finished-product verification
• Continuous viable and non-viable environmental monitoring
• Method validation and ongoing laboratory controls
• Real-time and accelerated stability studies supporting assigned beyond-use dates

Laboratory testing provides hospitals and clinics with dependable batch-to-batch consistency.

Controlled Handling & Storage

MOS and MPI maintain strict handling controls to protect product integrity:

• Validated storage for temperature-sensitive and light-sensitive sterile drug products
• Controlled environments for humidity, temperature, and air quality
• MOS-specific cGMP finished-goods storage rooms
• Full lot-level traceability and inventory documentation

These controls support stable supply chains for high-volume institutional customers.

cGMP Distribution & Shipping

A dedicated, compliant distribution area ensures efficient and documented product handling:

• cGMP-compliant MOS shipping area
• Integration with McGuff's national distribution network
• Documented chain-of-custody controls
• Support for cold-chain logistics when required
• Lot-level traceability through distribution

This infrastructure helps maintain reliable, continuous supply to providers across the country.

Documentation & Technical Support

To support pharmacists, clinicians, and regulatory teams, MOS provides:

• Certificates of Analysis (COAs)
• Certificates of Conformance (as applicable)
• Stability data
• Product specifications and SDS
• Osmolarity and formulation details
• Technical support from pharmacists and manufacturing professionals

This documentation simplifies audits, accreditation reviews, and internal compliance requirements for hospitals and clinics.

International & Nationwide Distribution

• International export capability in accordance with FDA 801(e) and the regulatory expectations of receiving countries
• MOS is actively applying for authorization to distribute sterile drug products in all 50 states and U.S. territories