McGuff Outsourcing Solutions is an FDA-registered 503B outsourcing facility that manufactures sterile compounded drug products under current Good Manufacturing Practice (cGMP) standards for use by licensed healthcare facilities.

McGuff Outsourcing Solutions supplies sterile drug products only to:

• Pharmacies
• Hospitals
• Clinics
• Licensed IV hydration clinics
• Physician practices
• Surgery centers
• Government medical facilities
• Other licensed healthcare providers

McGuff Outsourcing Solutions does not sell directly to consumers or patients.

No. 503B compounded products are not FDA-approved, but they are manufactured under Section 503B of the Federal Food, Drug, and Cosmetic Act and must comply with full cGMP requirements, including sterility, endotoxin, potency, and container-closure integrity inspection.

To establish an account, healthcare facilities provide:

• Facility license
• Authorized purchaser information
• Shipping and receiving details

McGuff Outsourcing Solutions onboarding specialists guide all customers through the credentialing process.

Orders may be placed through:

• McGuff Outsourcing Solutions Customer Support: 1-877-444-1133
• Email ordering (for registered customers)

All orders undergo license and compliance verification.

Yes. McGuff Outsourcing Solutions can register multiple authorized purchasers. Updates can be made at any time through Customer Support.

Pricing is available to registered customers upon request and may vary by product, batch, and availability.

COAs are available:

• On the McGuff Outsourcing Solutions Downloads page (for many products)
• By request through Customer Support at 1-877-444-1133

COAs are provided for the specific batch shipped.

All sterile drug products undergo:

• Sterility testing
• Endotoxin testing
• Potency (assay) testing
• Container-closure integrity inspection
• Visual inspection for particulates and defects

Only batches that meet all quality specifications are released by the Quality Unit.

Product-specific storage conditions are listed on:

• Product labels
• Safety Data Sheets
• Product specification documents

Many products require refrigerated, controlled room temperature, or light-protective storage.

Contact McGuff Outsourcing Solutions Customer Support at 1-877-444-1133. A formal investigation will be initiated per cGMP requirements.

Yes. Products requiring special temperature conditions are shipped using validated cold-chain packaging and Good Distribution Practices (GDP) guidelines.

Yes. Tracking is provided for U.S. and international shipments. It is available on our website and through our U.S.-based Pharmaceutical Customer Support Specialists.

Contact McGuff Outsourcing Solutions within 48 hours of receipt so we can evaluate and resolve the issue promptly.

Yes. McGuff Outsourcing Solutions ships sterile 503B compounded drug products internationally where lawful.

Upon request, McGuff Outsourcing Solutions can provide:

• Certificate of Analysis (COA)
• Certificate for Foreign Government (CFG)
• Certificate of Pharmaceutical Product (CPP)
• Certificate of Free Sale
• Certificate of Origin
• Other regulatory documents requested by foreign authorities

The international customer (or their customs broker) serves as the Importer of Record and is responsible for all import compliance requirements.

Your total satisfaction is 100% guaranteed. McGuff Outsourcing Solutions proudly stands behind all products we manufacture and the service we provide. We are committed to ensuring that every customer receives courteous, professional, and responsive support with each order and interaction.

If a product or service experience does not meet your expectations, please contact us and we will make every reasonable effort to resolve the issue promptly. Our U.S.-based Pharmaceutical Customer Support Specialists handle all order and account inquiries, while our licensed Pharmacists are available for professional consultation on product use, development, and therapeutic questions.

All concerns must be arranged within 15 days of receipt. Please call 1-877-444-1133, and our U.S.-based customer service team will assist you.

Due to the nature of sterile compounded products, returns are accepted only when:

• The product was shipped in error
• McGuff Outsourcing Solutions directs a return for quality reasons
• A regulatory recall occurs

All returns require prior written authorization.

In the event of a recall, McGuff Outsourcing Solutions:

• Notifies affected customers
• Provides written instructions
• Covers reasonable return shipping costs if appropriate

Contact McGuff Outsourcing Solutions at 1-877-444-1133 or report through the FDA MedWatch program at www.fda.gov/medwatch.

A 503B outsourcing facility:

• Compounds sterile drugs under full cGMP
• Is inspected by the FDA
• May produce large batches without patient-specific prescriptions
• Performs full sterility, potency, endotoxin, and integrity testing

503B: cGMP manufacturing, batch testing, interstate distribution

503A: Made by traditional pharmacies, patient-specific prescriptions required

McGuff Outsourcing Solutions does not currently ship controlled substances internationally and will only do so domestically if future DEA registration is obtained.

For U.S. customers:

• Facility license
• Authorized purchaser information
• Shipping address details

For international customers:

• Import permits
• Country-specific regulatory approvals
• Licensed foreign wholesaler or distributor authorization