Enter a search term.
If you can't find what you were looking for, please contact us using one of the methods below so we can better serve you.
Table of Contents
- Scope
- Regulatory Legality & Intended Use
- Export & Import Responsibilities
- Quality & Certificates
- Freight, Incoterms®, Title & Risk
- Orders, Lead Times & Delivery
- Storage, Handling & Acceptance
- Returns, Recalls & Adverse Event Reporting
- Labeling, Serialization & Documentation
- Prohibited Promotion and Indications
- Warranties & Disclaimers
- Indemnity & Liability
- Anti-Diversion & Re-Export
- Governing Law & Dispute Resolution
- Entire Agreement
- Appendix A – Regulatory Certificates
Scope
These Terms govern international sales and shipments of compounded drug products prepared by McGuff Outsourcing Solutions (MOS), an FDA-registered 503B outsourcing facility.
Regulatory Legality & Intended Use
a. Shipments are made only where lawful in both the U.S. and destination country.
b. Products are for healthcare professional use only, not for consumer resale.
c. 503B products are not FDA-approved but are prepared in compliance with Section 503B of the Federal Food, Drug, and Cosmetic Act and applicable USP standards.
Export & Import Responsibilities
a. McGuff Outsourcing Solutions acts as exporter of record unless otherwise stated.
b. The Customer or its broker acts as importer of record and is responsible for all duties, taxes, and import permits.
c. McGuff Outsourcing Solutions will not export to embargoed or sanctioned destinations.
d. Controlled substances are not shipped internationally without required authorization.
Quality & Certificates
a. Each shipment includes a Certificate of Analysis (CoA).
b. Regulatory certificates (CFG, CPP, Free Sale) available upon request. Please see Appendix A for further information.
c. Temperature-controlled shipments follow Good Distribution Practices (GDP).
McGuff Outsourcing Solutions will cooperate with regulatory authorities as required by law and may provide supporting documentation or certificates as reasonably requested by the Customer for lawful importation.
Freight, Incoterms®, Title & Risk
a. Freight costs are added to invoices unless otherwise agreed.
b. Default term: Incoterms® 2020 DAP (Delivered at Place).
c. Risk transfers per agreed Incoterm; title passes upon full payment.
d. Cargo insurance is Customer’s responsibility unless otherwise arranged.
Orders, Lead Times & Delivery
a. Many 503B products are made to order.
b. McGuff Outsourcing Solutions is not responsible for customs delays or force majeure.
Storage, Handling & Acceptance
a. Customer must ensure prompt receipt and proper storage.
b. Notification of any issues is required within 48 hours of delivery.
Returns, Recalls & Adverse Event Reporting
Due to the nature of compounded sterile drug products and regulatory requirements, McGuff Outsourcing Solutions does not accept product returns unless expressly authorized for verified quality defects, shipping errors, or regulatory recalls.
“Verified product quality defects” include sterility failures, potency failures, labeling errors, or deviations from McGuff Outsourcing Solutions specifications.
McGuff Outsourcing Solutions may issue credits, replacements, or resolutions at its sole discretion.
No return is accepted without written authorization. Products must follow McGuff Outsourcing Solutions instructions for return, chain of custody, and integrity.
Customers must promptly report any adverse drug experiences or product complaints to McGuff Outsourcing Solutions at 1 (877) 444-1133.
Labeling, Serialization & Documentation
a. Labels are in English and compliant with U.S. 503B requirements.
b. Country of Origin: USA.
c. Customer must inform McGuff Outsourcing Solutions of destination-country serialization requirements prior to order confirmation.
Prohibited Promotion and Indications
The Customer shall not modify, translate, repackage, relabel, advertise, or promote products inconsistently with McGuff Outsourcing Solutions labeling or U.S. law.
Unauthorized statements about safety, efficacy, or intended use are prohibited.
Warranties & Disclaimers
a. McGuff Outsourcing Solutions warrants product conformity to CoA at shipment.
b. No other warranties, express or implied, are provided.
c. Customer is responsible for lawful importation and use.
Indemnity & Liability
a. Customer shall indemnify McGuff Outsourcing Solutions for losses resulting from unlawful resale or import noncompliance.
b. McGuff Outsourcing Solutions’s total liability shall not exceed the purchase price.
Anti-Diversion & Re-Export
Customer shall not resell, transfer, or re-export products contrary to export laws and must maintain traceability to the end healthcare facility.
Customer shall not engage in promotional or labeling activities inconsistent with McGuff Outsourcing Solutions-approved information.
Governing Law & Dispute Resolution
These Terms are governed by California law. Venue is Orange County, California, USA.
Parties shall attempt good-faith negotiation for 30 days before legal action.
In case of translation differences, the English version prevails.
Entire Agreement
These Terms, together with any executed agreements, constitute the entire understanding regarding international shipments.
1. Certificate to Foreign Government (CFG)
Issued by: U.S. Food and Drug Administration (FDA)
Purpose: Confirms that a drug, biologic, or device is legally marketed in the U.S., meets FDA regulatory requirements, and is eligible for export.
Use: Often required by foreign health authorities to verify that the product originates from a licensed, compliant U.S. manufacturer.
2. Certificate of a Pharmaceutical Product (CPP)
Issued by: FDA or participating WHO-member regulatory authority
Purpose: Certifies that a pharmaceutical product is authorized for marketing in the country of origin, is manufactured under GMP, and that the manufacturer holds a valid license.
Use: Commonly required by foreign regulators during import registration of pharmaceutical products.
3. Certificate of Free Sale (CFS)
Issued by: FDA or State Health Department
Purpose: Confirms that the product is lawfully sold and distributed in the U.S. and that the manufacturer complies with applicable laws and regulations.
Use: Typically required for non-prescription drugs, cosmetics, and medical devices to demonstrate that the product is freely available in the domestic market.
Summary Table:
| Acronym | Full Name | Issued By | Typical Use | Confirms |
|---|---|---|---|---|
| CFG | Certificate to Foreign Government | FDA (U.S.) | Export of FDA-regulated products | Legally marketed & exportable in U.S. |
| CPP | Certificate of a Pharmaceutical Product | FDA or WHO authority | Product registration abroad | Approved, GMP-compliant, licensed manufacturer |
| CFS | Certificate of Free Sale | FDA or State Health Dept. | General export documentation | Lawfully sold in the U.S. |
© 2025 McGuff Outsourcing Solutions All rights reserved.
This document and its contents are proprietary to McGuff Outsourcing Solutions and may not be reproduced, distributed, or used in any form without prior written authorization.
