Appendix B: Draft 503B Outsourcing Facility Services Agreement

# Appendix B: Draft 503B Outsourcing Facility Services Agreement

INSTRUCTIONS FOR ATTORNEY REVIEW

503B outsourcing facility arrangements are among the most heavily scrutinized in peptide regulation. The FDA's position on what constitutes permissible office-use compounding has narrowed significantly. Before using this template: 1. Confirm that your intended use actually qualifies as "office use" under current FDA guidance 2. Have counsel review the clinical setting description for accuracy 3. Confirm that the facility's 503B registration is current and that they are in good standing with FDA 4. Review volume limitations and patient population scope for regulatory appropriateness 5. Confirm that the adverse event and reporting provisions meet 503B requirements 6. Assess whether a 503A arrangement would be more appropriate for your use case ---

503B OUTSOURCING FACILITY SERVICES AGREEMENT

This 503B Outsourcing Facility Services Agreement ("Agreement") is entered into as of [DATE] by and between: [CLINIC/PRACTICE NAME], a [STATE] [ENTITY TYPE] with principal offices at [ADDRESS] ("Practice"), and [FACILITY NAME], an FDA-registered outsourcing facility under Section 503B of the FD&C Act, with principal offices at [ADDRESS] ("Facility"). ---

RECITALS

WHEREAS, Practice operates a clinical setting in which peptide therapies are administered to patients within a licensed medical practice; WHEREAS, Facility is an FDA-registered outsourcing facility authorized to compound medications for office use pursuant to Section 503B of the FD&C Act and applicable FDA guidance; WHEREAS, Practice wishes to engage Facility to provide office-use compounding services for peptide preparations administered within Practice's clinical setting; WHEREAS, the Parties wish to establish the terms under which Facility will provide such office-use compounding services; NOW, THEREFORE, the Parties agree as follows: ---

ARTICLE 1: DEFINITIONS

1.1 "503B" means Section 503B of the Federal Food, Drug, and Cosmetic Act, as amended, and applicable FDA regulations and guidance. 1.2 "Office Use" means the use of compounded drugs by or in a licensed medical practice or hospital for or with patients, without a patient-specific prescription, consistent with FDA's interpretation of Section 503B and applicable guidance. 1.3 "Clinical Setting" means Practice's licensed clinical facility located at [ADDRESS], as further described in Exhibit A, where Patient Services are provided and Peptide Preparations are administered. 1.4 "Patient Services" means the clinical services provided by Practice's licensed providers to patients within the Clinical Setting, as further described in Exhibit A. 1.5 "Peptide Preparations" means the specific compounded peptide preparations described in Exhibit B. ---

ARTICLE 2: SCOPE OF SERVICES

2.1 Engagement. Practice engages Facility to provide office-use compounding services for Peptide Preparations administered within the Clinical Setting, and Facility accepts such engagement. 2.2 Limitation to Office Use. All compounding under this Agreement shall be strictly limited to Office Use — meaning Peptide Preparations compounded under this Agreement shall be administered within Practice's Clinical Setting to patients receiving Patient Services. Peptide Preparations shall not be dispensed to patients for self-administration outside the Clinical Setting without a separate, valid Patient-Specific Prescription. 2.3 No Patient-Specific Prescriptions. This Agreement does not authorize Facility to compound pursuant to individual patient-specific prescriptions. Patient-specific compounding remains subject to a separate Pharmacy Services Agreement (Appendix A). 2.4 Regulatory Compliance. Facility shall perform all compounding services in compliance with: - (a) Section 503B of the FD&C Act and applicable FDA regulations (21 CFR Part 207); - (b) FDA Guidance for Industry: Repackaging of Biologics for Single-Patient Use; - (c) Applicable USP standards for compounding; - (d) Facility's Standard Operating Procedures, as provided to Practice; and - (e) The quality and testing requirements in Exhibit C. ---

ARTICLE 3: CLINICAL SETTING AND PATIENT POPULATION

3.1 Clinical Setting Description. Practice represents and warrants that the Clinical Setting is a licensed medical practice operating under the supervision of licensed healthcare providers, as further described in Exhibit A. Practice shall notify Facility promptly of any material change in the Clinical Setting that may affect the permissibility of Office Use compounding. 3.2 Patient Population. Practice shall use Peptide Preparations only for patients who are receiving Patient Services at the Clinical Setting. The patient population shall be as described in Exhibit A. 3.3 Volume Limitations. Practice acknowledges that Office Use compounding is subject to volume limitations under FDA guidance. Practice shall work with Facility to ensure that compounding volumes remain within permissible limits. Facility shall notify Practice if it believes order volumes exceed what FDA would consider consistent with legitimate Office Use. ---

ARTICLE 4: ORDERING AND FULFILLMENT

4.1 Orders. Practice shall submit orders for Peptide Preparations in accordance with the ordering procedures set forth in Exhibit D. Each order shall identify the Peptide Preparation, quantity, and anticipated administration schedule. 4.2 No Advance Stocking. Practice shall not maintain an inventory of Peptide Preparations in excess of what is reasonably anticipated for administration within [30] days based on Practice's patient volume. 4.3 Fulfillment. Facility shall use commercially reasonable efforts to fulfill orders within [5-7] business days of receipt. Facility shall notify Practice promptly of any supply constraints or delays. 4.4 Receipt and Administration. Upon receipt of Peptide Preparations, Practice shall: - (a) Verify the shipment against the order; - (b) Store in accordance with labeled conditions; - (c) Administer only to patients receiving Patient Services at the Clinical Setting; - (d) Document each administration event in the patient's medical record; and - (e) Maintain administration records for audit purposes. ---

ARTICLE 5: QUALITY AND TESTING

5.1 Testing Requirements. All Peptide Preparations shall be tested in accordance with Exhibit C. Testing shall include identity, potency, sterility, and endotoxin testing as appropriate. 5.2 COA. Facility shall provide a COA with each batch of Peptide Preparations, documenting testing results, batch number, and expiration date. 5.3 Recall Procedures. In the event of a recall or withdrawal of any Peptide Preparation, Facility shall promptly notify Practice and shall bear the cost of return and replacement for any Peptide Preparation that does not meet specifications. ---

ARTICLE 6: RECORDS AND REPORTING

6.1 Facility Records. Facility shall maintain records of all compounding activities in accordance with 21 CFR Part 207, including: drugs compounded, components used, batch numbers, quantities, and the Clinical Setting to which each batch was provided. 6.2 Practice Administration Records. Practice shall maintain records of each administration of a Peptide Preparation to a patient, including: patient identifier, date, preparation administered, and administering provider. 6.3 FDA Reporting. Facility shall be responsible for all required FDA reporting, including adverse event reports and deviation reports. Facility shall provide Practice with a copy of any report submitted to FDA that relates to Peptide Preparations provided under this Agreement. 6.4 Inspection. Facility shall promptly notify Practice of any FDA inspection related to Peptide Preparations and of any FDA enforcement action or warning letter received by Facility. ---

ARTICLE 7: FEES

[Insert fee structure per Exhibit E] ---

ARTICLE 8: REGULATORY REPRESENTATIONS

8.1 Facility Representations. Facility represents and warrants that: - (a) Facility is and will remain duly registered with FDA as a 503B outsourcing facility; - (b) Facility holds all required state licenses and registrations; - (c) Facility's compounding activities under this Agreement comply with Section 503B and applicable FDA guidance; - (d) Facility will notify Practice immediately if its FDA registration is revoked, suspended, or subject to any enforcement action; and - (e) Facility maintains professional liability insurance in customary amounts. 8.2 Practice Representations. Practice represents and warrants that: - (a) The Clinical Setting is a licensed medical practice operating within applicable state and federal law; - (b) Peptide Preparations will be administered only within the Clinical Setting to patients receiving Patient Services; - (c) Practice will not dispense Peptide Preparations for patient self-administration outside the Clinical Setting without a separate, valid Patient-Specific Prescription; and - (d) Practice holds all required business licenses and registrations. ---

ARTICLE 9: TERM AND TERMINATION

9.1 Term. [Insert term] 9.2 Termination for Cause. [Insert termination for cause provisions] 9.3 Transition. Upon termination, Facility shall cooperate with Practice to transition to a successor arrangement and shall fulfill all outstanding orders received prior to termination. ---

ARTICLE 10: INDEMNIFICATION

[Insert mutual indemnification provisions] ---

SIGNATURE PAGE

[CLINIC/PRACTICE NAME] By: _________________ Name: _______________ Title: _______________ Date: _______________ [FACILITY NAME] By: _________________ Name: _______________ Title: _______________ Date: _______________ ---

EXHIBIT A: Clinical Setting and Patient Population Description

[To be completed — describe the clinical setting, types of providers, patient population, and types of clinical services provided]

EXHIBIT B: Peptide Preparations in Scope

[To be completed — specific peptides, dosage forms, and strengths]

EXHIBIT C: Quality Standards and Testing Requirements

[To be completed — specific testing requirements, frequency, COA format]

EXHIBIT D: Ordering Procedures

[To be completed — order submission process, quantities, lead times]

EXHIBIT E: Fees

[To be completed — per-unit fees, volume pricing, payment terms] --- *END OF APPENDIX B*