Appendix A: Draft Pharmacy Services Agreement (503A)

# Appendix A: Draft Pharmacy Services Agreement (503A)

INSTRUCTIONS FOR ATTORNEY REVIEW

This agreement template is provided as a starting point for drafting a 503A Pharmacy Services Agreement. Before using this template: 1. Have your attorney review all terms for compliance with applicable state pharmacy law in your state(s) of operation 2. Confirm that the scope of services accurately reflects your actual operational model 3. Ensure the prescription requirements align with your clinical protocols 4. Review the pricing structure with counsel for anti-kickback compliance 5. Confirm that the pharmacy's license and registration status are current before execution 6. Tailor the quality standards and testing requirements to the specific peptides within scope ---

PHARMACY COMPOUNDING SERVICES AGREEMENT

This Pharmacy Compounding Services Agreement ("Agreement") is entered into as of [DATE] by and between: [COMPANY NAME], a [STATE] [ENTITY TYPE] with principal offices at [ADDRESS] ("Company"), and [PHARMACY NAME], a [STATE] licensed pharmacy with principal offices at [ADDRESS] ("Pharmacy"). Collectively referred to as the "Parties" or individually as a "Party." ---

RECITALS

WHEREAS, Company operates or facilitates a telehealth platform or clinical practice that connects licensed healthcare providers with patients who may benefit from compounded peptide therapies; WHEREAS, Pharmacy is a state-licensed pharmacy authorized to compound medications pursuant to Section 503A of the Federal Food, Drug, and Cosmetic Act ("FD&C Act") and applicable state pharmacy law; WHEREAS, Company wishes to engage Pharmacy to provide compounding services for patient-specific prescriptions issued by licensed providers within Company's network; WHEREAS, the Parties wish to establish the terms under which Pharmacy will provide such compounding services; NOW, THEREFORE, in consideration of the mutual covenants and agreements set forth herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows: ---

ARTICLE 1: DEFINITIONS

1.1 "Compound" or "Compounding" means the preparation of a drug product by a licensed pharmacist or under the supervision of a licensed pharmacist in a state-licensed pharmacy pursuant to a valid patient-specific prescription, in accordance with Section 503A of the FD&C Act and applicable state pharmacy law. 1.2 "Patient-Specific Prescription" means a prescription issued by a licensed healthcare provider for a specific named patient, in the provider's professional judgment, pursuant to a valid prescriber-patient relationship, and which includes all elements required by applicable federal and state law. 1.3 "Peptide Therapies" means the specific compounded peptide preparations within the scope of this Agreement, as described in Exhibit A attached hereto. 1.4 "Prescription Requirements" means the minimum content and procedural requirements for valid prescriptions under this Agreement, as described in Article 4 and Exhibit B. 1.5 "Services" means the compounding, quality assurance, dispensing, and related services to be provided by Pharmacy pursuant to this Agreement. ---

ARTICLE 2: SCOPE OF SERVICES

2.1 Engagement. Company hereby engages Pharmacy to provide the Services described herein, and Pharmacy accepts such engagement, upon the terms and conditions set forth in this Agreement. 2.2 Compounding Services. Pharmacy shall compound Peptide Therapies pursuant to valid Patient-Specific Prescriptions transmitted by Company's providers in accordance with the Prescription Requirements. 2.3 Quality Standards. All compounding services shall be performed in compliance with: - (a) Section 503A of the FD&C Act and applicable FDA guidance; - (b) United States Pharmacopeia (USP) Chapters <795> and <823> as applicable; - (c) The pharmacy's Standard Operating Procedures, as provided to Company and updated from time to time; - (d) All applicable state pharmacy laws and regulations; and - (e) The quality standards and testing requirements set forth in Exhibit C. 2.4 Excluded Services. This Agreement does not authorize Pharmacy to: - (a) Compound medications without a valid Patient-Specific Prescription; - (b) Compound medications for office use without specific written authorization as described in a separate office-use addendum; - (c) Fill prescriptions written by providers who are not licensed in the patient's state of residence; or - (d) Dispense any medication that does not meet the Prescription Requirements. ---

ARTICLE 3: PRESCRIPTION REQUIREMENTS

3.1 Minimum Prescription Content. All Patient-Specific Prescriptions transmitted to Pharmacy shall include, at minimum: - (a) Patient's full legal name and date of birth; - (b) Prescribing provider's full name, license number, and state of licensure; - (c) The specific peptide compound, strength, and dosage form; - (d) Route of administration; - (e) Quantity to be dispensed; - (f) Directions for use; - (g) Refill authorization (if any), not to exceed a [90]-day supply without a new prescription; - (h) Date of issuance; and - (i) The clinical indication or medical necessity supporting the prescription, as documented in the patient's medical record. 3.2 Prescription Validation. Upon receipt of a Patient-Specific Prescription, Pharmacy shall: - (a) Verify that the prescription contains all required elements; - (b) Confirm that the prescribing provider holds a valid license in the patient's state; - (c) Review the prescription for clinical and regulatory appropriateness; and - (d) Notify Company within [24] hours if Pharmacy determines that a prescription does not meet the Prescription Requirements or should not be filled for clinical or regulatory reasons. 3.3 Prescription Rejection. Pharmacy may decline to fill any prescription that does not meet the Prescription Requirements, that presents clinical or regulatory concerns, or for which Pharmacy cannot verify the required elements. Pharmacy shall document the basis for any rejection and notify Company promptly. 3.4 No Standing Orders. Pharmacy shall not maintain a standing order or inventory of compounded peptides for Company. Each prescription must represent a discrete compounding event for a named patient. ---

ARTICLE 4: PRESCRIBING PROVIDER REQUIREMENTS

4.1 Provider Network. Company shall maintain a network of licensed healthcare providers ("Providers") authorized to prescribe Peptide Therapies within the scope of this Agreement. 4.2 Provider Licensing. Company shall ensure that each Provider: - (a) Holds a valid, active license to prescribe in the state where the patient is located at the time of the prescription; - (b) Is acting within the scope of their license for the prescribed therapy; - (c) Has documented the clinical evaluation and medical necessity in the patient's medical record; and - (d) Has obtained and documented informed consent from the patient prior to issuing the prescription. 4.3 Compliance Responsibility. Company shall be solely responsible for the acts and omissions of its Providers in connection with the issuance of prescriptions. Pharmacy shall have no liability for prescriptions that meet the Prescription Requirements but reflect inadequate clinical judgment by the prescribing Provider. ---

ARTICLE 5: QUALITY ASSURANCE AND TESTING

5.1 Testing Requirements. All Peptide Therapies compounded under this Agreement shall be tested in accordance with the testing requirements set forth in Exhibit C. Testing shall include, at minimum: - (a) Identity testing; - (b) Potency/purity testing; - (c) Sterility testing where applicable; and - (d) Endotoxin testing where applicable. 5.2 Certificate of Analysis. For each batch of Peptide Therapies, Pharmacy shall provide Company with a Certificate of Analysis (COA) documenting the testing results. The COA shall identify the batch, the prescription(s) it fulfills, and the testing methodology used. 5.3 Source Verification. Company may, at its expense, periodically verify the source and chain of custody of active pharmaceutical ingredients (APIs) used in compounding. Pharmacy shall cooperate with any such verification and shall provide relevant supplier documentation upon reasonable request. 5.4 Adverse Event Reporting. Each Party shall promptly notify the other Party of any adverse event or product quality complaint of which it becomes aware in connection with Peptide Therapies. Pharmacy shall report adverse events to applicable regulatory authorities as required by law and shall cooperate with Company's investigation of any complaint. ---

ARTICLE 6: DISPENSING AND DELIVERY

6.1 Dispensing. Pharmacy shall dispense compounded Peptide Therapies directly to the patient or to the clinical setting designated on the prescription, pursuant to the prescription instructions. 6.2 Packaging and Labeling. All dispensed medications shall be packaged and labeled in compliance with applicable state and federal law, including all required elements of a prescription drug label. 6.3 Delivery. Pharmacy shall use commercially reasonable efforts to fulfill prescriptions within [3-5] business days of receipt of a valid Patient-Specific Prescription. Pharmacy shall notify Company promptly of any circumstances likely to cause material delay. 6.4 Temperature-Sensitive Products. For temperature-sensitive Peptide Therapies, Pharmacy shall use appropriate packaging and shipping methods to maintain required temperature conditions during transit. Pharmacy shall provide Company with tracking information for all shipments. ---

ARTICLE 7: FEES AND PAYMENT

7.1 Fees. Company's fees for the Services shall be as set forth in Exhibit D attached hereto. 7.2 Invoicing. Pharmacy shall invoice Company [monthly/per-prescription] for Services rendered. Invoices shall include sufficient detail to identify the prescriptions fulfilled and the fees charged. 7.3 Payment Terms. Company shall pay undisputed invoices within [30] days of receipt. Company may dispute any invoice in good faith by providing written notice within [15] days of receipt, specifying the disputed amount and the basis for the dispute. 7.4 Fee Adjustments. Either Party may request a fee adjustment upon [60] days' written notice. Fee adjustments shall be documented in a written amendment to Exhibit D signed by both Parties. ---

ARTICLE 8: REGULATORY COMPLIANCE

8.1 Pharmacy Obligations. Pharmacy shall maintain: - (a) A valid state pharmacy license in good standing; - (b) All required state and federal registrations; - (c) Professional liability insurance in amounts customary for similarly situated pharmacies; and - (d) Compliance with all applicable state and federal compounding regulations. 8.2 Company Obligations. Company shall maintain: - (a) Appropriate business licenses and registrations; - (b) Provider credentialing and supervision infrastructure; - (c) Compliance with all applicable telehealth regulations in the states of operation; and - (d) Policies requiring Providers to comply with prescribing standards. 8.3 Regulatory Changes. Either Party shall promptly notify the other Party of any regulatory change that materially affects its ability to perform its obligations under this Agreement. The Parties shall work together in good faith to address any compliance gaps created by regulatory changes. ---

ARTICLE 9: RECORDS AND AUDIT

9.1 Pharmacy Records. Pharmacy shall maintain records of all compounding activities, testing, and dispensing in accordance with applicable state and federal requirements for a minimum of [3] years from the date of dispensing. 9.2 Company Records. Company shall maintain patient medical records in accordance with applicable state and federal requirements, including records of clinical evaluations, prescriptions issued, and informed consent. 9.3 Audit Rights. Company may, upon reasonable notice and during normal business hours, audit Pharmacy's compliance with the terms of this Agreement, including quality standards, testing documentation, and prescription validation procedures. Audits shall be conducted no more than [once per year] absent a good-faith concern regarding compliance. ---

ARTICLE 10: CONFIDENTIALITY

10.1 Confidential Information. Each Party agrees to maintain the confidentiality of the other Party's Confidential Information and not to disclose such information except as necessary to perform its obligations under this Agreement or as required by law. 10.2 Protected Health Information. To the extent any information exchanged constitutes Protected Health Information (PHI) under HIPAA, the Parties shall comply with all applicable HIPAA requirements. A Business Associate Agreement (BAA) shall be executed concurrently with or as an addendum to this Agreement. ---

ARTICLE 11: TERM AND TERMINATION

11.1 Term. This Agreement shall commence on the Effective Date and continue for an initial term of [one (1) year], unless earlier terminated. Thereafter, this Agreement shall automatically renew for successive [one (1)-year] terms unless either Party provides written notice of non-renewal at least [60] days prior to the end of the then-current term. 11.2 Termination for Cause. Either Party may terminate this Agreement upon [30] days' written notice if the other Party materially breaches this Agreement and fails to cure such breach within the [30]-day notice period. 11.3 Termination for Regulatory Reasons. Either Party may terminate this Agreement immediately upon written notice if continued performance would violate applicable law or if the terminating Party's regulatory licenses or registrations are revoked or restricted. 11.4 Transition Obligations. Upon termination, Pharmacy shall: - (a) Complete fulfillment of all prescriptions received prior to the termination date; - (b) Cooperate in the transition of patients to a successor pharmacy; - (c) Transfer patient records and compounding records to Company or its designee; and - (d) Not charge Company for costs associated with transition activities beyond those specifically described herein. ---

ARTICLE 12: INDEMNIFICATION

12.1 Pharmacy Indemnification. Pharmacy shall indemnify, defend, and hold harmless Company and its officers, directors, employees, and agents from and against any and all claims, damages, losses, and expenses (including reasonable attorneys' fees) arising out of or relating to: - (a) Pharmacy's negligence or willful misconduct; - (b) Pharmacy's breach of this Agreement or applicable law; or - (c) Any act or omission of Pharmacy in connection with the compounding or dispensing of Peptide Therapies. 12.2 Company Indemnification. Company shall indemnify, defend, and hold harmless Pharmacy and its officers, directors, employees, and agents from and against any and all claims, damages, losses, and expenses (including reasonable attorneys' fees) arising out of or relating to: - (a) Company's negligence or willful misconduct; - (b) Company's breach of this Agreement or applicable law; or - (c) The acts or omissions of Company's Providers in connection with the issuance of prescriptions. ---

ARTICLE 13: GENERAL PROVISIONS

13.1 Governing Law. This Agreement shall be governed by and construed in accordance with the laws of the State of [STATE], without regard to its conflict of laws principles. 13.2 Entire Agreement. This Agreement, together with its Exhibits, constitutes the entire agreement between the Parties with respect to the subject matter hereof and supersedes all prior and contemporaneous agreements, understandings, negotiations, and discussions. 13.3 Amendment. This Agreement may be amended only by a written instrument signed by both Parties. 13.4 Assignment. Neither Party may assign this Agreement without the prior written consent of the other Party. 13.5 Notices. All notices required under this Agreement shall be in writing and delivered to the addresses set forth above. 13.6 Severability. If any provision of this Agreement is held invalid or unenforceable, the remaining provisions shall remain in full force and effect. 13.7 Waiver. The failure of either Party to enforce any provision of this Agreement shall not constitute a waiver of that Party's right to enforce that provision or any other provision. ---

SIGNATURE PAGE

IN WITNESS WHEREOF, the Parties have executed this Pharmacy Compounding Services Agreement as of the date first written above. [COMPANY NAME] By: _______________________________ Name: _____________________________ Title: ____________________________ Date: _____________________________ [PHARMACY NAME] By: _______________________________ Name: _____________________________ Title: ____________________________ Date: _____________________________ ---

EXHIBIT A: Scope of Peptide Therapies

[To be completed — list specific peptides, dosage forms, and clinical applications within scope] ---

EXHIBIT B: Prescription Requirements (Detailed)

[To be completed — detailed Prescription Requirements reflecting clinical protocols] ---

EXHIBIT C: Quality Standards and Testing Requirements

[To be completed — specific testing requirements, COA format, third-party lab requirements] ---

EXHIBIT D: Fees and Payment Terms

[To be completed — per-prescription fees, volume pricing tiers, payment terms] --- *END OF APPENDIX A*