PHARMACY COMPOUNDING SERVICES CONTRACT
This agreement is entered into between Pharmacy Solutions and , Located at (the “Facility”) (collectively referred to herein as the “Parties”). WHEREAS Pharmacy Solution is a pharmacy that provides pharmacy compounding services; and WHEREAS the Facility requires compounding services in the ordinary course of its providing medical care within the scope of a valid doctor-patient relationship; and WHEREAS the Parties wish to memorialize their relationship and to acknowledge the rights and responsibilities of the parties with respect to Pharmacy Solutions provision of compounded preparations to the Facility; NOW THEREFORE the Parties. In the exchange of mutual consideration and the covenants contained herein agree as follows:
1. Pharmacy Solutions shall provide compounded preparations in reasonable quantities to Facility’s practitioner for “office use” by the practitioner. For purposes of this Agreement, “office use” means the provision and administration of a compounded preparation to a patient by the practitioner in the practitioner’s office or by the practitioner in a health care facility or treatment setting, including a hospital, ambulatory surgical center, or pharmacy. “Reasonable quantity” with reference to compounded preparations means an amount of a drug that: (A) does not exceed the amount a practitioner anticipates may be used in the practitioner’s office before the expiration date of the drug; (B) is reasonable considering the intended use of the compounded drug and the nature of the practitioner’s practice; and (C) for any practitioner and all practitioners as a whole, is not greater than an amount the pharmacy is capable of compounding in compliance with pharmaceutical standards for identity, strength, quality, and purity of the compounded drug that are consistent with United States Pharmacopoeia guidelines and accreditation practices.
2. Pharmacy compounding services provided by Pharmacy Solutions shall comply with Federal and State laws regulating the practice of compounding pharmacy. Pharmacy Solutions agrees to verify the source of the raw materials to be used in a compounded drug; to comply with applicable United States Pharmacopoeia guidelines, including the testing requirements, to comply with all applicable competency and accrediting standards as determined by the Texas State Board of Pharmacy (the “Board”); and to comply with Board rules, including rules regarding the reporting of adverse events by practitioners and recall procedures for compounded products.
3. Facility’s drug room will maintain the appropriate record systems consistent with applicable state and federal law for all drugs compounded by Pharmacy Solutions for Facility’s patients. Upon request, Facility will provide Pharmacy Solutions access to the records associated with the preparations compounded by Pharmacy Solutions.
4. The label affixed to all drugs compounded under the terms of this Agreement will identify Pharmacy Solutions as the compounding pharmacy.
5. Facility warrants that it has legal authority to request and administer compounded preparations and to transfer its prescriptions to Pharmacy Solutions for compounding and will notify Pharmacy Solutions immediately if its authority under this section is revoked by State or Federal authorities.
6. Facility shall track compounded prescriptions received from Pharmacy Solutions to dispensing patients. Facility shall record on patient’s chart, medication order of medication administration record the lot number and beyond use date of a compounded preparation administered to the patient. Facility will notify Pharmacy Solutions immediately if it receives any complaints regarding the preparations compounded by Pharmacy Solutions.
7. Pharmacy Solutions shall maintain a written procedure for the recall of any compounded preparations provided to Facility for office use or to a pharmacy for administration. The recall procedures shall require (1) notification to the practitioner, facility, and pharmacy to which the preparation was distributed; (2) notification to the Texas Department of the State Health Services; (3) notification to the patient; (4) quarantine of the product if there is suspicion of harm to a patient; (5) a mandatory recall if there is confirmed or probable harm to a patient; and notification to the board if a mandatory recall is instituted.
8. Facility shall indemnify, defend and hold harmless Pharmacy Solutions, its directors, officers, agents and employees against any actions, suits, proceedings, liabilities, and damages arising from the acts or omissions of pharmacy, physicians, employees or agents other than Pharmacy Solutions in connection with this Agreement. Facility shall give Pharmacy Solutions timely notice of any claim or suit instituted of which it has knowledge that in any way, directly or indirectly, affects or might affect Pharmacy Solutions and Pharmacy Solutions shall have the right at its own expenses to participate in the defense of the same.
9. The initial terms of this Agreement shall be one (1) year from the date hereof (the “Initial Term”), unless sooner terminated as provided herein. Upon expiration of the initial Term, this Agreement shall automatically renew for successive additional one (1) year periods unless (i) either party has notified the other in writing at least sixty (60) days prior to the expirations of the then current term that the notifying party elects not to renew this Agreement or (ii) this Agreement is sooner terminated as otherwise provided herein.
10. This Agreement may be canceled by either party giving the other party sixty (60) days prior written notice of termination, with or without cause.
11. Notwithstanding anything contained herein to the contrary, in the event there shall be a change in Federal or State law, regulations or general instructions (or in the application thereof), the adoption of new legislation or regulations applicable to this Agreement, or the initiation of an enforcement action with respect to legislation, regulations, or instructions applicable to this Agreement, any of which affects the continuing viability or legality of this Agreement, then either party man by notice propose an amendment to conform this Agreement to existing laws. If notice of such a change or amendment is given and if Pharmacy Solutions and Facility are unable within thirty (30) days thereafter to agree upon the amendment, then either party may terminate this Agreement by thirty (30) days notice to the other, unless sooner termination is required by law or circumstance.
12. During the term of this Agreement and surviving its expiration or termination, Pharmacy Solutions will regard and preserve as confidential and not disclose publicly or to any third party all information related to the business of Facility and its clients and patients that may be obtained as the result of performance under this Agreement, and Facility shall assume the same responsibility with respect to Pharmacy Solutions.
13. Pharmacy Solutions agrees to comply with the applicable provisions of the Administrative Simplification section of the Health Insurance Portability and Accountability Act of 1996. Pharmacy Solutions agrees not to use or further disclose any protected health information or individually identifiable health information (collectively, the “Protected Health Information”), concerning a patient other than as permitted by this Agreement and the requirements of HIPAA or regulations promulgated under HIPAA including without limitation the Federal Privacy Regulations. Pharmacy Solutions will implement appropriate safeguards to prevent the use or disclosure of a patient’s Protected Health Information other than as provided for by this Agreement.
14. Facility may not assign its rights or delegate its duties under this Agreement without the prior written consent of Pharmacy Solutions rights and obligations under this Agreement may be assigned or delegated upon notice to Facility.
15. Waiver by Pharmacy Solutions of any breach of the provisions of this Agreement shall not operate or be construed as a waiver of any subsequent breach by Facility.
16. In the event any provision of this Agreement is found to be unenforceable or invalid, such provision shall be severable from this Agreement and shall not affect the enforceability or validity of any other provision contained in this Agreement.
17. This Agreement shall be construed and governed in accordance with Texas law.
18. Other than terms of payment, this Agreement represents the entire agreement between the parties and supersedes all prior agreements, written and oral, with respect thereof. This Agreement may be modified or amended only by a written agreement executed by both parties to the Agreement.
19. The terms and conditions of this Agreement, in its entirety, will be held in the strictest confidence by both parties. Disclosure of any part of this agreement by Facility to a third party, individual or business entity, without the prior written consent of the Pharmacy Solutions, is grounds for termination of this Agreement.
20. Whenever used herein, the phrases “Pharmacy Solutions” and “approval of Pharmacy Solutions” shall mean the consent or approval by Pharmacy Solutions Pharmacist-in-Charge.
Signed by IN WITNESS WHEREOF, the parties have signed this Agreement this.
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Document Name: PHARMACY COMPOUNDING SERVICES CONTRACT
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