Legal Disclaimer & Pharmaceutical Compliance Policy
Effective Date: June 19, 2026 | Renew Lab Group, Houston, Texas
1. Research Use Only — Not for Human or Veterinary Use
All products manufactured and distributed by Renew Lab Group, including bacteriostatic water for injection (BAC Water), sterile diluents, and associated laboratory supplies, are manufactured and labeled exclusively for Research Use Only (RUO). These products are not intended for, and must not be used in, diagnostic, therapeutic, clinical, or any other application involving human patients or animals. Any use outside of controlled laboratory research environments is strictly prohibited.
⚗️ For Research Use Only. Not intended for human or veterinary use.
2. Qualified Purchaser Requirement
Renew Lab Group sells its products exclusively to:
- Licensed compounding pharmacies operating under applicable state board of pharmacy licensure
- Accredited hospitals, medical centers, and healthcare systems with verified institutional purchasing authority
- Federally funded and accredited research institutions, universities, and laboratories
- Licensed pharmaceutical manufacturers and contract development and manufacturing organizations (CDMOs)
- Qualified scientific researchers operating under appropriate institutional review board (IRB) or biosafety committee oversight
- Veterinary research facilities under appropriate IACUC oversight
By placing an order with Renew Lab Group, the purchasing entity represents and warrants that it is a qualified purchaser meeting all applicable federal, state, and local regulatory requirements for the acquisition of pharmaceutical-grade research materials.
3. Regulatory Compliance Statement
Renew Lab Group operates its Houston, Texas manufacturing and testing facility in accordance with the following regulatory frameworks and standards:
USP Compliance
- USP <1> Injections and Implanted Drug Products
- USP <71> Sterility Tests
- USP <85> Bacterial Endotoxins Test — endotoxin levels maintained at <0.1 EU/mL
- USP <621> Chromatography — HPLC purity verification
- USP <643> Total Organic Carbon
- USP <645> Water Conductivity
- USP <797> Pharmaceutical Compounding — Sterile Preparations
- USP <1231> Water for Pharmaceutical Purposes
FDA Regulatory Framework
Our facility operates in accordance with current Good Manufacturing Practice (cGMP) guidelines as set forth in 21 CFR Parts 210 and 211. Our quality systems include documented procedures for manufacturing, testing, storage, and distribution of pharmaceutical-grade waters. Renew Lab Group maintains comprehensive documentation including batch records, certificate of analysis (COA) documentation, and deviation management protocols.
Texas State Regulatory Compliance
Renew Lab Group is subject to oversight by the Texas State Board of Pharmacy (TSBP) and operates in compliance with Texas Health and Safety Code Chapter 431 (Texas Food, Drug, and Cosmetic Act) and applicable Texas Administrative Code provisions governing pharmaceutical manufacturing and distribution.
4. Certificate of Analysis (COA) and Testing Documentation
Every batch of bacteriostatic water produced by Renew Lab Group is subject to comprehensive quality testing before release, including:
| Test Parameter | Method | Specification |
|---|---|---|
| HPLC Purity | USP <621> | ≥99.0% benzyl alcohol purity |
| Bacterial Endotoxins | USP <85> LAL | <0.1 EU/mL |
| Sterility | USP <71> | No growth in 14-day incubation |
| pH | USP <791> | 4.5 – 7.0 |
| Particulate Matter | USP <788> | Meets USP requirements |
| Total Organic Carbon | USP <643> | ≤500 ppb |
| Water Conductivity | USP <645> | ≤1.3 µS/cm at 25°C |
| Benzyl Alcohol Concentration | HPLC | 0.9% ± 0.1% |
A Certificate of Analysis (COA) documenting all test results is provided with every order. COAs are batch-specific and traceable to the manufacturing lot number. Purchasers are encouraged to retain COA documentation for their own compliance records.
5. No Medical Claims or Advice
Nothing on this website, in our product descriptions, or in any communications from Renew Lab Group constitutes medical advice, clinical recommendations, or therapeutic guidance. Renew Lab Group does not make any representations regarding the safety or efficacy of its products for any human or veterinary application. All scientific and educational content provided on this website is intended for informational purposes relating to laboratory research only.
Researchers and scientific professionals should consult all applicable regulatory guidelines, institutional review processes, and professional standards applicable to their work before utilizing any research material.
6. Intellectual Property Notice
All content on this website, including text, graphics, logos, images, product descriptions, blog articles, research guides, and data compilations, is the intellectual property of Renew Lab Group or its licensors and is protected by United States and international copyright laws. Unauthorized reproduction, distribution, or modification of any content from this website is prohibited without prior written consent from Renew Lab Group.
7. Limitation of Liability
To the maximum extent permitted by applicable law, Renew Lab Group shall not be liable for any direct, indirect, incidental, special, consequential, or exemplary damages arising from:
- The use or misuse of any product purchased from Renew Lab Group outside of qualified research applications
- Reliance on any informational content provided on this website for clinical, diagnostic, or therapeutic purposes
- Any interruption of service, delivery delays, or product availability issues outside of our reasonable control
- Any claims arising from regulatory non-compliance by the purchasing entity
8. Indemnification
Purchasers of Renew Lab Group products agree to indemnify, defend, and hold harmless Renew Lab Group, its officers, directors, employees, agents, and affiliates from and against any claims, liabilities, damages, losses, and expenses (including reasonable attorneys fees) arising out of or in connection with: (a) the purchaser’s use of products outside of qualified research applications; (b) the purchaser’s violation of any applicable law or regulation; or (c) any misrepresentation by the purchaser regarding its qualified purchaser status.
9. Governing Law and Jurisdiction
These terms and all disputes arising from the purchase of products from Renew Lab Group shall be governed by the laws of the State of Texas, without regard to its conflict of law provisions. Any legal proceedings shall be brought exclusively in the federal or state courts located in Harris County, Texas.
10. Privacy Policy Reference
Renew Lab Group collects and processes personal information in accordance with our Privacy Policy. By using our website or placing an order, you consent to our data practices as described therein. We do not sell, rent, or share personal information with third parties except as required by law or as necessary to fulfill your order.
11. Updates to This Policy
Renew Lab Group reserves the right to update this Legal Disclaimer and Compliance Policy at any time. The effective date at the top of this page will reflect the most recent revision. Continued use of our website or products following any update constitutes acceptance of the revised terms.
Frequently Asked Questions
Is Renew Lab Group’s bacteriostatic water FDA-approved?
Our bacteriostatic water is manufactured in accordance with FDA cGMP guidelines (21 CFR Parts 210 and 211) and USP monograph specifications. It is produced for research use only and is not an FDA-approved drug product. Every batch is third-party tested and accompanied by a full Certificate of Analysis.
Who can legally purchase research-grade bacteriostatic water?
Qualified purchasers include licensed compounding pharmacies, accredited hospitals and research institutions, pharmaceutical manufacturers, and credentialed scientific researchers operating under appropriate institutional oversight. Renew Lab Group verifies purchaser qualifications and reserves the right to decline any order that does not meet our qualified purchaser standards.
What certifications and standards does your facility maintain?
Our Houston, TX facility operates under USP <797> sterile compounding standards, cGMP guidelines, ISO-compliant cleanroom protocols, and Texas State Board of Pharmacy regulations. We conduct HPLC purity testing, bacterial endotoxin testing (LAL), sterility testing (USP <71>), and full physicochemical characterization on every production batch.
How do I obtain a Certificate of Analysis for my order?
A Certificate of Analysis is automatically included with every order from Renew Lab Group. Your COA is batch-specific, traceable to your order lot number, and documents all quality test results including HPLC purity, endotoxin levels, sterility, pH, and particulate matter. You can also request COA documentation directly through our contact page.
Questions About Compliance or Ordering?
Our team is available to answer regulatory questions and help qualified researchers and institutions place orders with confidence.
