Research Use Disclaimer

1. Intended Use Statement

All products offered by BAC Water Depot, including but not limited to bacteriostatic water in any volume or format, are sold for research and laboratory use only. Each unit is labeled in accordance with the U.S. Food and Drug Administration regulation at 21 CFR § 809.10(c)(2)(i), which requires the labeling of research-use products to bear the statement: "For Research Use Only. Not for use in diagnostic procedures."

These products are not approved, cleared, intended, or labeled for any of the following:

• Human administration, ingestion, injection, infusion, inhalation, or topical use.
• Veterinary use, including any administration to animals.
• Diagnostic procedures, including but not limited to those defined under the Federal Food, Drug, and Cosmetic Act.
• Clinical, therapeutic, or prophylactic applications of any kind.
• Any use that constitutes the practice of medicine, pharmacy, or veterinary medicine.
• Resale or redistribution for any of the above purposes.

1.1 Federal Regulatory Categorization

BAC Water Depot products are classified as Research Use Only (RUO). RUO designation under 21 CFR § 809.10 means the product is in a laboratory phase of development and is not yet ready for use in clinical investigations under 21 CFR Part 812 (Investigational Device Exemption), Part 50 (Protection of Human Subjects), or Part 56 (Institutional Review Boards). The product is not subject to the premarket review requirements of 21 U.S.C. § 360e because it is not held out for diagnostic or therapeutic use.

The Company does not promote, market, or facilitate the use of its Products for any application beyond research and laboratory use, in alignment with FDA guidance regarding the distribution of in vitro diagnostic products labeled for Research Use Only (FDA Guidance, November 2013).

2. No Medical or Pharmaceutical Guidance

BAC Water Depot does not provide and expressly disclaims any:

• Medical advice, instructions, or recommendations.
• Dosing, preparation, or reconstitution instructions for any use.
• Instructions for human or animal injection, infusion, or administration.
• Pharmaceutical or clinical guidance of any kind.

Any use of our products outside the scope of qualified research and laboratory applications is strictly outside the intended use of these products and is not supported, endorsed, or facilitated by this Company.

3. Buyer Responsibility

By placing an order with BAC Water Depot, you represent, warrant, and agree that:

• You are a qualified research or laboratory professional.
• You are purchasing Products solely for research or laboratory purposes.
• You have confirmed that the Product is appropriate for your specific research application.
• You will not use, sell, or distribute the Products for human or veterinary use or administration.
• You have reviewed all applicable laws and regulations in your jurisdiction regarding the purchase and use of research supplies.
• You assume all risk and liability associated with any use of Products outside their stated intended use.

4. No Warranties for Off-Label Use

The Company makes no warranties, express or implied, regarding the fitness, safety, or efficacy of its Products for any use other than qualified research and laboratory applications. Any use of our Products outside the stated intended use is entirely at the buyer's own risk. The Company accepts no liability for any consequences arising from unauthorized, off-label, or improper use of its Products.

5. Regulatory Compliance

Buyers are solely responsible for ensuring that their purchase and use of Products complies with all applicable federal, state, and local laws and regulations, including but not limited to:

• The Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301 et seq.) and implementing regulations in 21 CFR.
• The Controlled Substances Act (21 U.S.C. § 801 et seq.) and DEA regulations in 21 CFR Parts 1300–1321, as applicable to any compound reconstituted using our Products.
• State pharmacy and laboratory licensing statutes.
• Institutional Biosafety Committee (IBC) and Institutional Animal Care and Use Committee (IACUC) policies, where applicable.
• Good Laboratory Practice (21 CFR Part 58) and Good Manufacturing Practice (21 CFR Parts 210–211, 820) standards relevant to the buyer's research program.

BAC Water Depot reserves the right to refuse any order, cancel any sale, or suspend any account where the Company has reason to believe that the buyer is not a qualified research professional or that the Product is being procured for an unauthorized end use. Suspicious or repeated attempts to procure Products for unauthorized purposes may be reported to applicable regulatory authorities.

6. Anti-Diversion & End-Use Verification

The Company maintains an anti-diversion program designed to limit distribution of its Products to qualified research and laboratory buyers. As part of this program:

• Buyers must affirmatively confirm research-use eligibility at the time of checkout.
• Bulk orders (typically 25 vials or more) require additional review and may require documentation of institutional affiliation, licensure, or research program description.
• The Company may decline service to buyers in jurisdictions where the sale or use of research supplies of this category is restricted.
• Order records (including buyer identity, ship-to address, and lot numbers) are retained for the period required under applicable record-retention regulations and may be made available to regulatory authorities upon valid legal request.

7. Questions

Questions about our research use policy? Contact us or review our Compliance Policy.