Compounding Pharmacy Disclosure Statement

NexGen Pharmaceuticals is an industry-leading veterinary compounding pharmacy, offering sterile and non-sterile compounding services nationwide. Compounding gives NexGen better flexibility in formulating medications to better fit the needs of veterinarians and the owners of companion and exotic animals. We are also able to offer medications with preferred routes of administration, and to avoid formulations that can cause allergic reactions.

In recent years, changes to Federal and State regulations which govern compounding pharmacies, veterinarians and the patients who use compounded medications have necessitated full disclosure between all of these parties.

In keeping with the above regulations, NexGen Pharmaceuticals wishes to provide as much clarity as possible regarding our role as a veterinary compounding pharmacy and the nature of what we do as such, compared to other pharmaceutical companies.

Definitions and Clarifications

There are two primary categories of drugs that can be ordered through a prescription dispensed by a physician or veterinarian: These encompass commercially available drugs (branded and generics), and compounded medications.

Commercially-available drugs:

• Manufactured by pharmaceutical firms that are compliant with U.S. Food and Drug Administration (FDA) Current Good Manufacturing Practices. They are routinely inspected by the FDA to ensure ongoing compliance.
• Available by prescription and are available at retail pharmacies.
• FDA-approved and reviewed by the FDA for safety and efficacy.
• Approved by the FDA for one or more specific indications. They contain package inserts that explain usage, warnings, contraindications, precautions, adverse reactions and potential drug interaction information.

Compounded medications:

• Prepared by pharmacies that operate under state law, United States Pharmacopeia (USP) requirements and USP Good Compounding Guidelines.
• Available (by prescription) through licensed pharmacies that are uniquely-equipped to compound drug formulations. NexGen Pharmaceuticals is one such pharmacy.
• Not reviewed by the FDA or State Boards of Pharmacy for safety and efficacy, nor are they reviewed under the FDA's New Drug Application process.

Patient and Animal Owner Rights and Veterinarian Responsibilities

As with any prescribed medication, it is the responsibility of the prescribing veterinarian to inform their clients as to the nature of the medication, its effects and any known precautions. These parties are also responsible for informing animal owners in the event that a compounded medication is being prescribed.

Animal owners should also be advised that the compounded medication:

• Is being prescribed based upon an assessment of medical need on the part of the individual patient, and that the veterinarian has the explicit right to prescribe a compounded medication based upon their knowledge of the patient’s health and their professional knowledge of the presenting ailment and the medication(s) prescribed.
• Is prepared by a licensed pharmacy.
• Has not been reviewed or approved by the FDA for safety or efficacy, nor has it undergone the FDA’s New Drug Application process mentioned above.

Please feel free to contact NexGen Pharmaceuticals if you have any questions or concerns regarding this disclosure policy.