Sterile Compounding

At Custom Scripts Pharmacy, compounding sterile preparations is one of our main specialties. We are authorized to dispense in all 50 states. We offer a wide variety of preparations specific to pain management physicians.

It is a standard for Custom Scripts Pharmacy to provide each medication with quality, potency, and purity. The success to compounding quality is in observing not only the final preparation quality, but also ensuring safety and quality throughout the entire process.

We provide excellent quality control standards at every step of the fulfillment process. Each process is validated to provide exact documentation of our ongoing proactive evaluation using barcode technology. Each of our measuring scales is incorporated into our computer system which allows the ability to track each compound to the minute detail. Custom Scripts Pharmacy ensures Safety and Quality control standards. With these measurement of standards we are able to increase efficiency and offer each individual patient the highest of quality preparations.

On January 1, 2004, a new standard on compounding sterile products (USP General Chapter <797> Pharmaceutical Compounding – Sterile Preparations) became effective. These new stringent guidelines detail the following twelve domains of quality necessary for compounding high-risk sterile preparations: compounding conditions, QA program and practices, contamination risk levels, outcome monitoring, reports and documentation, personnel garb, education, training, evaluation, storage and handling in the pharmacy, process validation, and end product sterility and identity testing. The most significant effect of these new enforceable requirements will be their use as a reference for drug and practice quality standards.

We have reviewed, in detail, all of the requirements of USP <797>, and we take great pride in exceeding all of these requirements for compounding HIGH-RISK sterile preparations. In addition, we are also compliant with the brand new requirements for Sterile Compounding for the State of Florida. Custom Scripts Pharmacy quality program includes:

• Custom Script’s state-of-the-art Barrier Isolation Units that are certified on a biannual basis
• All powders received are from registered manufacturers or suppliers accompanied by a certificate of analysis and material data safety sheets
• All preparations undergo sterility testing
• Drug Utilization Review (DUR) is performed
• Qualified media-fill personnel prepare all preparations
• We conduct routine environmental microbiological testing and strictly adhere to aseptic technique guidelines.
• Our pharmacy environment meets or exceeds USP High Risk Sterile Compounding guidelines
  We at Custom Scripts Pharmacy are proud that we have met the challenge of USP<797>. This standard protects the patient and helps ensure pharmacy quality standards. We have enclosed our pharmacy compliance guideline checklist to assure you that we do meet the
  compliance of USP <797>.

Examples of our intrathecal services:

• Baclofen
• Bupivacaine
• Clonidine
• Fentanyl
• Hydromorphone
• Ketamine
• Morphine
• Sufentanil

If you have any questions in regards to your HIGH-RISK compounding needs, please contact Custom Scripts Pharmacy today.