Compliance 2.0 is a comprehensive approach to meeting the regulatory requirements for pharmaceutical compounding in any practice setting. 
CUSTOMIZED POLICIES & PROCEDURES MANUALS
                     CONTENTS & APPENDIXES                        SOPs                          PERSONNEL TRAINING                ENVIRONMENTAL                     VISUAL AUDITS                     RECORD KEEPING

                     CONTENTS & APPENDIXES                        SOPs                          PERSONNEL TRAINING                ENVIRONMENTAL                     VISUAL AUDITS                     RECORD KEEPING

In addressing the current challenges in the pharmacy compounding regulatory environment, ITL Consulting holds true to its mission in providing truly innovative ways to enhance the practice of pharmacy compounding. Instead of struggling to edit pre-made, one-size-fits-all standard operating procedures, we provide pharmacies with a superior option- a customized manual that reflects the key differences in each pharmacy's practice. In the same manner compounding tailors medication for individual patients, we gather the important information from the practice to produce an accurate and compliant set of policies and procedures for each unique practice. We also offer our California Compliance Guide outlining key points and nuances of the law as an added reference. 

Product Features:

  • Convenient solution for hospitals and pharmacies seeking California license for sterile compounding (LSC) 
  • Cross referenced and compliant with all California regulations pertaining to pharmacy compounding
  • Features <USP> 797 compliant training material and checklist for sterile compounding and aseptic technique
  • Includes supporting documents like employee training records for easy management of staff 
  • Training for hazardous drugs and high-risk compounding
  • Comprehensive equipment and facility SOPs 
  • Quality assurance and quantitative testing program
  • Customizable templates for upkeep and addition of new policies

QUALITY ASSURANCE

Quality assurance (QA) in pharmacy compounding is central in achieving the highest levels of patient safety. A QA program is an ongoing, evolving set of activities and responsibilities determined by law and executed by practitioners to reduce the risk of patient harm. 

The great complexity and many nuances of QA programs pose a challenge to busy pharmacies. Often times there are elements of quality that go overlooked during routine practice. Our objectives for QA consulting are 3-fold: 

  1. to design a QA program appropriate for the pharmacy practice
  2. to educate those involved to become quality champions
  3. to empower the pharmacy to be a self-sustaining quality practice

As unique as each pharmacy practice is, each QA program also differs and requires a firm understanding of technique, process and law in order to achieve exceptional results

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REGULATIONS