The Science of Pharmaceutical Compounding®: Non-Sterile Technician Training
A University of Florida College of Pharmacy accredited Knowledge based Activity
Registration and Contact Information:
For more information and to register for this activity
The following dates represent activities offered for this activity in the 2017 calendar year:
June 16th – 18th in Aventura, FL
The Knowledge-Based Activity will provide compounding technicians with the necessary skills for the safe handling of nonhazardous and hazardous drugs while preparing non-sterile dosage forms.
Activity content surrounding relevant law, regulatory guidelines, and standards of practice is subdivided into a unique system, referred to as System P, which is a categorical breakdown of all required standards of practice; personnel, property, procedure, process, preparation, and patient. This section of the activity places emphasis on quality assurance and quality control through the implementation of standard operating procedures addressing all facets of current standards of practice.
The activity engages the technician to understand the concept of compounding by composition (an in-depth look at the chemistry of solutions and dispersions in the form of emulsions and suspensions), and then apply this concept to the compounding of solid, semi-solid, and liquid dosage forms. Preparatory procedures are then related to the combination of routes of delivery, dosage form, preparatory state-of-matter, and the final state-of-matter of the compounded medication. Finally, there is an exploration in excipient selection, function, and application in relation to composition, dosage form, and route of delivery. Pharmaceutical calculations are presented in detail providing a required level of quality control and quality management during the compounding process.
Finally, the participant is introduced to process development which leads to the establishment of pharmacy practice-specific master formulation records. A master formulation record template is also introduced and serves equally well as a process development record and compounding record that can be implemented in everyday practice.
The Practice-Based Activity will provide the compounding technician with a strong foundation and skill set required to perform day-to-day activities surrounding the safe handling, management, and compounding of non-hazardous and hazardous medications. The practicing technician will relate dosage form composition to formulation preparatory procedures and techniques. Excipient function and their impact on chemical composition, dosage form integrity, and suitability for a patient will be reviewed.
Relationships between quality initiatives and System P (a system that provides a categorical breakdown of required standard operating procedures), which include personnel, property, procedure, process, preparation, and patient, will be established. The value of thinking, and taking action, from the perspectives of quality, risk, and verification will also be explored.
Standard operating procedure requirements and their associated recording logs and forms will be detailed. Meaningful interpretations, subsequent to data mining from logs and forms will be created providing insight into the value of maintaining accurate and complete records. Technicians will establish, and then evaluate facility designs for their workflow efficiencies. During this experience, the technician will gain knowledge and insight into when and where tasks and procedures should be performed.
Finally, the technician will work with and complete a master formulation record. These records will then be critiqued by others. This is a valuable exercise while working with one of the most important documents for which technicians will follow and detail during their day-to-day activities within a non-sterile compounding practice.
Technicians with professional interest in performing pharmacy compounding
A two part activity; self-study with learning assessment and live event with competency assessment.
Overall Learning Objectives of Self-Study Activity
1. Recall standard operating procedures associated with the management and safe handling of non-hazardous and hazardous drug compounding as indicated in the United States Pharmacopeia; Chapter <795> and related chapters.
2. Relate dosage form chemical composition (solutions and dispersions; suspensions and emulsions), routes of delivery, and delivery systems to preparatory procedures for non-sterile compounded medications.
3. Recognize the relevance of excipients and their functions to chemical composition, routes of delivery, and delivery systems.
4. Repeat pharmaceutical calculations, in support of a performance checking system, between pharmacist and technician, related to specific dosage forms and preparatory procedures.
5. Repeat laboratory practices, procedures, and preparatory techniques related to the day-to-day activities of a compounding technician, and to the compounding of non-sterile dosage forms.
6. Recognize the importance of deactivation, decontamination, disinfection, and cleaning procedures for non-hazardous and hazardous drug compounding.
7. State the use of personal protective equipment for non-hazardous and hazardous drug compounding.
8. Recall general personnel roles and responsibilities including medical surveillance and a hazardous drug management information program.
9. Repeat written procedures related to process development documents that lead to the establishment of a master formulation record.
10. List the requirements of a master formulation record and compounding record.
Overall Learning Objectives of Live Activity
1. Support the detailed requirements necessary to build efficient and effective standard operating procedures to manage a non-sterile non-hazardous and/or non-sterile hazardous drug compounding practice.
2. Support the quality, risk, and verification initiatives held by a compounding pharmacy as a foundation for excellence in support of the integrity of the compounding industry.
3. Create relationships between control, perform, verify, and document against the six categories of System P; personnel, property, procedure, process, preparation, and patient.
4. Value and evaluate the data from recordings from logs and forms related to standard operating procedures, a shared responsibility between pharmacist and technician.
5. Assess workflow dynamics-related considerations, should the technician which to make recommendations for change, as it applies to facility design requirements for non-hazardous and hazardous drug compounding.
6. Construct relationships between routes of delivery, chemical composition, and preparatory procedures for non-sterile dosage forms so as to gain an appreciation for the preparatory procedures and excipient requirements of a compounded medication.
7. Support the transition from process development, to master formulation record, and to compounding record through the use of a template designed to incorporate the parameters for all three formulation stages.
8. Prepare a broad range of non-sterile dosage forms; hydro-alcoholic gels, lollipops, chewable treats for animals, capsules, troches, suppositories, and creams.
9. Evaluate compounded dosage forms through the use of specific verification protocols in compliance with current standards of practice; includes qualitative and quantitative performance measures.
Due to the number of highly qualified facilitators involved with this activity, their names, credentials and biographies will be made available upon request
Participant Completion Requirements
- To receive CPE credits for the Home Study component, participants must complete a learning assessment with a score of 70% and submit a completed evaluation to the University of Florida College of Pharmacy.
- To receive CPE credits for the Live Event component, participants must demonstrate full and satisfactory participation, and submit a completed evaluation to the University of Florida College of Pharmacy.
Participants registered in the United States: The University of Florida College of Pharmacy will report CPE credits to the CPE Monitor. A paper copy of a statement of credit may be obtained from your NABP e-profile.
Participants registered other than in the United States: Pharmacists and technicians will receive a statement of credit by mail.
Declarations and Disclosures
The University of Florida College of Pharmacy believes it is important for the reader to be aware of relevant affiliations and financial relationships regarding the development, design, and facilitation of accredited Activities and any material created in support of an Activity. This Activity, its content, material, and presenters, is independent of any known bias, prejudice, or commercial interest. Content and material presented will provide an in-depth representation with fair, full disclosure, and equitable balance. Topics which are promotional or designed for the purpose of endorsing a specific commercial product will not be presented.
The University of Florida College Pharmacy has requested that LP3 Network Inc. assist with the marketing of this Activity. LP3 Network Inc. is an independent corporation specialized in the development and design of continuing education material. LP3 Network Inc. has an established agreement with Medisca ensuring that it has no influence on LP3 Network Inc. as it relates to continuing education offerings.
The University of Florida College of Pharmacy encourages participation in its continuing education programs by all qualified persons without regard to race, sex, creed, national origin, or religion.
UFCOP will make reasonable accommodations for persons with disabilities under the guidelines of the Americans with Disabilities Act and Section 504 of the Rehabilitation Act (federal legislation).
This activity is accredited by the University of Florida College of Pharmacy in accordance with ACPE Standards for Quality and Interpretive Guidelines. The University of Florida College of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as providers of continuing pharmacy education. The University of Florida College of Pharmacy has allocated 40 hours of continuing education credit (4.0 CEUs) to this knowledge based activity. The activity consists of 20 hours of self-study (2.0 CEUs) and 20 hours live participation (2.0 CEUs). The UAN’s for the self-study include 0012-9999-16-011-H04-T for pharmacy technicians; for the live activity 0012-9999-16-012-L04-T for pharmacy technicians. The activity accreditation is 01/01/2016-01/01/2019
An unrestricted educational grant has been provided by MEDISCA Inc. toward the purchase of electromechanical equipment, reusable and disposable devices, protective and safety supplies, and chemicals specific to compounded medications prepared during laboratory sessions.
Food and Beverage
As a matter of activity programming, meals and refreshments during live activities have been provided by LP3 Network Inc.
Cancellation and Refund Policy
A written request must be sent to LP3 Network Inc. requesting a ‘Cancellation without Transfer’ to an alternate live activity event date. If cancellation occurs at greater than or equal to 31 days from the live activity event date, then the registrant will receive a 75% refund; 15-30 days is a 50% refund; and less than or equal to 14 days will result in no refund.
The transfer policy is only in effect if requested greater than or equal to 14 days prior to original live activity event date. Failure to submit the “Transfer Request” at least 14 days prior to original live activity event date will default to the “Cancellation and Refund Policy”. The transfer policy can only be applied one (1) time. Transfer to a new live activity event date must be within the current calendar year. Failure to attend the new live activity event will result in no refund and will no longer be transferable. Confirmation of the new activity date is subject to approval by LP3 Network Inc. based on the number of available seats within the selected live activity event.
Special rates for hotel accommodations have been arranged for activity participants. Payment for hotel accommodations is at the expense of the activity participant.
The University of Florida College of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.