The Science of Pharmaceutical Compounding®: Non-Sterile Training
A University of Florida College of Pharmacy accredited Knowledge and Practice-based Activity
Registration and Contact Information:
For more information and to register for this activity
Call 1-844-408-9453 or visit https://www.lp3network.com/courses/science-of-pharmaceutical-compounding-non-sterile
The activity will provide compounding pharmacists and technicians with the competency to prepare current and viable pharmacotherapeutic non-sterile dosage forms. Unique concepts will be taught facilitating a decision-making process the pharmacist and technician can apply in their day-to-day practice. Consideration will be given to meeting the physician’s prescription and patient-specific need, compliance-related solutions, medical necessity, and legal and regulatory guidelines. A significant emphasis will be placed on quality assurance and quality control as it relates to dosage form design, pharmaceutical calculations and the validation of preparatory procedures that are part of Master Formulation Records. Practical techniques and technology-related applications are developed through hands-on experience in a compounding laboratory environment where pharmacists and technicians will be trained in all aspects of non-sterile preparatory procedures. Pharmacists and technicians have the opportunity to develop important aspects of a business development and marketing plan.
The following dates represent activities offered for this activity in the 2016 calendar year:
Pharmacists and Technicians new to compounding or with an existing compounding practice
A two part activity; self-study with learning assessment and live event with competency assessment
The Knowledge-Based Activity will provide compounding pharmacists and technicians with the necessary
understanding of how to manage a non-hazardous and hazardous drug compounding facility while preparing current
and viable therapeutic non-sterile dosage forms relevant to today’s medical and market needs.
The activity is centered on core concepts providing a strong foundation to follow for the compounding pharmacist
and technician. These concepts include; be a star (to be morally, ethically, politically, legally, and clinically sound in
one’s decision-making), balancing stability with suitability (finding balance between formulation chemistry and
dosage form appropriateness for the patient), compounding with appropriate compromise (acknowledging that with
each new route of delivery and delivery system there are potentially new side effects that need to be addressed),
compounding by composition (an in-depth look at the chemistry of solutions and dispersions in the form of emulsions
and suspensions), and balancing efficiency with effectiveness (doing the right thing right as it applies to business
Activity content 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. Each category is
defined and detailed. This system places emphasis on quality assurance and quality control through the
implementation of standard operating procedures addressing all facets of current standards of practice.
This activity introduces the participant 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
A review of physiological pathways helps the compounder to appropriately select delivery systems that will optimize
bioavailability; the optimization of drug absorption without undue deleterious side effects being the goal. Once
routes of delivery and delivery system options are decided upon, excipient selection and their use in the compounded
mixture are reviewed. Finally, the preparatory procedure itself is addressed with direct relationships to dosage form
composition. Generalized preparatory procedures related to combinations of routes of delivery, dosage form,
preparatory state-of-matter (solid, semi-solid and liquid), and final state-of-matter are presented.
Pharmaceutical calculations are presented in detail providing even greater assurance of quality control and quality
management during the compounding process.
The central core concepts and the components of System P, when combined, make for a formidable infrastructure
upon which to establish a new, or redefine an existing, compounding practice.
The Practice-Based Activity is divided into five subsections; business, quality, science, preparatory procedures and calculations for dosage forms, and the actual preparation of dosage forms. The activity covers non-hazardous and hazardous drug compounding. The business subsection brings to light the necessity to build a unique identity, direction, and consistency in the delivery of the marketing message for the participant’s compounding practice. Participants will construct marketing messages, and then rehearse the delivery of those messages while developing verbal communication skills. Participants will also have the opportunity to evaluate marketing material utilizing an assessment tool they can continue to use in their practice.
Financial management through the examination of a start-up cost spreadsheet is compared and contrasted against acquisition cost pricing analyses used to establish the selling price for compounded medications. Expenses incurred to grow a compounding practice are presented across several months. A steady and realistic growth expectation is expressed in a profits only spreadsheet. The number of compounded prescriptions multiplied by their associated selling price enables the establishment of this revenue stream spreadsheet. Participants can then compare the expenditures against the revenues to see clearly the rate of growth over time of net profits for a compounding practice. For a new compounding practice these two spreadsheets can be used as milestones.
The quality subsection features the bringing together of System P, a categorical breakdown of required standards of practice defined by personnel, property, procedure, process, preparation, and patient. This well organized categorization of standards of practice yield equally organized standard operating procedures. No standard operating procedure is complete without a foundation upon which to build it and appropriately designed recording logs and forms for documentation purposes. Hence, the concepts of quality, risk, and verification, as well as control, perform, verify, and document. These two control parameters help to govern over the activities of a compounding practice.
A compounding practice would be remiss if it were to not engage in quality management initiatives. Equally so, an ongoing risk management system need be in place that consistently looks for potential challenges that could affect performance measures of any kind. In order to ensure a compounding practice’s quality of preparation and on a more global scale, industry integrity, a verification system applied before, during, and after the performance of any task need address efficacy, reliability, and validity as three fundamental categories of analytical parameters.
The scientific underpinnings subsection provides practical examples for the participant to apply the balance concept that explores dosage form stability and its suitability for a patient and customization with appropriate compromise as it relates to a compounded medication. However, to build up this subsection a broad range of factors that can affect stability and suitability are examined through case scenario assessments. These cases enable the participant to establish relationships between dosage forms, their respective chemical composition, and the preparatory procedures used in their design. To combine these subjects is to help ensure a compounded medication’s integrity, potency, strength, administration, and bioavailability.
The preparatory procedure subsection introduces the participant to a unique template that can serve well during the process development phase, and act as a master formulation record and compounding record. The actual process of developing a master formulation record affords the opportunity to engage the activity participant in a review of pre-formulation, in-process, and post-formulation qualification factors that when not addressed can result in inappropriate drug concentrations in a compounded medication.
The actual practical and hands-on preparation of dosage forms bridges the gap between theory and practice. Participants will perform preformulation calculations, prepare an array of current and popular dosage forms, and adhere to a series of standard operating procedures while formulating in the lab environment. Post-verification procedures will be performed on the dosage forms prepared to learn how to assess the accuracy and precision related to the drug concentration per unit application to within acceptable margins of error as per USP.
This activity culminates with a comprehensive case assessment utilizing all that has been learned during the activity. Select cases will be assigned to small groups of participants that will work collaboratively using a complex flowchart as a guide. A template will be provided requiring detailing on the part of the groups. Verbal presentations of the group’s findings are made while the remaining participants utilize yet another template to assess the presentation. A question and answer period will ensue. This final event affords the highest degree of interactive learning and a means in which to assess one’s own level of competency gained during the entire activity.
Overall Learning Objectives of Self-Study Activity
(P DENOTES PHARMACIST; T DENOTES TECHNICIAN)
- Explain business development and marketing plans leading to a successful practice and a competitive advantage. (P)
- Identify rules related to dosage form stability and patient-specific suitability of compounded preparations. (P/T)
- Describe non-sterile compounding-related USP guidelines and related standards of practice. (P/T)
- Recall and verbalize required levels of efficacy, validity, reliability and safety for a non-sterile compounding practice. (P/T)
- Explain process validation techniques related to specific dosage forms. (P/T)
- Demonstrate pharmaceutical calculations related to specific dosage forms and preparatory procedures. (P/T)
- Identify excipients and their functions in non-sterile dosage form-related delivery systems. (P/T)
- Identify excipient and active ingredient characteristics that will result in stable and suitable dosage forms. (P/T)
- Identify laboratory practices, procedures and preparatory techniques related to compounded dosage forms. (P/T)
- Summarize a broad range of non-sterile preparatory
Overall Learning Objectives of Live Activity
(P DENOTES PHARMACIST; T DENOTES TECHNICIAN)
- Apply USP regulatory guidelines and related standards of practice to measurable compounding-related performance. (P/T)
- Prepare a broad range of non-sterile preparations representing commonly compounded dosage forms; capsules, troches, lollipops, pastes, ointments, creams, lotions, gels and suppositories. (P/T)
- Perform process validation techniques related to specific dosage forms. (P/T)
- Perform pharmaceutical calculations related to specific dosage forms and preparatory procedures. (P/T)
- Apply principals of ‘Compounding by Chemical Composition’ to the practice of pharmacy compounding. (P)
- Apply the ‘Balance Concept’ to the practice of pharmacy compounding; balancing dosage form stability with suitability. (P)
- Apply the ‘Balance Concept’ to marketing a compounding practice; balancing efficiency with effectiveness. (P)
- Apply principals of ‘Customization with Appropriate Compromise’ to the practice of pharmacy compounding. (P)
- Apply ingredient-related physical and chemical properties to dosage form design and preparatory procedures. (P/T)
- Detail a Master Formulation Record that serves as a comprehensive compounding practice template. (P/T)
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
Activity participants are required to achieve a 70% passing grade associated with a self-study learning assessment prior to attending the live event. Full attendance and the completion of an activity evaluation and practical skill set competency evaluation are a compulsory requirement to achieve credit for the live event.
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 this activity and its financial supporter and the financial supporter’s affiliates.
This activity has been approved by, and is hosted by, the University of Florida College of Pharmacy and is independent of any known bias, prejudice or commercial interest. The University of Florida College of Pharmacy has requested that LP3 Network Inc. assist with the marketing of this activity. LP3 Network Inc. is an independent corporation. LP3 Network Inc. has an established agreement with MEDISCA Inc. ensuring that it has no influence on LP3 Network Inc. as it relates to activity offerings.
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 48 hours of continuing education credit (4.8 CEUs) to this actvity. The activity consists of 24 hours of self-study (2.4 CEUs), 1 hour is designated as law, and 24 hours live participation (2.4 CEUs). The UAN’s for the self-study include 0012-9999-16-005-H04-P and 0012-9999-16-006-H03-P for pharmacists (both knowledge based) and 0012-9999-16-005-H04-T and 0012-9999-16-006-H03-T (both knowledge based) for pharmacy technicians; for the live practice based activity 0012-9999-16-007-L04-P for pharmacists and 0012-9999-16-007-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.