FOR PHARMACISTS:

1. Defend oneself as a compounding pharmacist before the medical community while advocating the advantages of compounded medications.
2. Assess marketing material and marketing messages against a set of criteria to determine the accuracy, appeal, and overall ability to promote a compounding practice.
3. Assess and evaluate expenditures and revenue spreadsheet values over time, as a direct reflection of the costs and earnings of a compounding practice.
4. Assess acquisition costs in order to establish the selling price of a compounded medication.
5. Arrange one’s own standard operating procedures, incorporating System P as a means of their categorization.
6. Defend quality, risk, and verification initiatives as a foundation in support of the integrity of the compounding industry.
7. Create relationships between control, perform, verify, and document against the six categories of System P: personnel, property, procedure, process, preparation, and patient.
8. Construct quality, risk, and verification protocols for each of the six categories of System P.
9. Value the requirements under the USP Chapter <800> addressing hazardous drug management and containment: personal protective equipment, hazard communication, medical surveillance, waste management, deactivation and decontamination, handling, storage, preparation, labeling, packaging, shipping, and transportation.
10. Value the data from recordings of logs and forms related to standard operating procedures and the corrective measures that should be investigated following an assessment of data that falls outside of acceptable norms, parameters, and specifications.
11. Assess structural, functional, and workflow dynamics-related considerations, as they apply to facility design requirements for non-hazardous and hazardous drug compounding.
12. Construct relationships between routes of delivery, chemical composition, and generalized preparatory procedures for non-sterile dosage forms.
13. Analyze clinical case scenarios utilizing the concepts of being a “STAR”, balancing stability and suitability, and customization with appropriate compromise, to aid in the decision-making processes related to medication therapy.
14. Support the transition from process development, to master formulation record, to compounding record through the use of a template designed to incorporate the parameters for all three formulation stages.
15. Manage a clinical case scenario through the use of a flow chart to navigate through decision-making requirements, leading to a compounded medication.
16. Prepare a broad range of non-sterile dosage forms: hydro-alcoholic gels, rapid dissolve tablets, lollipops, chewable treats for animals, capsules, troches, suppositories, and creams.

FOR TECHNICIANS:

1. Support the marketing initiatives and critical messages put forth by pharmacy owners, specifically their accuracy, appeal, and overall ability to promote a compounding practice.
2. Formulate a healthy opinion surrounding the expenditures and revenues generated by a compounding practice, while reading financial spreadsheets that are a direct reflection of its costs and earnings.
3. Assess acquisition costs associated with technological and chemical purchases in order to appreciate the selling price of a compounded medication.
4. Compare standard operating procedure requirements against an established system used for their categorization, in an effort to ensure the completeness of SOPs in the compounding pharmacy.
5. 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.
6. Create relationships between control, perform, verify, and document against the six categories of System P: personnel, property, procedure, process, preparation, and patient.
7. Support any and all quality, risk, and verification protocols undertaken by a compounding pharmacy for each of the six categories of System P.
8. Support the initiatives of a compounding pharmacy in relation to the USP Chapter <800> addressing hazardous drug management and containment through: personal protective equipment, hazard communication, medical surveillance, waste management, deactivation and decontamination, handling, storage, preparation, labeling, packaging, shipping, and transportation.
9. Value the data from recordings of logs and forms related to standard operating procedures, a shared responsibility between pharmacist and technician, and the corrective measures that should be investigated following an assessment of data that falls outside of acceptable norms, parameters, and specifications.
10. Assess structural, functional, and workflow dynamics-related considerations, should the technician wish to make recommendations for change, as it applies to facility design requirements for non-hazardous and hazardous drug compounding.
11. Construct relationships between routes of delivery, chemical composition, and generalized preparatory procedures for non-sterile dosage forms, so as to gain an appreciation for the preparatory procedures and excipient requirements of a compounded medication.
12. Assess clinical case scenarios utilizing the concepts of being a “STAR”, balancing stability and suitability, and customization with appropriate compromise, so as to gain an appreciation of the complexities surrounding dosage form design and its relationship to medication therapy.
13. Support the transition from process development, to master formulation record, to compounding record through the use of a template designed to incorporate the parameters for all three formulation stages.
14. Value a clinical case scenario flow chart that helps the compounder navigate decision-making requirements, leading to a compounded medication.
15. Prepare a broad range of non-sterile dosage forms: hydro-alcoholic gels, rapid dissolve tablets, lollipops, chewable treats for animals, capsules, troches, suppositories, and creams.

USP <800> FAQ

Wondering if USP <800> applies to you and your practice? Check out our Hazardous Compounding FAQ for more information.