Sterile Compounding Training

National Intravenous (IV) Training Course for Pharmacists and Pharmacy Technicians

          Course Dates: The weekends of May 4th, July 13th,             September 21st, or November 16th

         Location: Dallas – Fort Worth Area

This program offers home-study and hands-on training for pharmacy technicians and pharmacy technician trainees who compound sterile preparations and all pharmacists who compound sterile preparations or supervise those who compound sterile preparations. Instruction is provided in proper aseptic technique, pharmaceutical calculations, hazardous drug handling, quality assurance, USP compounding regulations, related accreditation standards, and government mandates. Successful completion of the course provides 20 hours of ACPE accredited CE for pharmacists and 40 hours for pharmacy technicians.

Pharmacy Education Resources (PER) “National Sterile Compounding Training Manual for Pharmacists” is a 20-hour ACPE approved program available to Pharmacists. The goal of the manual is to provide the pharmacist with advanced information beyond the general basis of knowledge concerning sterile pharmaceutical products. This manual provides basic knowledge to develop an understanding of concepts, techniques, and procedures related to the preparation of sterile and hazardous pharmaceutical products obtained from USP Chapters 795, 797, 800, 1163, and 1176. The training program covers all topics listed in sub-section 4(D) of TAC 291.133 and includes instruction, experience and demonstrated proficiency in the following areas:

(i) aseptic technique;
(ii) critical area contamination factors;
(iii) environmental monitoring;
(iv) structure and engineering controls related to facilities;
(v) equipment and supplies;
(vi) sterile preparation calculations and terminology;
(vii) sterile preparation compounding documentation;
(viii) quality assurance procedures;
(ix) aseptic preparation procedures including proper gowning and gloving technique;
(x) handling of hazardous drugs, if applicable;
(xi) cleaning procedures; and
(xii) general conduct in the clean room.

Pharmacy Technicians
Attendance of the following sessions are required:

Wednesday  prior to Live Course Date at 6:30 pm CST
(Calculations Review/ Virtual Training)

Saturday      8 am to 6 pm
(Live Hands-on Training)

Sunday         8 am to 6 pm
(Live Hands-on Training and Process Validations)

0156-9999-23-066-B07-T
Live Credit Hours: 22.0 (0.22 CEUs)
Home-Study Credit Hours: 18.0 (0.18 CEUs)
Type: Practice-based
Expiration: 07/10/2026

Course Objectives
At the completion of this activity, the participant will be able to:

1. Duplicate appropriate calculations as required to prepare a variety of sterile compounded preparations. (reconstitution, drug dose, iv flow rate, etc.)
2. Describe the various sterile compounding areas: anteroom, buffer room, clean room, and the compounding, storage, and cleaning requirements for each area.
3. Recall the various ISO Class 5 Hoods and Isolators to determine the appropriate method required for cleaning each.
4. List the proper methods for documenting environmental quality control in the ISO Clean Areas.
5. Demonstrate @ 100% accuracy on Process Validation (PV) Checklist aseptic hand washing.
6. Demonstrate @ 100% accuracy on PV Checklist proper gowning and sterile gloving technique.
7. Demonstrate @ 100% accuracy on PV Checklist proper horizontal hood cleaning technique.
8. Demonstrate @ 100% accuracy on PV Checklist proper vertical hood or Barrier Isolator cleaning technique.
9. Demonstrate @ 100% accuracy on PV Checklist proper powder vial reconstitution technique.
10. Demonstrate @ 100% accuracy on PV checklist proper liquid vial and ampule technique.
11. Demonstrate @ 100% accuracy on PV Checklist proper hazardous drug preparation technique.

Pharmacists
Attendance of the following session is required:
       

Saturday      8 am to 6 pm
(Live Hands-on Training)

Sunday            8 am to 6 pm
(Live Hands-on Training and Process Validations)

Optional for Pharmacists: (Recommended For Participants with No or Minimum Sterile Compounding Experience)

Wednesday  prior to Live Course Date at 6:30 pm CST
(Calculations Review/ Virtual Training)

0156-9999-23-065-B07-P
Live Credit Hours: 2.0 (0.02 CEUs)
Home-Study Credit Hours: 18.0 (0.18 CEUs)
Type: Practice-based
Expiration: 07/10/2026

Course Objectives
At the completion of this activity, the participant will be able to:

1. Express appropriate formulations and methods for the calculation of various sterile compounded preparations.
2. Describe the 3 CSP Categories used in sterile compounding and the compounding storage and cleaning requirements for each CSP Category.
3. Identify the various ISO Class 5 Hoods and Isolators with the appropriate sterile compounding procedure that applies to each.
4. Recognize different tests and methods that can verify that the compounded preparation is sterile.
5. Demonstrate @ 100% accuracy on the Process Validation (PV) Checklist for aseptic hand washing.
6. Demonstrate @ 100% accuracy on PV Checklist with proper gowning and sterile gloving technique.
7. Demonstrate @ 100% accuracy on PV Checklist proper horizontal hood cleaning technique.
8. Demonstrate @ 100% accuracy on PV Checklist proper vertical hood or Barrier Isolator cleaning technique.
9. Demonstrate @ 100% accuracy on PV Checklist proper powder vial reconstitution technique.
10. Demonstrate @ 100% accuracy on the PV checklist with proper liquid vial and ampule technique.
11. Demonstrate @ 100% accuracy on PV Checklist with proper hazardous drug preparation technique.

To receive credit for this activity the participant must provide all relevant participant registration materials, documentation of training hours, 9 Process Validation Evaluation Checklists with 100% accuracy supervised by FocusRx, and pass one (1) written exam, via the LecturePanda, with a score of 75% or greater. Participants will have three (3) exam attempts. 
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