“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 795, 797, 800, 1163, and 1176.  A set of 9 “Process Validation Checklists” have been included.  This is required in evaluating the reader’s ability to actually demonstrate sterile technique.  Most state boards of pharmacy require process validation at least annually.

Education Procedure

This section details the step-by-step process from purchase to credit issuance.

1. A purchase is made.
2. The individual is provided with the Sterile Products Training manual.
3. Pharmacy Education Resources provides TSHP approved participant information.
4. The Evaluator completes the Evaluator Approval Form here: http://bit.ly/PER-Evaluator
5. Once the Evaluator receives the official approval from TSHP, the participant may begin the program.
6. Participant reads the textbook materials and works their way through the chapter quizzes. Evaluators are to assist in this process as determined by the needs of the participant and facility.
7. Evaluator and Participant complete the Process Validation Evaluation Checklist portions of the program. Evaluators are required to supervise all portions of the experiential training required by this program. Evaluators must supervise technician participants for a minimum of 22 hours; pharmacist participants a minimum of 2 hours.
8. Evaluators submit all Process Validation Evaluation Checklists for processing by Pharmacy Education Resources via this online form: PER-Participant Documents
9. Once approved, by Pharmacy Education Resources, the participant (evaluator will be copied) will receive instructions to complete the online exam via email. Participants and Evaluators are instructed to complete the exam within 30 days of this notice.
10. Participants that pass the exam will have their credit transferred to the My CPE Monitor system (provided they have correctly entered their NABP ePID and date of birth into LecturePanda) within 72 hours. 
11. On a monthly basis, Pharmacy Education Resources and TSHP audit documentation to confirm no unauthorized exams have been completed. Any unauthorized exams taken will have credit issuance revoked. 
12. On a monthly basis, TSHP will issue an invoice to Pharmacy Education Reources based on successful participant completion.

Failure Procedure:

Should a participant fail the electronic exam, they will receive notice of the re-exam with instructions from TSHP.  A maximum of three (3) attempts can be made.  If a participant makes three unsuccessful attempts, they will need to begin the process again, starting with the purchase of a new program.

Authors:

Liz Johnson Wilroy, MA Ed, BS, CPhT, PhTR
Daniel E. Garcia, Pharm D, RPh
N. Pauline Thomas Parks, MS, RPh
Roderick L. Dunn, PhD, MS, CPhT, PhTR

The speakers have been determined to have no relevant financial conflict of interests.

The Texas Society of Health-System Pharmacy (TSHP) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. 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 a TSHP approved “Evaluator,” and pass one (1) written exam, via LecturePanda, with a score of 75% or greater. Participants will have three (3) exam attempts. All credit is issued through LecturePanda and transferred to ACPE. This will appear on the My CPE Monitor system within 72 hours. Participants will need to provide the NABP ePID and date of birth(month/day) to register for the exam on LecturePanda. It is the responsibility of the participant to complete the exam and evaluations in order to receive the certificate of completion for the program. 

This activity is made possible through a joint-providership between TSHP and Pharmacy Education Resources.

For questions regarding program purchase, program content, participant validation or course materials, contact PER at customerservice@pharmacyeducation.cc or by phone at (281) 497-4742.

For questions regarding program accreditation or status of your submission, contact TSHP at education@tshp.org or by phone at (512) 906-0546.

Pharmacy Education Resources National Sterile Compounding Training Manual for Pharmacists
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 which can verify that the compounded preparation is sterile.
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.

Statement of Topics Covered in Intravenous Training Programs

Pharmacy Education Resources Intravenous Training Programs for Pharmacists providing 20 hr ACPE and Technicians providing 40 hr ACPE since 1995 cover 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.