BCSCP Lectures: USP <797> Sterile Preparations

Activity Preview

This series of webinars discuss key sterile compounding standards in USP General Chapter <797> Pharmaceutical Compounding—Sterile Preparations. The course will

  • Describe the scope and purpose of USP <797>, the microbial contamination risk levels, and methods of sterilization. 
  • Describe the facility and engineering control requirements for the sterile compounding areas as well as the environmental monitoring requirements.
  • Outline the personnel training, garbing, and assessment requirements and the quality control and quality assurance processes to ensure quality compounded preparations.

Learning Objectives

At the completion of this application-based activity, participants will be able to:

  • Distinguish between low-, medium-, and high- risk Compounded Sterile Preparations (CSPs)
  • List the Beyond-use Dates (BUD) for low-, medium-, and high- risk CSPs
  • Describe the situations where immediate-use CSPs are appropriate and the BUD
  • Define the elements of a cleanroom, including primary and secondary engineering controls
  • List the precautions needed for compounding hazardous drugs
  • List the requirements for semiannual certification of sterile preparation areas
  • List the personnel, facilities, and equipment requirements.
  • Differentiate viable and non-viable monitoring
  • Identify the steps to take if microbial isolates are identified

Activity type: Application-based
Target Audience: Pharmacists 
Learning Level: 2

Accreditation Information

ACPE Logo

The American Pharmacists Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. The following activity is approved for 6.5 contact hours of CPE credit (0.65 CEUs). The ACPE Universal Activity Number for this activity is 202-0000-21-278-H04-P.

To obtain credit for completing Sterile Compounding Exam Review Webinar: USP <797> Sterile Preparations, the participant must complete all the modules in full, complete the evaluation, and then CLAIM credit. Participants need to have a valid pharmacist.com username and password and a CPE Monitor account to claim credit. After credit has been claimed, please visit CPE monitor for your transcript.

To obtain BCACP recertification creditcomplete the activities in full, the assessments with a score of 70% or better, answer the evaluation questions, and then CLAIM the Board Certification credit. Participants need to have a valid MyBPS account to claim recertification credit. After recertification credit has been claimed, a participant can access transcript by signing into your MyBPS account.

Per Board of Pharmacy Specialties policy you will only have one opportunity to successfully complete the BCACP recertification assessment during this release year.

 

Initial release date: 08/13/2021
Expiration date to claim credit: 08/13/2024 - No credit can be claimed after this date

Development

Sterile Compounding Exam Review Webinar: USP <797> Sterile Preparations is an online educational activity for pharmacists developed by the American Pharmacists Association and the U.S. Pharmacopeia. © 2020 American Pharmacists Association and U.S. Pharmacopeia

Disclosures

USP staff disclosures, if any, will be included in webinar activity. For a complete list of APhA staff disclosures, visit the APhA website at www.pharmacist.com/apha-disclosures

Fee

The fee for this activity is $260 for both APhA members and non-members

System Requirements

Computer and internet access are required to complete this activity.  Please visit our website to view the Technology System Requirements in order to have a positive learning experience.

Credit Information

Activity Number Credit Amount Accreditation Period
ACPE# 0202-0000-21-278-H04-P 0.65 CEUs August 13, 2021 - August 13, 2024
BCSCP_21278H04P 6.5 Hours August 13, 2021 - August 13, 2022