Compounding Non-Sterile Preparations: USP <795> and <800>

Activity Preview

USP General Chapters numbered under <1000> are enforceable by regulators and accreditation organizations.  These include USP <795> Pharmaceutical Compounding – Nonsterile Preparations and USP <800> Hazardous Drugs – Handling in Healthcare Settings.  Many state boards of pharmacy include them in regulations.   Pharmacists and pharmacy technicians who compound must be aware of and comply with the USP chapters and related best practices.  Compounding hazardous drugs include requirements in addition to those in <795>.   This lesson identifies the requirements and guides compounders to comply with best practices to protect patients from harm.

Learning Objectives: 

At the completion of this activity, the pharmacist will be able to:

1. Describe how USP standards become part of regulatory requirements, accreditation standards, and best practice recommendations
2. Differentiate elements of nonsterile compounding, including categories, types of components, expiration vs. beyond-use dates, and documentation
3. State the scope and controls designed to protect healthcare personnel from contamination with hazardous drugs
4. Cite the document which lists drugs that are hazardous to healthcare personnel
5. Identify the types of hazardous drugs and dosage forms that may be considered for an Assessment of Risk and the related contamination controls and work practices

At the completion of this activity, the pharmacy technician will be able to:

1. Describe how USP standards become part of regulatory requirements, accreditation standards, and best practice recommendations
2. Differentiate elements of nonsterile compounding, including categories, types of components, expiration vs. beyond-use dates, and documentation
3. State the scope and controls designed to protect healthcare personnel from contamination with hazardous drugs
4. Cite the document which lists drugs that are hazardous to healthcare personnel
5. Identify the types of hazardous drugs and dosage forms that may be considered for an Assessment of Risk and the related contamination controls and work practices

Activity type: Knowledge-based

Target Audience: Pharmacists and Pharmacy Technicians

Learning level: 1

Accreditation Information

The American Pharmacists Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  This activity is approved for 2.0 contact hours of CPE credit (0.20 CEUs). The ACPE Universal Activity Number for this activity is 0202-0000-17-232-H07-P/T.

To obtain credit for "Compounding Non-Sterile Preparations: USP <795> and <800>," complete the assessment with a grade of 70% or better, complete both evaluations, and then CLAIM credit. Participants need to have a valid pharmacist.com username and password to claim credit. After credit has been claimed, please visit CPE monitor for your transcript.

APhA continuing pharmacy education policy allows two opportunities to successfully complete the continuing pharmacy education assessment. Please note that the questions may not appear in the same order as printed and you will not be permitted to submit the assessment a third time. The current policy of the APhA Education Department is to not release the correct answers to any of our CPE tests. This policy is intended to maintain the integrity of the CPE activity and the assessment.

Initial release date: October 1, 2017
Expiration date: October 1, 2020 - NO CREDIT GRANTED AFTER THIS DATE

Development

"Compounding Non-Sterile Preparations: USP <795> and <800>” is a home-study continuing education activity for pharmacists and pharmacy technicians developed by the American Pharmacists Association.

Authors

Patricia C. Kienle, RPh, MPA, FASHP

Director, Accreditation and Medication Safety

Cardinal Health Innovative Delivery Solutions

106 Elmwood Drive

Wilkes Barre, PA 18702-7226

Patricia.Kienle@cardinalhealth.com

Advisory Board

Ryan A. Forrey, PharmD, MS, FASHP

Senior Manager

Hazardous Drug Safety

Becton Dickinson

Atlanta, GA

Disclosures

Patricia C. Kienle, RPh, MPA, FASHP declares that she is employed by Cardinal Health.

Ryan A. Forrey, PharmD, MS, FASHP declares that he is employed by Becton Dickinson.

APhA’s editorial staff declares no conflicts of interest or financial interests in any product or service mentioned in this activity, including grants, employment, gifts, stock holdings, and honoraria. For complete staff disclosures, please see the Education and Accreditation Information section at www.pharmacist.com/apha-disclosures.

Fee

There is no fee associated with this activity for members of the American Pharmacists Association. There is a $25 fee for nonmembers.

System Requirements

Computer and Internet access is required to complete this activity.  Please visit our website to view the Technology System Requirements to have a positive learning experience.

Credit Information

Activity Number Credit Amount Accreditation Period
ACPE# 0202-0000-17-232-H07-P 0.2 CEUs October 01, 2017 - October 01, 2020
ACPE# 0202-0000-17-232-H07-T 0.2 CEUs October 01, 2017 - October 01, 2020